Azelta tablets 75 mg No. 10

Instructions for Azelta tablets 75 mg No. 10

Composition

active ingredient: oseltamivir;

1 tablet contains oseltamivir 75.00 mg in the form of oseltamivir phosphate 98.50 mg;

Excipients: microcrystalline cellulose (type 102), crospovidone, microcrystalline cellulose (type 101), colloidal anhydrous silica, povidone, magnesium stearate.

Dosage form

Pills.

Main physicochemical properties: round, biconvex tablets of white color.

Pharmacotherapeutic group

Antivirals for systemic use. Direct-acting antivirals. Neuraminidase inhibitors. Oseltamivir. ATX code J05A H02.

Pharmacological properties

Pharmacodynamics

Oseltamivir phosphate is a prodrug of the active metabolite (oseltamivir carboxylate).

The active metabolite is a selective inhibitor of the influenza virus neuraminidase enzyme, which is a glycoprotein on the surface of the virion. The activity of the viral enzyme neuraminidase is important for the entry of the virus into uninfected cells, the release of newly formed viral particles from infected cells, and the subsequent spread of the virus in the body.

Oseltamivir carboxylate inhibits neuraminidase of influenza A and B viruses in vitro. Oseltamivir phosphate inhibits viral replication and pathogenicity in vitro. Oseltamivir administered orally inhibits replication of influenza A and B viruses and pathogenicity in animal models of influenza infection in vivo at antiviral exposures similar to those achieved in humans at a dose of 75 mg twice daily.

The antiviral activity of oseltamivir has been confirmed against influenza A and B viruses in experimental studies involving healthy volunteers.

The IC50 values of oseltamivir for the neuraminidase enzyme of clinical isolates of influenza A viruses ranged from 0.1 nM to 1.3 nM, and for influenza B viruses were 2.6 nM. Published data have reported higher IC50 values for influenza B viruses, with a median of 8.5 nM.

Oseltamivir resistance

Clinical trials

The risk of influenza viruses with reduced susceptibility or high resistance to oseltamivir has been studied in clinical trials. The development of oseltamivir-resistant virus during treatment was more common in children than in adults, ranging from less than 1% in adults to 18% in infants under 1 year of age. Children carrying oseltamivir-resistant virus generally shed virus for longer periods of time compared with those carrying non-resistant virus. However, treatment-emergent oseltamivir resistance did not affect response to treatment or lead to prolonged influenza symptoms.

Overall, a higher incidence of oseltamivir resistance was observed in immunocompromised adults receiving standard or double doses of oseltamivir for 10 days [14.9% (10/67) in the standard dose group and 2.8% (2/71) in the double dose group] compared with studies in healthy adults receiving oseltamivir. The majority of patients who developed resistance were transplant recipients (8/10 patients in the standard dose group and 2/2 patients in the double dose group). The majority of patients with oseltamivir-resistant virus were infected with influenza A virus and shed virus for a longer period.

*Full genotyping was not performed in all studies.

Flu prevention

There is no evidence of drug resistance associated with the use of oseltamivir in clinical trials conducted to date for post-exposure prophylaxis (7 days), post-exposure prophylaxis (10 days), and seasonal prophylaxis (42 days) in immunocompromised patients. No resistance was observed in the 12-week prophylaxis study in immunocompromised patients.

Clinical and observational data

Oseltamivir-resistant viruses isolated from patients treated with oseltamivir and oseltamivir-resistant laboratory strains of influenza viruses have been found to contain mutations in the N1 and N2 neuraminidases. Resistance mutations tended to be specific to the viral subtype. Since 2007, naturally occurring resistance associated with the H275Y mutation has been sporadically identified in seasonal H1N1 strains. Oseltamivir susceptibility and prevalence of such viruses have been shown to vary seasonally and geographically. In 2008, H275Y was found in > 99% of circulating H1N1 isolates in Europe. In 2009, the H1N1 influenza virus (“swine flu”) was almost uniformly susceptible to oseltamivir, with sporadic reports of resistance when the drug was used for treatment and prophylaxis.

Pharmacokinetics

Absorption

After oral administration, oseltamivir phosphate is readily absorbed from the gastrointestinal tract and is extensively converted to the active metabolite (oseltamivir carboxylate) by hepatic esterases. At least 75% of an oral dose reaches the systemic circulation as the active metabolite, and less than 5% as the parent drug. Plasma concentrations of both the prodrug and the active metabolite are dose-proportional and are therefore independent of food intake.

