Lucrin Depot 3-Month

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Leuprorelin acetate 11.25mg (Powder for injection compartment)

متاح من:

AbbVie Limited

INN (الاسم الدولي):

Leuprorelin acetate 11.25 mg (Powder for injection compartment)

جرعة:

11.25 mg

الشكل الصيدلاني:

Injection (depot)

تركيب:

Active: Leuprorelin acetate 11.25mg (Powder for injection compartment) Excipient: Carmellose sodium Glacial acetic acid Polylactic acid (PLA) powder for injection compartment Mannitol Polysorbate 80 Water for injection

الوحدات في الحزمة:

Syringe, glass, 1 compartment pwdr + 1 comp. diluent, 1 dose unit

الفئة:

Prescription

نوع الوصفة الطبية :

Prescription

المصنعة من قبل:

Takeda Pharmaceutical Company Limited

الخصائص العلاجية:

Lucrin (leuprorelin acetate) is indicated · in metastatic prostate cancer · in locally advanced prostate cancer, as an alternative to surgical castration · as an adjuvant treatment to radiotherapy in patients with high-risk localized or locally advanced prostate cancer · as an adjuvant treatment to radical prostatectomy in patients with locally advanced prostate cancer at high risk of disease progression

ملخص المنتج:

Package - Contents - Shelf Life: Syringe, glass, 1 compartment pwdr + 1 comp. diluent - 1 dose units - 36 months from date of manufacture stored at or below 25°C 24 hours opened stored at or below 25°C

تاريخ الترخيص:

2005-09-29

نشرة المعلومات

Lucrin®
1
LUCRIN®
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; uterine fibroids,
endometriosis and breast cancer in women; 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 HAVE 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 TAKING 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 taking 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
•
Monitor your blood glucose regularly if you have diabetes
•
Remind any doctor, nurse, dentist or pharmacist 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 but take care until you know
how it affects you.
DRINKING

خصائص المنتج

Lucrin Depot PDS
Version 12
9 October 2023
Page 1 of 47
NEW ZEALAND DATA SHEET
1.
LUCRIN
® DEPOT 3.75 MG PREFILLED DUAL-CHAMBER SYRINGE (PDS) INJECTION
LUCRIN
® DEPOT 11.25 MG PREFILLED DUAL-CHAMBER SYRINGE (PDS) INJECTION
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lucrin Depot PDS is a formulation of leuprorelin acetate supplied as
sterile lyophilised microspheres which,
when mixed with the accompanying diluent, forms a suspension.
Lucrin Depot contains either 3.75 mg or 11.25 mg of leuprorelin
acetate per single dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pre-filled dual-chamber syringe containing a powder in one compartment
and a diluent in the other
compartment which, when mixed, forms a suspension for injection.
Powder:
A sterile, lyophilised, white, odourless powder.
Diluent:
A clear, odourless, slightly viscous, sterile solvent.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
PROSTATE CANCER
Lucrin Depot 3.75 mg and 11.25 mg are indicated:
•
in metastatic prostate cancer,
•
in locally advanced prostate cancer, as an alternative to surgical
castration,
•
as an adjuvant treatment to radiotherapy in patients with high-risk
localised or locally advanced prostate
cancer,
•
as an adjuvant treatment to radical prostatectomy in patients with
locally advanced prostate cancer at high
risk of disease progression.
UTERINE FIBROIDS
Lucrin Depot 3.75 mg and 11.25 mg are indicated in the treatment of
leiomyoma uteri (uterine fibroids) for a
period of six months. Therapy may be preoperative prior to myomectomy
or hysterectomy or it may provide
symptomatic relief for the perimenopausal woman who does not desire
surgery.
Lucrin Depot PDS
Version 12
9 October 2023
Page 2 of 47
ENDOMETRIOSIS
Lucrin Depot 3.75 mg and 11.25 mg are indicated in the treatment of
endometriosis for a period of six months.
It can be used as sole therapy or as an adjunct to surgery.
CENTRAL PRECOCIOUS PUBERTY
Lucrin Depot 3.75 mg is indicated in the treatment of children with
central precocious pubert