Pregnyl 5000 I.U. Powder and Solvent for Solution for Injection

البلد: سنغافورة

اللغة: الإنجليزية

المصدر: HSA (Health Sciences Authority)

العنصر النشط:

HUMAN CHORIONIC GONADOTROPHIN

متاح من:

MSD PHARMA (SINGAPORE) PTE. LTD.

ATC رمز:

G03GA08

جرعة:

5000 iu/ampoule

الشكل الصيدلاني:

INJECTION, POWDER, FOR SOLUTION

تركيب:

HUMAN CHORIONIC GONADOTROPHIN 5000 iu/vial

طريقة التعاطي:

SUBCUTANEOUS, INTRAMUSCULAR

نوع الوصفة الطبية :

Prescription Only

المصنعة من قبل:

N V ORGANON

الوضع إذن:

ACTIVE

تاريخ الترخيص:

1990-05-03

نشرة المعلومات

Tekeningnr.: 12.233/12.511 Formaat: 160 x 300  mm
■ Zwart
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 a full list of 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:
• Sterility due to absence of
follicle ripening or ovulation
• Luteal phase support
In the male:
• Hypogonadotropic
hypogonadism
• Delayed puberty associated with
insufficient gonadotropic
pituitary function
• Cryptorchidism, not due to
anatomical obstruction
• Sterility in selected cases of
deficient spermatogenesis
4.2 Posology and method of
administration
Dosage in the female:
• Sterility due to absence of
follicle ripening or ovulation
Usually, 5000–10000 I.U. for 
1 or 3 days in sequence to
treatment with an FSH-
containing preparation 
• Luteal phase support
A repeat injection of 5000 I.U.
may be given 7 days later to
prevent insufficiency of the
corpus luteum
Dosage in the male:
• Hypogonadotropic hypogonadism
500–1000 I.U. 2–3 times per
week. 
• Delayed puberty associated with
insufficient gonadotropic
pituitary function
1500 I.U. twice weekly for at
least 6 months
• Cryptorchidism, not due to
anatomical obstruction
– Under 6 years of age: 500 I.U.
twice weekly for 6 weeks
– Over 6 years of age: 1000 I.U.
twice weekly for 6 weeks.
If necessary, this treatment can
be repeated.
• Sterility in selected cases of
deficient spermatogenesis
Usually, 3000 I.U. per week in
combination with a 
FSH-containing preparation
Method of

خصائص المنتج

SG-CCDS-MK8829-SOi-062019
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. A vial contains 5000 IU
hCG.
For a full list of 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
:

Sterility due to absence of follicle ripening or ovulation

Luteal phase support
In the male
:

Hypogonadotropic hypogonadism

Delayed puberty associated with insufficient gonadotropic pituitary
function

Cryptorchidism, not due to anatomical obstruction

Sterility in selected cases of deficient spermatogenesis
4.2 Posology and method of administration
Dosage in the female
:

Sterility due to absence of follicle ripening or ovulation
Usually, 5000–10000 I.U. for 1 or 3 days in sequence to treatment
with an FSH-containing
preparation

Luteal phase support
A repeat injection of 5000 I.U. may be given 7 days later to prevent
insufficiency of the corpus
luteum
Dosage in the male
:

Hypogonadotropic hypogonadism
500–1000 I.U. 2–3 times per week.

Delayed puberty associated with insufficient gonadotropic pituitary
function
1500 I.U. twice weekly for at least 6 months.

Cryptorchidism, not due to anatomical obstruction
-
Under 6 years of age: 500 I.U. twice weekly for 6 weeks.
-
Over 6 years of age: 1000 I.U. twice weekly for 6 weeks.
If necessary, this treatment can be repeated.

Sterility in selected cases of deficient spermatogenesis
Usually, 3000 I.U. per week in combination with a FSH-containing
preparation
Method of administration
After addition of the solvent to the freeze-d