PREGNYL INJECTION 5000 IU

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

CHORIONIC GONADOTROPHIN

Available from:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (International Name):

CHORIONIC GONADOTROPHIN

Units in package:

3Units Units; 1 Units Units; 1 X 1 Vials

Manufactured by:

N.V. ORGANON

Patient Information leaflet

Not Applicable

Summary of Product characteristics

LPC -MK8829 -062019
Pregny l®
Powder and solvent for solution for injection
1. Name of the medicinal product
Pregnyl 5000 IU powder and solvent for solution 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 gonadotropin (hCG)] which is obtained from the
urine of pregnant women, has luteinizing hormone (LH) activity. A vial contains 5000 IU
hCG
For a full list of excipients, see 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 fema le:
• Ovulation induction in sub fertility due to anovulation or impaired follicle -ripening
• Preparation of follicles for puncture in controlled ovarian hyperstimulation programs
(for medically assisted reproductive techniques).
• Luteal phase support
In the m ale: