国家: 新西兰
语言: 英文
来源: Medsafe (Medicines Safety Authority)
Daunorubicin hydrochloride 2.14 mg/mL equivalent to daunorubicin 2 mg/mL
Pfizer New Zealand Limited
Daunorubicin hydrochloride 2.14 mg/mL (equivalent to daunorubicin 2 mg/mL)
2 mg/mL
Solution for injection
Active: Daunorubicin hydrochloride 2.14 mg/mL equivalent to daunorubicin 2 mg/mL Excipient: Sodium chloride Water for injection
Vial, plastic, 10 mL PP with halobutyl rubber stopper, crimp cap and plastic flip-off lid, 1 dose unit
Prescription
Prescription
Meiji Seika Kaisha Ltd
Daunorubicin Injection is indicated for the treatment of the following: · Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease.
Package - Contents - Shelf Life: Vial, plastic, 10 mL PP with halobutyl rubber stopper, crimp cap and plastic flip-off lid - 1 dose units - 2 years from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light
2011-02-24
Version: pfddauni11121 Supersedes: pfddauni11120 Page 1 of 16 NEW ZEALAND DATA SHEET 1. PRODUCT NAME Pfizer (Perth) Daunorubicin 2 mg/mL solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSTION Each vial of Pfizer (Perth) Daunorubicin contains 2.14 mg/mL daunorubicin hydrochloride (equivalent to 2 mg/mL daunorubicin). For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Solution for injection. Pfizer (Perth) Daunorubicin is a sterile, red, isotonic, preservative free solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Pfizer (Perth) Daunorubicin is indicated for the treatment of the following: Acute lymphocytic (lymphoblastic) leukaemia: Daunorubicin is usually reserved for use in cases shown to be resistant to other drugs. However, combined treatment with daunorubicin, vincristine and a steroid has been used in the early stages of this disease. Acute myeloblastic leukaemia: Daunorubicin has been used in all stages, alone or in combination with other cytotoxic agents (e.g., cytarabine). Disseminated solid tumours: Daunorubicin has been investigated for use in these tumours and found to be effective in some cases of disseminated neuroblastoma and rhabdomyosarcoma. 4.2 DOSE AND METHOD OF ADMINISTRATION DOSE The dosage of each individual injection may vary from 0.5 to 3 mg/kg, with the frequency of repetition according to the dose: 0.5 to 1 mg/kg repeated at intervals of one or more days 2 mg/kg repeated at intervals of four or more days 2.5 or 3 mg/kg, if used, should only be given at seven to fourteen day intervals. Dosage must be adjusted to meet individual requirements of each patient, on the basis of clinical response and appearance or severity of toxicity. One injection has sometimes sufficed; Version: pfddauni11121 Supersedes: pfddauni11120 Page 2 of 16 commonly three to six injections have been necessary; occasionally up to 10 injections in one series have been used. When second or subsequent injections are to be given the dos 阅读完整的文件