Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
benzydamine (benzydamine hydrochloride)
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Via Vecchia Del Pinocchio
A01AD02
benzydamine (benzydamine hydrochloride)
0,255mg/dose (150mg/100ml)
spray for local use
30ml (176 doses) plastic container with pump dispenser
OTC
Registered
2020-12-26
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Tantum Verde spray for local use 1,5 mg/ml 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 ml of solution contain:_ _ _active substance:_ benzydamine hydrochloride 0.15 g, equivalent to benzydamine 0.134 g; For the complete list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Spray for local use Colourless transparent liquid with the specific mint odour. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Symptomatic treatment of pain and irritation, including those accompanied by pain in oropharyngeal zone (for example, gingivitis, stomatitis, and pharyngitis), as well as the results of conservative stomatological procedures or after teeth extraction. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Administer 2-6 times a day (with each spray 0.17 ml of the solution is sprayed out). _Adults and adolescents over 12 years of age: _by 4-8 sprays 2-6 times a day. _Children _ (6 – 12 years): the medicinal product should be administered only after doctor recommendation and in prescribed doses. Do not exceed the recommended dose. 4.3. CONTRAINDICATIONS - hypersensitivity to active ingredient or to any of excipients listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Administration of this medicinal product, especially for the extended period may lead to hypersensitivity development. In such case the drug administration should be stopped and it is necessary to consult a doctor, who has prescribed an appropriate treatment. Oro-pharyngeal ulcerations can be a sign of more serious pathologies in a limited number of patients. Therefore, in the event that the symptoms persist for more than three days, the patient should contact their doctor or dentist as needed. The use of benzidamine is not recommended in patients with hypersensitivity to acetylsalicylic acid or other NSAIDs. This medicine should be administered with caution in subjects who in the past have had episodes of bronchial asthma, as bronchospasm could occur in this type of pa Прочитать полный документ