PREGNYL 5000IU Powder for solution for injection (2017)
Βιβλιογραφική αναφορά
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Περιεχόμενα
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 (hCG)] which is obtained from the urine of pregnant women, has luteinizing hormone (LH) activity. ...
Pharmaceutical form
Powder for solution for injection. The powder is a white, dry powder or cake.
Therapeutic indications
In the female Sterility due to the absence of follicle-ripening or ovulation. In combination with FSH or HMG, promotion of controlled superovulation in medically assisted reproduction programmes. In the ...
Posology and method of administration
Posology In the female Sterility due to the absence of follicle-ripening or ovulation 5,000–10,000 IU hCG to induce ovulation, following treatment with an FSH (Follicle Stimulating Hormone) or HMG (Human ...
Contraindications
Hypersensitivity to human gonadotrophins or any of the excipients listed in section 6.1(see section 4.4). Presence of uncontrolled non-gonadal endocrinopathies (e.g. thyroid, adrenal or pituitary disorders). ...
Special warnings and precautions for use
In males and females Hypersensitivity reactions Hypersensitivity reactions, both generalised and local; anaphylaxis; and angioedema have been reported. If a hypersensitivity reaction is suspected, discontinue ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed; interactions with commonly used medicinal products can therefore not be excluded.
Pregnancy and lactation
Not applicable.
Effects on ability to drive and use machines
As far as known Pregnyl has no influence on the ability to drive and use machines.
Undesirable effects
Frequency is unknown for all undesirable effects described below (cannot be determined with available data). Immune system disorders: In rare cases generalized rash or fever may occur. General disorders ...
Overdose
The toxicity of human chorionic gonadotrophic hormone is very low. However, too high a dose may lead to hyperstimulation of the ovaries (see OHSS, see section 4.4).
Pharmacodynamic properties
Pharmacotherapeutic group: gonadotrophins ATC code: G03GA01 Pregnyl is a preparation of human chorionic gonadotrophin obtained from the urine of pregnant women. It stimulates the steroidogenesis in the ...
Pharmacokinetic properties
In a study performed in healthy male subjects, maximal hCG plasma levels were reached after a single IM or SC injection of hCG at approximately six and sixteen hours respectively; in addition, maximum ...
Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
List of excipients
Powder for injection contains: Carmellose sodium Mannitol (E421) Disodium phosphate (anhydrous) Sodium dihydrogen phosphate (anhydrous)
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 36 months.
Special precautions for storage
Store in refrigerator (2°C 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 is available in packs of 1, 3 or 10 ampoules of powder and solvent. Not all pack sizes may be marketed. ...
Special precautions for disposal and other handling
Pregnyl should be reconstituted with the solvent provided. Do not use if the solution contains particles or if the solution is not clear. Since an opened ampoule cannot be resealed in such a way to further ...
Marketing authorization holder
Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN119BU, UK
Marketing authorization number(s)
PL 00025/0556
Date of first authorization / renewal of the authorization
24 February 1991/25 March 2003
Date of revision of the text
30 November 2017
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