SYNAREL

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

NAFARELIN ACETATE

Dostopno od:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

Koda artikla:

H01CA02

Farmacevtska oblika:

NASAL SOLUTION

Sestava:

NAFARELIN ACETATE 2 MG/ML

Pot uporabe:

NASAL

Tip zastaranja:

Required

Izdeluje:

PFIZER INC, USA

Terapevtsko območje:

NAFARELIN

Terapevtske indikacije:

- Controlled ovarian stimulation programmes prior to in-vitro fertilisation.- Hormonal management of endometriosis, including pain relief and reduction of endometrial lesions. - Uterine fibroids.

Datum dovoljenje:

2021-11-30

Navodilo za uporabo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor‘s prescription only
SYNAREL
® 2 MG/ML
NASAL SOLUTION
ACTIVE INGREDIENT
nafarelin acetate 2 mg/mL
Each actuation releases 200 mcg nafarelin
Inactive ingredients and allergens: See section 2 under ’Important
information about some of this medicine‘s ingredients‘ and section
6 ’Further information‘.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE 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 for you. Do not pass it on
to others. It may harm them, even if it seems to you that their
medical condition is similar to yours.
THIS MEDICINE IS FOR USE IN WOMEN ONLY.
1. WHAT IS THIS MEDICINE INTENDED FOR?
as
part
of
a
combination
therapy
for
controlled
ovarian
stimulation prior to in-vitro fertilisation.
hormonal
management
of
endometriosis
)development
of
uterine mucosal cells outside of the uterus(, including pain relief
and reduction of endometrial lesions.
treatment of uterine fibroids.
THERAPEUTIC GROUP:
gonadotrophin releasing hormone agonist.
This medicine works by reducing the normal response of your
body to a hormone called gonadotrophin releasing hormone. As a
result, your ovaries produce less of a hormone called oestrogen.
After about one month of taking Synarel, this will cause your
periods to either stop or be reduced in amount.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
You
are
sensitive
)allergic(
to
gonadotrophin
releasing
hormone, its agonists, or any of the other ingredients in this
medicine )see section 6(.
You are pregnant or may become pregnant whilst taking
this medicine. If you are taking Synarel as part of a fertility
programme, your pregnancy will be planned to take place
after you stop taking this medicine.
You
suffer
from
vaginal
bleeding
that
has
not
been
diagnosed.
You are currently breast-feeding.
You are un

Lastnosti izdelka

Synarel LPD CC 100322
2021-0073386
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SYNAREL
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Solution containing 2mg/ml of nafarelin (as acetate) supplied in
bottles fitted with a metered spray
pump that delivers 200 micrograms of nafarelin base per spray.
This medicine contains 0.01 mg benzalkonium chloride in each spray
(0.1 mL per spray)
which is equivalent to 0.1 mg/mL.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Nasal spray, solution
Clear, colourless to slightly yellow, solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NAFARELIN ACETATE IS INDICATED FOR:
Use in controlled ovarian stimulation programmes prior to in-vitro
fertilisation
Hormonal management of endometriosis, including pain relief and
reduction of endometrial lesions.
Uterine fibroids
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Synarel
®
is for administration by the intranasal route only.
The 60 dose unit bottle is sufficient for 30 days' treatment at 400
mcg (2 sprays) per day, and 15
days' treatment at 800 mcg (4 sprays) per day.
Patients should be advised that the use of the contents of the
container beyond the abovementioned
treatment-days may result in delivery of an insufficient amount of
nafarelin acetate.
CONTROLLED OVARIAN STIMULATION PRIOR TO _IN-VITRO _FERTILISATION
400 mcg or 800 mcg daily administered as follows:
400 MCG:
one spray (200mcg) to one nostril in the morning and one spray (200
mcg) to the other
nostril in the evening.
800 MCG:
one spray to each nostril (2x200 mcg) in the morning, and one spray to
each nostril
(2x200 mcg) in the evening.
Synarel LPD CC 100322
2021-0073386
In the use of Synarel
®
in endometriosis, the aim is to induce chronic pituitary
desensitisation,
which gives a menopause-like state maintained over many months.
However, in the use of
Synarel
®
associated with controlled ovarian stimulation prior to
_in-vitro_
fertilisation, the aims of
the treatment protocols are different, as follows:
In
the
"long