Natflu capsules 75 mg No. 10




Instructions for Natflu capsules 75 mg No. 10
Composition
active ingredient: oseltamivir;
1 capsule contains oseltamivir phosphate equivalent to oseltamivir 30 mg or 45 mg or 75 mg;
excipients: pregelatinized starch (starch 1500), croscarmellose sodium, povidone K-30, talc, sodium stearyl fumarate, hard gelatin capsules;
capsule shell:
30 mg capsules: red iron oxide, yellow iron oxide, titanium dioxide, gelatin, blue ink;
45 mg capsules: black iron oxide, titanium dioxide, gelatin, blue ink;
75 mg capsules: red iron oxide, yellow iron oxide, black iron oxide, titanium dioxide, gelatin, blue ink;
blue ink:
shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, concentrated ammonia solution, FD & C Blue 2 Aluminum lake dye.
Dosage form
The capsules are hard.
Main physicochemical properties:
30 mg capsules: filled with white or almost white powder, size “4” capsules with a yellow cap imprinted with “30mg” in blue ink and a yellow body imprinted with “NAT” in blue ink;
45 mg capsules: filled with white or almost white powder, size “4” capsules with a gray cap imprinted “45mg” in blue ink and a gray body imprinted “NAT” in blue ink;
75 mg capsules: filled with white or almost white powder, size “2” capsules with a yellow cap imprinted with “75mg” in blue ink and a gray body imprinted with “NAT” in blue ink.
Pharmacotherapeutic group
Antivirals for systemic use. Direct-acting antivirals. Neuraminidase inhibitors. Oseltamivir. ATC 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 penetration 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 when administered orally inhibits the 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 in healthy volunteers.
The IC50 values of oseltamivir for the neuraminidase enzyme of clinical isolates of influenza A viruses ranged from 0.1 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.
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 therefore independent of food intake.
Distribution
In humans, the mean volume of distribution of the active metabolite at steady state is approximately 23 L, equivalent to the volume of extracellular body fluid. Since 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 vitro. No phase 2 conjugates for either compound were detected in vivo.
Breeding
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.
The pharmacokinetics of oseltamivir have been studied in children aged 1 to 16 years in a single-dose pharmacokinetic study. The pharmacokinetics of multiple-dose oseltamivir 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 on a mg/kg basis. Following a 2 mg/kg dose, the same exposure to oseltamivir carboxylate was observed as 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), steady-state exposure to the active metabolite is 25–35% higher than in younger patients (<65 years) given similar doses of oseltamivir. The elimination half-life in elderly patients is similar to that in younger patients. Based on drug exposure and tolerability, no dose adjustment is necessary in elderly patients, except in patients with moderate or severe renal impairment (creatinine clearance <60 mL/min).
Patients with kidney damage
Administration of oseltamivir phosphate 100 mg twice daily for 5 days to patients with varying degrees of renal impairment demonstrated that oseltamivir carboxylate exposure is inversely proportional to decreased renal function.
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.
Pregnant women
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% over the entire pregnancy) to the active metabolite in pregnant women compared to non-pregnant women. However, the lower predicted 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 analyses have demonstrated that administration of oseltamivir to immunocompromised adults and children (<18 years of age) (as described in section 4.2) results in an increase in predicted exposure (approximately 5-50%) to the active metabolite compared to immunocompetent patients with comparable creatinine clearance. Due to the wide safety profile of the active metabolite, no dose adjustment is necessary in immunocompromised patients. However, the dose should be adjusted in immunocompromised patients with renal impairment as recommended in section 4.2.
Analysis of pharmacokinetic and pharmacodynamic data from two studies in immunocompromised patients demonstrated no significant additional benefit from doses exceeding the standard dose.
Indication
Natflu is indicated for adults and children aged 1 year and over who have symptoms consistent with influenza during the influenza virus's circulation. Efficacy has been demonstrated when treatment is initiated within two days of symptom onset.
Flu prevention
- Prevention of influenza in adults and children aged 1 year and older after contact with a person with clinically diagnosed influenza during influenza virus circulation.
- The appropriate use of Natflu 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 cases 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 administered to individuals aged 1 year and older.
The use of Natflu does not replace influenza vaccination.
The use of antiviral agents for the treatment and prevention of influenza should be based on official recommendations. The decision to use oseltamivir for the treatment and prevention of influenza should take into account the characteristics of circulating influenza viruses, the available information on the susceptibility of influenza viruses to drugs in each season, and the impact of the disease in different geographical regions and patient groups (see section 5.1).
Contraindication
Hypersensitivity to oseltamivir phosphate or to any component of the drug.
Interaction with other medicinal products and other types of interactions
The pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of CYP450 and glucuronidase systems (see section 5.2), suggest that clinically significant interactions with other medicinal products are unlikely.
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 to 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
Pharmacokinetic interactions between oseltamivir and its main metabolite when co-administered with paracetamol, acetylsalicylic acid, cimetidine and antacids (magnesium hydroxide and aluminum hydroxide, calcium carbonate), rimantadine or warfarin (in patients taking stable doses of warfarin and not sick with influenza) have not been identified.
