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Oseltamivir (Capsules) Instructions for Use

ATC Code

J05AH02 (Oseltamivir)

Active Substance

Oseltamivir

Clinical-Pharmacological Group

Antiviral drug

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; neuraminidase inhibitors

Pharmacological Action

Antiviral agent. It is a prodrug, whose active metabolite (Oseltamivir carboxylate) selectively inhibits the neuraminidase of influenza virus types A and B. Neuraminidase is a glycoprotein that catalyzes the cleavage of the bond between the terminal sialic acid and the sugar, thereby promoting the spread of the virus in the respiratory tract (release of virions from the infected cell and penetration into the cells of the respiratory epithelium, preventing the inactivation of the virus by epithelial mucus). Oseltamivir carboxylate acts outside cells and competitively inhibits viral neuraminidase.

It inhibits the growth of influenza virus in vitro and suppresses virus replication and its pathogenicity in vivo. Reduces the release of influenza A and B viruses from the body.

It does not affect the production of antibodies in response to the administration of an inactivated influenza vaccine.

The frequency of resistance of clinical virus isolates is 2%.

Efficacy for treatment has been proven when therapy is initiated within two days of the onset of symptoms.

Pharmacokinetics

After oral administration, it is almost completely absorbed from the gastrointestinal tract; absorption does not depend on food intake. It has a “first-pass” effect through the liver. Under the action of intestinal and hepatic esterases, it is converted into an active metabolite. 75% of the orally administered dose enters the systemic circulation as the active metabolite, less than 5% as the parent substance. Plasma concentrations of both the prodrug and the active metabolite are dose-proportional.

The mean Vd of the active metabolite is 23 L. Plasma protein binding is 3%.

It is excreted as the active metabolite mainly by the kidneys through glomerular filtration and tubular secretion. The T1/2 of oseltamivir is 1-3 hours. Oseltamivir carboxylate is not further metabolized and is excreted by the kidneys; its T1/2 is 6-10 hours. Renal clearance is 18.8 L/h. It is excreted through the intestines – less than 20%.

In elderly patients (65-78 years), the steady-state concentration of the active metabolite is 25-35% higher than in younger patients. In patients with renal failure, the elimination rate of oseltamivir carboxylate is inversely proportional to the creatinine clearance value.

Indications

Treatment of influenza in the presence of typical influenza symptoms during the period of influenza virus circulation in the general population.

For the treatment of influenza in adults and children, including full-term newborns, in the presence of typical influenza symptoms during the period of influenza virus circulation in the general population.

For post-exposure prophylaxis of influenza in adults and children aged 1 year and older after contact with a clinically diagnosed influenza case during the period of influenza virus circulation in the general population.

For post-exposure prophylaxis of influenza in children under 1 year of age during an influenza pandemic outbreak.

ICD codes

ICD-10 code Indication
J10 Influenza due to identified seasonal influenza virus
ICD-11 code Indication
1E30 Influenza due to identified seasonal influenza virus

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Capsules

Take orally.

For the treatment of influenza in adults: 75 mg twice daily for 5 days; for immunocompromised patients – including after organ or tissue transplantation, use for 10 days is recommended. Treatment should be started as early as possible: within the first two days of the onset of influenza symptoms.

Prophylaxis of influenza in adults and adolescents (aged 13-17 years): after contact with a sick person – 75 mg once daily for at least 10 days; during the seasonal influenza epidemic – 75 mg once daily for up to 6 weeks or up to 12 weeks in immunocompromised patients. The prophylactic effect lasts as long as the drug is taken.

In case of impaired renal function, dose adjustment is carried out according to a special scheme.

In children, the dose is set depending on age, body weight, and indications.

Adverse Reactions

Infections and infestations Common – bronchitis, infections caused by Herpes simplex, nasopharyngitis, upper respiratory tract infections, sinusitis. In children, common – otitis media.

Blood and lymphatic system disorders Rare – thrombocytopenia.

Immune system disorders Uncommon – hypersensitivity reactions; rare – anaphylactic reactions, anaphylactoid reactions.

