Quốc gia: New Zealand
Ngôn ngữ: Tiếng Anh
Nguồn: Medsafe (Medicines Safety Authority)
Buserelin acetate 1.05 mg/mL equivalent to 1 mg/mL Buscerelin
sanofi-aventis new zealand limited
Buserelin acetate 1.05 mg/mL (= 1 mg/mL Buscerelin)
1 mg/mL
Solution for injection
Active: Buserelin acetate 1.05 mg/mL equivalent to 1 mg/mL Buscerelin Excipient: Benzyl alcohol Monobasic sodium phosphate dihydrate Sodium chloride Sodium hydroxide Water for injection
Vial, 2 x 5.5 mL, 11 mL
Prescription
Prescription
Sanofi-Aventis Deutschland GmbH
For the treatment of endometriosis not primarily requiring surgical treatment. Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins.
Package - Contents - Shelf Life: Vial, 2 x 5.5 mL - 11 mL - 24 months from date of manufacture stored at or below 25°C protect from light
1990-10-16
New Zealand Data Sheet 19-Sep-2018 Suprefact - Buserelin acetate Property of the Sanofi group - strictly confidential Suprefact-ccdsv8-dsv9-19sep18 Page 1 DATA SHEET 1 SUPREFACT ® 1 MG/ML SOLUTION FOR INJECTION Suprefact 1 mg/mL solution for injection. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for injection contains 1.05 mg of buserelin acetate as the active substance, equivalent to 1 mg buserelin, in aqueous solution, and benzyl alcohol as preservative. For the full list of excipients, see section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of endometriosis not primarily requiring surgical treatment. Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins. For the treatment of advanced hormone-dependant prostatic carcinoma; however, not after bilateral orchiectomy (no further reduction of testosterone level by buserelin to be expected). 4.2 DOSE AND METHOD OF ADMINISTRATION Before commencing therapy, the possibility of pregnancy should be excluded. DOSE _FOR ENDOMETRIOSIS _ 200 micrograms buserelin by subcutaneous (S.C) injection increasing to 500 micrograms daily, depending upon symptomatic response. New Zealand Data Sheet 19-Sep-2018 Suprefact - Buserelin acetate Property of the Sanofi group - strictly confidential Suprefact-ccdsv8-dsv9-19sep18 Page 2 Treatment should be started on the first or second day of the menstrual period in order to exclude, as far as possible, the existence of pregnancy. Treatment is usually given for 6 months and should not exceed 9 months. The inception of buserelin treatment may cause ovulation and contraceptive measures should be in place. _FOR ADJUNCTIVE USE IN OVULATION INDUCTION _ 600 micrograms buserelin by S.C. injection as a divided dose 3 times daily. Treatment should start in the early follicular phase (day 1) or, provided the existence of any early pregnancy has been excluded, in the midluteal phase (day 21). It should Đọc toàn bộ tài liệu