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, no change in the safety profile and frequency of adverse reactions was recorded.
There is no mechanism of interaction with oral contraceptives.
Application features
Oseltamivir is effective only against 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 oseltamivir does not replace influenza vaccination.
The use of oseltamivir should not affect the determination of individuals for annual influenza vaccination. Protection against influenza continues only while taking oseltamivir. The drug should be used for the treatment and prevention of influenza only when there is reliable epidemiological data indicating that the virus is circulating. The susceptibility of circulating influenza virus strains to oseltamivir has been shown to be highly variable, so the physician should consider the most recent information on the susceptibility of currently circulating viruses to oseltamivir before making a decision to use oseltamivir.
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.
Heart/respiratory disease
The efficacy of oseltamivir in patients 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 provide dosing recommendations (see section 5.2).
Neuropsychiatric disorders
Neuropsychiatric disorders have been reported in patients with influenza (predominantly children and adolescents) treated with oseltamivir. Such disorders have also been reported in patients with influenza who did not receive this drug. Patients should be closely monitored for behavioral changes, and the benefits and risks of continued treatment should be carefully weighed for each patient (see section 4.8).
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.
Use during pregnancy or breastfeeding
Pregnancy
Influenza is associated with adverse effects on pregnancy and fetal development, and with the development of major congenital malformations, including congenital heart defects. A large amount of data on the use of oseltamivir during pregnancy, obtained in the post-marketing period and in observational studies (more than 1000 outcomes of exposure during the first trimester of pregnancy), indicate that oseltamivir is not associated with malformative or fetal/neonatal toxicity. However, in one observational study, in the absence of an increase in the cumulative development of 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 (CI) 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. In addition, 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 it is necessary to use oseltamivir during pregnancy, the available information on the safety and efficacy of the drug, as well as the pathogenicity of the circulating influenza virus strain, should be taken into account.
Breastfeeding period
In lactating rats, oseltamivir and the active metabolite are excreted in human milk. There is very limited information on breastfed infants treated with oseltamivir 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 at low levels that may result in subtherapeutic exposure to the infant. Based on these data, as well as the pathogenicity of the circulating influenza virus strain and the condition of the nursing woman, consideration may be given to the use of oseltamivir 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.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the reaction speed when driving vehicles or other mechanisms.
Method of administration and doses
Method of application
For oral use.
Dosage
Doses of 75 mg can be taken as follows:
1 capsule of 75 mg or
1 capsule of 30 mg plus 1 capsule of 45 mg.
Adults and adolescents aged 13 and over
Treatment
The recommended dosage regimen for Natflu is 1 capsule of 75 mg 2 times a day orally for 5 days for adults and adolescents (13–17 years) with a body weight of more than 40 kg.
Treatment should be started as early as possible, within the first two days of flu symptoms.
For immunocompromised patients (adults and adolescents (13–17 years) with a body weight of more than 40 kg), the recommended dosage regimen of Natflu is 1 capsule of 75 mg 2 times a day orally for 10 days (see section “Dosage in special cases. Immunocompromised patients”).
Treatment should be started as early as possible, within the first two days of flu symptoms.
Prevention after contact with a person with influenza
The recommended dose of Natflu for the prevention of influenza after close contact with an infected person is 75 mg orally once daily for 10 days in adults and adolescents (13–17 years) weighing more than 40 kg. Treatment should be started as soon as possible within two days of contact with an infected person.
Prevention during the seasonal flu epidemic
The recommended dose for prevention during an outbreak of seasonal influenza is 75 mg once daily for 6 weeks.
Children aged 1 to 12 years
Treatment
Recommended dosage regimen of the drug with body weight adjustment for the treatment of children aged 1 year and older:
Body weight | Recommended dose for 5 days |
from 10 to 15 kg | 30 mg 2 times a day |
>15 kg to 23 kg | 45 mg 2 times a day |
>23 kg to 40 kg | 60 mg 2 times a day |
>40 kg | 75 mg 2 times a day |
Treatment should be started as soon as possible within the first two days of flu symptoms.
Post-exposure prophylaxis
Recommended dosage regimen of Natflu for post-exposure prophylaxis:
Body weight | Recommended dose for 10 days |
from 10 to 15 kg | 30 mg once daily |
>15 kg to 23 kg | 45 mg once daily |
60 mg once daily | |
>40 kg | 75 mg once daily |
Prevention during the seasonal flu epidemic
Prophylaxis during seasonal influenza epidemics in children under 12 years of age has not been studied.
Dosage in special cases
Patients with liver dysfunction
No dose adjustment is necessary for treatment or prophylaxis in patients with hepatic impairment. The safety and pharmacokinetics of oseltamivir have not been studied in children with hepatic impairment.
