Country: Iżrael
Lingwa: Ingliż
Sors: Ministry of Health
LIDOCAINE HYDROCHLORIDE MONOHYDRATE; TRIAMCINOLONE ACETONIDE
TARO PHARMACEUTICAL INDUSTRIES LTD
A01AC01
PASTE
LIDOCAINE HYDROCHLORIDE MONOHYDRATE 3 G / 100 G; TRIAMCINOLONE ACETONIDE 0.1 G / 100 G
LOCAL ORAL
Not required
TARO PHARMACEUTICAL INDUSTRIES LTD
TRIAMCINOLONE
TRIAMCINOLONE
Adjunctive treatment and temporary relief of pain and symptoms associated with oral inflammatory and ulcerative lesions.
2014-05-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is to be dispensed without a doctor’s prescription ORACORT E ORAL PASTE ACTIVE INGREDIENTS - 1 gram of the preparation contains: Triamcinolone acetonide 1 mg Lidocaine hydrochloride monohydrate 30 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 according to the instructions in the section about dose in this leaflet. 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 E is indicated as an adjunctive treatment and for the temporary relief of symptoms and pain associated with oral inflammatory and ulcerative lesions. THERAPEUTIC GROUP: Triamcinolone acetonide: synthetic corticosteroid for local treatment, with anti-inflammatory, antipruritic, and vasoconstrictive properties. Lidocaine: local anesthetic. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingredients or to any of the additional ingredients this medicine contains (see section 6). You are sensitive (allergic) to other amino amide local anesthetics. There exists a viral (such as herpes), fungal and/or bacterial infection 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 requires medical supervision. • If you are sensitive t Aqra d-dokument sħiħ
Oracort E SPC – 08.2022 SUMMARY OF PRODUCT CHARACTERISTICS NAME OF THE MEDICINAL PRODUCT _ _ ORACORT E _ _ QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Triamcinolone Acetonide 1 mg Lidocaine Hydrochloride monohydrate 30 mg Topical Oral Paste _ _ EXCIPIENTS: Paraffin liquid, gelatin, pectin, sodium carboxymethylcellulose, polyethylene. INDICATIONS AND USAGE Oracort E is indicated for adjunctive treatment and temporary relief of pain and symptoms associated with oral inflammatory and ulcerative lesions. DESCRIPTION Oracort E, 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: Oracort E SPC – 08.2022 Each gram of Oracort E contains 1 mg triamcinolone acetonide and 30 mg lidocaine hydrochloride monohydrate in an emollient dental paste. 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. Lidocaine reversibly prevents opening of Na+ channels and thus the development of an action potential. The active substance binds to a specific receptor on the Na+ channel of the nerve, thereby preventing the transport of ions through the pores and thus the development of an action potential. This leads to suppression of conduction loca Aqra d-dokument sħiħ