Distribution

In humans, the mean volume of distribution of the active metabolite at steady state is approximately 23 L. This is a volume equivalent to the volume of extracellular body fluid. Because the neuraminidase activity is extracellular, oseltamivir carboxylate reaches all major sites of influenza infection.

The binding of the active metabolite to human plasma proteins is low (approximately 3%).

Metabolism

Oseltamivir phosphate is extensively converted to oseltamivir carboxylate by esterases, which are predominantly found in the liver. Neither oseltamivir phosphate nor the active metabolite are substrates or inhibitors of cytochrome P450 isoenzymes in in vitro studies. No phase 2 conjugates for either compound were detected in vivo.

Breeding

Absorbed oseltamivir is eliminated primarily (> 90%) by conversion to oseltamivir carboxylate, which is not further transformed and is excreted in the urine. In most patients, the maximum plasma concentration of the active metabolite declines with a half-life of 6-10 hours. The active metabolite is excreted entirely by the kidneys. Renal clearance (18.8 l/h) exceeds glomerular filtration rate (7.5 l/h), indicating that the drug is also excreted by tubular secretion. Less than 20% of the administered radiolabeled drug is excreted in the feces.

Pharmacokinetics in special groups.

Children aged 1 year and over

The pharmacokinetics of oseltamivir have been studied in children aged 1 to 16 years in a single-dose pharmacokinetic study. Multiple-dose pharmacokinetics have been studied in a small number of children in a clinical efficacy study. In younger children, elimination of the prodrug and active metabolite occurred more rapidly than in adults, resulting in lower exposures expressed as milligrams per kilogram of body weight per dose. A 2 mg/kg dose provides the same exposure to oseltamivir carboxylate as that achieved in adults after a single 75 mg dose (equivalent to approximately 1 mg/kg). The pharmacokinetics of oseltamivir in children and adolescents aged 12 years and older are similar to those in adults.

Elderly patients

In elderly patients (65-78 years), the exposure of the active metabolite at steady state is 25-35% higher than in younger patients (< 65 years) when using similar doses of oseltamivir. The half-life of the drug in elderly patients is not significantly different from that in younger patients. Based on drug exposure and tolerability, no dose adjustment is necessary for elderly patients, except in patients with moderate or severe renal impairment (creatinine clearance < 60 ml/min) (see section "Method of administration and dosage").

Patients with kidney damage

Administration of oseltamivir phosphate 100 mg twice daily for 5 days in patients with varying degrees of renal impairment demonstrated that oseltamivir carboxylate exposure is inversely proportional to the decrease in renal function. For dosage, see section 4.2.

Patients with liver damage

Based on in vitro studies, neither a significant increase in oseltamivir exposure nor a significant decrease in the exposure of the active metabolite of oseltamivir is expected in patients with hepatic impairment (see section 4.2).

A pooled population pharmacokinetic analysis indicates that the oseltamivir dosing regimen described in the Dosage and Administration section results in lower exposure (on average 30% across all trimesters) to the active metabolite in pregnant women compared to non-pregnant women. However, the predicted lower exposure remains above the inhibitory concentrations (IC95 values) and therapeutic influenza strain ranges. In addition, observational data suggest a benefit of the current dosing regimen in this patient population. Therefore, no dose adjustment is recommended for pregnant women for the treatment or prevention of influenza (see Use during pregnancy and lactation).

Immunocompromised patients

Population pharmacokinetic analysis data indicate that treatment with oseltamivir in immunocompromised adult patients (as described in section 4.2) resulted in increased exposure (up to 50%) to the active metabolite compared to immunocompetent adult patients with comparable creatinine clearance. Due to the wide safety profile of the active metabolite, no dose adjustment is necessary in immunocompromised adult patients. However, for immunocompromised adult patients with renal impairment, the dose should be adjusted according to the recommendations in section 4.2.

Indication

Flu treatment

Azela is indicated for adults and children aged 6 years and older weighing more than 40 kg who have symptoms consistent with influenza during the course of influenza virus circulation. Efficacy has been demonstrated when treatment is initiated within two days of the first onset of symptoms.