Patients with renal impairment
Treatment of influenza. The dose adjustment of oseltamivir required for adults and adolescents (13–17 years) with moderate or severe renal impairment is given in the table below:
Creatinine clearance | Recommended dose for treatment |
>60 ml/min | 75 mg 2 times a day |
>30 to 60 ml/min | 30 mg 2 times a day |
>10 to 30 ml/min | 30 mg once daily |
≤10 ml/min | not recommended (data not available) |
patients on hemodialysis | 30 mg after each hemodialysis session |
patients on peritoneal dialysis* | 30 mg once |
*Data obtained from studies in patients on continuous ambulatory peritoneal dialysis (CAPD); clearance of oseltamivir carboxylate is expected to be higher when using automated continuous cyclic peritoneal dialysis (CCPD). The treatment regimen may be changed from CCPD to CAPD if deemed necessary by the nephrologist.
Influenza prevention. The dose adjustment of oseltamivir required for adults and adolescents (13–17 years) with moderate or severe renal impairment is given in the table:
Creatinine clearance | Recommended dose for prevention |
>60 ml/min | 75 mg once daily |
>30 to 60 ml/min | 30 mg once daily |
>10 to 30 ml/min | 30 mg every other day |
≤10 ml/min | not recommended (data not available) |
patients on hemodialysis | 30 mg after every second hemodialysis session |
patients on peritoneal dialysis* | 30 mg once a week |
* Data from studies in patients on PAPD; oseltamivir carboxylate clearance is expected to be higher with automated PCPD. Treatment regimen may be changed from PCPD to PAPD if deemed necessary by the nephrologist.
There are insufficient data to make 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.
Immunocompromised patients
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).
Children
Use in children over 1 year of age with a body weight of more than 10 kg who are able to swallow the capsule.
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, overdose was not recorded.
Adverse reactions reported in overdose were similar in nature and distribution to those observed with therapeutic doses of oseltamivir (see section "Adverse reactions").
Specific antidote is unknown.
Children
Overdose has been reported more frequently in children than in adults and adolescents. Caution should be exercised when administering oseltamivir to children.
Adverse reactions
The overall safety profile of oseltamivir is based on data from the treatment of influenza in 6049 adults/adolescents and 1473 children treated with oseltamivir or placebo, and on data from the prevention of influenza in 3990 adults/adolescents and 253 children treated with oseltamivir or placebo in clinical trials. In addition, 199 immunocompromised adults received oseltamivir for the treatment of influenza and 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.
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 (≥1/10000, <1/1000), very rare (<1/10000), 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 invasions: common – bronchitis, herpes simplex, upper respiratory tract infections, nasopharyngitis, sinusitis;
Blood and lymphatic system disorders: rarely – thrombocytopenia;
Immune system disorders: uncommon – hypersensitivity reaction; rare – anaphylactic and anaphylactoid reactions;
Mental disorders: rarely common – agitation, abnormal behavior, anxiety, confusion, delusions, delirium, hallucinations, nightmares, self-harm;
Nervous system disorders: very common – headache; common – insomnia; uncommon – impaired consciousness, convulsions;
On the part of the organs of vision: rarely - visual impairment;
From the side of the cardiac system: uncommon – cardiac arrhythmias;
Respiratory, thoracic and mediastinal disorders: common – cough, rhinorrhea, sore throat;
Gastrointestinal: very common - nausea; common - vomiting, abdominal pain (including upper), dyspepsia; rare - gastrointestinal bleeding, hemorrhagic colitis;
Hepatobiliary system: uncommon – increased liver enzymes; rare – fulminant hepatitis, hepatic failure, hepatitis;
Skin and subcutaneous tissue disorders: 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.
Treatment and prevention of influenza in children
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: common – headache;
Blood and lymphatic system disorders: frequency unknown – lymphadenopathy;
On the part of the organs of vision: common - conjunctivitis (including eye redness, discharge from the eyes and pain);
From the side of the organs of hearing and vestibular apparatus: common - earache; uncommon - disorders of the eardrum;
Respiratory, thoracic and mediastinal disorders: very common – cough, nasal congestion; common – rhinorrhea; frequency unknown – asthma (including exacerbation), epistaxis;
Gastrointestinal: 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
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, such as 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
Treatment of influenza in immunocompromised patients was evaluated in two studies using standard or high (double or triple) doses of oseltamivir. The safety profile of oseltamivir observed in these studies was consistent with that observed in previous clinical studies in which oseltamivir was used for the treatment of influenza in non-immunocompromised patients of all ages (patients without other diseases or patients with risk factors [comorbid cardiac and/or respiratory diseases]). The most common adverse reaction in immunocompromised children was vomiting (28%).
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.
Do not use after the expiration date.
Storage conditions
Store at a temperature not exceeding 30 °C.
Keep out of reach of children.
Packaging
10 capsules in a blister. 1 blister in a cardboard box.
Vacation category
According to the recipe.
Producer
Natco Pharma Limited.
Location of the manufacturer and address of its place of business
Pharma Division, Kothur, Rangareddy, Telangana 509228, India.
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