Salvacyl 11.25mg powder and solvent for suspension for injection vials

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Triptorelin

Доступно од:

Ipsen Ltd

АТЦ код:

L02AE04

INN (Међународно име):

Triptorelin

Дозирање:

11.25mg

Фармацеутски облик:

Powder and solvent for suspension for injection

Пут администрације:

Intramuscular

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 08030402; GTIN: 3582186001332

Информативни летак

___________________________________________________________________________________________________________
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, other medicines that regulate the
production and release of sex
hormones, or any of the other ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
At the beginn

Карактеристике производа

OBJECT 1
SALVACYL
Summary of Product Characteristics Updated 25-Apr-2016 | Ipsen Ltd
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 indicated for 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. There is no relevant use of
Salvacyl in the paediatric population.
_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 regularly, for example
prior to