Lucrin Depot 6-month

البلد: نيوزيلاندا

اللغة: الإنجليزية

المصدر: Medsafe (Medicines Safety Authority)

العنصر النشط:

Leuprorelin acetate 30mg (powder for injection compartment)

متاح من:

AbbVie Limited

INN (الاسم الدولي):

Leuprorelin acetate 30 mg (powder for injection compartment)

جرعة:

30 mg

الشكل الصيدلاني:

Injection (depot)

تركيب:

Active: Leuprorelin acetate 30mg (powder for injection compartment) Excipient: Carmellose sodium Glacial acetic acid Lactic acid Mannitol Polysorbate 80 Water for injection

الوحدات في الحزمة:

Syringe, glass, rubber stopper and front assembly one compartment of powder and one of 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, rubber stopper and front assembly one compartment of powder and one of diluent - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at or below 25°C protect from light

تاريخ الترخيص:

2005-09-29

نشرة المعلومات

Lucrin Depot PDS
14 November 2019
Page 1 of 5
Version
7
LUCRIN
® DEPOT PDS
_A PREFILLED DUAL-CHAMBERED SYRINGE (PDS) FOR INJECTION CONTAINING _
_3.75 MG, 11.25 MG OR 30 MG OF LEUPRORELIN ACETATE _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you are given LUCRIN
DEPOT PDS.
This leaflet answers some
common questions about
LUCRIN DEPOT PDS.
It does not take the place of
talking to your doctor or
pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you taking LUCRIN
DEPOT PDS against the
benefits they expect it will have
on you.
IF YOU HAVE ANY CONCERNS
ABOUT BEING GIVEN THIS
MEDICINE, TALK TO YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to
read it again
.
WHAT LUCRIN DEPOT
PDS IS USED FOR
LUCRIN DEPOT PDS is a
synthetic form of the naturally
occurring gonadotropin
releasing hormone.
LUCRIN DEPOT PDS is used
to block the secretion of
hormones and can be used in
the following conditions:
Prostate Cancer (3.75mg,
11.25mg and 30mg)
Endometriosis, Uterine Fibroids
and Breast Cancer (3.75mg and
11.25mg)
Central Precocious Puberty
(early onset of puberty) in
children (3.75mg)
Your
doctor
may
have
prescribed
LUCRIN
DEPOT
PDS for another purpose. Ask
your
doctor
if
you
have
any
questions about why LUCRIN
DEPOT
PDS
has
been
prescribed for you
.
LUCRIN DEPOT PDS is
available only with a doctor's
prescription.
LUCRIN DEPOT PDS is not
addictive.
BEFORE YOU ARE GIVEN
LUCRIN DEPOT PDS
WHEN YOU MUST NOT BE
GIVEN LUCRIN DEPOT PDS
You must not be given
LUCRIN DEPOT PDS if you
have ever had an allergy to
other drugs similar to LUCRIN
DEPOT PDS or any of the
ingredients listed at the end of
this leaflet.
Symptoms of an allergic
reaction may include:
•
shortness of breath,
wheezing or difficulty
in breathing
•
swelling of the face,
lips, tongue or other
parts of the body
•
rash, itching or hives on
the skin
You must not be given
LUCRIN DEPOT PDS if the
packaging is broken or shows
any signs of tampering.
Y

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