Flu prevention

Prevention of influenza in adults and children aged 6 years and older weighing more than 40 kg after contact with a person with clinically diagnosed influenza during the period of influenza virus circulation; the appropriate use of Azelta for the prevention of influenza should be determined on a case-by-case basis, taking into account the circumstances and the patient population requiring protection. In exceptional situations (e.g. in case of discrepancies between the circulating influenza virus and the influenza virus against which vaccination was carried out and during a pandemic), seasonal prophylaxis may be carried out in individuals aged 6 years and older weighing more than 40 kg.

The use of Azelta does not replace influenza vaccination.

The use of antivirals for the treatment and prevention of influenza should be based on official recommendations. The decision to use oseltamivir for treatment and prevention should take into account the characteristics of circulating influenza viruses, available information on the susceptibility of influenza viruses to drugs in each season, the impact of the disease in different geographical regions and patient groups.

Contraindication

Hypersensitivity to the active substance or to other components of the drug.

Moderate or severe renal failure.

Body weight less than 40 kg.

Interaction with other medicinal products and other types of interactions

The pharmacokinetic properties of oseltamivir, such as weak binding to plasma proteins and metabolism independent of CYP450 and glucuronidase systems, suggest that clinically significant interactions with other drugs are unlikely.

Probenecid

No dose adjustment is required when oseltamivir and probenecid are co-administered in patients with normal renal function. Concomitant administration of probenecid, a potent inhibitor of the anion pathway of renal tubular secretion, approximately doubles the exposure of the active metabolite of oseltamivir.

Amoxicillin

Oseltamivir does not show a kinetic interaction with amoxicillin, which is eliminated by the same pathway as oseltamivir, indicating a weak interaction with oseltamivir via this pathway.

Renal excretion

Clinically significant interactions with other drugs involving competition for renal tubular secretion are unlikely due to the known safety margins of most of these drugs, the elimination characteristics of the active metabolites (glomerular filtration and anionic tubular secretion), and the volume of excretion by these routes. However, caution should be exercised when prescribing oseltamivir to patients taking drugs with a similar excretion pathway and a narrow therapeutic index (e.g., chlorpropamide, methotrexate, phenylbutazone).

Additional information

In phase III clinical trials of oseltamivir for the treatment and prevention of influenza, the drug was administered with commonly used drugs, such as ACE inhibitors (enalapril, captopril), thiazide diuretics (bendrofluazide), antibiotics (penicillin, cephalosporin, azithromycin, erythromycin and doxycycline), H2-receptor blockers (ranitidine, cimetidine), beta-blockers (propranolol), xanthines (theophylline), sympathomimetics (pseudoephedrine), opioids (codeine), corticosteroids, inhaled bronchodilators, analgesics (acetylsalicylic acid, ibuprofen and paracetamol). When oseltamivir was used together with the listed drugs, changes in the safety profile and the incidence of adverse reactions were not recorded.

There is no mechanism of interaction with oral contraceptives.

Application features

Oseltamivir is effective only in diseases caused by influenza viruses. There are no data on the effectiveness of oseltamivir in any diseases caused by pathogens other than influenza viruses.

The use of the drug does not replace vaccination against influenza. The use of the drug should not affect the screening of individuals for annual vaccination against influenza. Protection against influenza lasts only while taking the drug. Azelta should be used for the treatment and prevention of influenza only when there is reliable epidemiological data indicating the circulation of the virus. It has been demonstrated that the susceptibility of circulating strains of influenza virus to the drug is highly variable, so the physician should take into account the latest information on the susceptibility of currently circulating viruses to oseltamivir before making a decision on the use of the drug.

Severe skin reactions and hypersensitivity reactions

Anaphylaxis and severe skin reactions, including toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme, have been reported during post-marketing use of oseltamivir. Oseltamivir should be discontinued and appropriate treatment instituted if such reactions are observed or suspected.

Severe comorbidities

There is no information on the safety and efficacy of oseltamivir in patients with severe or unstable illness at imminent risk of hospitalization.

Immunocompromised patients

The safety and efficacy of oseltamivir for the treatment and prevention of influenza in immunocompromised patients have not been established. However, the duration of treatment for influenza in immunocompromised adults should be 10 days, as shorter courses of oseltamivir have not been studied in this population.

Heart/respiratory disease

The efficacy of oseltamivir in the treatment of individuals with chronic heart and/or respiratory disease has not been established. In such patients, no difference in the incidence of complications was observed between the treatment and placebo groups.

Severe renal failure

Dose adjustment of oseltamivir for treatment and prophylaxis is recommended for adults and adolescents (13–17 years) with severe renal impairment. There are insufficient clinical data in children with renal impairment aged 1 year and older to make dosage recommendations.

