Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release suspension for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Triptorelin pamoate

Available from:

Ipsen Pharmaceuticals Limited

ATC code:

L02AE; L02AE04

INN (International Name):

Triptorelin pamoate

Dosage:

22.5 milligram(s)

Pharmaceutical form:

Powder and solvent for prolonged-release suspension for injection

Prescription type:

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

Therapeutic area:

Gonadotropin releasing hormone analogues; triptorelin

Authorization status:

Marketed

Authorization date:

2011-04-08

Patient Information leaflet

______________________________________________________________________________________________________
Document name: 175_DEC22.5_IE v2
Reason for change:
Article 61(3) to harmonise the ‘Warnings and precautions’ section
of PIL
Document replaced: 173_DEC22.5_IE
Preparation Date: 19/07/2023
Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
DECAPEPTYL
® 6-MONTH
22.5 MG POWDER AND SOLVENT FOR PROLONGED-RELEASE 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, 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 6-month is and what it is used for
2.
What you need to know before you use Decapeptyl 6-month
3.
How to use Decapeptyl 6-month
4.
Possible side effects
5.
How to store Decapeptyl 6-month
6.
Contents of the pack and other information
1.
WHAT DECAPEPTYL 6-MONTH IS AND WHAT IT IS USED FOR
Decapeptyl 6-month contains triptorelin, which is similar to a hormone
called gonadotropin releasing
hormone (GnRH analogue).
Triptorelin belongs to a group of medicines called GnRH analogues. It
is a long acting formulation
designed to slowly deliver 22.5 mg of triptorelin over a 6-month
period (twenty four weeks). In men,
triptorelin lowers the levels of the hormone testosterone. In women,
it lowers the levels of the hormone
oestrogen.
IN MEN:
Decapeptyl 6-month is used to treat both locally advanced prostate
cancer (limited in the prostate
gland itself) and prostate cancer which has spread to other parts of
the body (metastatic cancer).
IN CHILDREN 2 YEARS OF AGE AND OLDER
Decapeptyl

Summary of Product characteristics

Health Products Regulatory Authority
25 September 2023
CRN00DQ8Z
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Decapeptyl 6-month 22.5 mg Powder and solvent for prolonged-release
suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains triptorelin pamoate equivalent to 22.5 mg
triptorelin.
After reconstitution in 2mL solvent, 1 mL of reconstituted suspension
contains 11.25mg of triptorelin.
Contains sodium but less than 1mmol (23mg) sodium per vial.
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection
Powder: White to off-white powder.
Solvent: Clear solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Decapeptyl 6-month is indicated for the treatment of locally advanced
or metastatic, hormone-dependent prostate cancer.
Decapeptyl 6-month is indicated for the treatment of central
precocious puberty (CPP) in children 2 years and older (with an
onset of CPP before 8 years in girls and 10 years in boys).
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Decapeptyl 6-month is 22.5 mg of triptorelin
(1 vial) administered every six months (twenty four
weeks) as a single intramuscular injection.
In patients with metastatic castration resistant prostate cancer not
surgically castrated receiving triptorelin and eligible for
treatment with androgen biosynthesis inhibitors, treatment with
triptorelin needs to be continued.
_ _
_Patients with renal or hepatic impairment _
No dosage adjustment is necessary for patients with renal or hepatic
impairment.
_Paediatric population _
CENTRAL PRECOCIOUS PUBERTY (BEFORE 8 YEARS IN GIRLS AND 10 YEARS IN
BOYS)
The treatment of children with Decapeptyl 6-month should be under the
overall supervision of a paediatric endocrinologist or
of a paediatrician or an endocrinologist with expertise in the
treatment of central precocious puberty.
Treatment should be stopped around the physiological age of puberty in
boys a