Psychiatric disorders Rare – anxiety, inappropriate behavior, anxiety, confusion, delirium, delirium, hallucinations, nightmares, self-injury.

Nervous system disorders Very common – headache (common in children); common – insomnia; uncommon – altered consciousness, seizures.

Eye disorders Rare – visual impairment. In children, common – conjunctivitis (including eye redness, discharge, and pain).

Ear and labyrinth disorders In children, common – earache; uncommon – tympanic membrane disorders.

Cardiac disorders Uncommon – arrhythmia.

Respiratory, thoracic and mediastinal disorders Common – cough, sore throat, rhinorrhea (including in children); in children, very common – cough, nasal congestion.

Gastrointestinal disorders Very common – nausea; common – vomiting (very common in children), abdominal pain (including upper abdominal pain) (including in children), dyspepsia; rare – gastrointestinal bleeding, hemorrhagic colitis; in children, very common – vomiting, common – abdominal pain (including upper abdominal pain).

Hepatobiliary disorders Uncommon – increased liver enzyme activity; uncommon – fulminant hepatitis, hepatic failure, hepatitis.

Skin and subcutaneous tissue disorders Uncommon – eczema, dermatitis, rash, urticaria; rare – angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis. In children, uncommon – dermatitis (including allergic and atopic dermatitis).

General disorders and administration site conditions Common – pain, dizziness (including vertigo), fatigue, fever, limb pain.

Contraindications

Chronic renal failure (creatinine clearance less than 10 ml/min), hepatic failure, hypersensitivity to oseltamivir.

Use in Pregnancy and Lactation

Oseltamivir should be used during pregnancy and breastfeeding only if the expected clear benefit to the nursing mother outweighs the risk to the child.

Use in Hepatic Impairment

Dose adjustment is not required for the treatment and prevention of influenza in patients with impaired liver function. Studies in pediatric patients with impaired liver function have not been conducted.

Use in Renal Impairment

In adult patients and adolescents (13-17 years) with severe renal failure, dose adjustment is recommended for the treatment and prevention of influenza. Clinical data for dose adjustment in infants and children (aged 1 year and older) with renal impairment are not available.

Pediatric Use

It is used in children according to indications, in recommended doses, in the appropriate dosage form.

Data for determining the dose in premature infants (postconceptional age 36 weeks) are not available.

Geriatric Use

Dose adjustment is not required, except for elderly patients with moderate or severe renal impairment.

Special Precautions

The use of oseltamivir does not replace vaccination against influenza.

The use of antiviral drugs for the treatment and prevention of influenza should be determined based on official recommendations. Decisions regarding the use of oseltamivir for the treatment and prevention of influenza should be made taking into account data on circulating influenza viruses, available information on drug susceptibility patterns for each season, and the impact of the disease in different geographical regions and patient populations.

Oseltamivir is effective only against disease caused by the influenza virus. Data on the efficacy of oseltamivir in the treatment of diseases caused by other agents are not available.

The use of oseltamivir should not affect the evaluation of patients during annual influenza vaccination.
Protection against influenza lasts only as long as Oseltamivir is taken.

Oseltamivir should be used only for the treatment and prevention of influenza and only if reliable epidemiological data indicate that the influenza virus is circulating in the general population.

The sensitivity of circulating influenza virus strains to oseltamivir can vary significantly.
Therefore, when prescribing the drug, the most recent available information on the sensitivity of the circulating virus to oseltamivir must be taken into account.

Patients should be carefully monitored for changes in behavior; the risk and benefit of continuing therapy should be assessed for each patient individually.

Drug Interactions

Drugs that block tubular secretion increase the concentration of the active metabolite by 2-3 times (due to inhibition of the process of active tubular secretion in the kidneys), which does not require dose adjustment.

