البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
NAFARELIN ACETATE
PFIZER PFE PHARMACEUTICALS ISRAEL LTD
H01CA02
NASAL SOLUTION
NAFARELIN ACETATE 2 MG/ML
NASAL
Required
PFIZER INC, USA
NAFARELIN
- Controlled ovarian stimulation programmes prior to in-vitro fertilisation.- Hormonal management of endometriosis, including pain relief and reduction of endometrial lesions. - Uterine fibroids.
2021-11-30
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 اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة