Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Chlorhexidine gluconate
Ecolab Deutschland GmbH
D08AC; D08AC02
Chlorhexidine gluconate
4 percent weight/volume
Cutaneous solution
Biguanides and amidines; chlorhexidine
Marketed
1995-10-16
1 HYDREX SURGICAL SCRUB 4.0% W/V CUTANEOUS SOLUTION CHLORHEXIDINE GLUCONATE SKIN CLEANSERA cutaneous (relating to the skin) solution also containing Ponceau 4R (E124), Dialkylamine Oxide, Glycerol, Industrial Methylated Spirit, Hydroxyethyl Cellulose, Purified Water and Perfume (Hibetone). For use as an antiseptic hand wash, a pre-operative hand scrub and a pre-operative skin preparation prior to surgery. FOR EXTERNAL USE ONLY HOW TO USE MEDICAL AND NURSING STAFF: Antiseptic hand wash – wet the hands and forearms, apply 5ml of Hydrex Surgical Scrub and wash for 1 minute. Rinse thoroughly and dry. Pre- operative surgical scrub – wet the hands and forearms, apply 5ml of Hydrex Surgical Scrub and wash for 1 minute, cleaning the fingernails with a brush. Rinse and repeat the procedure using a further 5ml of Hydrex Surgical Scrub and wash for 2 minutes. Rinse thoroughly and dry. PATIENTS: Pre-operative skin preparation – wash the whole body with 25ml of Hydrex Surgical Scrub on at least two occasions, usually the day before and on the day of the operation. Rinse thoroughly and dry. DO NOT USE in body openings (e.g. nose and ears). AVOID contact with eyes, ears, brain and meninges (skin covering the brain and spinal cord). Use with care in newborn babies and infants, especially those born prematurely. Hydrex Surgical Scrub may cause chemical burns. ACTIONS TO BE TAKEN IF SWALLOWED – If you accidentally swallow Hydrex Surgical Scrub you should go to the accident and emergency department of your nearest hospital. POSSIBLE SIDE EFFECTS - Chlorhexidine can very rarely cause hypersensitivity, including anaphylactic shock (throat or lip swelling, low blood pressure), and allergic reactions (e.g. dermatitis, itching, redness, eczema, rash, hives, skin irritation, blisters). Chemical burns in neonates and infants. If any of these reactions occur, stop using the product and seek medical attention immediately. REPORTING OF SIDE EFFECTS If you get any side effects, talk to your doctor Đọc toàn bộ tài liệu
Health Products Regulatory Authority 21 May 2019 CRN0091ZM Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Hydrex Surgical Scrub 4.0% w/v Cutaneous Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine gluconate 4% w/v (equivalent to 40mg/ml) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous Solution. Red-coloured antiseptic solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use as an antiseptic hand wash, a pre-operative hand scrub and a pre-operative skin preparation to surgery. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION ANTISEPTIC HAND WASH - wet the hands and forearms, apply 5 ml of skin cleanser and wash for one minute. Rinse thoroughly and dry. PRE-OPERATIVE SURGICAL SCRUB - wet hands and forearms, apply 5 ml of skin cleanser and wash for one minute, cleaning the finger nails with a brush. Rinse and repeat the procedure using a further 5 ml of skin cleanser and wash for 2 minutes. Rinse thoroughly and dry. PRE-OPERATIVE SKIN PREPARATION - the patient should wash his whole body with 25 ml of the cleanser on at least two occasions, usually the day before and on the day of the operation. 4.3 CONTRAINDICATIONS Avoid contact with eyes, middle ear, brain and meninges. Known hypersensitivityto the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8). 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE For external use only. Keep out of the reach and sight of children. Do not use in body cavities. Hydrex Surgical Scrub contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Hydrex Surgical Scrub should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4. Đọc toàn bộ tài liệu