ELIGARD ® POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 22.5mg

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Leuprorelin 20.87 mg eqv to Leuprorelin Acetate

Available from:

DCH AURIGA SINGAPORE

ATC code:

L02AE02

Dosage:

22.5 mg

Pharmaceutical form:

INJECTION, POWDER, LYOPHILIZED, FOR SUSPENSION,EXTENDED RELEASE

Composition:

Leuprorelin 20.87 mg eqv to Leuprorelin Acetate 22.5 mg

Administration route:

SUBCUTANEOUS

Prescription type:

Prescription Only

Manufactured by:

Tolmar Inc. (Powder and Solvent)

Authorization status:

ACTIVE

Authorization date:

2014-02-25

Patient Information leaflet

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

Summary of Product characteristics

04006198
Other events: Cases of ureteral obstruction and spinal cord
compression, which may contribute
to paralysis with or without fatal complications, have been reported
with GnRH agonists. If spinal
cord compression or renal impairment develops, standard treatment of
these complications should
be instituted.
Patients with vertebral and/or brain metastases as well as patients
with urinary tract obstruction
should be closely monitored during the irst few weeks of therapy.
4.5 Interaction with other medicinal products and other forms of
interaction
No pharmacokinetic drug-drug interaction studies have been performed
with ELIGARD. There
have been no reports of any interactions of leuprorelin acetate with
other medicinal products.
Since androgen deprivation treatment may prolong the QT interval, the
concomitant use of
ELIGARD with medicinal products known to prolong the QT interval or
medicinal products able to
induce Torsade de pointes such as Class IA
e.g., quinidine,disopyramide procainamide or Class
III
e.g., amiodarone, sotalol, dofetilide, ibutilide antiarrhythmic
medicinal products, methadone,
moxiloxacin, antipsychotics, etc. should be carefully evaluated see
section ..
4.6 Pregnancy and lactation
Not applicable as ELIGARD is contraindicated in women. Expected
hormonal changes that occur
with Eligard treatment increase the risk for pregnancy loss. In
non-clinical studies in rats, major
fetal abnormalities were observed after administration of leuprorelin
acetate throughout gestation.
There were increased fetal mortality and decreased fetal weights in
rats and rabbits. The efects
of fetal mortality are expected consequences of the alterations in
hormonal levels brought about
by this drug. The possibility exists that spontaneous abortion may
occur. It is not known whether
leuprorelin acetate is excreted into human milk.
. EFECTS ON ABILITY TO DRIVE AND USE MACHINES
No studies on the efects of ELIGARD on the ability to drive and use
machines have been
performed.
The ability to drive and operate machines may be