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PREGNYL 5000IU Powder for solution for injection (2017)

Αναφορές

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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