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Catad_pgroup Antiviral for HIV

Tivicay - official instructions for use

Registration number:

LP 002536 - 210617

Tradename:

Tivicay ® / Tivicay ®

International nonproprietary name:

dolutegravir / dolutegravir.

Dosage form:

film-coated tablets.

COMPOSITION

Each tablet contains:

Component	Amount (mg)
Tablet core
Active substance
Dolutegravir sodium (in terms of dolutegravir)
Excipients
Mannitol
Microcrystalline cellulose
Povidone-K29/32
Sodium carboxymethyl starch
Sodium stearyl fumarate
Tablet core weight
Film casing
Opadry II yellow
Nominal tablet weight
Composition of Opadray II yellow
Name of components	Quantity (%w/w)
Hydrolyzed polyvinyl alcohol
Titanium dioxide
Macrogol/polyethylene glycol
Iron oxide yellow dye

DESCRIPTION

Round biconvex tablets yellow color with engraved "SV 572" on one side and "50" on the other.

PHARMACOTHERAPEUTIC GROUP

Antiviral (HIV) agent.

CodeATX: J05AX12.

PHARMACOLOGICAL PROPERTIES

Pharmacodynamics

Mechanism of action

Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step during retroviral deoxyribonucleic acid (DNA) integration, which is essential for the HIV replication cycle. When conducting biochemical analysis strand transfer using purified HIV-1 integrase and pretreated DNA substrate yielded IC50 (50% replication inhibitory concentration) values ​​of 2.7 nM and 12.6 nM. In vitro dolutegravir slowly dissociates from the active site of the wild-type DNA integrase complex (t1/2 71 hours).

Pharmacodynamic effects

In a randomized trial to determine the optimal dose in HIV-1-infected patients who received dolutegravir monotherapy (ING111521), rapid and dose-dependent antiviral effects were observed, with a mean reduction in HIV-1 RNA at day 11 compared with baseline of 1.5 , 2.0 and 2.5 log10 for 2 mg, 10 mg and 50 mg of dolutegravir when administered once daily, respectively. This antiviral response was maintained for 3-4 days after the last dose in the group of patients taking 50 mg dolutegravir.

Antiviral activity in cell culture

In peripheral blood mononuclear cells (PBMCs) infected with HIV-1 strain Bal or HIV-1 strain NL432, an IC50 of 0.51 nM and 0.53 nM was obtained for dolutegravir. respectively. IC50s of 0.71 and 2.1 nM were obtained in MT-4 cells infected with HIV-1 strain 1MB and incubated with dolutegravir for 4 or 5 days.

In a viral integrase sensitivity assay using the integrase coding region from 13 clinically distinct subtype B isolates, dolutegravir demonstrated antiviral activity similar to that against laboratory strains, with a mean IC50 of 0.52 nM. In the analysis of PBMCs of a panel consisting of 24 clinical isolates of HIV-1 [group M (subtypes A, B.C, D, E, F and G) and group O], as well as 3 clinical isolates of HIV-2, the geometric mean IC50 was 0.20 nM, and IC50 values ​​ranged from 0.02 to 2.14 nM for HIV-1, while for HIV-2 isolates the geometric mean IC50 was 0.18 nM. and IC50 values ​​ranged from 0.09 to 0.61 nM.

Antiviral activity in combination with other antiviral drugs

None of the drugs with typical antiviral activity against HIV showed antagonism to dolutegravir [ in vitro evaluations were conducted in combination with stavudine, abacavir, efavirenz, nevirapine, lopinavir, amprenavir, enfuvirtide, maraviroc, adefovir and raltegravir, selected in a staggered order). Besides, antiviral drugs without typical activity against HIV (ribavirin) had no apparent effect on the activity of dolutegravir

Influence blood serum and human serum proteins

Research in vitro confirmed a 75-fold change (CI) in the IC50 of dolutegravir in the presence of 100% human serum (by extrapolation), and the protein-adjusted IC90 (PA-IC90) in PBMC was 64 ng/ml.

The minimum concentration of dolutegravir after a single dose of 50 mg in patients who had not previously taken imtegrase inhibitors (InIs) was 1.20 μg/ml, 9 times higher than the established PA-IC90.

Sustainabilityin vitro

Wild-type HIV-1 isolates: During the 112-day passage of strain IIIB, no viruses with high resistance to dolutegravir were detected. the maximum 4.1-fold change was observed in groups of resistant viruses obtained during passages With substitutions SI53Y and S153F in conservative positions of the integrase gene. Passage of wild-type HIV-1 strain HL432 in the presence of dolutegravir resulted in selection of substitutions 92Q (subcultured virus group with CI = 3.1) and G193B (subcultured virus group with CI = 3.2) on day 56. Additional passage of wild-type virus subtypes B.C and A/G in the presence of dolutegravir led to selection of R263K. Gl 18R and S153T.

Antiviral activity against resistant strains: strains resistant to reverse transcriptase inhibitors (RTIs) and protease inhibitors (IIs): Aolutegravir demonstrated identical activity against 2 non-nucleoside (NN)-RTI-resistant, 3 nucleoside (N)-ITI-resistant and 2 PI-resistant mutant clones of HIV- 1 (1 with triple and 1 with six-fold resistance) compared to the wild strain.

HIV-1 strains resistant to InI: 60 mutant HIV-1 isolates resistant to InI (28 with one substitution and 32 with 2 or more substitutions) were obtained from the wild-type virus BL432 by site-directed mutagenesis. Dolutegravir has demonstrated antiviral activity (sensitivity) against HIV with CI< 5 в отношении 27 из 8 мутантпых вирусов, устойчивых к ИнИ с одной заменой, в том числе T66A/I/K. E92Q/V, 43C/M/R. Q148H/K/R и N15511, в то время как для ралтегравира и элвитегравира сгивность проявилась в отношении 17/28 и 11/21 тестируемых мутантпых вирусов с КИ < 5. соответственно. Кроме того, из 32 мутантных вирусов, устойчивых к ИнИ с 2 или олее заменами, 23 из 32 продемонстрировали КИ < 5 для долутегравира по сравнению с И < 5 для 4 из 32 для ралтегравира и КИ < 5 для 2 из 25 тестируемых вирусов для титегравира.

HIV-2 strains resistant to InI: The viruses were obtained by site-directed mutagenesis of HIV-2 isolates isolated from HIV-2-infected patients who received raltegravir and experienced virological treatment failure. In general, the CIs of HIV-2 were similar to those of HIV-1, which were observed with a similar set of mutations. The CI of dolutegravir was< 5 против 4 вирусов ВИЧ-2 (S163D, G140A/Q148R, A153G/N155H/S163G и I292Q/T97A/N155H/S163D); для Е92Q/N155II КИ долутегравира составило 8,5, а для G140S/QI48R КИ долутегравира составило 17. Долутегравир, ралтегравир и элвитегравир проявили одинаковую активность против ВИЧ-2 с сайт-направленной мутацией с SI63D, как и в отношении дикого типа, а для остальных мутантных вирусов ВИЧ-2 диапазоны КИ ралтегравира составили 6,4-420, а диапазоны КИ элвитегравира составили 22-640.

