国家: 亚美尼亚
语言: 英文
来源: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
xylometazoline (xylometazoline hydrochloride)
Takeda GmbH
R01AA07
xylometazoline (xylometazoline hydrochloride)
1mg/ml
drops nasal
10ml vial-dropper
OTC
Registered
2016-09-15
1 SUMMARY OF PRODUCT CHARACTERISTICS FOR X YMELIN, NASAL DROPS, SOLUTION 1. NAME OF THE MEDICINAL PRODUCT Xymelin 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Xylometazoline hydrochloride 0.5 mg/ml and 1 mg/ml Excipients, see point 6.1. 3. PHARMACEUTICAL FORM Nasal drops, solution 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Acute respiratory diseases with signs of rhinitis, acute allergic rhinitis, pollinosis, sinusitis, eustachitis, middle otitis (in order to reduce the nasopharyngeal mucosal oedema). Patient’s preparation for diagnostic manipulations in the nasal passages. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intranasal. _0.05% drops for children from 2 to 6 years of age_: Apply 1-2 drops into each nostril 1-2 times daily. Do not use more than 3 times in 24 hours. _0.1% drops for adults and children over 6 years of age_: apply 2-3 drops into each nostril (repeat if necessary). Do not use more than 3 times in 24 hours. Use medication for not more than 10 days. Use the product in children only under adult’s supervision. Use the product only for such indications, method of administration and doses, specified in the patient information leaflet. 4.3 CONTRAINDICATIONS High sensitivity to drug components, arterial hypertension, tachycardia, atherosclerosis, glaucoma, atrophic rhinitis, thyrotoxicosis, surgeries on meninx (history of), condition following transsphenoidal surgery, pregnancy, children below 2 years of age (for Xymelin 0.05%); children below 6 years of age (for Xymelin 0.1%). Do not use the product in case of inhibitor of monoamine oxidase (IMO) or tricyclic antidepressant therapy, including 14 days after dechallenge. 2 WITH CAUTION Diabetes mellitus, cardiovascular diseases, including CHD, stenocardia, LONG QT INTERVAL SYNDROME; porphyria, breastfeeding period, prostatic hyperplasia, in case of hypersensitivity to adrenergic agents accompanied with insomnia, dizziness, arrhythmia, tremor, elevated blood pressure. PATIENTS WITH LONG QT INTERVAL SYNDROME USING XYLOMETAZOLINE MAY BE EXPOSED 阅读完整的文件