Riik: Uus-Meremaa
keel: inglise
Allikas: Medsafe (Medicines Safety Authority)
Chorionic gonadotrophin 500 [iU] (material -Hormone HCG ex Netherlands,Belgium);
Pharmaco (NZ) Ltd
Chorionic gonadotrophin 500 IU (material -Hormone HCG ex Netherlands,Belgium)
500 IU
Injection with diluent
Active: Chorionic gonadotrophin 500 [iU] (material -Hormone HCG ex Netherlands,Belgium) Excipient: Gelatin Sodium chloride
Ampoule, 1 x 1 mL, 1 mL
Prescription
Prescription
NV Organon
Package - Contents - Shelf Life: Ampoule, 1 x 1 mL - 1 mL - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, 1 x 500 IU - 500 IU - 36 months from date of manufacture stored at 8° to 15°C (Cool) protect from light - Combination pack, 3 x (powder + diluent) - 3 dose units - 36 months from date of manufacture stored at 2° to 15°C protect from light
1969-12-31
NEW ZEALAND DATA SHEET Page 1 of 6 1. PRODUCT NAME PREGNYL ® 1500 IU powder for injection PREGNYL ® 5000 IU powder for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION PREGNYL consists of a freeze-dried powder for injection and a solvent for reconstitution. The active ingredient [human chorionic gonadotrophin (hCG)] which is obtained from the urine of pregnant women, has luteinizing hormone (LH) activity. An ampoule or vial contains 1500 or 5000 IU hCG. For a full list of excipients see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. The powder is a white, dry powder or cake. The solvent is a clear and colourless aqueous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _In the female _ • Ovulation induction in subfertility due to anovulation or impaired follicle-ripening. • Preparation of follicles for puncture in controlled ovarian hyperstimulation programmes (for medically assisted reproductive techniques). • Luteal phase support. _In the male _ • Hypogonadotrophic hypogonadism (also cases of idiopathic dysspermias have shown a positive response to gonadotrophins). • Delayed puberty associated with insufficient gonadotrophic pituitary function. • Cryptorchidism, not due to anatomical obstruction. 4.2 DOSE AND METHOD OF ADMINISTRATION _Dosage in the female _ Ovulation induction in subfertility due to anovulation or impaired follicle-ripening Usually, one injection of 5,000-10,000 IU PREGNYL to complete treatment with an FSH-containing preparation. Preparation of follicles for puncture in controlled ovarian hyperstimulation programs Usually, one injection of 5,000-10,000 IU PREGNYL to complete treatment with an FSH-containing preparation. Luteal phase support Two to three repeat injections of 1,000 to 3,000 IU each may be given within nine days following ovulation or embryo transfer (for example, on day 3, 6 and 9 after ovulation induction). _Dosage in the male _ Hypogonadotrophic hypogonadism 1,000-2,000 IU PREGNYL, two to three times per week. If Lugege kogu dokumenti