LUCRIN leuprorelin acetate 5mg/mL injection multidose vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

leuprorelin acetate

Available from:

Abbvie Pty Ltd

INN (International Name):

leuprorelin acetate

Authorization status:

Registered

Patient Information leaflet

LUCRIN
® INJECTION
_Leuprorelin acetate_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Lucrin Injection.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT LUCRIN IS USED
FOR
Lucrin is used to treat prostate
cancer.
It belongs to a group of medicines
called gonadotropin releasing
hormone agonists.
It works by blocking the secretion of
hormones from testes. In some types
of cancer, these hormones help the
cancer cells to grow. By blocking
these hormones, Lucrin may slow or
stop the growth of prostate cancer.
ASK YOUR DOCTOR OR PHARMACIST IF
YOU HAVE ANY QUESTIONS ABOUT WHY
IT HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
Lucrin is available only with a
doctor's prescription.
Lucrin should not be given to
children.
BEFORE YOU ARE GIVEN
LUCRIN
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT RECEIVE LUCRIN IF YOU HAVE
AN ALLERGY TO:
•
ANY MEDICINE SIMILAR TO LUCRIN
•
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
PREGNANCY AND BREASTFEEDING
Although not relevant to prostate
cancer patients, Lucrin should not be
used during pregnancy or while
breastfeeding.
DO NOT ADMINISTER AFTER THE EXPIRY
DATE PRINTED ON THE PACK OR IF THE
PACKAGING IS DAMAGED OR SHOWS
SIGNS OF TAMPERING.
If it has expired or is damaged return
it to your pharmacist for disposal.
_BEFORE YOU ARE GIVEN LUCRIN_
TELL YOUR DOCTOR IF YOU HAVE ANY
ALLERGIES TO ANY OTHER MEDICINES,
FOODS, PRESERVATIVES O

Summary of Product characteristics

_LUCRIN leuprorelin acetate 5mg/mL _
_injection multidose _
_Version 16 _
_09 October 2018 _
_Page 1 of 10 _
AUSTRALIAN PRODUCT INFORMATION
LUCRIN (LEUPRORELIN ACETATE)
1.
NAME OF THE MEDICINE
NON-PROPRIETARY NAME
Leuprorelin acetate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5mL multi-dose vial contains 2.8mL of solution (14 doses). In
0.2mL solution contains 1mg of
leuprorelin acetate.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Clear, sterile solution supplied in clear glass multi-dose vials
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Lucrin (leuprorelin acetate) is indicated in the palliative treatment
of metastatic or locally extensive
prostatic cancer (Stage C and D).
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose is 1mg (0.2mL) administered as a single daily
subcutaneous injection. As
with other drugs administered chronically by subcutaneous injection,
the injection site should be
varied periodically.
Note:
Parenteral
drug
products
should
be
inspected
visually
for
particulate
matter
and
discolouration prior to administration, whenever solution and
container permit.
4.3 CONTRAINDICATIONS
Although not relevant to the approved indication, leuprorelin is
contraindicated in pregnancy due to
its embryotoxic effects. (See Section 4.6 Fertility, Pregnancy and
Lactation)
Although not relevant to the approved indication, leuprorelin acetate
should not be administered to
a nursing mother as it is not known whether leuprorelin acetate is
excreted into human milk. (See
Section 4.6 Fertility, Pregnancy and Lactation)
Although not relevant to the approved indication, leuprorelin acetate
should not be administered to
patients with undiagnosed vaginal bleeding.
_LUCRIN leuprorelin acetate 5mg/mL _
_injection multidose _
_Version 16 _
_09 October 2018 _
_Page 2 of 10 _
Leuprorelin acetate injection is contraindicated in patients with
known hypersensitivity to leuprorelin
acetate or similar nonapepetides or any of the excipients.
4.4 SPECIAL WARNINGS A