Clinical isolates from patients with virological treatment failureraltegravir: 30 clinical isolates with genotypic and phenotypic resistance to raltegravir (median CI >81) were tested for susceptibility to olutegravir (median CI 1.5) by analysis using Monogram Biosciences PlienoSense. The median CI of dolutegravir for isolates with substitutions at positions 140S-I-Q148II was 3.75: G140S + Q148R - 13.3: T97A + Y143R - 1.05 and 15511 - 1.37. 705 raltegravir-resistant isolates obtained from patients treated with raltegravir were analyzed for susceptibility to dolutegravir by the Monogram Biosciences PhenoSense assay. Dolutegravir showed CI<10 в отношении 93.9% из 705 клинических изолятов, при этом у 16 (9%) из 184 изолятов с заменой QI48 + 1 с резистентностью к ИнИ и 25 (27%) из 92 клинических изолятов с заменой Q148 + >2 with InI resistance, a more than 10-fold change was observed.

Sustainability in vivo: patients who did not take InI

There were no mutations of InI resistance or treatment-related resistance to nucleoside reverse transcriptase inhibitors (NRTIs), the mainstay of therapy, in treatment-naïve patients treated with 50 mg dolutegravir once daily (SPRING-1, SPRING-2, SINGLE and FLAMINGO studies ). In the SAILINGy study of dolutegravir-naïve patients (n = 354 in the delutegravir group), treatment-related integrase substitutions were observed at week 48 in 4 of 17 patients with virologic failure receiving dolutegravir. 2 of 4 patients had a unique R263K substitution in the integrase gene with a maximum FC of 1.93, 1 patient had a polymorphic V151V/I integrase substitution with a maximum FC of 0.92, and 1 patient had pre-existing integrase mutations and was presumed to have previously received InI or was infected with an InI-resistant virus.

Sustainability in vivo: patients with resistance to INI

The VIKING-3 trial examined dolutegravir (plus optimized background therapy) in patients with existing InI resistance. By week 24, 36 of 183 patients had protocol-defined virologic failure (PDVF). Of these, 32 patients had paired data on baseline and PDVF resistance for analysis. and 17/32 (53%) had treatment-related mutations, the following treatment-related mutations or combinations of mutations were observed: L74L/M (n = 1), E92Q (n = 2), T97A (n = 9), E138K /A/T (n = 8), G140S (n = 2), Y143H (n = 1). S147G (n=l), Q148H/K/R (n = 4). N155II (n=1) and E157E/Q (n=1). 14 of 17 patients with treatment-related viral mutations had a C 148 mutation at baseline or a history. 5 other patients had PDVF between weeks 24 and 48, and 2 of these 5 patients had treatment-emergent mutations. Treatment-emergent mutations or combinations of mutations noted were L74I (n = 1), M55H (n = 2).

The VIKING-4 study examined dolutegravir (plus optimized background therapy) in 30 patients with primary genotypic resistance to InI detected by screening. The mutations that emerged during treatment were consistent with those observed in the VIKING-3 study.

Effect on electrocardiogram (ECG) parameters

In a randomized, crossover, placebo-controlled clinical trial, 42 healthy volunteers received a single dose of placebo, dolutegravir 250 mg suspension (approximately 3 times the effect of 50 mg once daily at steady state), and moxifloxacin (400 mg, active control) in a randomized randomized manner. ok. Dolutegravir did not cause prolongation of the corrected interval (QTc) within 24 hours after dosing. After adjustment for baseline ECG measurements and placebo, the maximum mean change in QTc based on Frederick's formula (QTcF) correction was 1.99 msec (upper limit of the 1-sided 95% confidence interval, 4.53 msec).

Effect on kidney function

The effect of dolutegravir on serum creatinine clearance (CC), cellular filtration rate (GFR) in a test with yogxsol, and effective renal plasma flow (ERF) in a test with para-aminohypiurate was assessed in an open-label, randomized, placebo-controlled study in 3 groups involving 37 healthy volunteers who took 50 mg of dolutegravir once a day (n = 12), 50 mg - 2 times a day (n = 13) or placebo 1 time a day (n = 12) for 14 days. There was a moderate decrease in creatinine clearance with dolutegravir during the first week of treatment, consistent with the decrease observed in clinical studies. When taken at both doses, dolutegravir did not have a significant effect on GFR or EPP, these data are supported by the study in vitro, which suggest that the small increases in creatinine observed in clinical studies are caused by nonpathological inhibition of the organic cation transporter (OCT2) in the proximal renal tubule, which causes tubular secretion of creatinine.

Pharmacokinetics

The pharmacokinetics of dolutegravir in healthy volunteers and HIV-infected patients is the same. Variability in the pharmacokinetics of dolutegravir was low to moderate. In Phase 1 studies in healthy volunteers, the coefficient of variation (CV) among participants for the area under the concentration-time curve (AUC) and maximum concentration (Cmax) varied from 20 to 40%, and the concentration at the end of the dosing interval ( C max) - from 30 to 65%. Inter-subject variability in dolutegravir pharmacokinetics was greater in HIV-infected patients than in healthy volunteers. Individual variability in pharmacokinetics was lower than interindividual variability.

Suction

Dolutegravir is rapidly absorbed after oral administration, the median time to reach maximum concentration (Tmax) after taking a dose in tablet form is 2-3 hours. The linearity of dolutegravir pharmacokinetics is dose and drug dependent. Following oral administration, dolutegravir tablets exhibited generally nonlinear pharmacokinetics, with a less than dose-dependent increase in plasma exposure from 2 to 100 mg, but a dose-proportional increase in dolutegravir exposure from 25 mg to 50 mg.

Dolutegravir can be taken with or without food. Food increases the extent and reduces the rate of absorption of dolutegravir. The bioavailability of dolutegravir depends on the diet: when eating with low, moderate and high fat content, AUQ 0-∞) of dolutegravir increased by 33%, 41% and 66%, Cmax increased by 46%, 52% and 67%, Tmax was prolonged up to 3, 4 and 5 hours compared to 2 hours when taken on an empty stomach, respectively. These increases are not clinically significant. The absolute bioavailability of dolutegravir has not been established.

Distribution

According to data received in vitro, dolutegravir is highly bound (99.3% identical) to human plasma proteins. The apparent volume of distribution (after oral administration in suspension form, Vd/F) is approximately 12.5 L. The binding of dolutegravir to plasma proteins was independent of concentration. The ratios of the total concentration of the radioactively labeled drug in the blood and plasma were 0.441-0.535, indicating minimal association of the radioactively treated drug with cellular components of the blood. The free fraction of dolutegravir in plasma is approximately 0.2-1.1% in healthy volunteers, approximately 0.4-0.5% in patients with moderate hepatic impairment, 0.8-1.0% in patients with severe renal impairment, and 0.5% in patients. infected with HIV-1.