Neuropsychiatric disorders

Cases of neuropsychiatric disorders have been reported in influenza patients (predominantly children and adolescents) while taking the drug. Such disorders have also been reported in influenza patients who did not take the drug. Patients should be closely monitored for behavioral changes, and the benefits and risks of continued treatment should be carefully assessed for each patient.

Disposal of unused and expired medication.

The release of the medicinal product into the environment should be minimised. The medicinal product should not be disposed of in wastewater or household waste. For disposal, use a so-called waste collection system, if available.

Ability to influence reaction speed when driving vehicles or other mechanisms

Oseltamivir does not affect the reaction rate when driving or using other mechanisms.

Use during pregnancy or breastfeeding

Influenza is associated with adverse effects on pregnancy, fetal development, and major congenital malformations, including congenital heart defects. A large body of post-marketing and observational data on oseltamivir use in pregnancy (more than 1000 outcomes from first trimester exposure) suggests that oseltamivir is not associated with malformative or fetal/neonatal toxicity. However, in one observational study, despite the lack of an increase in cumulative congenital malformations, the results for major congenital heart defects diagnosed within 12 months of birth were inconclusive. In this study, the incidence of major congenital heart defects after first-trimester oseltamivir exposure was 1.76% (7 infants out of 397 pregnancies) compared with 1.01% for pregnancies without oseltamivir exposure in the general population (hazard ratio 1.75, 95% confidence interval 0.51 to 5.98). The clinical significance of these findings is unclear because the study had a limited sample size. The study was also underpowered to reliably assess specific types of major congenital defects, and it was not possible to fully compare women with and without oseltamivir exposure, including whether they had influenza.

Animal studies do not indicate reproductive toxicity.

If necessary, the use of oseltamivir during pregnancy may be considered taking into account the available information on safety and benefit, as well as the pathogenicity of the circulating influenza virus strain.

Breast-feeding

In lactating rats, oseltamivir and its active metabolite are excreted in human milk. There is very limited information on breastfed infants whose mothers received oseltamivir during this period and on the excretion of oseltamivir in human milk. Limited data demonstrate that oseltamivir and its active metabolite have been detected in human milk, but their levels were low, which may result in subtherapeutic doses to the infant. Given these data, as well as the pathogenicity of the circulating influenza virus strain and the condition of the nursing woman, the use of oseltamivir may be considered if the potential benefit to the nursing woman is clear.

Fertility

Based on preclinical data, there is no evidence of an effect of oseltamivir on male or female fertility.

Method of administration and doses

Adults and adolescents aged 13 and over

Treatment

The recommended dosage regimen of the drug is 75 mg of oseltamivir 2 times a day for 5 days.

Treatment should be started on the first or second day of flu symptoms.

Prevention after contact with a person with influenza

The recommended dose of Azelta for the prevention of influenza after contact with a person with influenza is 75 mg of oseltamivir once daily for 10 days. The drug should be started no later than the first 2 days after contact.

Prevention during the seasonal flu epidemic

The recommended dose for prophylaxis during a seasonal flu epidemic is 75 mg of oseltamivir once daily for 6 weeks.

Children aged ≥ 6 – <13 years

The recommended dosage regimen of the drug is 75 mg of oseltamivir 2 times a day for 5 days for children aged 6 years and older with a body weight of more than 40 kg.

Treatment should be started on the first or second day of flu symptoms.

Prevention after contact with a person with influenza

The recommended dose of Azelta for the prevention of influenza after contact with a person with influenza is 1 tablet of 75 mg once a day orally for 10 days for children aged 6 years and older with a body weight of more than 40 kg.

Prevention during the seasonal flu epidemic

Prophylaxis during seasonal influenza epidemics in children under 12 years of age has not been studied.

The drug in tablet form is not used in newborns and children under 6 years of age. This dosage form is not intended for the treatment of children weighing less than 40 kg, as well as for the use of doses below 75 mg. In all of the above cases and for patients who have difficulty swallowing tablets, it is recommended to use oseltamivir preparations in a different dosage form and dose.

Dosage in special cases

Patients with liver dysfunction

No dose adjustment is necessary for treatment or prophylaxis in patients with hepatic impairment. Studies in children with hepatic impairment have not been conducted.

