Šalis: Izraelis
kalba: anglų
Šaltinis: Ministry of Health
TRIAMCINOLONE ACETONIDE
TARO INTERNATIONAL LTD, ISRAEL
A01AC01
PASTE
TRIAMCINOLONE ACETONIDE 0.1 %
TOPICAL
Not required
TARO PHARMACEUTICALS INC., CANADA
TRIAMCINOLONE
TRIAMCINOLONE
Indicated for the adjunctive treatment and the temporary relief of symptoms associated with oral inflammatory and ulcerative lesions.
2020-05-31
PK-3021-4 1216-4 DOR-13559-1216-02 PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is to be dispensed without a doctor’s prescription ORACORT ORAL PASTE ACTIVE INGREDIENT - 1 gram of the preparation contains: Triamcinolone Acetonide 1 mg Inactive ingredients and allergens: See section 6 - “Additional Information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. The medicine is not usually recommended for infants and children under two years of age. Under this age, contact a doctor. Use this medicine correctly. Consult a pharmacist if you need further information. Contact a doctor if the signs of your illness (symptoms) get worse or do not improve after 7 days. 1. WHAT IS THE MEDICINE INTENDED FOR? Oracort is indicated as an adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory and ulcerative lesions. THERAPEUTIC GROUP: Synthetic corticosteroids for local treatment, with anti-inflammatory, antipruritic, and vasoconstrictive properties. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: · You are sensitive (allergic) to the active ingredient or to any of the additional ingredients this medicine contains. · There exist viral (such as herpes simplex), fungal and/or bacterial infections of the mouth and/ or throat or tuberculosis of the skin, especially during prolonged use of the preparation. SPECIAL WARNINGS ABOUT USING THE MEDICINE • Do not use this medicine frequently, or for a long period, without consulting the doctor. • Special caution is required when using in children. Use in children and adolescents must be carried out under medical supervision. Caution recommended when using in elderly patients. • If you are sensitive to any food or medication, inform the doctor before taking the medicine. • If local irritation develops, stop treatment and ref Perskaitykite visą dokumentą
Oracort SPC – 12.2020 SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT _ _ ORACORT _ _ QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Triamcinolone Acetonide Topical Paste, 0.1% _ _ EXCIPIENTS: Mineral oil, fine gelatin powder, pectin, sodium carboxymethylcellulose, polyethylene. INDICATIONS AND USAGE Oracort (triamcinolone acetonide topical paste, 0.1%) is indicated for adjunctive treatment and the temporary relief of symptoms associated with oral inflammatory and ulcerative lesions. DESCRIPTION Oracort (triamcinolone acetonide topical paste, 0.1%), contains the corticosteroid triamcinolone acetonide in an adhesive vehicle suitable for application to oral tissues. Triamcinolone acetonide is designated chemically as 9-fluoro-11 β , 16 α , 17, 21-tetrahydroxypregna-1, 4-diene-3, 20- dione cyclic 16, 17-acetal with acetone. The structural formula of triamcinolone acetonide is as follows: Each gram of Oracort contains 1 mg triamcinolone acetonide in an emollient dental paste containing gelatin, pectin, and carboxymethylcellulose sodium in a plasticized hydrocarbon gel (a Oracort SPC – 12.2020 polyethylene and mineral oil gel base). CLINICAL PHARMACOLOGY Like other topical corticosteroids, triamcinolone acetonide has anti- inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A. PHARMACOKINETICS The extent of absorption through the oral mucosa is determined by multiple factors including the vehicle, the integrity of the mucosal barrier, the duration of therapy, and the presence of infla Perskaitykite visą dokumentą