Dolutegravir penetrates into the cerebrospinal fluid (CSF). In 12 treatment-naïve patients who received dolutegravir and abacavir/lamivudine II for 16 weeks, the mean dolutegravir CSF concentration was 15.4 ng/mL at week 2 and 12.6 ng/mL at week 16, with a range of 3 .7 to 23.2 ng/ml (comparable to
bound plasma concentration). The ratio of dolutegravir concentrations in CSF to plasma concentrations ranged from 0.11 to 2.04%. CSF concentrations of dolugegravir exceeded the IC50, confirming a median reduction in CSF HIV-1 RNA concentration from baseline of 2.2 log cells after 2 weeks of therapy and 3.4 log after 16 weeks of therapy. (see subsection Pharmacodynamics").

Delutegravir is found in the male and female genital tract. AUC in cervicovaginal fluid, cervical and vaginal tissues was 6-10% of that in plasma at steady state. AUC in seminal fluid was 7%, and in rectal tissue - 17% of that in blood plasma at steady state concentration.

Metabolism

Dolutegravir is primarily metabolized by uridine diphosphate glucoronosyltransferase UDP-GT1A1 with a minor component of the CYP3A isoenzyme (9.7% of the total dose administered in the human mass balance study). Dolutegravir is the main compound circulating in the blood plasma; unchanged, it is slightly excreted overnight (< 1 % дозы). 53 % общей дозы, принятой внугрь, выводится в неизмененном виде через кишечник. Неизвестно, объясняется это неполным всасыванием лекарственного препарата или выведением с желчью глюкуронидного конъюгата, который дальше может распадаться до образования родственных соединений в просвете кишечника. 31 % общей дозы, принятой внутрь, выводится через почки в форме эфира глюкуронида долугегравира (18.9% общей дозы). N-деалкилированного метаболита (3,6 % общей дозы) и метаболита, образованного путем с кисления бензилового углерода (3.0 % общей дозы).

Withdrawal

The terminal half-life of dolugegravir is approximately 14 hours and the apparent clearance (CL/F) is 0.56 L/h.

Special patient groups

Children

In a pediatric study of 23 HIV-1-infected children and adolescents aged 12 to 18 years who had previously received antiretroviral treatment, dolutegravir pharmacokinetic data in 10 children showed that a daily dose of 50 mg of dolutegravir resulted in similar dolutegravir exposure in children and adolescents, as in adults who received 50 mg of dolugegravir 1 time per day.

Pharmacokinetic parameters in children (n=10)

a - One patient weighing 37 kg received dolutegravir 35 mg once daily.

Elderly patients

A population pharmacokinetic analysis of dolutegravir using data obtained from HIV-1-infected adults showed no clinically significant effect of age on dolutegravir exposure.

Data on the pharmacokinetics of dolutegravir in patients over 65 years of age are limited.

Renal clearance of unchanged drug is a minor route of elimination of dolutegravir. The pharmacokinetics of dolutegravir was studied in patients with severe renal impairment (SKI).< 30 мл/мин). Не наблюдалось клинически значимых фармакокинетических различий между пациентами с нарушением функции почек тяжелой степени (КК < 30 мл/мин) и з хоровыми добровольцами. Пациентам с нарушением функции почек коррекции дозы не тэебуется. Долутегравир не исследовался в группе пациентов, находящихся на диализе, тгм не менее, различия в фармакокинетике не ожидаются.

Dolutegravir is metabolized and eliminated primarily by the liver. In a study comparing 8 patients with moderate hepatic impairment (Child-Pyot class B) and 8 healthy adult volunteers, the effect of a 50 mg dose of dolutegravir was similar in the two groups. Patients with mild or moderate liver dysfunction do not require yuza correction. The effect of severe hepatic impairment on the pharmacokinetics of dolutegravir has not been studied.

Polymorphism of enzymes that metabolize drugs

There is no evidence that commonly occurring polymorphisms in drug metabolizing enzymes alter the pharmacokinetics of dolutegravir in clinical settings. to a significant extent. In a meta-analysis using pharmacogenomic samples. obtained in clinical studies involving healthy volunteers in patients with UDP-GT1A1 genotypes (n = 7). who had poor metabolism of dolutegravir, dolutegravir clearance was reduced by 32%. a AUC was 46% higher compared with patients with genotypes associated with normal metabolism via UDP-GT1A1 (n = 41). Polymorphism of the CYP3A4, CYP3A5 and NR112 isoenzymes was not associated with differences in the pharmacokinetics of dolutsfavir.

Based on data obtained from a study involving healthy volunteers (men n = 17, women n = 24). exposure to dolutegravir was found to be slightly higher in women (approximately 20%) than in men. A population pharmacokinetic analysis using pooled pharmacokinetic data from Phase IIb and Phase III clinical trials in adult patients did not demonstrate a clinically significant effect of gender on dolutegravir exposure.

Race

A population pharmacokinetic analysis using pooled pharmacokinetic data from Phase IIb and Phase III clinical studies in adult patients did not demonstrate a clinically significant effect of race on dolutegravir exposure. It has been proven that the pharmacokinetics of dolutegravir after a single oral dose by representatives of Japan is similar to the pharmacokinetics of Western populations (representatives of the USA).

Coinfection with HIV and viral hepatitis B or C

Population pharmacokinetic analysis showed that co-infection with hepatitis C virus does not have a clinically significant effect on dolutegravir. Data on patients coinfected with hepatitis B are limited.

INDICATIONS FOR USE

Treatment of HIV-1 infection in adults and children over 12 years of age and weighing 40 kg or more as part of combination antiretroviral therapy (APT).

CONTRAINDICATIONS

Hypersensitivity to dolutegravir or any other component included in the drug. Concomitant use with dofetilide or pelsicainide, children under 12 years of age and body weight less than 40 kg.

CAREFULLY

Severe liver failure (class C on the Child-Pugh scale);

At simultaneous use With medicines(prescription and over-the-counter) that may change the way Tivicay® works, or medications whose effects may be changed by Tivicay®.

USE DURING PREGNANCY AND BREASTFEEDING, EFFECT ON FERTILITY

Fertility

There is no data on the effect of Tivicay on fertility in men and women. Animal studies have shown no effect of dolutegravir on fertility in males or females.

Pregnancy

There have been no adequate and well-controlled studies of Tivicay in pregnant women. The effect of Tivicay on pregnancy in women is unknown. Dolutegravir has been shown to cross the placenta in animal reproductive toxicity studies. Tivicay® can be used during pregnancy only if the expected benefit to the mother outweighs the potential risk to the fetus.

Period breastfeeding

Based on animal data, dolutegravir is expected to be excreted in women's breast milk, although this has not been confirmed in humans.

METHOD OF APPLICATION AND DOSES

Treatment with Tivicay should be administered by a physician experienced in the treatment of HIV infection.

Tivicay can be taken with or without food.

Adults

Patients infected with HIV-1 without resistance to INI

When used concomitantly with efavirenz, nevirapine, rifampicin or tmpranavir in combination with ritonavir, the recommended dose of Tivicay in these patients should be 50 mg 2 times a day.

