Pregnyl

País: Nova Zelanda

Idioma: anglès

Font: Medsafe (Medicines Safety Authority)

ingredients actius:

Chorionic gonadotrophin 5000 [iU];  

Disponible des:

Merck Sharp & Dohme (New Zealand) Limited

Designació comuna internacional (DCI):

Chorionic gonadotrophin 5000 IU

Dosis:

5000 IU

formulario farmacéutico:

Injection with diluent

Composición:

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

Unidades en paquete:

Ampoule, Diluent, 1 mL

clase:

Prescription

tipo de receta:

Prescription

Fabricat per:

Aspen Oss B.V

indicaciones terapéuticas:

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

Resumen del producto:

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 -  

Data d'autorització:

1969-12-31

Fitxa tècnica

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