Pregnyl

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Chorionic gonadotrophin 5000 [iU];  

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Chorionic gonadotrophin 5000 IU

Dosage:

5000 IU

Pharmaceutical form:

Injection with diluent

Composition:

Active: Chorionic gonadotrophin 5000 [iU]   Excipient: Carmellose sodium Dibasic sodium phosphate dihydrate Mannitol Monobasic sodium phosphate dihydrate Sodium chloride

Units in package:

Ampoule, Diluent, 1 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Aspen Oss B.V

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

Product summary:

Package - Contents - Shelf Life: Ampoule, Diluent - 1 mL - 36 months from date of manufacture stored at or below 25°C - Ampoule, glass, powder for injection - 5000 IU -   - Combination pack, vial presentation (powder + diluent) - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, ampoule presentation (powder + diluent) - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Combination pack, ampoule presentation (powder + diluent) - 3 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, Diluent - 1 mL -   - Vial, glass, single dose, powder for injection - 5000 IU -  

Authorization date:

1969-12-31

Summary of Product characteristics

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