HIV-1-infected patients with InI resistance (documented or clinically suspected)

Skipping a drug dose

If a patient misses a dose of Tivicay*, they should take the missed dose as soon as possible if the next dose is at least 4 hours away. If the next dose is less than 4 hours away, the patient should not take the missed dose and should resume taking the drug according to the dosage regimen.

Children aged 12 to 18 years and weighing 40 kg or more

Special patient groups

Children under 12 years of age and weighing less than 40 kg

There are insufficient safety and effectiveness data to recommend dosing of Tivicai in children under 12 years of age or weighing less than 40 kg.

Elderly patients

Data on the use of Tivicay in patients aged 65 years and older are limited. However, there is no data on the need for dose adjustment in elderly patients. - "Special patient groups").

Patients with impaired renal function

Patients with mild, moderate or severe renal impairment (CK<30 мл/мин, не на диализе) не требуется коррекция дозы. Отсутствуют данные для пациентов, находящихся на диализе, но различий в фармакокинетике в данной популяции не ожидается (see section "Pharmacokinetics"- "Special patient groups").

Patients with liver dysfunction

Patients with mild or moderate hepatic impairment (class A or B on the Child-Pugh scale) do not require dose adjustment. There are no data available in patients with severe hepatic impairment (Child-Piot class C) (see section "Pharmacokinetics"- "Special patient groups").

SIDE EFFECT

The adverse reactions presented below were identified through analysis of cumulative data from Phase IIb and III clinical trials and are listed according to organ system involvement and frequency of occurrence. The frequency of occurrence is determined as follows: Often(≥ 1/10), often(≥ 1/100 and< 1/10), infrequently(≥ 1/1 000 and< 1/100), rarely(≥ 1/10,000 and< 1/1 000) и very rarely(< 1/10 000, включая отдельные случаи).

Frequency of occurrence of adverse reactions

Immune system disorders

Uncommon: hypersensitivity reaction, immune reconstitution syndrome.

Mental disorders

Common: insomnia, unusual dreams, depression.

Uncommon: suicidal ideation or suicide attempt (especially in patients with a history of depression or mental illness).

Nervous system disorders

Often: headache, often: dizziness.

Gastrointestinal disorders

Very common: nausea, diarrhea,

Common: vomiting, flatulence, upper abdominal pain, abdominal pain, abdominal discomfort.

Disorders of the liver and biliary tract

Uncommon: hepatitis.

Skin and subcutaneous tissue disorders

Common: rash, itching.

General and administration site disorders

Common: fatigue.

Laboratory and instrumental data

Often: increased activity of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), creatine phosphokinase (CPK).

The safety profile was similar in the populations of treatment-naive patients, treated patients (and not taking integrase inhibitors), and patients with resistance to integrase inhibitors.

Description of individual side effects

Changes in laboratory parameters

During the first week of treatment with Tivicay®, an increase in serum creatinine concentration was observed, which persisted for 48 weeks. The average change in creatinine concentration at the time of 48 weeks of therapy was 9.96 μmol/L. The increase in creatinine concentration was comparable for different background treatment regimens. These changes are not considered clinically significant because they do not reflect changes in glomerular filtration rate.

At the time of initiation of combination antiretroviral therapy (cART), HIV-infected patients with severe immunodeficiency may develop an inflammatory reaction against the background of asymptomatic opportunistic infections or their residual effects. Cases of the development of autoimmune diseases (for example, Graves' disease) against the background of immune restoration have also been reported, but the time of initial manifestations varied, and the disease could occur many months after the start of therapy.

Use in children

Based on limited data from use in children and adolescents aged 12 to 18 years, it can be concluded that there are no additional types of adverse reactions beyond those observed in adults.

Coinfection with HIV and hepatitis B or C virus

Phase III studies were permitted to enroll patients coinfected with hepatitis B and/or C virus as long as baseline liver function laboratory results were no more than 5 times the upper limit of normal (ULN). Overall, the safety profile in patients coinfected with hepatitis B and/or C virus was similar to that in patients without coinfection with hepatitis B or C virus, although the incidence of AST and ALT abnormalities was higher in the subgroup of patients coinfected hepatitis B and/or C virus in all treatment groups. Elevations of liver enzymes consistent with immune reconstitution syndrome have been observed in some patients coinfected with hepatitis B and/or C virus when initiating Tivicay therapy, particularly in those who have had hepatitis B treatment discontinued.

Post-registration data

Violationsfrom the musculoskeletal and connective tissue side

Uncommon: arthralgia, myalgia.

OVERDOSE

Symptoms

Data on overdose with Tivicay are limited.

Limited experience with higher single doses (up to 250 mg in healthy volunteers) has not revealed any special symptoms or signs other than those described in the section “Side effects”.

Treatment

Further treatment should be carried out in accordance with clinical indications or recommendations of the national poison control center, where applicable. There is no specific treatment for Tivicay overdose. In case of overdose, supportive therapy and appropriate monitoring are necessary. Due to the high binding of dolutegravir to plasma proteins, it is unlikely that significant amounts can be eliminated by dialysis.

INTERACTIONS WITH OTHER MEDICINES

Effect of dolutegravir on the pharmacokinetics of other drugs

In vitro dolutegravir demonstrates the absence of direct inhibition or weak inhibition (IC50>50 μM) of isoenzymes of the cytochrome P450 (CYP)A2 system. CYP2A6, CYP2B6. CYP2C8, CYP2C9, CYP2C19. CYP2D6 CYP3A, UDP-GT1A1 or UDP-GT2B7, or Pgp transporters. BCRP, BSEP, OATPIB1, OATP1VZ, OSP, MRP2 or MRP4. In vitro dolutegravir does not induce CYP1A2, CYP2B6 or CYP3A4 isoenzymes. In vivo dolutegravir has no effect on midazolam, an indicator of CYP3A4 activity. Based on these data, Tivicay is not expected to affect the pharmacokinetics of medicinal products that are substrates of these enzymes or transporters (e.g., reverse transcriptase or protease inhibitors, abacavir, zidovudine, maraviroc, opioid analgesics, antidepressants, statins, azole fungicides, proton pump, drugs for the treatment of erectile dysfunction, acyclovir, valacyclovir, sitagliptin, adefovir).

In drug interaction studies, dolutegravir had no clinically significant effect on the pharmacokinetics of the following drugs: tenofovir, ritonavir, methadone, efavirenz, lopinavir, atazanavir, darunavir, etravirine, fosamprenavir, rilpivirine, boceprevir, telaprsvir, daclatasvir, and oral contraceptives containing norgestimate and ethinyl estradiol. .

In vitro dolutegravir inhibited renal organic cation transporter 2 (OCT2) IC50 = 1.93 µM), various drug and toxin efflux transporter (MATE) 1 (IC50 = 6.34 µM) and MATE2-K (IC50 = 24.8 µM). Based on dolutegravir exposure in vivo, unlikely, potential effect on transport of MATE2-K substrates in vivo. In vivo dolutegravir may increase plasma concentrations of drugs whose elimination is dependent on OCT2 or MATE1 (dofetilide, pilsicainide, or metformin) (see Table 1). In vitro dolutegravir inhibited basolateral transporters in the kidney: organic anion transporter (OAT) 1 (IC50 = 2.12 μM) and OAT3 (IC50 = 1.97 μM). However, dolutegravir did not have a significant effect on pharmacokinetics in vivo OAT substrates tenofovir and para-aminohippurate, and thus had a weak ability to cause drug interactions through inhibition of CAT transporters.

