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
NEOLPHARMA INC, PUERO RICO
NAFARELIN
NAFARELIN
- Controlled ovarian stimulation programmes prior to in-vitro fertilisation.- Hormonal management of endometriosis, including pain relief and reduction of endometrial lesions. - Uterine fibroids.
2011-11-30
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 اقرأ الوثيقة كاملة
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 اقرأ الوثيقة كاملة