Salvacyl, 11.25 mg powder and solvent for prolonged-release suspension for injection

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Triptorelin

Mevcut itibaren:

Ipsen Pharmaceuticals Limited

ATC kodu:

L02AE; L02AE04

INN (International Adı):

Triptorelin

Doz:

11.25 milligram(s)

Farmasötik formu:

Powder and solvent for prolonged-release suspension for injection

Reçete türü:

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

Terapötik alanı:

Gonadotropin releasing hormone analogues; triptorelin

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

2015-08-21

Bilgilendirme broşürü

__________________________________________________________________________________________________________
Document name: 45_SAL_IE
Reason for change:
Article 61(3) to harmonise the ‘Warnings and precautions’ section
of PIL
Document replaced: 39_SAL_IE
Date of preparation: 24/05/2023
Page 1 of 9_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
SALVACYL
11.25 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 or pharmacist.
•
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, or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Salvacyl is and what it is used for
2.
What you need to know before you use Salvacyl
3.
How to use Salvacyl
4.
Possible side effects
5.
How to store Salvacyl
6.
Contents of the pack and other information
1.
WHAT SALVACYL IS AND WHAT IT IS USED FOR
Salvacyl contains triptorelin, which is similar to a hormone called
gonadotropin releasing hormone (GnRH
analogue). It is a long acting formulation designed to slowly deliver
11.25 mg of triptorelin over twelve
weeks. It acts by lowering the levels of the male hormone,
testosterone, in the body_. _
Salvacyl is_ _used to decrease sexual drive in adult men with severe
sexual deviations.
The treatment with Salvacyl is to be initiated and controlled by a
psychiatrist. The treatment should be given
in combination with psychotherapy, in order to decrease deviating
sexual behaviour.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE SALVACYL
DO NOT USE SALVACYL
•
If you suffer from serious osteoporosis (a condition that weakens your
bones).
•
If you are allergic to triptorelin

Ürün özellikleri

Health Products Regulatory Authority
04 May 2023
CRN00DJ95
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Salvacyl, 11.25 mg powder and solvent for prolonged-release suspension
for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One vial of powder contains 11.25 mg of triptorelin, as triptorelin
embonate.
After reconstitution in the 2 ml solvent, the reconstituted solution
contains 11.25 mg of triptorelin, as triptorelin embonate.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection
- Powder: White to slightly yellow powder
- Solvent: Clear solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Salvacyl is indicatedfor the reversible reduction of testosterone to
castrate levels in order to decrease sexual drive in adult men
with severe sexual deviations.
The treatment with Salvacyl is to be initiated and controlled by a
psychiatrist. The treatment should be given in combination
with psychotherapy, in order to decrease deviating sexual behaviour.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The recommended dose of Salvacyl is 11.25 mg triptorelin (1 vial)
administered every twelve weeks as a single intramuscular
injection.
_Paediatric population_
The safety and efficacy of Salvacyl in children have not been
established. Salvacyl is not indicated for use in neonates, infants,
children and adolescents.
_Patients with renal or hepatic impairment_
No dosage adjustment is necessary for patients with renal or hepatic
impairment.
Method of administration
For instructions on reconstitution of the medicinal product before
administration, see section 6.6.
_Precautions to be taken before handling or administrating the
medicinal product._
Since Salvacyl is a suspension of microgranules, inadvertent
intravascular injection must be strictly avoided.
Salvacyl must be administered under the supervision of a medically
qualified person (nurse or physician).
The therapeutic benefit should be monitored