Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triptorelin

Available from:

PCO Manufacturing Ltd.

ATC code:

L02AE04

INN (International Name):

Triptorelin

Dosage:

11.25 milligram(s)

Pharmaceutical form:

Powder and solvent for suspension for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

triptorelin

Authorization status:

Authorised

Authorization date:

2011-05-20

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
DECAPEPTYL
®
3-MONTH 11.25 MG POWDER AND SOLVENT FOR
SUSPENSION FOR INJECTION
triptorelin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
–
Keep this leaflet. You may need to read it again.
–
If you have any further questions, please ask your doctor, pharmacist
or nurse.
–
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
–
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Decapeptyl 3-month is and what it is used for
2.
What you need to know before you use Decapeptyl 3-month
3.
How to use Decapeptyl 3-month
4.
Possible side effects
5.
How to store Decapeptyl 3-month
6.
Contents of the pack and other information
1.
WHAT DECAPEPTYL 3- MONTH IS AND WHAT IT IS USED FOR
The active ingredient in Decapeptyl 3-month is triptorelin.
Triptorelin belongs to a group of medicines
called gonadotropin releasing hormone (GnRH) agonists. Triptorelin is
similar to the gonadotropin
releasing hormone which occurs naturally in your body. In men,
triptorelin lowers the levels of the
hormone testosterone.
In women, it reduces oestrogen levels.
DECAPEPTYL 3- MONTH HAS THREE DIFFERENT USES. IT IS USED IN MEN, WOMEN
AND CHILDREN TO TREAT
COMPLETELY DIFFERENT CONDITIONS.
THIS LEAFLET GIVES INFORMATION FOR ALL THREE USES OF DECAPEPTYL 3-
MONTH. PLEASE READ ALL THE
SECTIONS THAT ARE ABOUT YOU AND YOUR CONDITION.
MEN
IN MEN DECAPEPTYL 3-MONTH IS USED TO TREAT ADVANCED PROSTATE CANCER.
WOMEN
IN WOMEN DECAPEPTYL 3-MONTH IS USED TO TREAT ENDOMETRIOSIS – A
CONDITION IN WHICH THE TISSUE
THAT NORMALLY LINES THE UTERUS (ENDOMETRIUM) GROWS IN OTHER PLACES.
CHILDREN
IN CHILDREN DECAPEPTYL 3-MONTH IS USED TO TREAT PUBERTY THAT OCCURS AT
A VERY YOUNG AGE, I.E.,

Summary of Product characteristics

Health Products Regulatory Authority
04 July 2023
CRN00DNWC
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Decapeptyl 3-month, 11.25 mg powder and solvent for suspension for
injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains the quantity of triptorelin (as triptorelin
pamoate) to ensure that the minimum triptorelin quantity injected is
11.25 mg.
Excipient(s) with known effect: Sodium < 1 mmol (23 mg).
For the full list of excipients, see Section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for suspension for injection
_Product imported from Poland, Greece and Czech Republic:_
Powder for suspension for injection: Slightly yellow lyophilised cake.
Solvent for suspension for injection: Clear, colourless solution free
of suspended particles.
4 CLINICAL PARTICULARS
As per PA0869/003/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0869/003/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
D, L Lactide-glycolide copolymer
Mannitol
Sodium carmellose
Polysorbate 80
Water for injections
Product sourced from Greece: also contains nitrogen
6.2 INCOMPATIBILITIES
Not applicable. The product is not intended for admixture.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
The product should be used immediately after reconstitution. Any
remaining product should be discarded.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store below 25 °C.
Health Products Regulatory Authority
04 July 2023
CRN00DNWC
Page 2 of 3
6.5 NATURE AND CONTENTS OF CONTAINER
Product sourced from Poland and Czech Republic:
Powder for suspension for injection: Clear slightly tinted glass vial
(4 ml)
Solvent for suspension for injection: Clear glass ampoule (2 ml)
Box containing 1 vial and 1 ampoule with 1 syringe and 3 needles.
Product sourced from Greece is supplied in a cardboard box containing:
Type I glass vial of 5 ml volume containing the sterile solid
lyophilisate (microspheres).
Type l gla