Gonapeptyl CR 3.75 mg

Country: Jordan

Language: English

Source: JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

Active ingredient:

Triptorelin 3.75 mg

Available from:

مستودع البتراء للمواد الطبية - Petra Drug Store

ATC code:

L02AE04

INN (International Name):

Triptorelin 3.75 mg

Dosage:

3.75 mg

Units in package:

1 Syringe With 127mg Microcapsules & one Syringe with 1ml suspension agent

Manufactured by:

FERRING GMBH/GERMANY (المانيا)

Product summary:

121.73 :سعر الجمهور + الضريبة

Patient Information leaflet

GONAPEPTYL
® CR
NAME OF THE MEDICINAL PRODUCT
GONAPEPTYL CR
3.75 mg
Powder and solvent for suspension for injection
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 3.75 mg triptorelin (as acetate) to be
suspended in one ml sodium containing suspension agent.
PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
prolonged release in pre-filled syringes.
Visual description:
Before mixing: White to faintly yellow powder and a clear colourless
aqueous liquid.
After mixing: Homogeneous milky white to faintly yellow suspension.
CLINICAL PARTICULARS
Therapeutic indications
_MEN:_
-Treatment of hormone dependent locally advanced or metastatic
prostate cancer.
-Hormone sensitivity-assessment of a prostate carcinoma.
_WOMEN:_
-Preoperative reduction of myoma size to reduce the symptoms of
bleeding and pain in women with symptomatic uterine myomas.
-Symptomatic endometriosis confirmed by laparoscopy when suppression
of the ovarian hormonogenesis is indicated to the extent that surgical
therapy
is not primarily indicated.
-Down regulation and prevention of premature luteinizing hormone (LH)
surges in women undergoing controlled ovarian hyperstimulation for
assisted
reproductive technologies (ART).
_CHILDREN:_
-Treatment of confirmed central precocious puberty (girls under 9
years, boys under 10 years).
Posology and method of administration
The product should only be used under the supervision of an
appropriate specialist having requisite facilities for regular
monitoring of response.
It is important that the injection of the sustained release form be
performed strictly in accordance with the instructions given below.
Following reconstitution, the suspension has to be injected
immediately.
DOSAGE AND METHOD OF ADMINISTRATION
The dosage of one syringe, equivalent to 3.75 mg Triptorelin, is
injected either subcutaneously (e.g. into the skin of the abdomen, the
buttock or thigh)
or deep intramuscularly. The injection site should be changed each
time.
_MEN:_
-Once every four weeks an inject