ELIGARD ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 22.5mg

Land: Singapore

Språk: engelsk

Kilde: HSA (Health Sciences Authority)

Aktiv ingrediens:

Leuprorelin 20.87 mg eqv to Leuprorelin Acetate

Tilgjengelig fra:

DCH AURIGA SINGAPORE

ATC-kode:

L02AE02

Dosering :

22.5 mg

Legemiddelform:

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION,EXTENDED RELEASE

Sammensetning:

Leuprorelin 20.87 mg eqv to Leuprorelin Acetate 22.5 mg

Administreringsrute:

SUBCUTANEOUS

Resept typen:

Prescription Only

Produsert av:

Tolmar Inc. (Powder and Solvent)

Autorisasjon status:

ACTIVE

Autorisasjon dato:

2014-02-25

Informasjon til brukeren

ELIGARD 7.5 MG
ELIGARD 22.5 MG
ELIGARD 45 MG
1. NAME OF THE MEDICINAL PRODUCT

ELIGARD 7.5 mg powder and solvent for solution for injection 
  ELIGARD 22.5 mg powder and solvent for solution for injection 
  ELIGARD 45 mg powder and solvent for solution for injection 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION

  ELIGARD 7.5 mg 
   One prefilled syringe with powder for solution for
injection contains 7.5 mg 
leuprorelin acetate, equivalent to 6.96 mg leuprorelin.
  ELIGARD 22.5 mg 
   One prefilled syringe with powder for solution for injection
contains 22.5 mg 
leuprorelin acetate, equivalent to 20.87 mg leuprorelin. 
  ELIGARD 45 mg
   One prefilled syringe with
powder for solution for injection contains 45 mg leuprorelin 
acetate, equivalent to 41.7 mg leuprorelin.
 For 
_a full list of_ excipients, see section 6.1.
3. PHARMACEUTICAL FORM

Powder and solvent for solution for injection,
  Powder (Syringe B):
  Pre-filled syringe with a white to off-white powder.
  Solvent (Syringe A):
  Pre-filled syringe with a clear, colourless to
pale yellow solution
4. CLINICAL PARTICULARS

4.1 THERAPEUTIC INDICATIONS
   ELIGARD is indicated for the palliative treatment of hormone
dependent advanced 
prostate cancer.
  4.2 POSOLOGY AND METHOD OF ADMINISTRATION

  Dosage for Adult Males
   ELIGARD should be administered under the direction of a
healthcare professional 
having available the appropriate expertise for monitoring the
response to treatment.
   ELIGARD 7.5 mg is administered as a single subcutaneous
injection every month. 
The injected solution forms a solid medicinal product delivery depot
and provides 
continuous release of leuprorelin acetate for one month.
   ELIGARD 22.5 mg is administered as a single subcutaneous
injection every three 
months. The injected solution forms a solid medicinal
product delivery depot and 
provides continuous release of

Preparatomtale

1.
NAME OF THE MEDICINAL PRODUCT
ELIGARD 7.5 mg powder and solvent for solution for injection
ELIGARD 22.5 mg powder and solvent for solution for injection
ELIGARD 45 mg powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Powder and solvent for solution for injection
Powder (Syringe B):
Pre-filled syringe with a white to off-white powder.
Solvent (Syringe A):
ELIGARD 7.5 mg
One prefilled syringe with powder for solution for injection contains
7.5 mg leuprorelin acetate,
equivalent to 6.96 mg leuprorelin.
ELIGARD 22.5 mg
One prefilled syringe with powder for solution for injection contains
22.5 mg leuprorelin acetate,
equivalent to 20.87 mg leuprorelin.
ELIGARD 45 mg
One prefilled syringe with powder for solution for injection contains
45 mg leuprorelin acetate,
equivalent to 41.7 mg leuprorelin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection_._
Powder (Syringe B):
Pre-filled syringe with a white to off-white powder.
Solvent (Syringe A):
ELIGARD 7.5mg: Pre-filled syringe with a clear, colourless to pale
yellow/brown solution
ELIGARD 22.5mg & 45mg: Pre-filled syringe with a clear, colourless to
pale yellow solution
_ _
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELIGARD is indicated for the palliative treatment of hormone dependent
advanced prostate cancer._ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult Males _
ELIGARD should be administered under the direction of a healthcare
professional having available
the appropriate expertise for monitoring the response to treatment.
ELIGARD 7.5 mg is administered as a single subcutaneous injection
every month. The injected
solution forms a solid medicinal product delivery depot and provides
continuous release of
leuprorelin acetate for one month.
ELIGARD 22.5 mg is administered as a single subcutaneous injection
every three months. The
injected solution forms a solid medicinal product delivery depot and
provides continuous release
of leuprorelin