SPC, UK: Pregnyl 5000IU
||Merck Sharp & Dohme Limited
||Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
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συνδρομή διάρκειας 30 ημερών.
Name of the medicinal product
Pregnyl 5000 I.U. Powder for solution for injection.
Qualitative and quantitative composition
Pregnyl consists of a freeze-dried powder for injection. The active ingredient [human chorionic gonadotrophin ...
Powder for solution for injection. The powder is a white, dry powder or cake.
In the female Sterility due to the absence of follicle-ripening or ovulation. In combination with FSH ...
Posology and method of administration
Dosage In the female Sterility due to the absence of follicle-ripening or ovulation: 5,000–10,000 IU ...
Hypersensitivity to human gonadotrophins or any of the excipients of Pregnyl. Presence of uncontrolled ...
Special warnings and precautions for use
In the female Since infertile women undergoing assisted reproduction, and particularly IVF, often have ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed; interactions with commonly used medicinal products can therefore ...
Pregnancy and lactation
Effects on ability to drive and use machines
As far as known Pregnyl has no influence on the ability to drive and use machines.
Frequency is unknown for all undesirable effects described below (cannot be determined with available ...
The toxicity of human chorionic gonadotrophic hormone is very low. However, too high a dose may lead ...
Pharmacotherapeutic group: gonadotrophins ATC code: G03GA01 Pregnyl is a preparation of human chorionic ...
In a study performed in healthy male subjects, maximal hCG plasma levels were reached after a single ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included ...
List of excipients
Powder for injection contains: Carmellose sodium Mannitol (E421) Disodium phosphate (anhydrous) Sodium ...
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal ...
Special precautions for storage
Store at 2 to 8°C. Do not freeze. Keep the ampoules in the outer carton to protect from light.
Nature and contents of container
2ml ampoule containing freeze-dried powder with 1ml ampoule of solvent (sodium chloride 9mg/ml). Pregnyl ...
Special precautions for disposal and other handling
Pregnyl should be reconstituted with the solvent provided. Do not use if the solution contains particles ...
Marketing authorization holder
Organon Laboratories Limited Cambridge Science Park Milton Road Cambridge CB4 0FL U.K.
Marketing authorization number(s)
Date of first authorization / renewal of the authorization
24th February 1991/25th March 2003
Date of revision of the text
4th January 2012
Απαγορεύεται η αναπαραγωγή και αναδιανομή. Το έργο επεξεργασίας των παραπάνω πληροφοριών αποτελεί
πνευματική ιδιοκτησία της Ergobyte Πληροφορική Α.Ε. και προστατεύεται από τη νομοθεσία περί πνευματικών δικαιωμάτων.