DECAPEPTYL 0.1

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

TRIPTORELIN ACETATE

Dostopno od:

FERRING PHARMACEUTICALS LTD

Koda artikla:

L02AE04

Farmacevtska oblika:

SOLUTION FOR INJECTION

Sestava:

TRIPTORELIN ACETATE 0.1 MG/ML

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

FERRING GmbH ,GERMANY

Terapevtska skupina:

TRIPTORELIN

Terapevtsko območje:

TRIPTORELIN

Terapevtske indikacije:

IVF

Datum dovoljenje:

2022-05-31

Navodilo za uporabo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DECAPEPTYL 0.1
SOLUTION FOR SUBCUTANEOUS INJECTION
COMPOSITION:
Each syringe of Decapeptyl 0.1 contains 0.1 mg of triptorelin (as
acetate).
INACTIVE INGREDIENTS AND ALLERGENS: see section 2 ‘Important
information
about some of this medicine’s ingredients’ and section 6
‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
This leaflet contains concise information about this medicine. If you
have
any further questions, consult your doctor or pharmacist. This
medicine
has been prescribed to treat your illness. Do not pass it on to
others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is intended for infertility treatments.
THERAPEUTIC GROUP: synthetic analogue of the gonadotropin-releasing
hormone (GnRH).
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You are sensitive (allergic) to triptorelin acetate or to any of the
other
ingredients in this medicine (see section 6).
You are sensitive (allergic) to the gonadotropin-releasing hormone
(GnRH) or its analogues.
You are pregnant or breastfeeding (see section ‘Pregnancy and
breastfeeding’).
SPECIAL WARNINGS ABOUT USING THIS MEDICINE
BEFORE USING THIS MEDICINE, TELL YOUR DOCTOR IF:
There have been reports on depression that may be severe among
patients taking Decapeptyl. If you are taking this medicine and
develop a
depressed mood, tell your doctor.
There have been reports on mood changes during the course of
treatment with this medicine. Your doctor will monitor your condition
if
you
have
depression.
In rare cases, treatment with this medicine can cause brain hemorrhage
(pituitary apoplexia). If you experience a sudden headache, vomiting
or
vision disturbances – contact your doctor immediately.
Treatment with this medicine may lead to thinning of bones and an
in

Lastnosti izdelka

1
1.
NAME OF THE MEDICINAL PRODUCT.
DECAPEPTYL
®
0.1
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 disposable syringe with 1 ml solution for injection contains 100 ug
triptorelin acetate,
corresponding to 95.6 ug 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
IVF.
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 Decapeptyl 0.1 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 Decapeptyl 0.1 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 Decapeptyl 0.1 should be considered. The total
duration of treatment is
usually 4-7 weeks. When using Decapeptyl 0.1, luteal phase support
should be provided
according to the reproductive medical center's practice.
_Special population _
No
specific
dose
recommendations
are
given
for
subjects
with
renal
or
hepatic
impairment. A clinical study indicated that the risk of accumulation
of triptorelin in
patients with severe liver and renal impairment is small (see section
5.2).
Method of administration
Treatment with Decapeptyl 0.1 should be initiated under the
supervision of a physician
experienced in the treatment