Use Oseltamivir with caution in combination with drugs that have a narrow therapeutic index (for example, chlorpropamide, methotrexate, phenylbutazone).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Or

Ozon Pharm, LLC (Russia)

Dosage Forms

Bottle Rx Icon Oseltamivir Capsules 30 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.
Capsules 45 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.
Capsules 75 mg: 5, 7, 10, 14, 15, 20, 21, 25, 28, 30, 35, 40, 42, 50, 56, 70, 100, or 140 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 2, capsule body and cap are yellow, opaque; capsule contents are a mixture of powder and granules white or white with a yellowish tint; compaction of the capsule contents into lumps shaped like the capsule is allowed, easily destroyed when pressed.

1 caps.
Oseltamivir phosphate 39.41 mg,
   Equivalent to oseltamivir content 30 mg

Excipients: corn starch – 54.35 mg, pregelatinized starch – 40 mg, povidone K25 – 5.76 mg, croscarmellose sodium – 3.04 mg, sodium stearyl fumarate – 1.44 mg.

Capsule body composition quinoline yellow dye 0.75%, sunset yellow FCF dye – 0.0059%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition quinoline yellow dye 0.75%, sunset yellow FCF dye – 0.0059%, titanium dioxide – 2%, gelatin – up to 100%.

5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs (5) – cardboard packs.
5 pcs. – blister packs (10) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
7 pcs. – blister packs (5) – cardboard packs.
7 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (5) – cardboard packs.
14 pcs. – blister packs (10) – cardboard packs.


Capsules hard gelatin size No. 2, capsule body and cap are dark gray, opaque; capsule contents are a mixture of powder and granules white or white with a yellowish tint; compaction of the capsule contents into lumps shaped like the capsule is allowed, easily destroyed when pressed.

1 caps.
Oseltamivir phosphate 59.12 mg,
   Equivalent to oseltamivir content 45 mg

Excipients: corn starch – 81.52 mg, pregelatinized starch – 60 mg, povidone K25 – 8.64 mg, croscarmellose sodium – 4.56 mg, sodium stearyl fumarate – 2.16 mg.

Capsule body composition iron oxide black dye – 0.54%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition iron oxide black dye – 0.54%, titanium dioxide – 2%, gelatin – up to 100%.

5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs (5) – cardboard packs.
5 pcs. – blister packs (10) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
7 pcs. – blister packs (5) – cardboard packs.
7 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (5) – cardboard packs.
14 pcs. – blister packs (10) – cardboard packs.


Capsules hard gelatin size No. 0, capsule body is light gray, cap is yellow, opaque; capsule contents are a mixture of powder and granules white or white with a yellowish tint; compaction of the capsule contents into lumps shaped like the capsule is allowed, easily destroyed when pressed.

1 caps.
Oseltamivir phosphate 98.53 mg,
   Equivalent to oseltamivir content 75 mg

Excipients: corn starch – 135.87 mg, pregelatinized starch – 100 mg, povidone K25 – 14.4 mg, croscarmellose sodium – 7.6 mg, sodium stearyl fumarate – 3.6 mg.

Capsule body composition iron oxide black dye – 0.05%, titanium dioxide – 2%, gelatin – up to 100%.
Capsule cap composition quinoline yellow dye – 0.75%, sunset yellow FCF dye – 0.0059%, titanium dioxide – 2%, gelatin – up to 100%.

5 pcs. – blister packs (1) – cardboard packs.
5 pcs. – blister packs (2) – cardboard packs.
5 pcs. – blister packs (3) – cardboard packs.
5 pcs. – blister packs (4) – cardboard packs.
5 pcs. – blister packs (5) – cardboard packs.
5 pcs. – blister packs (10) – cardboard packs.
7 pcs. – blister packs (1) – cardboard packs.
7 pcs. – blister packs (2) – cardboard packs.
7 pcs. – blister packs (3) – cardboard packs.
7 pcs. – blister packs (4) – cardboard packs.
7 pcs. – blister packs (5) – cardboard packs.
7 pcs. – blister packs (10) – cardboard packs.
10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – blister packs (2) – cardboard packs.
10 pcs. – blister packs (3) – cardboard packs.
10 pcs. – blister packs (4) – cardboard packs.
10 pcs. – blister packs (5) – cardboard packs.
10 pcs. – blister packs (10) – cardboard packs.
14 pcs. – blister packs (1) – cardboard packs.
14 pcs. – blister packs (2) – cardboard packs.
14 pcs. – blister packs (3) – cardboard packs.
14 pcs. – blister packs (4) – cardboard packs.
14 pcs. – blister packs (5) – cardboard packs.
14 pcs. – blister packs (10) – cardboard packs.