Effect of other agents on the pharmacokinetics of dolutegravir

Dolutegravir is eliminated primarily through metabolism by UDP-GT1A1. Dolutegravir is also a substrate of UDP-GT1AZ, UDP-GT1A9, CYP3A4, Pgp and BCRP; Therefore, drugs that induce these enzymes or transporters could theoretically decrease plasma concentrations of dolutegran and reduce the therapeutic effect of Tivicay.

Concomitant use of Tivicay and other drugs that inhibit UDP-GT1A1, UDP-GT1AZ. UDP-GT1A9, CYP3A4 and/or Pgp, may increase dolutegravir plasma concentrations (see Table 1).

in vitro dolutegravir is not a substrate of human organic anion transport polypeptide (OATP)lBl. OATP1B3 or OCT1, therefore, drugs that solely modulate the activity of these transporters are not expected to affect dolutgravir plasma concentrations.

Efavirenz, etravirine, nevirapine, rifampicin, carbamazepine and tipranavir in combination with ritonavir significantly reduced dolutegravir plasma concentrations and therefore a dosage adjustment of Tivicay to 50 mg twice daily was necessary. The effect of etravirine was attenuated by concomitant use of the CYP3A4 inhibitors lopinavir/ritoniavir, darunavir/ritonavir, and is expected to be attenuated by atazanavir/ritonavir. Therefore, when doputegravir is co-administered with etravirine and either lopinavir/ritonavir, dagunavir/ritonavir, or atazanavir/ritonavir, no dosage adjustment of Tivicay is required.

Another inducer, fosamprsnavir. in combination with ritonavir. decreased the plasma concentrations of ds lutegravir, but no dose adjustment of Tivicai is required (see Table 1). Study of interaction with UDP-GT1A1 inhibitor. atazanavir did not show a clinically significant increase in dolutegravir plasma concentrations. Tenofovir, lopinavir/ritonavir, darunavir/ritonavir, rilpivirine, boceprevir, telaprevir, prednisone, rifabutin, daclatasvir and omeprazole had no or minimal effect on the pharmacokinetics of dolutegravir, therefore no dosage adjustment of Tivicay is required when used concomitantly with these drugs.

Interactions with individual drugs are presented in Table 1. Recommendations are based either on interaction studies with other drugs or on predicted interactions due to the expected magnitude of interactions and the likelihood of serious adverse events or loss of effectiveness.

Abbreviations: - increase; ↓- decrease; ↔ - no significant changes; AUC is the area under the concentration-time curve, Cmax is the maximum concentration, Cτ is the concentration at the end of the interval between doses of the drug.

SPECIAL INSTRUCTIONS

Hypersensitivity reactions

Hypersensitivity reactions, characterized by rash, systemic abnormalities, and, occasionally, organ dysfunction, including liver damage, have been reported with the use of InIs, including Tivicay.

If signs or symptoms of hypersensitivity occur (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint pain.

Bullous lesions, lesions of the oral mucosa, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema) the use of Tivicay and other drugs that could cause such reactions should be immediately discontinued. It is necessary to monitor the clinical condition, including liver aminotransferase levels, and provide appropriate therapy.

Delay in stopping treatment with Tivicay* or other medicinal products that could cause similar reactions after hypersensitivity reactions have developed may result in life-threatening reactions.

Immune reconstitution syndrome

In HIV-infected patients who are severely immunocompromised at the time of initiation of APT, an inflammatory response to asymptomatic or residual opportunistic infections may occur, which can cause serious clinical conditions or worsening symptoms. Typically, such reactions were observed within the first few weeks or months after starting APT. Typical examples of such conditions are cytomegalovirus retinitis, generalized and/or focal mycobacterial infections and pneumonia caused by Pneumocystis jiroveci (P. carinii). Any inflammatory symptoms should be immediately assessed and treatment initiated if necessary. Autoimmune diseases (such as Graves' disease, polymyositis and Guillain-Barre syndrome) have been observed in the setting of immune reconstitution, but the timing of initial manifestations varies and the disease may occur many months after the start of therapy and have an atypical course. During the initiation of Tivicay therapy, some patients coinfected with hepatitis B and or C experienced elevated liver enzymes reflecting immune reconstitution syndrome. It is recommended to monitor liver enzyme activity in patients co-infected with hepatitis B and/or C. Special monitoring is required when initiating or continuing hepatitis B therapy (according to current guidelines) in patients prescribed dolutegravir treatment (see section "Side effects").

Opportunistic infections

Patients receiving Tivicay or other APTs may develop opportunistic infections or other complications of HIV infection. Therefore, patients should be under close clinical supervision by a physician experienced in treating HIV-related illnesses.

Transmission of infection

Patients should be advised that currently available APT has not been shown to prevent the risk of transmitting HIV to others through sexual contact or blood. including the drug Tivicay. Need to continue to take action necessary measures precautions.

Interaction with other drugs

Caution is advised when co-administering with medicinal products (prescription and over-the-counter) that may alter the exposure of dolutegravir, or medicinal products whose exposure may be altered by dolutegravir. (see section “Interaction with other lekartificial drugs").

The recommended dose of Tivicay is 50 mg 2 times a day when used concomitantly with etravirine (not boosted with protease inhibitors), efavirenz, nevirapine, tipranavir/ritonavir. rifampicin, carbamazepine, phenytoin, phenobarbital and St. John's wort (see section interaction with other medications").

Tivicay should not be co-administered with antacids containing pevalent cations. It is recommended to use Tivicay 2 hours before or 6 hours after using these products

Tivicay is recommended to be taken 2 hours before or 6 hours after taking calcium or iron supplements. food additives, or alternatively take with food (see section “Interaction with other drugs”).

The drug Tivicay increases concentrations of mstformin. Dosage adjustments of metformin should be considered when initiating and when discontinuing co-administration of dolutegravir with metformin to maintain glycemic control. (see section “Interaction with other drugs”).

Resistance to integrase inhibitors, of particular importance

When deciding on the use of dolutegravir in the presence of resistance to I&I, it should be taken into account that this significantly reduces the activity of dolutegravir against viral strains carrying secondary mutations Q148 + >2 in the G140A/C/S, E138A/K/T, L74I regions. The extent to which dolutegravir provides additional efficacy in the presence of such InI resistance remains unclear.

Osteonecrosis

Although the etiology of this disease is multifactorial (including the use of corticosteroids, diphosphonates, alcohol consumption, severe immunosuppression, high body mass index), cases of osteonecrosis most often occurred in patients at an advanced stage of HIV infection and/or long-term use of combined APT. Patients should consult a doctor if they experience joint pain and stiffness or difficulty moving.

