Suprefact

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Buserelin acetate 1.05 mg/mL equivalent to 1 mg/mL Buscerelin

Tilgængelig fra:

sanofi-aventis new zealand limited

INN (International Name):

Buserelin acetate 1.05 mg/mL (= 1 mg/mL Buscerelin)

Dosering:

1 mg/mL

Lægemiddelform:

Solution for injection

Sammensætning:

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

Enheder i pakken:

Vial, 2 x 5.5 mL, 11 mL

Klasse:

Prescription

Recept type:

Prescription

Fremstillet af:

Sanofi-Aventis Deutschland GmbH

Terapeutiske indikationer:

For the treatment of endometriosis not primarily requiring surgical treatment. Pituitary desensitisation in preparation for ovulation induction regimens using gonadotrophins.

Produkt oversigt:

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

Autorisation dato:

1990-10-16

Produktets egenskaber

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