Leuprorelin Sandoz

País: Nueva Zelanda

Idioma: inglés

Fuente: Medsafe (Medicines Safety Authority)

Ingredientes activos:

Leuprorelin acetate 3.78mg equivalent to 3.6 mg leuprorelin

Disponible desde:

Sandoz New Zealand Limited

Designación común internacional (DCI):

Leuprorelin acetate 3.78 mg (= 3.6 mg leuprorelin)

Dosis:

3.6 mg

formulario farmacéutico:

Subcutaneous implant

Composición:

Active: Leuprorelin acetate 3.78mg equivalent to 3.6 mg leuprorelin Excipient: Polyglactin

tipo de receta:

Prescription

Fabricado por:

BCN Peptides SA

indicaciones terapéuticas:

Palliative treatment of patients with advanced, hormone-dependent prostate carcinoma

Resumen del producto:

Package - Contents - Shelf Life: Syringe, containing injectable implant , unit packed in PET/Al/PE sealed bag in carton - 1 implants - 36 months from date of manufacture stored at or below 30°C - Syringe, containing injectable implant , unit packed in PET/Al/PE sealed bag in carton - 2 implants - 36 months from date of manufacture stored at or below 30°C - Syringe, containing injectable implant , unit packed in PET/Al/PE sealed bag in carton - 3 implants - 36 months from date of manufacture stored at or below 30°C - Syringe, containing injectable implant , unit packed in PET/Al/PE sealed bag in carton - 5 implants - 36 months from date of manufacture stored at or below 30°C

Fecha de autorización:

2015-12-11

Información para el usuario

181026-leuprorelin-sandoz-cmi
Page 1 of 7
NEW ZEALAND CONSUMER MEDICINE INFORMATION
LEUPRORELIN SANDOZ
_LEUPRORELIN ACETATE 3.6 MG, IMPLANT IN PRE-FILLED SYRINGE [MONTHLY] _
_LEUPRORELIN ACETATE 5 MG, IMPLANT IN PRE-FILLED SYRINGE [3 MONTHLY] _
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start using Leuprorelin
Sandoz.
This leaflet answers some common questions about Leuprorelin Sandoz.
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 using Leuprorelin
Sandoz against the benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT LEUPRORELIN SANDOZ IS USED FOR
The active substance of Leuprorelin Sandoz (leuprorelin acetate)
belongs to the group of inhibitors of
certain sex hormones.
Leuprorelin Sandoz acts on the pituitary gland, briefly stimulating
then curbing production of the
hormones that control the production of the sex hormones in the
testes. This means that the
concentrations of the sex hormones subsequently fall and, with
continued administration, remain at
this
level.
After
discontinuing
Leuprorelin
Sandoz
the
concentrations
of
the
pituitary
and
sex
hormones return again to the normal range.
Leuprorelin Sandoz is used for symptomatic treatment of advanced
hormone-dependent tumours of
the prostate (prostate carcinoma).
Your doctor may have prescribed Leuprorelin Sandoz for another reason.
Ask your doctor if you have
any questions about why Leuprorelin Sandoz has been prescribed for
you.
This medicine is available only with a doctor's prescription.
Leuprorelin Sandoz is not addictive.
BEFORE YOU USE LEUPRORELIN SANDOZ
_ _
_WHEN YOU MUST NOT USE IT _
Do not use Leuprorelin Sandoz if:
•
you are ALLERGIC to leuprorelin or the other ingredient in this
medicine; polylactic acid.
181026-leuprorelin-

Ficha técnica

181030-Leuprorelin Sandoz-ds
Page 1 of 14
NEW ZEALAND DATA SHEET
LEUPRORELIN SANDOZ IMPLANT (LEUPRORELIN ACETATE)
1.
PRODUCT NAME
LEUPRORELIN SANDOZ, 3.6 mg or 5 mg, implant in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains 3.6 mg or 5 mg leuprorelin (as leuprorelin
acetate).
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Implant in pre-filled syringe.
Biodegradable white to slightly yellowish cylinder shaped stick
(length 10 mm) in a pre-filled
syringe.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Palliative treatment of patients with advanced hormone-dependent
prostate carcinoma.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
The indication for treatment should be established and the long-term
therapy monitoring
carried out by physicians experienced in tumour therapy.
_LEUPRORELIN SANDOZ 3.6 mg: _
The recommended dose is a single dose of 3.6 mg once monthly.
After the second administration, its use can be postponed by up to 2
weeks in exceptional cases,
without
usually
impairing
the
therapeutic
effect
in
most
patients
(see
Section
5.2
Pharmacokinetic properties).
_LEUPRORELIN SANDOZ 5 mg: _
The recommended dose is a single-dose of 5 mg once every 3 months.
If, in exceptional cases, the date of administration is postponed by
up to 4 weeks, in the majority
of patients the therapeutic effect should not be impaired (see Section
5.2 Pharmacokinetic
properties).
DOSAGE ADJUSTMENT IN

renal impairment
No dosage adjustment is necessary for patients with renal or hepatic
impairment, or in older
people.
181030-Leuprorelin Sandoz-ds
Page 2 of 14

Paediatrics
LEUPRORELIN SANDOZ is contraindicated in children and adolescents see
Section 4.3
Contraindications.
METHOD OF ADMINISTRATION
One implant is injected subcutaneously into the anterior abdominal
wall.
Before injection, a local anaesthetic may be given.
It is recommended that administration of an anti-androgen is started
as adjunctive therapy about
5 days before starting LE