Valsts: Izraēla
Valoda: angļu
Klimata pārmaiņas: Ministry of Health
BENZYDAMINE HYDROCHLORIDE
RAZ PHARMACEUTICS LTD, ISRAEL
A01AD02
MOUTHWASH
BENZYDAMINE HYDROCHLORIDE 0.15 %W/V
LOCAL ORAL
Not required
AZIENDA CHIMICHE RIUNITE ANGELINI FRANSESCO A.C.R.A.F SPA, ITALY
BENZYDAMINE
Locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat influding: Traumatic conditions : Pharyngitis following tonsillectomy or the use of a naso-gastric tube .Inflammatory conditions : Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy. Dentistry : For use after dental operations.
2014-03-31
SUMMARY OF PRODUCT CARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TANTUM VERDE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Clear, green liquid, with a typical mint flavour containing Benzydamine hydrochloride 0.15% w/v. 100 ml contain: Active ingredient: benzydamine hydrochloride 0.15g Excipient(s) with known effects: Methyl parahydroxybenzoate Ethanol Mint flavour with benzyl alcohol, cinnamyl alcohol, citral, citronellol, eugenol, geraniol, isoeugenol, D- limonene and linalool. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Liquid for use as mouthwash/gargle. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tantum Verde is a locally acting analgesic and anti-inflammatory treatment for the relief of painful inflammatory conditions of the mouth and throat including: Traumatic conditions: Pharyngitis following tonsillectomy or the use of a naso-gastric tube. Inflammatory conditions: Pharyngitis, aphthous ulcers and oral ulceration due to radiation therapy. Dentistry: For use after dental operations. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For oromucosal administration . CHILDREN: Not suitable for children aged 12 years or under. Adults and children above the age of 12: Rinse or gargle with 15 ml of Tantum Verde mouthwash for 2-3 times daily, to be used pure or diluted (in this case adding in the dosage measure 15 ml of water). Do not exceed the prescribed dose. Method of Administration: The solution should be expelled from the mouth after use. Uninterrupted treatment should not exceed seven days, except under medical supervision 4.3 CONTRAINDICATIONS Tantum Verde is contra-indicated in patients with known hypersensitivity to the active substance benzydamine hydrocholoride or to any of the excipients listed in section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Benzydamine use is not advisable in patients with hypersensitivity to acetylsalicylic acid or other NSAID's. Tantum Verde should generally be used undiluted, but if 'stinging' occurs, the rinse may be diluted with water. Izlasiet visu dokumentu