Gonapeptyl Daily Solution for Injection 0.1mg per 1ml

Nazione: Malta

Lingua: inglese

Fonte: Medicines Authority

Principio attivo:

TRIPTORELIN

Commercializzato da:

Ferring SPA Via Senigallia 18/2, Milan, Italy

Codice ATC:

L02AE04

INN (Nome Internazionale):

TRIPTORELIN 2 mg

Forma farmaceutica:

SOLUTION FOR INJECTION

Composizione:

TRIPTORELIN 2 mg

Tipo di ricetta:

POM

Area terapeutica:

ENDOCRINE THERAPY

Stato dell'autorizzazione:

Withdrawn

Data dell'autorizzazione:

2009-03-24

Foglio illustrativo

Page 1 of 7 PACKAGE LEAFLET
Page 2 of 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
GONAPEPTYL 0.1 MG/ML, SOLUTION FOR INJECTION
triptorelin-acetate
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 Gonapeptyl is and what it is used for
2.
What you need to know before you use Gonapeptyl
3.
How to use Gonapeptyl
4.
Possible side effects
5.
How to store Gonapeptyl
6.
Contents of the pack and other information
1.
WHAT GONAPEPTYL IS AND WHAT IT IS USED FOR
This medicine is provided as an injection fluid in a disposable
syringe for single use. It is given as
an injection under the skin of the lower abdomen.
This medicine contains triptorelin, which is a synthetic analogue of
the natural gonadotrophin
releasing hormone (GnRH). GnRH regulates the release of gonadotrophins
(sex hormones:
luteinising hormone (LH) and follicle-stimulating hormone (FSH)).
Gonapeptyl blocks GnRH
action, thereby reducing the levels of LH and FSH (so-called
downregulation). This results in
preventing premature ovulation (release of egg cells).
This medicine is used to treat women in assisted reproduction
techniques (ART). In ART
occasionally ovulation may occur too early, causing a significant
reduction in the chance of
getting pregnant. Gonapeptyl is used for downregulation and prevention
of premature LH surges
that might cause such a premature release of egg cells.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE GONAPEPTYL DO NOT
USE GONAPEPTYL:
-
if you are
ALLERGIC
to
TRIPTORELIN ACETATE
or any of the other ingredients

Scheda tecnica

Page 1 of 10
_ _
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 10
1.
NAME OF THE MEDICINAL PRODUCT
Gonapeptyl 0.1 mg/1 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe of 1 ml solution for injection contains 100
micrograms triptorelin acetate
equivalent to 95.6 micrograms triptorelin free base.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gonapeptyl 0.1 mg/1 ml is indicated for downregulation and prevention
of premature luteinizing
hormone (LH) surges in women undergoing controlled ovarian
hyperstimulation for assisted
reproductive technologies (ART).
In clinical trials Gonapeptyl 0.1 mg/1 ml has been used in cycles
where urinary and recombinant
human follicle stimulating hormone (FSH) as well as human menopausal
gonadotrophin (HMG)
were used for stimulation.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Treatment can be started in the early follicular phase (day 2 or 3 of
the menstrual cycle) or in the
mid-luteal phase (day 21-23 of the menstrual cycle or 5-7 days before
expected start of menses).
Controlled ovarian hyperstimulation with gonadotrophins should be
started after approximately
2-4 weeks of Gonapeptyl treatment. Ovarian response should be
monitored clinically (including
ovarian ultrasound alone or preferably in combination with measurement
of oestradiol levels) and
the dose of gonadotrophins adjusted accordingly. When a suitable
number of follicles have
reached an appropriate size, treatment with Gonapeptyl and
gonadotrophin is stopped and a
single injection of hCG is administered to induce the final follicular
maturation. If
downregulation is not confirmed after 4 weeks (determined by
ultrasound documentation of a
shedded endometrium alone or preferably in combination with
measurement of oestradiol levels),
discontinuation of Gonapeptyl should be considered. The total duration
of treatment is usually 4-7
weeks.
When using G