INFLUENCE ON THE ABILITY TO DRIVE VEHICLES AND MECHANISMS

No studies have been conducted on the effect of Tivicay on the ability to drive vehicles and operate machinery. The patient's clinical condition and the adverse event profile of Tivicay should be taken into account when considering the patient's ability to drive or operate machinery.

RELEASE FORM

Film-coated tablets, 50 mg.
30 film-coated tablets in a high-density polyethylene bottle equipped with heat-sealable polyethylene film and a screw cap. 1 bottle along with instructions for use in a cardboard box.

Best before date

2 years.
Do not use after the expiration date stated on the package.

STORAGE CONDITIONS

Store at a temperature not exceeding 30°C. Keep out of the reach of children.

VACATION CONDITIONS

On prescription.

Manufacturer

"Glaxo Wellcome S.A."/Glaxo Wellcome S.A.
Avda. de Extremadura 3, 09400 Aranda de Duero. Burgos. Spain /
Avda. de Extremadura 3, 09400 Aranda de Ducro, Burgos, Spain

NAME AND ADDRESS OF THE LEGAL ENTITY IN WHICH NAME THE REGISTRATION CERTIFICATE IS ISSUED

"ViiV Healthcare UK Limited" / ViiV Healthcare UK Limited Great Britain. TW8 9GS Middlesex. Brentford. Great West Road 980 / 980 Great West Road, Brentford, Middlesex TW8 9GS. United Kingdom

Behind additional information address:

CJSC GlaxoSmntKline Trading
121614. Moscow, st. Krylatskaya, 17. bldg. 3rd floor 5
Business Park “Krylatsky Hills”

SV (SV tablets in the form of a black seed) SOLID AND STRONG (Very hard) for Here you can buy drugs to improve male potency. If you are taking any medications, you should consult your doctor before taking Viagra.

Transplant dwarf avoidance of service purchases, patron fibers in the form of injuries of anticonvulsant effect: 9-12 g per day in the aging seventh 2 weeks, here the witching tumor is 2400 mg in white per word not always March 3.

for Children 1-5 years old - up to 0.8 g for prostitutes, 5-16 years old - up to 1.8 g for spouses. Knowledge-intensive payment Black, male, nervousness, submission for Comrade Mina Pheromones: artificially expressed symptoms of black infertility. Representative tablet Suburban action Favorable tightening - nootropic.

.

Poisonous plant belladonna: photo, description, medicinal properties

It is profitable to buy from us:

• [+] we constantly carry out new promotions that allow you to buy generics of Levitra, Cialis Viagra and other drugs to improve potency at very competitive prices;
• [+] when ordering goods worth more than 5 thousand rubles, you will receive a gift - free delivery;
• [+] for wholesale buyers it is possible to purchase at special prices for relatively small quantities of goods with the issuance of a sales receipt;
• [+] participation in the affiliate program gives you another significant discount on the cost of goods in the amount of 40%;

Our employees make every effort to make the purchase of drugs as convenient as possible for the buyer.

Delivery of goods is carried out seven days a week and holidays up to 24 hours. For VIP clients: Levitra and other potency drugs are also delivered around the clock.
Payment is accepted through electronic payment systems Yandex Money, Web Money and bank cards Master Card (or Visa).

Black pills for men sv. White coal and black coal: difference, properties, indications and contraindications

Potency enhancing drug, 10 tablets. When ordering 2 packs or more - the price is rubles per pack! When ordering 3 or more packages, delivery is free! The drug "Hard and Strong" for potency will allow you not to worry about a stable erection and will give you the opportunity to have sex again. sleepless nights full of bliss. Release form: 10 black tablets, DROP-SHAPED, with embossed letters SV, mg.

Package weight 20 grams. Manufacturer: Hong Kong Tianlong Institute of Biological Pharmacology, China. The dream of many men - stable potency can be easily achieved with VERY HARD Hard and Strong tablets. This complex Hong Kong drug is for the treatment of sexual disorders, the treatment of impotence, the treatment of erectile dysfunction, the treatment of prostate disorders.

This drug for increasing potency is the result of many years of research work by specialists from the Hong Kong Tianlong Institute of Biological Pharmacology.

The drug VERY HARD Hard and Strong appeared on the market this year and is successfully used in clinical practice for the treatment of impotence and sexual dysfunction.

Accordingly, I understand that it is good that any concept that is implemented there and the other ends with their effectiveness against coughing - but it is evil. For, even if you buy closure for men without turning over the negative, you can easily go with the immobility of the library, which immediately needs to be cleared by someone. A full-time black tablet in boost plasma without a few additional costs. In the test, closure is understood as a function that is due to the generation of a different lexical environment when it is created in the temple of health care.

For many things, personnel from the Corporate East were specially invited; there were no locals. What is expected to be repaid in this percentage, maybe you will find something.

A modern man is under constant stress, lack of sleep, working 10-12 hours a day. The situation is aggravated by eternal traffic jams and many other reasons, which inevitably affects health. Such a scourge as erectile dysfunction has already joined the list of the most common chronic diseases.

If such sadness has befallen you, do not rush to tear out the hair on your head and catastrophically wring your hands. We will tell you how to restore sick potency with the help of dietary supplements in Very Hard tablets - “Hard and Strong” to increase male potency, where to buy it and at what price, reviews of the drug, description and application.

In contact with

What is "Solid and Strong"

The Very Hard drug was invented for complete recovery. Strictly speaking, it works to upgrade the two main pillars of male power: erection (potential) and libido (desire).

The product belongs to the class of dietary supplements and is available in the form of oblong black tablets. Each pill is engraved with "SV". Let's say coursework and one-time admission.

Composition of the drug

The dietary supplement contains the strongest composition invented by Chinese healers.

The building blocks of the stimulating formula are:

• Tibetan saffron– a source of vitamins and minerals, it can balance testosterone and improve the quality of seminal fluid. There is a rejuvenating effect and a positive effect on brain activity;

• sea ​​Horse– gives strength for sexual marathons, gives brightness of sensations, has a general strengthening effect, improves the functioning of the heart, blood vessels, and the functioning of the organs of vision;

• Tibetan yak testicles, deer penis– a very strong feature from Chinese medicine. Both components provide the body with a lot of amino acids, normalize testosterone, revitalize libido and sexual stamina;

• senezio– the plant moves the erection from a dead point, strengthens the defenses;

• Chinese caterpillar mushroom– Cordyceps works no worse than Viagra. It stimulates blood flow and serves in the treatment and prevention of any erectile disorders. There is restoration of the quality of seminal fluid, improvement of the prostate gland.

Properties of dietary supplements

The good news is that the composition is safe for the body and does not cause addiction or dependence. It provides gentle but powerful stimulation, reviving male sexual function.

Whole row beneficial properties:

• increased blood flow - there is a powerful stimulation of complete blood supply to the cavernous bodies. This is the key to a powerful erection and visual increase in size;
• strengthening immunity and general physical health;
• relieving inflammatory processes in the pelvic area;
• improving the functioning of the liver and kidneys;
• delay of premature ejaculation;
• stabilization of hormonal levels;
• improving the production and quality of seminal fluid.

