देश: सिंगापुर
भाषा: अंग्रेज़ी
स्रोत: HSA (Health Sciences Authority)
Triptorelin Embonate 16.8 mg eqv Triptorelin
ORIENT EUROPHARMA PTE LTD
L02AE04
11.25 mg
INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION
Triptorelin Embonate 16.8 mg eqv Triptorelin 11.25 mg
INTRAMUSCULAR
Prescription Only
Debiopharm Research & Manufacturing SA
ACTIVE
2013-03-11
_ _ Page 1 of 11_ _ PAMORELIN ® NAME OF THE MEDICINAL PRODUCT Pamorelin Powder for Suspension for Injection. Strengths: 3.75 mg, 11.25 mg, and 22.5 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Pamorelin 3.75mg contains triptorelin embonate equivalent to 3.75 mg triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 1.875 mg of triptorelin. Each vial of Pamorelin 11.25 mg contains triptorelin embonate equivalent to 11.25 mg triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 5.625 mg of triptorelin. Each vial Pamorelin 22.5 mg contains triptorelin embonate equivalent to 22.5 mg triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 11.25 mg of triptorelin. PHARMACEUTICAL FORM Pamorelin is supplied as lyophilized powder for Intramuscular (IM) injection. Powder: White to off-white powder. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Pamorelin is indicated for the treatment of locally advanced or metastatic, hormone- dependent prostate cancer. POSOLOGY AND METHOD OF ADMINISTRATION Pamorelin is administered by a single intramuscular injection. As with other medicinal products administered by injection, the injection site should be varied periodically. Dosing schedule depends on the products strength selected (see Table 1). TABLE 1 : PAMORELIN RECOMMENDED DOSING PAMORELIN 3.75MG (1MONTH FORMULATION) The recommended dose of Pamorelin is 3.75 mg triptorelin (1 vial) administered once a month (i.e. every 4 weeks) as a single intramuscular injection. PAMORELIN 11.25MG (3 MONTH FORMULATION) DOSAGE 3.75 MG 11.25 MG 22.5 MG Recommended dose 1 injection every 4 weeks 1 injection every 12 weeks 1 injection every 24 weeks _ _ Page 2 of 11_ _ The recommended dose of Pamorelin is 11.25 mg t पूरा दस्तावेज़ पढ़ें
SUMMARY OF PRODUCT CHARCTERISTICS _ _ Page 1 of 18 _ _ PAMORELIN ® NAME OF THE MEDICINAL PRODUCT Pamorelin Powder for Suspension for Injection. Strengths: 3.75 mg, 11.25 mg, and 22.5 mg QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Pamorelin 3.75mg contains triptorelin embonate equivalent to 3.75 mg of triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 1.875 mg of triptorelin. Each vial of Pamorelin 11.25 mg contains triptorelin embonate equivalent to 11.25 mg of triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 5.625 mg of triptorelin. Each vial Pamorelin 22.5 mg contains triptorelin embonate equivalent to 22.5 mg of triptorelin. After reconstitution in 2 ml solvent, 1 ml of reconstituted suspension contains 11.25 mg of triptorelin. PHARMACEUTICAL FORM Pamorelin is supplied as lyophilized powder for intramuscular (IM) injection. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS Pamorelin 3.75 mg, 11.25 mg, and 22.5 mg is indicated for the treatment of locally advanced or metastatic, hormone-dependent prostate cancer. Pamorelin 3.75 mg, 11.25 mg, and 22.5 mg are indicated as concomitant to and following radiotherapy in patients with high-risk localized or locally advanced prostate cancer. Pamorelin 3.75 mg is indicated for the treatment of endometriosis. Pamorelin 3.75 mg is indicated for the pituitary down-regulation in the context of assisted reproduction technology. Pamorelin 22.5 mg is indicated for the treatment of central precocious puberty (CPP) in children of 2 years of age and older with an onset of CPP before 8 years in girls and 10 years in boys. POSOLOGY AND METHOD OF ADMINISTRATION Pamorelin is administered by a single intramuscular injection. Dosing schedule depends on the product strength selected (see Table 1). SUMMARY OF PRODUCT CHARCTERISTICS _ _ Page 2 of 18 _ _ TABLE 1: PAMORELIN RECOMMENDED DOSING No dosage adjustment is necessary for patients with renal or hepatic impairment. In women the treatment of en पूरा दस्तावेज़ पढ़ें