Marketing Authorization Holder

Izvarino Pharma LLC (Russia)

Dosage Forms

Bottle Rx Icon Oseltamivir Capsules 30 mg: 10, 15, 30, 60, or 90 pcs.
Capsules 45 mg: 10, 15, 30, 60, or 90 pcs.
Capsules 75 mg: 10, 15, 30, 60, or 90 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 4, from white or almost white to white with a yellowish tint, the capsule body and cap are opaque; the capsule contents are a powder or compacted powder mass from white or almost white to white with a yellowish tint.

1 caps.
Oseltamivir phosphate 39.4 mg,
   Equivalent to Oseltamivir 30 mg

Excipients : pregelatinized corn starch, povidone K30, croscarmellose sodium, talc, sodium stearyl fumarate.

Capsule composition: titanium dioxide, gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.


Capsules hard gelatin size No. 3, from white or almost white to white with a yellowish tint, the capsule body and cap are opaque; the capsule contents are a powder or compacted powder mass from white or almost white to white with a yellowish tint.

1 caps.
Oseltamivir phosphate 59.1 mg,
   Equivalent to Oseltamivir 45 mg

Excipients : pregelatinized corn starch, povidone K30, croscarmellose sodium, talc, sodium stearyl fumarate.

Capsule composition titanium dioxide, gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.


Capsules hard gelatin size No. 1, from white or almost white to white with a yellowish tint, the capsule body and cap are opaque; the capsule contents are a powder or compacted powder mass from white or almost white to white with a yellowish tint.

1 caps.
Oseltamivir phosphate 98.5 mg,
   Equivalent to Oseltamivir 75 mg

Excipients : pregelatinized corn starch, povidone K30, croscarmellose sodium, talc, sodium stearyl fumarate.

Capsule composition: titanium dioxide, gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
15 pcs. – contour cell packs (1) – cardboard packs.
15 pcs. – contour cell packs (2) – cardboard packs.
15 pcs. – contour cell packs (4) – cardboard packs.
15 pcs. – contour cell packs (6) – cardboard packs.

Marketing Authorization Holder

Citypharm LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

Bottle Rx Icon Oseltamivir Capsules 30 mg
Capsules 45 mg
Capsules 75 mg

Dosage Form, Packaging, and Composition

Capsules

1 caps.
Oseltamivir 30 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only


Capsules

1 caps.
Oseltamivir 45 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only


Capsules

1 caps.
Oseltamivir 75 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell packs (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell packs (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell packs (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only

Marketing Authorization Holder

Avexima JSC (Russia)

Manufactured By

Avexima Siberia LLC (Russia)

Or

Irbit Chemical Pharmaceutical Plant, JSC (Russia)

Dosage Forms

Bottle Rx Icon Oseltamivir Avexima Capsules 30 mg: 10 pcs.
Capsules 45 mg: 10 pcs.
Capsules 75 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 4, opaque, body and cap light blue; capsule contents are a mixture of granules and powder white or almost white or a compressed mass white or almost white, crumbling under light pressure.

1 caps.
Oseltamivir phosphate 39.4 mg,
   Equivalent to oseltamivir content 30 mg

Excipients : pregelatinized corn starch – 18.56 mg, povidone K-30 – 2.68 mg, croscarmellose sodium – 1.36 mg, sodium stearyl fumarate – 0.68 mg, talc – 3.32 mg.

Capsule shell composition: titanium dioxide (E171), brilliant blue (E133), azorubine (E122), gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.


Capsules hard gelatin size No. 4, opaque, body and cap blue; capsule contents are a mixture of granules and powder white or almost white or a compressed mass white or almost white, crumbling under light pressure.