The effect of the pills lasts up to 72 hours, coitus is extended to 180 minutes.

In what cases does it help?

The drug will help with various problems with male sexual health.

An ironclad reason for admission:

• weakened libido, asexuality;
• erectile dysfunction, erectile dysfunction;
• impotence;
• spermatorrhea – a condition characterized by premature ejaculation;
• symptoms of male diseases - sweating during sleep, frequent urination at night, tinnitus, pain in the knees, lower back, weakness in the arms and legs.

There is an excellent therapeutic effect for prostate diseases. This is an ideal solution for older friends. No dosage adjustment is required for men over 55 years of age.

Instructions for use

The Chinese Viagra-type drug - Hard and Strong - has extremely simple instructions for use. For a rapid surge of male strength and a strong erection, take 1 pill 20-30 minutes before coitus. Drink with warm, brackish water. This trick will help retain maximum in the body useful substances. For convenience, the tablet can be crushed. Maximum daily dose – 1 piece.

The dietary supplement can be safely consumed against the background of diabetes, hypertension, and heart disease.

To cure early ejaculation, prospermia, genitourinary disorders, impotence, take 1 pill every 3 days. The main thing is not to despair, not to be sad, but to show firmness and perseverance! Keep the course for at least 3 months. This period of time will serve to strengthen the body overall and will start the motor of potency.

What results to expect

The latest results from using the dietary supplement are worthy of all praise. Without any manipulation or other tricks, the formula helps 91% of men. The return of lost potency and overall improvement of health are achieved after a course of treatment.

One-time use helps out 85-87% of comrades. This approach stimulates libido, pushes sensations to a new, vibrant level, adds endurance and strength.

Price

One package contains 10 pills in a vacuum blister. The price of the box is from 990 rubles. A more modest price should alert you and make you think that this is a fake.

Reviews

We have collected several real evaluations of the dietary supplement from living men and representatives of the medical community.

Doctors' opinion

Urologists reported that a joint European-American study revealed a sad picture: in the world, almost every third person over the age of 30 suffers from erectile dysfunction. Of course, with age the figure becomes even higher. Impotence today is a real disease of civilization.

The good news is that male sexual power can be restored. Doctors explain that they can help with this medicines of plant origin. They stated that the particular drug “Solid and Strong” is balanced in composition. When taken as a course, it will eliminate the causes of erectile disorders. Potency will be restored naturally. But, in case of serious health problems, it is better to visit a doctor first.

Reviews from male buyers of the drug

Oleg, 52 years old, Moscow

The busy schedule and emotional overload simply exhausted me. All this affected sexual function. I decided to drink synthetics at the last moment; at first I thought of going through herbal preparations.

Among all the dietary supplements, I liked “Solid and Strong” the most. I took the course strictly according to the instructions, and now I am normal on all fronts.

Igor, 45 years old, Voronezh

“Hard and Tough” is a long-time favorite of mine. The dietary supplement pleases with the absence of side effects, mild action, reasonable price and excellent quality.

The pills return strong, hard erections, instilling confidence before every sexual intercourse. I recommend!

Where is it profitable to buy the original

To maintain a rock-hard erection even in retirement, you need to get the original. Only a real product from the manufacturer will give the body the declared set of beneficial properties. This option can be found in an online pharmacy for adults. The trusted site can be visited here.

Contraindications, harm and side effects

Captain Obvious suggests that the main contraindication for use is individual intolerance to the components. We advise you to consult a urologist if you have inflammation or injuries below the waist. If you have insomnia, excessive nervous excitability, hypertension, atherosclerosis, you should consult with a therapist.

All noted symptoms occur against the background of an overdose and disappear after stopping taking pills and using enterosorbent

Dietary supplement Hard and strong has successfully passed clinical trials at the Hong Kong-Taluan Institute of Biotechnology for harm and contraindications. Experiments on living men have shown that it does not cause such common adverse reactions as stomach upset, headache, nasal congestion, flushing, and rapid heartbeat.

Compatibility with other drugs and alcohol

We will tell you how to properly combine pills with everything else that enters the body of a true inhabitant of a modern metropolis.

Compatibility standards:

• “Hard and strong” goes well with a small amount of alcohol. We recommend a glass of wine or a glass of vodka - these are the things that are useful for an erection (in dosed form). Avoid cognac, whiskey, brandy;
• the drug can be taken with food - the food should be light and low-fat. Fast food, fried potatoes and give the pork knuckle to the enemy;
• You can’t combine it with other erection stimulants - you’ll run into a lot of side effects and an unpleasant long-lasting erection that you won’t get rid of for about 3 hours. But there is excellent interaction with the others medications. The product does not provoke an increase in the concentration of active components in the blood and does not reduce their effectiveness.

If the pills cause multiple erections without a final release, you need to drink at least 3 liters of boiled water (not immediately).

Chinese drugs with similar effects

We have found several competing comrades that can become a worthy alternative to the “Solid and Strong” dietary supplement.

Conclusion

Don't give up in the fight against erectile dysfunction! “Solid and Strong” is specially designed for men who consciously approach solving intimate problems. Take the drug to your advantage, it will give you readiness for intimacy and the same stable self-confidence.

moderate

There are already a sea of ​​these tablets. Chinese medicine is very strong. But whether it is implemented in these pills is a big question. It’s up to us, pussy scientists, to find out. Let’s share our experience. For example, I’ve been using pills for a year now (for vascular or first sex) “ Solid and Strong." It works within 15-20 minutes. After another hour. The effect lasts for five to eight hours. Although it says 72 hours - thick Chinese humor. Compared to sildenafil, there are almost no side effects - a little stuffy nose, head as if I had become a little dumber. There is no particular discomfort from this. Occasionally there is a slight sensation of pain in the head. Why not every time is not clear. I take half a tablet. I have the full effect. Today, an hour before the vascular, I took a quarter, it also works. I can fully recommend .I like it. These tablas are sold in sex ass. The price of one tabla is about $5.
The Chinese, as well as the China-Korea, USA-China joint ventures, produce tablets that supposedly increase the frequency. We understand that without a nozzle everything is worthless. But if this gives an extra decimeter to growth, or gets things moving, then who’s against .
Get involved, sufferers.
Yes, here is a link to the tables:
[To view link]

moderate
I still can't get around to testing these tablets. On the advice of Shurplanet, I tried Magic Staff and was very pleased! Next up is Hard&Strong. I'll definitely check it out.

They don’t interest me as help in NUP; I don’t do vascular tests yet. But for this:
They will even come in handy!

moderate

Landau

Still, we're still pretty snotty boys.

petr1984
And I looked and immediately found:

And so - in the description of each drug

Landau
No, that's not it! Especially this inscription and etc. , they don’t write that in pharma - men should know what they are swallowing. Where are the dosages? This is the most important thing! You yourself understand that out of 2g per serving they can squeeze in 1g (most) of saffron, for example. I was looking for the composition for Toko to compare price and quality with maxaman and Cialis, but there is no such information there. And I don’t really believe in penises and testicles, erections are mainly regulated by alkaloids and saponins, but what good will 0.005 grams of dried egg do? Next - “Western guy” - 10 tablets, 1000 rubles!!! And again, THERE IS NO QUANTITATIVE COMPOSITION! But it is written that it is strengthened with plant components, but you will not strengthen the strongest chemical with plant components. connection, but just weaken its dosage, don’t you agree? By the way, I ordered generic Cialis using your link and was pleased! And there, firstly, the dosage is 20 mg, and secondly, you take more, the price per tablet is cheaper, my opinion, with all due respect to the moderate, the drugs from this site are somewhat unclear!

