LUCRIN DEPOT leuprorelin acetate 45mg powder for suspension prefilled dual-chamber syringe injection
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
30-08-2021
Summary of Product characteristics
(SPC)
30-08-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
leuprorelin acetate, Quantity: 45 mg
Available from:
Abbvie Pty Ltd
INN (International Name):
leuprorelin acetate
Pharmaceutical form:
Injection
Composition:
Excipient Ingredients: mannitol; polylactic acid; stearic acid; glacial acetic acid; carmellose sodium; polysorbate 80; water for injections
Administration route:
Intramuscular
Units in package:
1 prefilled dual chamber syringe
Prescription type:
(S4) Prescription Only Medicine
Therapeutic indications:
Lucrin Depot is indicated for the palliative treatment of metastatic or locally advanced prostate cancer.
Product summary:
Visual Identification: White, lyophilised powder which, when reconstituted, becomes a milky suspension; Container Type: Syringe; Container Material: Glass; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2015-05-12
Patient Information leaflet
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CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING LUCRIN?
Lucrin contains the active ingredient leuprorelin acetate. Lucrin is
used to treat prostate cancer in men and precocious (unusually
early) puberty in children.
For more information, see Section 1. Why am I using Lucrin? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LUCRIN?
Check the list of ingredients at the end of the CMI. Do not use Lucrin
if you have ever had an allergic reaction to any of them.
Talk to your doctor before you use this medicine if he/she is not
aware that you have any other medical conditions, take any other
medicines or are pregnant or plan to become pregnant or are
breastfeeding.
For more information, see Section 2. What should I know before I use
Lucrin? in the full CMI.
3.
WHAT IF I AM USING OTHER MEDICINES?
Some medicines may interfere with Lucrin and affect how it works or
Lucrin may interfere with other medicines and affect how they
work.
A list of these medicines is in Section 3. What if I am using other
medicines? in the full CMI.
4.
HOW DO I USE LUCRIN?
•
Lucrin Injection is given by your doctor or nurse.
•
The Lucrin dose and how frequently it is given is based on your
doctor's assessment.
More instructions can be found in Section 4. How do I use Lucrin? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING LUCRIN?
THINGS YOU
SHOULD DO
•
Keep all your appointments, including those for blood tests or bone
density checks.
•
Remind any doctor or dentist you visit that you are using Lucrin.
THINGS YOU
SHOULD NOT DO
•
Do not miss a scheduled injection.
DRIVING
OR USING
MACHINES
•
It is unlikely that Lucrin will affect your ability to drive or use
machines.
DRINKING
ALCOHOL
•
There is no information on the use of Lucrin with alcohol.
LOOKING AFTER
YOUR MEDICINE
•
Store Lucrin in a cool dry place away f
Read the complete document
Summary of Product characteristics
LUCRIN PDS PI
Version 16
24 August 2021
Page 1 of 37
AUSTRALIAN PI – LUCRIN
DEPOT
® AND LUCRIN DEPOT
® PAEDIATRIC
(LEUPRORELIN ACETATE)
PREFILLED DUAL-CHAMBER SYRINGE (PDS) INJECTION
1
NAME OF THE MEDICINE
Leuprorelin acetate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
LUCRIN DEPOT 1-MONTH 7.5 MG PDS INJECTION: each prefilled dual chamber
syringe contains
7.5 mg leuprorelin acetate in the front chamber and 1 mL of diluent in
the rear chamber.
LUCRIN DEPOT 3-MONTH 22.5 MG PDS INJECTION: each prefilled dual
chamber syringe
contains 22.5 mg leuprorelin acetate in the front chamber and 1.5 mL
of diluent in the rear
chamber.
LUCRIN DEPOT 4-MONTH 30 MG PDS INJECTION: each prefilled dual chamber
syringe contains
30 mg leuprorelin acetate in the front chamber and 1.5 mL of diluent
in the rear chamber.
LUCRIN DEPOT 6-MONTH 45 MG PDS INJECTION: each prefilled dual chamber
syringe contains
45 mg leuprorelin acetate in the front chamber and 1.5 mL of diluent
in the rear chamber.
LUCRIN DEPOT PAEDIATRIC 30 MG
PDS INJECTION: each prefilled dual chamber syringe
contains 30 mg leuprorelin acetate in the front chamber and 1.5 mL of
diluent in the rear
chamber.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Prefilled dual chamber syringe consisting of powder for injection and
diluent.
POWDER FOR INJECTION
White lyophilised powder once reconstituted becomes a milky
suspension.
DILUENT
Clear colourless solution.
LUCRIN PDS PI
Version 16
24 August 2021
Page 2 of 37
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LUCRIN Depot PDS injection is indicated for:
•
The palliative treatment of metastatic or locally advanced prostate
cancer
LUCRIN Depot Paediatric 3-Month 30mg PDS injection is indicated for:
•
The treatment of children with central precocious puberty (CPP).
4.2
DOSE AND METHOD OF ADMINISTRATION
Overall treatment with LUCRIN must be done under the supervision of a
physician; however,
administration of the drug product may be done by a healthcare
professional experienced in
Read the complete document
