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Oseltamivir Phosphate (Tamiflu)

Trade Name : Tamiflu

Genentech, Inc.

CAPSULE

Strength 75 mg/1

OSELTAMIVIR PHOSPHATE

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Oseltamivir Phosphate (Tamiflu) which is also known as Tamiflu and Manufactured by Genentech, Inc.. It is available in strength of 75 mg/1 per ml. Read more

Oseltamivir Phosphate (Tamiflu) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • TAMIFLU is an influenza neuraminidase inhibitor (NAI) indicated for:
  • Limitations of Use
  • Treatment of influenza
  • Prophylaxis of influenza
  • TAMIFLU Capsules:
  • TAMIFLU for Oral Suspension: 6 mg per mL (final concentration when constituted)
  • Capsules: 30 mg, 45 mg, 75 mg ()
  • For oral suspension: 360 mg oseltamivir base supplied as powder (constituted to a final concentration of 6 mg/mL) ()
  • TAMIFLU is contraindicated in patients with known serious hypersensitivity to oseltamivir or any component of the product. Severe allergic reactions have included anaphylaxis and serious skin reactions including toxic epidermal necrolysis, Stevens-Johnson Syndrome, and erythema multiforme .
  • Patients with known serious hypersensitivity to oseltamivir or any of the components of TAMIFLU ()
  • No data
  • Serious skin/hypersensitivity reactions such as Stevens-Johnson Syndrome, toxic epidermal necrolysis and erythema multiforme: Discontinue TAMIFLU and initiate appropriate treatment if allergic-like reactions occur or are suspected. ()
  • Neuropsychiatric events: Patients with influenza, including those receiving TAMIFLU, particularly pediatric patients, may be at an increased risk of confusion or abnormal behavior early in their illness. Monitor for signs of abnormal behavior. ()
  • The following serious adverse reactions are discussed below and elsewhere in the labeling:
  • Most common adverse reactions (>1% and more common than with placebo):
  • To report SUSPECTED ADVERSE REACTIONS, contact Genentech at 1-888-835-2555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • Treatment studies u2013 Nausea, vomiting, headache. ()
  • Prophylaxis studies u2013 Nausea, vomiting, headache, pain. ()
  • Live attenuated influenza vaccine (LAIV), intranasal:
  • Avoid administration of LAIV within 2 weeks before or 48 hours after TAMIFLU use, unless medically indicated. ()
  • No data
  • Reports of overdoses with TAMIFLU have been received from clinical trials and during postmarketing experience. In the majority of cases reporting overdose, no adverse reactions were reported. Adverse reactions reported following overdose were similar in nature to those observed with therapeutic doses of TAMIFLU .
  • TAMIFLU (oseltamivir phosphate), an influenza neuraminidase inhibitor (NAI), is available as:
  • In addition to the active ingredient, each capsule contains croscarmellose sodium, povidone K30, pregelatinized starch, sodium stearyl fumarate and talc. The 30 mg capsule shell contains gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. The 45 mg capsule shell contains black iron oxide, gelatin, and titanium dioxide. The 75 mg capsule shell contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide. Each capsule is printed with blue ink, which includes FD&C Blue No. 2 as the colorant.
  • In addition to the active ingredient, the powder for oral suspension contains monosodium citrate, saccharin sodium, sodium benzoate, sorbitol, titanium dioxide, tutti-frutti flavoring, and xanthan gum.
  • Oseltamivir phosphate is a white crystalline solid with the chemical name (3R,4R,5S)-4-acetylamino-5-amino-3(1-ethylpropoxy)-1-cyclohexene-1-carboxylic acid, ethyl ester, phosphate (1:1). The chemical formula is CHNO (free base). The molecular weight is 312.4 for oseltamivir free base and 410.4 for oseltamivir phosphate salt. The structural formula is as follows:
  • No data
  • In 2-year carcinogenicity studies in mice and rats given daily oral doses of the prodrug oseltamivir phosphate up to 400 mg/kg and 500 mg/kg, respectively, the prodrug and the active form oseltamivir carboxylate induced no statistically significant increases in tumors over controls. The mean maximum daily exposures to the prodrug in mice and rats were approximately 130- and 320-fold, respectively, greater than those in humans at the recommended clinical dose based on AUC comparisons. The respective safety margins of the exposures to the active oseltamivir carboxylate were 15- and 50-fold.
  • Oseltamivir was found to be non-mutagenic in the Ames test and the human lymphocyte chromosome assay with and without enzymatic activation and negative in the mouse micronucleus test. It was found to be positive in a Syrian Hamster Embryo (SHE) cell transformation test. Oseltamivir carboxylate was non-mutagenic in the Ames test and the L5178Y mouse lymphoma assay with and without enzymatic activation and negative in the SHE cell transformation test.
  • In a fertility and early embryonic development study in rats, doses of oseltamivir at 50, 250, and 1500 mg/kg/day were administered to females for 2 weeks before mating, during mating and until day 6 of pregnancy. Males were dosed for 4 weeks before mating, during mating, and for 2 weeks after mating. There were no effects on fertility, mating performance or early embryonic development at any dose level. The highest dose in this study was approximately 115 times the human systemic exposure (AUC) of oseltamivir carboxylate that occurs after administration of the maximum recommended human dose.
  • No data
  • No data
  • Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
  • Distributed by:n n A Member of the Roche Group1 DNA WaySouth San Francisco, CA 94080-4990u00a92019 Genentech, Inc. All rights reserved
  • Licensor:Gilead Sciences, Inc.Foster City, California 94404
  • No data
  • No data
  • Representative sample of labeling (see thesection for complete listing):
  • NDC 0004-0802-85
  • Tamiflu
  • 30 mg
  • Each capsule contains oseltamivir phosphate equivalent to 30 mgoseltamivir (free base).
  • Rx only
  • 10 Capsules
  • Genentech
  • 10175386
  • NDC 0004-0801-85
  • Tamiflu
  • 45 mg
  • Each capsule contains oseltamivir phosphate equivalent to 45 mgoseltamivir (free base).
  • Rx only
  • 10 Capsules
  • Genentech
  • 10175387
  • NDC 0004-0800-85
  • Tamiflu
  • 75 mg
  • Each capsule contains oseltamivir phosphate equivalent to 75 mgoseltamivir (free base).
  • Rx only
  • 10 Capsules
  • Genentech
  • 10175388
  • NDC 0004-0822-05
  • Tamiflu
  • 6 mg/mL
  • Each mL contains 6 mgoseltamivir base afterconstitution.
  • 60 mL (usable volumeafter constitution)
  • Rx only
  • Genentech
  • 10167501

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Comparator Sourcing for Clinical Trials

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Validated Cold Chain Shipment

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