국가: 이스라엘
언어: 영어
출처: Ministry of Health
LIDOCAINE HYDROCHLORIDE
RAFA LABORATORIES LTD
N/A
GEL
LIDOCAINE HYDROCHLORIDE 2 %
LOCAL ORAL, MUCOSAL, TOPICAL
Not required
RAFA LABORATORIES LTD, JERUSALEM
Local anesthetic, not to be used for procedures requiring sterile products
2021-11-30
1 PATIENT LEAFLET ACCORDING TO THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 This medicine is sold without a doctor’s prescription ESRACAIN GEL ACTIVE INGREDIENT: Lidocaine hydrochloride 2% For the list of inactive ingredients, please see section 6. READ THIS ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have any further questions, please refer to your doctor or pharmacist. Refer to your doctor if the symptoms get worse or do not improve after 3-5 days. The gel is not intended for relieving teething pains in children and infants. The gel is usually not intended for children under the age of 2 years and in any case children under the age of 3 will be treated under medical supervision only (see details below on use in children). Use this medicine in the correct manner. Consult the pharmacist if you need additional information. 1. WHAT IS THE MEDICINE INTENDED FOR? This medicine is intended for use as a topical anesthetic for local relief of pain of the skin and mucous membranes. Do not use this medicine in sterile procedures. THERAPEUTIC GROUP: Local anesthetic of the amide group. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE IF: Do not use if you are sensitive (allergic) to the active ingredient, to any other local anesthetic of the amide group, or to any of the other ingredients the medicine contains (for the list of inactive ingredients, please see section 6). Do not use in sterile procedures. Do not use on festering sores or large areas of skin. Frequent use of this medicine, on large areas of skin or for a long period may cause side effects due to excessive absorption (see section 'side effects'). SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE: Do not use this medicine frequently or for a long period without consulting a doctor. The recommended dosage should be strictly adhered to. Use of a too high or too frequent dosage, may cause serious and even life-threatening side effects, including sei 전체 문서 읽기
1 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Esracain® Gel 1.1 Qualitative and quantitative composition Lidocaine hydrochloride 2% 1 ml of gel contains 20 mg lidocaine hydrochloride. Excipients with known effect: Propylene glycol and benzalkonium chloride. 1 ml of gel contains approximately 20 mg propylene glycol. 1 ml of gel contains 0.15 mg benzalkonium chloride. For the full list of excipients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1.2 Pharmaceutical form Clear, colorless gel . 2 THERAPEUTIC INDICATIONS Local anesthetic, not to be used for procedures requiring sterile products. 3 CONTRAINDICATIONS • Lidocaine is contraindicated in patients who are hypersensitive to the active substance or to any of the excipients of the gel or components of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Lidocaine is contraindicated in patients with a known history of hypersensitivity to local anesthetics of the amide type or to other components of the gel (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • Not to be used for procedures requiring sterile products. • Lidocaine is contraindicated in patients with congenital or idiopathic methemoglobinemia and patients with glucose-6-phosphate dehydrogenase deficiency, which are more susceptible to drug-induced methemoglobinemia. • Lidocaine is contraindicated in infants who require treatment with methemoglobininducing agents, e.g., sulfonamides and are 12 months of age or younger (see 9 DRUG INTERACTIONS). 2 4 DOSAGE AND ADMINISTRATION 4.1 Recommended Dose and Dosage Adjustment Dosage for adults (over the age of 18): Use the smallest amount necessary to control your symptoms. • Usually the effective dose is no more than 5 to 10 mL per application. • No more than 6 doses should be used per day (24 hours). Dosage in Children: The gel is usually not intended for children under the age of 2 years and in any case children under the age of 3 will be treated under med 전체 문서 읽기