Synarel 200micrograms/dose nasal spray

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: MHRA (Medicines & Healthcare Products Regulatory Agency)

Veiklioji medžiaga:

Nafarelin acetate

Prieinama:

Pfizer Ltd

ATC kodas:

H01CA02

INN (Tarptautinis Pavadinimas):

Nafarelin acetate

Dozė:

200microgram/1dose

Vaisto forma:

Spray

Vartojimo būdas:

Nasal

Klasė:

No Controlled Drug Status

Recepto tipas:

Valid as a prescribable product

Produkto santrauka:

BNF: 06070200; GTIN: 5012882007836 5012882007829

Pakuotės lapelis

Page 1 of 8
PACKAGE LEAFLET: INFORMATION FOR THE USER
SYNAREL
® 2MG/ML NASAL SPRAY
NAFARELIN ACETATE
Important things that you SHOULD know about your medicine:

SYNAREL is for the treatment of endometriosis or as part of a
supervised fertility programme and is
for use by women only.

This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if
their symptoms are the same as yours.

You should take SYNAREL regularly as instructed by your doctor or
nurse, in order for it to be
effective.

Most people do not have serious problems when taking SYNAREL but side
effects can occur – see
Section 4 for details. If any of the side effects gets serious, or if
you notice any side effects not listed
in this leaflet, please tell your doctor or pharmacist.

Taking other medicines may sometimes cause problems. Check with your
doctor or pharmacist before
taking this or any other medicines.
Please read the rest of this leaflet. It includes other important
information on the safe and effective use of
this medicine that might be especially important to you. If you have
any further questions, ask your
doctor or pharmacist. This leaflet was last updated in 06/2016.
WHAT IS IN THIS LEAFLET
1.
What Synarel is and what it is used for
2.
What you need to know before you take Synarel
3.
How to take Synarel
4.
Possible side effects
5.
How to store Synarel
6.
Contents of the pack and other information
1. WHAT SYNAREL IS AND WHAT IT IS USED FOR
Synarel works by reducing the normal response of your body to a
hormone called GnRH (gonadotrophin
releasing hormone). As a result, your ovaries produce less of another
hormone called oestrogen. You
will notice the reduced amount of oestrogen usually by your periods
either stopping or being reduced in
amount after about one month of taking Synarel.
Synarel has to get into your blood stream before it can work. This
cannot happen if it is taken by mouth,
because your stomach acid will break it down and it will be digested.
Therefore, nasal inhalation

Prekės savybės

OBJECT 1
SYNAREL NASAL SPRAY
Summary of Product Characteristics Updated 13-Dec-2016 | Pfizer
Limited
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.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Nasal spray, solution.
Clear, colourless to slightly yellow, aqueous solution.
4. Clinical particulars
4.1 Therapeutic indications
The hormonal management of endometriosis, including pain relief and
reduction of endometriotic lesions.
Use in controlled ovarian stimulation programmes prior to in-vitro
fertilisation, under the supervision of
an infertility specialist.
4.2 Posology and method of administration
_Adult:_ Synarel is for administration by the intranasal route only.
Experience with the treatment of endometriosis has been limited to
women 18 years of age and older.
_Endometriosis:_ 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.
The recommended daily dose of Synarel is 200 mcg taken twice daily as
one spray (200 mcg of nafarelin)
to one nostril in the morning and one spray into the other nostril in
the evening (400 mcg/day). Treatment
should be started between days 2 and 4 of the menstrual cycle. The
recommended duration of therapy is
six months; only one 6-month course is advised. In clinical studies
the majority of women have only
received up to six-months treatment with Synarel.
_Controlled ovarian stimulation prior to in vitro fertilisation:_ In
the use of Synarel associated with
controlled ovarian stimulation prior to _in vitro_ fertilisation, the
long protocol should be employed,
whereby Synarel is continued through a period of transient
gonadotrophin stimulation lasting 10-15 days
(the 'flare effect') through to pituitary desensitisation
(down-regulation). Down-regulatio