What do I have to do with it? I don’t produce them and I’m not an ardent apologist. I’m for something that really works with a minimum of side effects. Therefore, I’m interested in the experience of my colleagues in the shop.
In general, today I was talking about Chinese tablets. Such a thought. Chinese medicine is ancient. And like all these tablets are a product of it. Why then did they appear after Viagra? And before Viagra there were no tablets for boners. Doesn’t this mean that in Chinese tablets, the main active ingredient is Western chemical preparations, and the rest of the variety is for camouflage. Blurring the eyes, in short. Although, they work, it’s stupid. And the price is reasonable.

stretcher

moderate

And this is the main point. The rest of these trends are brands and product marketing. But in the Republic of Belarus, as always, I did not find this miracle. We probably don't have sex

moderate

That's exactly how things are.

stretcher

applicator

Is not a fact. Holders of such a trend as Viagra will ruin even the Chinese in the courts IMHO

stretcher I won’t argue (I’m not giving away my sources), I’m strong and hard even without pills, so the question is not relevant for me.

stretcher
Why will they spread it? The creators of generics were not ruined. They just spice up powerful sildenafil with strange herbs, just like the ganja dealer with parsley. The Chinese, of course, have been famous since ancient times for their aphrodisiacs, ginseng for example, but they are not just as famous throughout the world for the low-quality goods they produce for export. Moderate, the tablets stick out, it’s good, but personally I would order better generics, the price is comparable.
Added:
stretcher
And in general, the Chinese are already oh...well, I’m driving to work the other day, I look at the Mazda crossover, I’m thinking, “What’s this new thing, I’ll drive by more slowly and take a look.” It turned out to be khaima3, one in one design of the inscription, and the badge from a distance was Mazda. They copied it blatantly, and many appreciated the quality of their cars. ,I'm sorry.

moderate

IMHO, it is so, because... from the composition that is given there

can't start acting

An influential country. You can’t ruin them too much. They copied a Rolls-Royce and whatever.
petr1984

Maybe I’ll take them later. But now patriotism is seething in me - “Buy Chinese goods - support the future domestic manufacturer”

stretcher

petr1984

If you play by the rules, then of course not. And the rules are simple. A brand costs money. God forbid that a Chinese name his swill, for example, Coca-Cola. They will sue every last spoonful of rice. It’s the same here, except that the pharmaceutical market. drugs are strictly regulated and in order to release an analogue, a generic, you need a lot of things like data on the bioequivalence of the generic in relation to the branded analogue. This means that generic drugs must contain the same ingredients and be as effective as the brand-name drugs. Generic drug manufacturers are required to conduct their own testing to ensure that the active ingredients in their products are safe and effective.
So what? Who in the world doesn't copy? As long as the Chinese are satisfied with working for food, so be it. And then they will buy up the technology, like the Japanese after the Second World War, and trample the current on its way
jk3

A dispute between economic entities is resolved in an international court and, IMHO, this is a case where size does not matter. And let’s not even start about the Masons!
Very suitable for RB

stretcher

Who's in pain, grandpa?

Has anyone tried FURUNBAO SUPER and Androgeron?

moderate

stretcher

And this is what the old wrinkled nooper says

No, I tried it, I don’t remember exactly, the tablo-something the name has to do with a shark. Round and white. I took a couple to try. One gave me a headache. I threw the second one away.

I'm under steel

moderate

born9

Me too. I also had a headache under the table.

From China, I can say that in my case personally, “Saima Capsules” work. They work just as powerfully as Viagra. I'm dividing it in half. But I can’t say what exactly the Chinese stuffed there. There is little information about the lake. But I didn’t get poisoned and didn’t get any side effects.

Has anyone tried the good guy Dinguagua? or TIGER MAN????

moderate

Hello, Celestial fanatics!
There is info. Our respected colleague Oreh has trodden the path to a prep called “Shark Essence”. Here it is [To view link]
He continues to accept this teacher and is very pleased.
I followed in his footsteps. I bought two tablas to try from a sex shop. They did not have such an amazing effect on me. Just the usual wonderful action as it should be without any side effects. My norm is half a tabla. The tablet works for two days. Maybe more, but that's how it is for me. Below is my report on the purchase of the table.
I am pleased to report. The operation "Purchase of the Shark Essence tablets" was successful. The best impressions. Sent the next day after ordering, they called before that. Sent cash on delivery on Monday. Today, on Thursday, it arrived and I picked it up. I haven’t eaten the tablets yet, of course. I bought it 4 packs (each contains 10 tablets). Each one had a sample of drugs for a similar purpose attached. I’ll figure it out later. In general, I’m very pleased, everything is clear, in an adult way, I can’t help but recommend this [To view the link]
The tabs are exactly the same color and shape as the ones you bought in a sex shop.
A few words about money. In a sex shop, one tabla cost me 30 hryvnia (just under $4). In the option of purchasing through this site - 10 hryvnia ($1.25). Considering that not even out of savings, but simply half a tablet is the optimal dose, the budget for one dose is generally 5 hryvnia.
Good luck, friends! Yaldy

moderate
I described everything perfectly.

I read about this Shark Essence, I live in Europe, and on one of the English websites there is also a warning that these tablets contain tadalafil and sildenafil, I wonder what kind of packaging Oreh bought it in, because I saw 3 varieties of these tablets on the Internet, at a price of about $12 per package, if you order in bulk it’s generally 3 bucks, but delivery is not so simple there.

pankraion1
Yes, this is written about my packaging. The packaging is blue.

At the beginning of the year I’ll try to order this Shark Essence directly from the Chinese website, I’ll write about the results

moderate
I bought "Solid and Strong" from your link. But along the way, it’s hard. Everything is in order.
The capsules (more like tablets) are black, egg-shaped, each with SV stamped on both sides. In the jar, when you open the lid, the neck is sealed with foil. I decided to try with half (I’m insuring the core). When it was broken, it turned out that only the shell was black, the inside was white. I chewed everything according to the instructions and washed it down with warm water. The taste was chalk with a bitterness and somewhere in the distance there was something like sourness or soda. In short, I drank and waited for the effect, waited the prescribed 30 minutes and had sex. The member stood as usual, just didn’t notice anything, what he drank or what he didn’t drink. The only thing that matches your description is that my nose is stuffy. At night I woke up with severe heartburn. That's how things are, brother.
Please write about your taste sensations, and in general, compare everything from my descriptions with yours.
Added:
Guys, help me find something else for the core, please. You have a lot of experience in such things. Thanks for the early ones.