PREGNYL 5000IU Powder for solution for injection

Active ingredients: Chorionic gonadotrophin (human)

Product name and form

Pregnyl 5000 I.U. powder for solution for injection.

Pharmaceutical Form

Powder for solution for injection. The powder is a white, dry powder or cake.

Qualitative and quantitative composition

Pregnyl consists of a freeze-dried powder for injection. The active ingredient [human chorionic gonadotrophin (hCG)] which is obtained from the urine of pregnant women, has luteinizing hormone (LH) activity.

An ampoule contains 5000 I.U. hCG.

For a full list of excipients, see section 6.1.

Active Ingredient

Human chorionic gonadotrophin stimulates the steroidogenesis in the gonads by virtue of a biological effect similar to that of LH (Luteinizing hormone, which is the same as interstitial cell stimulating hormone).

List of Excipients

Powder for injection contains:

Carmellose sodium
Mannitol (E421)
Disodium phosphate (anhydrous)
Sodium dihydrogen phosphate (anhydrous)

Pack sizes and marketing

2ml ampoule containing freeze-dried powder with 1ml ampoule of solvent (sodium chloride 9mg/ml). Pregnyl is available in packs of 1, 3 or 10 ampoules of powder and solvent.

Not all pack sizes may be marketed.

In correspondence please quote batch number.

Marketing authorization holder

Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN119BU, UK

Marketing authorization dates and numbers

PL 00025/0556

24 February 1991/25 March 2003


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