SYNAREL

국가: 이스라엘

언어: 영어

출처: Ministry of Health

유효 성분:

NAFARELIN ACETATE

제공처:

PFIZER PFE PHARMACEUTICALS ISRAEL LTD

ATC 코드:

H01CA02

약제 형태:

NASAL SOLUTION

구성:

NAFARELIN ACETATE 2 MG/ML

관리 경로:

NASAL

처방전 유형:

Required

Manufactured by:

NEOLPHARMA INC, PUERO RICO

치료 그룹:

NAFARELIN

치료 영역:

NAFARELIN

치료 징후:

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

승인 날짜:

2011-11-30

환자 정보 전단

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with
a doctor’s prescription only
NAME OF THE PREPARATION, ITS FORM AND STRENGTH
SYNAREL
® 2 MG/ML
NASAL SOLUTION
NAFARELIN ACETATE 2 MG/ML
EACH ACTUATION DELIVERS: NAFARELIN 200 MCG
A list of inactive and allergenic ingredients in the preparation
is in section 6.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE
MEDICINE. This leaflet contains concise information about
the medicine. If you have further questions, refer to the
doctor or pharmacist.
This medicine has been prescribed to treat 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.
The medicine is not intended for the treatment of young or
adolescent girls under 18 years of age. THE MEDICINE IS
INTENDED FOR USE IN WOMEN ONLY.
For information on side effects, please refer to Section 4.
1. WHAT IS THE MEDICINE INTENDED FOR?
∙ As a part of combination treatment for supervised follicular
stimulation, in preparation for in-vitro fertilization.
∙ Hormonal treatment of endometriosis (development of
endometrial cells outside of the uterus).
∙ Treatment of uterine fibroids.
THERAPEUTIC GROUP:
Gonadotropin hormone agonist.
2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF:
x you are sensitive (allergic) to the active ingredient, to the
gonadotropin hormone, to its agonists or to any of the
other ingredients contained in the medicine, detailed in
section 6.
x you are pregnant or may become pregnant during
treatment with the medicine. If you are taking Synarel
®
as part of fertility treatment, the pregnancy will be
planned for after completion of the treatment period
with this medicine.
x you are breastfeeding.
x you are suffering from undiagnosed vaginal bleeding.
SPECIAL WARNINGS REGARDING USE OF THE MEDICINE BEFORE TREATMENT WITH SYNAREL
®
, TELL THE DOCTOR IF:
∙ you are suffering from polycystic ovaries, as there is a
potential risk for exc

제품 특성 요약

Synarel LPD CC 14102018
2017-0032771
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.
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.
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:
Synarel LPD CC 14102018
2017-0032771
In
the
"long
protocol"
administration,
Synarel
®
is
continued
through
a
period
of
transient
gonadotrophin
stimulation
lasting
1