PREGNYL 5000 I.U.
Country: Israel
Language: English
Source: Ministry of Health
Summary of Product characteristics
(SPC)
17-08-2016
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Active ingredient:
HUMAN CHORIONIC GONADOTROPIN
Available from:
MERCK SHARP & DOHME ISRAEL LTD
ATC code:
G03GA01
Pharmaceutical form:
POWDER FOR SOLUTION FOR INJECTION
Composition:
HUMAN CHORIONIC GONADOTROPIN 5000 IU/ML
Administration route:
I.M
Prescription type:
Required
Manufactured by:
N.V. ORGANON, THE NETHERLANDS
Therapeutic group:
CHORIONIC GONADOTROPHIN
Therapeutic area:
CHORIONIC GONADOTROPHIN
Therapeutic indications:
In the female: Ovulation induction in infertility due to anovulation or impaired follicle-ripening. Preparation of follicles for puncture in controlled ovarian hyperstimulation programs. Luteal phase support. In the male: Hypogonadotropic hypogonadism (also cases of idiopathic dysspermias have shown a positive response to gonadotropins). Delayed puberty associated with insufficient gonadotropic pituitary function.Cryptorchidism not due to anatomical obstruction.
Authorization date:
2012-05-31
Summary of Product characteristics
RA 2400 IL S2(ref2.0)
Pregnyl®
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.
An ampoule contains 5000 IU hCG.
For 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 female:_
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infertility due to anovulation
or impaired follicle-ripening.
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puncture in controlled ovarian
hyperstimulation programs.
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_In the male:_
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hypogonadism (also cases of
idiopathic dysspermias have
shown a positive response to
gonadotropins).
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with insufficient gonadotropic
pituitary function.
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anatomical obstruction.
4.2 POSOLOGY AND METHOD OF
ADMINISTRATION
_Dosage in the female:_
t_ _
_Ovulation induction in _
_infertility due to anovulation or _
_impaired follicle-ripening_
Usually, one injection of
5,000-10,000 IU Pregnyl to
complete treatment with an
FSH-containing preparation.
t_ _
_Preparation of follicles for _
_puncture in controlled ovarian _
_hyperstimulation programs_
Usually, one injection of
5,000-10,000 IU Pregnyl to
complete treatment with an
FSH-containing preparation.
t_ _
_Luteal phase support_
Two to three repeat injections of
1000 to 3000 IU each may be
given within nine days following
ovulation or embryo transfer (for
example on day 3, 6 and 9 after
ovulation induction).
_Dosage in the male:_
t_ _
_Hypogonadotropic _
_hypogonadism_
1000-2000 IU Pregnyl, two
to three times per week. If the
main c
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