Patients with renal impairment

Treatment of influenza. In adults and adolescents (13–17 years of age) with moderate or severe renal impairment, Azela 75 mg is contraindicated as dose adjustment is required.

Influenza prevention: Azela 75 mg is contraindicated in adults and adolescents (13–17 years) with moderate or severe renal impairment, as dose adjustment is required.

There are insufficient clinical data to provide dosage recommendations for children under 12 years of age with renal impairment.

Elderly patients

No dose adjustment is necessary, except in the presence of moderate or severe renal impairment.

Treatment: The recommended oral dose of oseltamivir is 75 mg twice daily for 10 days for adults (see sections 4.4 and 4.8). Treatment should be initiated as soon as possible within the first two days of flu symptoms.

Seasonal prophylaxis: Longer durations (up to 12 weeks) of seasonal prophylaxis have been studied in immunocompromised patients (see sections 4.4 and 4.8).

Route of administration

Orally.

The tablets should be swallowed whole with water.

Children

The drug Azelta should be used in children aged 6 years and older with a body weight of more than 40 kg.

Overdose

Reports of overdose with oseltamivir have been received during clinical trials and during post-marketing use of the drug. In the majority of cases of overdose, no adverse reactions were reported. The adverse reactions reported in overdose were similar in nature and type to those observed with therapeutic doses of oseltamivir.

There is no specific antidote.

Children

Overdoses have been reported more frequently in children than in adults and adolescents.

Adverse reactions

Security Profile Summary

The overall safety profile of oseltamivir is based on data from 6049 adults and/or adolescents and 1473 children treated with oseltamivir or placebo for the treatment of influenza, and data from 3990 adults and/or adolescents and 253 children treated with oseltamivir or placebo for the prevention of influenza in clinical trials. In addition, 475 immunocompromised patients (including 18 children: 10 in the oseltamivir group, 8 in the placebo group) received oseltamivir or placebo for the prevention of influenza.

In adults and/or adolescents, the most common adverse events when taking the drug for the treatment of influenza were nausea and vomiting, and when taking it for the prevention of influenza - nausea. They were transient and usually occurred on the first or second day of treatment and disappeared after 1-2 days. In children, the most common adverse event was vomiting. In most cases, adverse reactions did not lead to the withdrawal of oseltamivir.

During post-marketing use of oseltamivir, the following serious adverse reactions have been reported rarely: anaphylactic and anaphylactoid reactions, liver disorders (hepatitis fulminant, liver function abnormalities and jaundice), angioedema, Stevens-Johnson syndrome and toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders (for neuropsychiatric disorders, see section 4.4).

The following categories were used to describe the frequency of adverse reactions: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data). Adverse reactions are assigned to a specific category based on the analysis of pooled clinical trial data.

Treatment and prevention of influenza in adults and adolescents

The most common adverse reactions that have been reported in studies of oseltamivir for the treatment and prevention of influenza in adults and adolescents, as well as in the post-marketing period when using the recommended dose (75 mg 2 times a day for 5 days for treatment and 75 mg 1 time a day for up to 6 weeks for prevention), are listed below.

The safety profile observed in patients receiving oseltamivir at the recommended dose for prophylaxis (75 mg once daily for up to 6 weeks) was similar to that observed in treatment studies, despite the longer duration of the prophylaxis studies:

Infections and infestations: common – bronchitis, herpes simplex, upper respiratory tract infections, nasopharyngitis, sinusitis; Blood and lymphatic system disorders: rare – thrombocytopenia; Immune system disorders: uncommon – hypersensitivity reaction; rare – anaphylactic and anaphylactoid reactions; Psychiatric disorders: rare – agitation, abnormal behaviour, anxiety, confusion, delusions, delirium, hallucinations, nightmares, self-harm; Nervous system disorders: very common – headache; common – insomnia; uncommon – impaired consciousness, convulsions; Visual disorders: rare – visual impairment; Cardiac disorders: uncommon – cardiac arrhythmias; Respiratory, thoracic and mediastinal disorders: common – cough, rhinorrhea, sore throat; Gastrointestinal disorders: very common – nausea; common - vomiting, abdominal pain (including upper), dyspepsia; rare - gastrointestinal bleeding, hemorrhagic colitis; from the hepatobiliary system: uncommon - increased liver enzymes; rare - fulminant hepatitis, hepatic failure, hepatitis; from the skin and subcutaneous tissue: uncommon - dermatitis, rash, eczema, urticaria; rare - angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis; frequency unknown - allergy, facial edema; general disorders and administration site conditions: common - dizziness (including vertigo), weakness, pain, hyperthermia, pain in extremities.

