Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL; Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL
AFT Pharmaceuticals Ltd
Granisetron hydrochloride 1.12 mg/mL (equivalent to granisetron 1 mg/mL)
1 mg/mL
Concentrate for injection
Active: Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL Excipient: Hydrochloric acid Nitrogen Sodium chloride Sodium hydroxide Water for injection Active: Granisetron hydrochloride 1.12 mg/mL equivalent to granisetron 1 mg/mL Excipient: Citric acid monohydrate Nitrogen Sodium chloride Sodium citrate Water for injection
Prescription
Qilu Pharmaceutical Co Ltd
For the prevention & treatment of nausea & vomiting induced by cytotoxic chemotherapy (adults & children)
Package - Contents - Shelf Life: Ampoule, glass, 1 mL per ampoule, 1 ampoule - 1 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, 3 mL per ampoule, 1 ampoule - 3 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, 1 mL per ampoule, 5 ampoules - 5 mL - 24 months from date of manufacture stored at or below 30°C protect from light - Ampoule, glass, 3 mL per ampoule, 5 ampoules - 15 mL - 24 months from date of manufacture stored at or below 30°C protect from light
2013-05-02
NEW ZEALAND DATA SHEET 1. GRANISETRON – AFT Granisetron hydrochloride equivalent to Granisetron 1 mg/mL solution for injection and 3 mg/3 mL, concentrated solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION GRANISETRON-AFT injection is a sterile clear solution containing granisetron hydrochloride. Granisetron-AFT injection is available as an ampoule containing granisetron hydrochloride, equivalent to 3 mg of granisetron free base in 3 mL; and equivalent to 1 mg of granisetron free base in 1 mL. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Granisetron-AFT, concentrated solution for injection, is indicated in: Adults: • for the prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy; • for the prevention of nausea and vomiting induced by radiotherapy. • prevention and treatment of post-operative nausea and vomiting Children: • for the prevention of nausea and vomiting induced by cytotoxic chemotherapy. 4.2 DOSE AND METHOD OF ADMINISTRATION Chemotherapy induced nausea and vomiting _Intravenous Administration _ _Adults:_ For prevention of nausea and vomiting in adults, a single dose of 3 mg of GRANISETRON- AFT should be administered as an intravenous infusion, diluted in 20 to 50 mL infusion fluid and administered over 5 minutes prior to the start of chemotherapy. The infusion should be commenced within 30 minutes before the start of chemotherapy. Prophylactic administration of GRANISETRON-AFT should be completed prior to the start of chemotherapy. In clinical trials, the majority of patients have required only a single dose of granisetron injection to control nausea and vomiting over 24 hours. For treatment of established nausea and vomiting in adults, a single dose of 1 mg of GRANISETRON-AFT should be administered as a 5 minute infusion. Further treatment doses of GRANISETRON-AFT may be administered if required at least 10 minutes apart. The maximum dose of GRAN Perskaitykite visą dokumentą