AFINITOR | Obat Baru Tahun 2009
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AFINITOR®(everolimus)
5 mg and 10 mg tablets
Trade name5 mg tablets
Afinitor 5 mg tablets
10 mg tabletsAfinitor 10 mg tablets
Description and CompositionPharmaceutical form
Tablet.
White to slightly yellow, elongated tablets with a bevelled edge and no score.
5 mg: The tablets are engraved with "5" on one side and "NVR" on the other.
10 mg: The tablets are engraved with "UHE" on one side and "NVR" on the other.
Active substance
5 mg tablets
Each tablet contains 5 mg everolimus.
10 mg tablets
Each tablet contain 10 mg everolimus
ExcipientsButylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone, lactose anhydrous.
IndicationsAfinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
Dosage and administrationTreatment with Afinitor should be initiated by a physician experienced in the use of anticancer therapies.
Afinitor should be administered orally once daily at the same time every day, either with or without food (see section Clinical Pharmacology).
Afinitor tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Afinitor 5 mg tablets
10 mg tabletsAfinitor 10 mg tablets
Description and CompositionPharmaceutical form
Tablet.
White to slightly yellow, elongated tablets with a bevelled edge and no score.
5 mg: The tablets are engraved with "5" on one side and "NVR" on the other.
10 mg: The tablets are engraved with "UHE" on one side and "NVR" on the other.
Active substance
5 mg tablets
Each tablet contains 5 mg everolimus.
10 mg tablets
Each tablet contain 10 mg everolimus
ExcipientsButylated hydroxytoluene (E321), magnesium stearate, lactose monohydrate, hypromellose, crospovidone, lactose anhydrous.
IndicationsAfinitor is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.
Dosage and administrationTreatment with Afinitor should be initiated by a physician experienced in the use of anticancer therapies.
Afinitor should be administered orally once daily at the same time every day, either with or without food (see section Clinical Pharmacology).
Afinitor tablets should be swallowed whole with a glass of water. The tablets should not be chewed or crushed.
Treatment should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
Sumber : Badan POM RI
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