Lucrin Depot Paediatric leuprorelin acetate 30 mg powder for injection prefilled dual chamber syringe

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

leuprorelin acetate, Quantity: 30 mg

제공처:

Abbvie Pty Ltd

INN (국제 이름):

leuprorelin acetate

약제 형태:

Injection, modified release

구성:

Excipient Ingredients: mannitol; polylactic acid

관리 경로:

Intramuscular

패키지 단위:

1 prefilled dual chamber syringe

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

Lucrin Depot Paediatric 30 mg 3-Month PDS Injection is indicated in the treatment of children with central precocious puberty (CPP).

제품 요약:

Visual Identification: White lyophilised powder which, when reconstituted, becomes a milky suspension; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Licence status A

승인 날짜:

2014-10-13

환자 정보 전단

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1
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

제품 특성 요약

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