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HSA Approval

DECAPEPTYL CR FOR INJECTION 3.75 mg/syringe

SIN09105P

DECAPEPTYL CR FOR INJECTION 3.75 mg/syringe

DECAPEPTYL CR FOR INJECTION 3.75 mg/syringe

December 28, 1996

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Regulatory Information

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

Formulation Information

INJECTION, POWDER, FOR SOLUTION

**Dosage and Administration** One syringe of DECAPEPTYL® CR is injected once every 28 days either subcutaneously (e.g. in the skin of the abdomen, the buttock or thigh) or intramuscularly. The injection site should be changed. Men Therapy of prostate carcinoma: It is important that the 4-week cycle be observed. As a diagnostic: It can be generally clarified after 3 months treatment whether the prostate cancer is androgen dependent or not. If so, administration can be continued. Women Uterine myoma and endometriosis: In view of the possible effect on bone density, therapy should not exceed a 6-month period. Assisted reproduction techniques: Single administration on cycle days 2 or 3 (follicular phase) or cycle day 22 (luteal phase). Children: Treatment starts with the injection of one syringe each, equivalent to 3.75 mg triptorelin, on days 0, 14, and 28. Thereafter one injection follows every 4 weeks. Should the effect be insufficient, the injections may be given every 3 weeks. Dosing should be based on body weight. Children weighing less than 20 kg receive 1.875 mg (half dose), children between 20 and 30 kg receive 2.5 mg (2/3 dose), and children with more than 30 kg body weight are given 3.75 mg triptorelin (full dose). Treatment should be stopped if a bone maturation of older than 12 years in girls and older than 13 years in boys has been achieved.

SUBCUTANEOUS, INTRAMUSCULAR

Medical Information

**Indications** DECAPEPTYL® CR is indicated in situations where lowering of sex steroid serum levels to castrate level is desired, such as prostate cancer, endometriosis or uterine myoma, or assisted reproduction techniques, e.g. IVF. Treatment of confirmed central precocious puberty (preterm sexual development) (girls under 9 years, boys under 10 years of age).

**Contraindications** Men - Hormone independent prostate carcinoma. - Following surgical castration. DECAPEPTYL® CR induces no further decrease in the testosterone level. Women - Clinically manifest osteoporosis or risk of osteoporosis (e.g. reduced bone density). - Pregnancy. - Lactation period. Assisted reproduction techniques: - Particularly in patients with polycystic ovaries, the use of DECAPEPTYL® CR should be considered with great precaution, when the number of ultra sonographically detected follicles exceeds 10. Men and Women Known hypersensitivity reaction to triptorelin, poly (DL-lactide-co-glycolide), dextran or any other ingredients. Children Progressive brain tumours.

L02AE04

triptorelin

Manufacturer Information

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING GMBH

Active Ingredients

TRIPTORELIN ACETATE 4.12 mg/syringe EQV TRIPTORELIN

3.75 mg/syringe

Triptorelin

Documents

Package Inserts

Decapeptyl CR for Injection PI.pdf

Approved: October 25, 2021

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