देश: आर्मेनिया
भाषा: अंग्रेज़ी
स्रोत: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
phenazone, lidocaine (lidocaine hydrochloride)
Biocodex
S02DA30
phenazone, lidocaine (lidocaine hydrochloride)
40mg/g+ 10mg/g
drops ear
15ml (16g) glass vial and dropper
OTC
Registered
2017-11-16
1/3 SUMMARY OF PRODUCTCHARACTERISTICS 1. NAME OF MEDICINAL PRODUCT OTIPAX ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition: 1g solution contain: Active substances: Phenazon.....................................40mg Lidocainehydrochloride.............10 mg Excipients: sodium thiosulfate, ethanol, glycerol, purified water. Excipient with known effect: glycerol. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Ear drops solution. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Local symptomatic treatment of certain painful conditions of the middle ear with intact tympanic membrane: - acute otitis media, - otitis, as a complication after flue - barotrauma otitis. 4.2. DOSAGE AND METHOD OF ADMINISTRATION Auricular route. In order to avoid unpleasant contact of the cold solution with the ear, warm the container between the hands before use. - Dropper bottle: instil 4 drops in the auditory meatus by applying gentle pressure to the soft part of the dropper, 2 or 3 times a day in the painful ear. 4.3. CONTRAINDICATIONS - tympanic perforation of infectious or traumatic origin (see section 4.4), - hypersensitivity to the active ingredient or to any of the components listed in section 6.1. 4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE SPECIAL WARNINGS As a precautionary measure, ENSURE THAT THE TYMPANIC MEMBRANE IS INTACT BEFORE ANY ADMINISTRATION. If there is tympanic breach, intra-auricular administration may bring the product into contact with the structures of the middle ear, with adverse effects upon them. This medicine contains an active ingredient which may give a positive result in the anti-doping tests. PRECAUTIONS FOR USE Limit treatment duration to 10 days. Management must be reviewed after that time. 4.5. INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION The data available to date do not suggest the possibility of clinically significant interactions. 2/3 4.6. FERTILITY, PREGNANCY AND LACTATION In the absence of any tympanic breach, systemic penetration is unlik पूरा दस्तावेज़ पढ़ें