1 caps.
Oseltamivir phosphate 59.1 mg,
   Equivalent to oseltamivir content 45 mg

Excipients : pregelatinized corn starch – 27.84 mg, povidone K-30 – 4.02 mg, croscarmellose sodium – 2.04 mg, sodium stearyl fumarate – 1.02 mg, talc – 4.98 mg.

Capsule shell composition: titanium dioxide (E171), allura red (E129), quinoline yellow (E104), brilliant blue (E133), gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.


Capsules hard gelatin size No. 2, opaque, body and cap blue; capsule contents are a mixture of granules and powder white or almost white or a compressed mass white or almost white, crumbling under light pressure.

1 caps.
Oseltamivir phosphate 98.5 mg,
   Equivalent to oseltamivir content 75 mg

Excipients : pregelatinized corn starch – 46.4 mg, povidone K-30 – 6.7 mg, croscarmellose sodium – 3.4 mg, sodium stearyl fumarate – 1.7 mg, talc – 8.3 mg.

Capsule shell composition: titanium dioxide (E171), black iron oxide (E172), brilliant blue (E133), gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – jars (1) – cardboard packs.

Marketing Authorization Holder

Triangle, LLC (Russia)

Manufactured By

Obnovlenie Pfc, JSC (Russia)

Dosage Form

Bottle Rx Icon Oseltamivir Reneval Capsules 75 mg: 10 or 30 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 1 with a white body and cap; capsule contents are a white or white with a yellowish tint powder.

1 caps.
Oseltamivir (as phosphate) 75 mg

Excipients : Capsule contents: pregelatinized corn starch, talc, croscarmellose sodium, povidone K30, calcium stearate.
Capsule body: titanium dioxide (E171), gelatin.
Capsule cap titanium dioxide (E171), gelatin.

10 pcs. – contour cell packs (1) – cardboard packs with insert.
10 pcs. – contour cell packs (3) – cardboard packs with insert.

Marketing Authorization Holder

Grotex, LLC (Russia)

Dosage Form

Bottle Rx Icon Oseltamivir solopharm Capsules 75 mg: 10, 20, 30, 40 or 80 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 2 white; contents – powder from white to almost white.

1 caps.
Oseltamivir (as phosphate) 75 mg

Excipients : pregelatinized starch, talc, povidone, croscarmellose sodium, sodium stearyl fumarate; capsule: titanium dioxide, gelatin.

10 pcs. – contour cell pack (1) – cardboard packs.
10 pcs. – contour cell pack (2) – cardboard packs.
10 pcs. – contour cell pack (3) – cardboard packs.
10 pcs. – contour cell pack (4) – cardboard packs.
10 pcs. – contour cell pack (8) – cardboard packs.

Marketing Authorization Holder

Velpharm, LLC (Russia)

Dosage Forms

Bottle Rx Icon Oseltamivir Velpharm Capsules 30 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Capsules 45 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Capsules 75 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Capsules hard gelatin size No. 2, body white, cap green; capsule contents are white or white with a yellowish tint powder.

1 caps.
Oseltamivir (as phosphate) 30 mg

Excipients : colloidal silicon dioxide (aerosil), copovidone, pregelatinized starch, croscarmellose sodium, sodium stearyl fumarate, talc.
Capsule shell composition: body titanium dioxide (E171), gelatin; cap yellow iron oxide (E172), quinoline yellow (E104), brilliant black (E151), titanium dioxide (E171), patent blue V (E131), gelatin.

10 pcs. – contour cell pack (1) – cardboard packs.
10 pcs. – contour cell pack (2) – cardboard packs.
10 pcs. – contour cell pack (3) – cardboard packs.
10 pcs. – contour cell pack (4) – cardboard packs.
10 pcs. – contour cell pack (5) – cardboard packs.
10 pcs. – contour cell pack (6) – cardboard packs.
10 pcs. – contour cell pack (7) – cardboard packs.
10 pcs. – contour cell pack (8) – cardboard packs.
10 pcs. – contour cell pack (9) – cardboard packs.
10 pcs. – contour cell pack (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.


Capsules hard gelatin size No. 2, body white, cap yellow; capsule contents are white or white with a yellowish tint powder.