A total of 1473 children (including healthy children aged 1–12 years and children with asthma aged 6–12 years) participated in clinical trials of oseltamivir for the treatment of influenza. Of these, 851 children were treated with oseltamivir suspension. A total of 158 children received the recommended dose of oseltamivir once daily in the home-based post-exposure prophylaxis studies (n = 99), the 6-week seasonal prophylaxis studies (n = 49), and the 12-week seasonal prophylaxis studies in immunocompromised children (n = 10).

The most common adverse reactions that have been reported in studies of oseltamivir for the treatment and prevention of influenza in children (when using age-based dosing - from 30 mg to 75 mg 1 time per day):

Infections and infestations: common - otitis media; frequency unknown - bronchitis, pneumonia, sinusitis; Nervous system disorders: common - headache; Blood and lymphatic system disorders: frequency unknown - lymphadenopathy; Visual disorders: common - conjunctivitis (including eye redness, eye discharge and pain); Hearing and vestibular disorders: common - earache; Uncommon - eardrum disorder; Respiratory, thoracic and mediastinal disorders: very common - cough, nasal congestion; common - rhinorrhea; frequency unknown - asthma (including exacerbation), epistaxis; Gastrointestinal disorders: very common - vomiting; common - nausea, abdominal pain (including upper), dyspepsia; frequency unknown - diarrhea; Skin and subcutaneous tissue disorders: uncommon – dermatitis (including allergic and atopic dermatitis).

Description of selected adverse reactions

Mental and neurological disorders

Influenza can be associated with a variety of neurological and behavioral symptoms, including hallucinations, delirium, and inappropriate behavior, and in some cases, fatal outcomes. These symptoms may be seen as manifestations of encephalitis or encephalopathy, but may also occur without obvious severe illness.

In patients with influenza, cases of seizures and delirium (including symptoms such as altered level of consciousness, confusion, inappropriate behavior, delusions, hallucinations, agitation, anxiety, nightmares), which in isolated cases led to accidental self-harm or death, have also been reported in the post-marketing setting with oseltamivir. These events have occurred primarily in children and adolescents and often had a sudden onset and rapid resolution. It is not known whether neuropsychiatric disorders are associated with the use of oseltamivir, as neuropsychiatric disorders have also been reported in patients with influenza who did not use this drug.

Hepatobiliary disorders

Hepatobiliary disorders, including cases of hepatitis and elevated liver enzymes, have been observed in patients with influenza-like illness. These cases included fatal fulminant hepatitis/hepatic failure.

Additional information about specific patient groups

Elderly patients and patients with chronic heart and/or respiratory diseases

The study population for the treatment of influenza included healthy adults/adolescents and patients with risk factors (patients at increased risk of developing complications associated with influenza, e.g. elderly patients and patients with chronic heart or respiratory diseases). Overall, the safety profile in adolescents and adults with chronic heart and/or respiratory diseases was qualitatively comparable to that in healthy volunteers.

Immunocompromised patients

In a double-blind study of influenza treatment, a total of 199 immunocompromised adult patients (evaluated for safety) were randomized to receive oseltamivir for 10 days: 98 patients received the standard dose of oseltamivir (75 mg twice daily) and 101 patients received the double dose (150 mg twice daily). The safety profile of oseltamivir observed in this study was consistent with that observed in previous clinical studies in which oseltamivir was used for the treatment of influenza in non-immunocompromised patients (patients without other diseases or patients with risk factors [comorbid cardiac and/or respiratory diseases]). The percentage of patients experiencing adverse events was lower in the standard dose group compared with the double dose group (49% and 59.4%, respectively).

In a 12-week prophylaxis study in 475 immunocompromised individuals, including 18 children aged 1–12 years, the safety profile in 238 patients treated with oseltamivir was comparable to that observed in clinical trials of oseltamivir for prophylaxis.

Children with bronchial asthma

Overall, the adverse reaction profile in children with bronchial asthma was qualitatively comparable to that in children healthy with respect to other diseases.

Expiration date

3 years.

Storage conditions

Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging

10 tablets in a blister, 1 blister in a pack.

Vacation category

Available on prescription.

Producer

Biopharm Ltd.

Location of the manufacturer and its business address

Walbrzyska Street 13, 60-198 Poznań, Poland.