GONAPEPTYL CR INJECTION 3.75MG X 1 SYRINGE

GONAPEPTYL CR INJECTION 3.75MG X 1 SYRINGE
Product Description
 
1 prefilled syringe with 172 mg controlled - release microcapsules and 1 prefilled syringe with solvent
Children: Treatment of confirmed central precocious puberty (girls under 9 years, boys under 10 years).
Women:
- Preoperative reduction of myoma size to reduce the symptoms of bleeding and pain in women with symptomatic uterine myomas.
- In assisted reproduction techniques to prevent premature LH surges.
- Symptomatic uterine myomas; when suppression of the ovarian hormonogenesis is indicated as a preoperative measure to reduce the size of individual myomas prior to scheduled myoma nucleation or hysterectomy.
- Symptomatic endometriosis confirmed by laparoscopy; when suppression of the ovarian hormonogenesis is indicated to the extent that surgical therapy is not primarily indicated.
Men: Treatment of advanced, hormone-dependent prostate carcinoma.
1. Name of the medicinal product
GONAPEPTYL DEPOT
3.75 mg
Powder and solvent for suspension for injection
2. 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.
The product contains 3.69 mg/ml equivalent to 0.160 mmol/ml sodium after reconstitution.
For a full list of excipients, see section 6.1
3. 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.
4. Clinical particulars
4.1 Therapeutic indications
Men:
Treatment of hormone dependent locally advanced or metastatic prostate cancer.
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.
Children:
Treatment of confirmed central precocious puberty (girls under 9 years, boys under 10 years).
4.2 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.
The treatment of children with triptorelin should be under the overall supervision of the paediatric endocrinologist or of a paediatrician or endocrinologist with expertise in the treatment of central precocious puberty.
It is important that the injection of the sustained release form be performed strictly in accordance with the instructions given in section 6.6.
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 every 28 days 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 injection with one syringe, equivalent to 3.75 mg triptorelin. In order to continually suppress testosterone levels, it is important to comply with a 4-weekly administration.
Women:
- Uterine myomas and endometriosis:
Once every four weeks an injection with one syringe, equivalent to 3.75 mg triptorelin. The treatment must be initiated in the first 5 days of the cycle.
Pack size Treatment Decapeptyl Cr 3.75 mg Inj (Triptorelin), Prescription, Treatment: Composition
FORMA FARMACÉUTICA Y FORMULACIÓN:
La jeringa pre-llenada contiene:
GONAPEPTYL® DAILY
Acetato de Triptorelina equivalente a 95.60 μg
Triptorelina
Vehículo cbp 1 ml
 
وصف المنتج
جونابيبتيل سي آر ٣٫٧٥ ملغم مسحوق ومذيب لتكوين معلَق للحقن
حقنة واحدة معبىة مسبقأ من المسحوق وحقنة واحدة معبىة مسبقأ من المحلول
للأطفال: لعلاج حالة البلوغ المبكر المركزي المثبتة تشخيصاً (عند الفتيات تحت ٩ سنوات، الفتيان تحت ١٠ سنوات)
للنساء:
- لتقليص ورم النسيج العضلي قبل الاستئصال الجراحي وذلك للتخفيف من أعراض النزيف والألم عند النساء اللاتي يعانين من أورام عضلية في الرحم المصحوبة بالأعراض.
- في التقنيات المساعدة على الإنجاب لمنع اندفاع الهرمون اللوتيني المبكّر.
- الأورام العضلية في الرحم المصحوبة بالأعراض؛ عندما يُشار إلى كبت تكوين الهرمونات المبيضية كإجراء سابق للجراحة من أجل تقليل حجم الورم العضلي الفردي قبل القيام بتنوي الورم العضلي أو استئصال الرحم المقرران.
- انتباذ بطانة الرحم المصحوبة بالأعراض التي أكدها تنظير البطن؛ عندما يشار إلى كبت الهرمونات المبيضية طالما لا يشار إلى العلاج الجراحي بشكل أساسي.
للرجال: علاج سرطان البروستات المتقدم المعتمد على الهرمونات