Pazopanib INN (Pazonib-200) (VOTRIENT)

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Pazopanib INN

Pazopanib INN 200 mg Tablet

Composition: Each film coated tablet contains Pazopanib 200 mg as Pazopanib HCl INN.

VOTRIENT

Indications: Pazonib-200 is indicated for the treatment of patients with advanced renal cell carcinoma (RCC). Pazonib-200 is indicated for the treatment of patients with advanced soft tissue sarcoma (STS) who have received prior chemotherapy.

VOTRIENT

Dosage and Administration: The recommended starting dose of Pazonib-200 is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Pazonib-200 should not exceed 800 mg. Tablets should not be crushed due to the potential for increased rate of absorption which may affect systemic exposure. If a dose is missed, it should not be taken if it is less than 12 hours until the next dose. Or, as directed by the registered physicians.

Use in Pregnancy and Lactation: Pazonib-200 can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. Pregnant women or women should be advised of childbearing potential of the potential risk to a fetus. Lactation: There is no information regarding the presence of Pazopanib or its metabolites in human milk, or their effects on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Pazonib-200, a lactating woman should be advised not to breastfeed during treatment with Pazonib-200 and for 2 weeks after the final dose.

Packing: Each box contains 30 tablets in a blister pack.

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Pazopanib INN (Pazonib-200) (VOTRIENT)

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