Pamorelin Powder for Suspension for Injection 22.5 mg per vial

देश: सिंगापुर

भाषा: अंग्रेज़ी

स्रोत: HSA (Health Sciences Authority)

सक्रिय संघटक:

Triptorelin Embonate 31 mg eqv Triptorelin

थमां उपलब्ध:

ORIENT EUROPHARMA PTE LTD

ए.टी.सी कोड:

L02AE04

डोज़:

22.5 mg

फार्मास्यूटिकल फॉर्म:

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION

रचना:

Triptorelin Embonate 31 mg eqv Triptorelin 22.5 mg

प्रशासन का मार्ग:

INTRAMUSCULAR

प्रिस्क्रिप्शन प्रकार:

Prescription Only

द्वारा बनाया गया:

Debiopharm Research & Manufacturing SA

प्राधिकरण का दर्जा:

ACTIVE

प्राधिकरण की तारीख:

2013-03-11

सूचना पत्रक

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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 
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The recommended dose of Pamorelin is 11.25 mg t

उत्पाद विशेषताएं

SUMMARY OF PRODUCT CHARCTERISTICS
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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
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TABLE 1: PAMORELIN RECOMMENDED DOSING
No dosage adjustment is necessary for patients with renal or hepatic
impairment.
In women the treatment of en