1 caps.
Oseltamivir (as phosphate) 45 mg

Excipients : colloidal silicon dioxide (aerosil), copovidone, pregelatinized starch, croscarmellose sodium, sodium stearyl fumarate, talc.
Capsule shell composition: body titanium dioxide (E171), gelatin; cap titanium dioxide (E171), yellow iron oxide (E172), gelatin.

10 pcs. – contour cell pack (1) – cardboard packs.
10 pcs. – contour cell pack (2) – cardboard packs.
10 pcs. – contour cell pack (3) – cardboard packs.
10 pcs. – contour cell pack (4) – cardboard packs.
10 pcs. – contour cell pack (5) – cardboard packs.
10 pcs. – contour cell pack (6) – cardboard packs.
10 pcs. – contour cell pack (7) – cardboard packs.
10 pcs. – contour cell pack (8) – cardboard packs.
10 pcs. – contour cell pack (9) – cardboard packs.
10 pcs. – contour cell pack (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.


Capsules hard gelatin size No. 1, body white, cap white; capsule contents are white or white with a yellowish tint powder.

1 caps.
Oseltamivir (as phosphate) 75 mg

Excipients : colloidal silicon dioxide (aerosil), copovidone, pregelatinized starch, croscarmellose sodium, sodium stearyl fumarate, talc.
Capsule shell composition: body titanium dioxide (E171), gelatin; cap titanium dioxide (E171), gelatin.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (6) – cardboard packs.
10 pcs. – contour cell packs (7) – cardboard packs.
10 pcs. – contour cell packs (8) – cardboard packs.
10 pcs. – contour cell packs (9) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
70 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
90 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Dosage Form

Bottle Rx Icon Oseltamivir-Akrikhin Capsules 75 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin, two-colored, size #1; body from white to light gray with a light yellow cap; capsule contents are a powder from white to white with a yellowish tint.

1 caps.
Oseltamivir (as phosphate) 75 mg

Excipients: pregelatinized starch, povidone (type K30), croscarmellose sodium, talc, sodium stearyl fumarate.

Capsule shell composition body (iron oxide black dye, titanium dioxide, gelatin), cap (iron oxide red dye, iron oxide yellow dye, titanium dioxide, gelatin).

10 pcs. – blister packs (1) – cardboard packs.

Marketing Authorization Holder

Pharmental Group, LLC (Russia)

Dosage Form

Bottle Rx Icon Oseltamivir-Nativ Capsules 75 mg: 10 pcs.

Dosage Form, Packaging, and Composition

Capsules are hard gelatin capsules size #2, with a white body and cap; capsule contents are a white or white with a yellowish tint powder.

1 caps.
Oseltamivir phosphate 98.5 mg
   Equivalent to oseltamivir content 75 mg

Excipients: pregelatinized starch – 46.4 mg, talc – 8.3 mg, povidone K30 – 6.7 mg, croscarmellose sodium – 3.4 mg, sodium stearyl fumarate – 1.7 mg.

Capsule shell composition:
Capsule body
titanium dioxide – 2%, gelatin – up to 100%;
capsule cap: titanium dioxide – 2%, gelatin – up to 100%.

10 pcs. – blister packs (1) – cardboard packs.
10 pcs. – polyethylene terephthalate jars (1) – cardboard packs.

Marketing Authorization Holder

Teva Pharmaceutical Industries, Ltd. (Israel)

Manufactured By

Balkanpharma-Dupnitsa, AD (Bulgaria)

Dosage Form

Bottle Rx Icon Oseltamivir-Teva Capsules 75 mg

Dosage Form, Packaging, and Composition

Capsules

1 caps.
Oseltamivir (as phosphate) 75 mg

10 pcs. – blisters – cardboard packs (10 pcs.) – Prescription only

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Bottle Rx Icon Oseltamivir-Vertex Capsules 75 mg

Dosage Form, Packaging, and Composition

Capsules

1 caps.
Oseltamivir (as phosphate) 75 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – blister packs – cardboard packs (10 pcs.) – Prescription only

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