Riik: Iisrael
keel: inglise
Allikas: Ministry of Health
ETHANOL; PROPANOL
GAMIDA CARE LTD., ISRAEL
D08AX53
SOLUTION
PROPANOL 18 %W/V; ETHANOL 45 %W/V
CUTANEOUS
Required
B.BRAUN MELSUNGEN AG, GERMANY
PROPANOL, COMBINATIONS
For hygienic and surgical hand disinfection.
2022-10-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed without a doctor’s prescription SOFTA-MAN VISCORUB CUTANEOUS SOLUTION ACTIVE INGREDIENTS: Ethanol 45 g/100 ml and propanol 18 g/100 ml For a list of inactive ingredients and allergens see Section 6. READ THE ENTIRE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have further questions, refer to your doctor or pharmacist. To use this medicine, follow the instructions in the dosage section of this leaflet. Consult the pharmacist if you need more information. 1. WHAT IS THIS MEDICINE INTENDED FOR? Softa-Man Viscorub is an alcoholic hand disinfectant for hygienic and surgical hand disinfection. THERAPEUTIC GROUP: skin disinfectant. When used on skin that is not injured, only very small amounts are absorbed through the skin and they have no effect on your body. The active ingredients in Softa-Man Viscorub are ethanol and propanol. This medicine is very effective against gram-positive and gram-negative bacteria, including antibiotic-resistant strains (such as the methicillin-resistant Staphylococcus aureus [MRSA]) and mycobacteria. Softa-Man Viscorub works well killing fungi and viruses, and quickly neutralizes rota viruses and viruses that have a sheath. 2. BEFORE USING THIS MEDICINE WARNINGS: • This medicine is for external use only. Avoid all contact with the eyes and mucous membranes. • Do not use on injured skin. Flammable. The solution’s flash point is 21°C. Keep away from flame and other sources of ignition. Do not smoke, do not swallow. Do not light a cigarette or expose to fire until the product has dried completely. Consult a doctor, pharmacist, or nurse before you start using the medicine. DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to the active ingredients ethanol and propanol or to any of the other ingredients that this medicine contains (see Section 6 in this leaflet). IF Lugege kogu dokumenti
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF MEDICINE Softa-Man ViscoRub Ethanol 45 % w/v ; Propanol 18 % w/v Cutaneous solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 100 grams of gel contains 55.70 g of ethanol (96% v/v); 21.00 g of propanol For full list of excipients, see _section 6.1_ . 3. PHARMACEUTICAL FORM Viscous non-sterile aqueous solution 4. CLINICAL INFORMATION 4.1 THERAPEUTIC INDICATIONS Softa-Man ViscoRub is indicated for hygienic and surgical hand disinfection. 4.2 DOSAGE AND ROUTE OF ADMINISTRATION Topical. At least 3 ml of undiluted Softa-Man ViscoRub should be applied on the dry palms of the hands and rubbed for: - at least 30 seconds for hygienic hand disinfection - at least 90 seconds for surgical hand disinfection The skin must remain moist for 30 or 90 seconds, accordingly. the skin should be left to dry and no rinse is needed. Softa-Man ViscoRub can be used without prior cleansing of the handsVisibly dirty hands should be washed with soap and water first. 4.3 CONTRAINDICATIONS Hypersensitivity to the active ingredient or to any of the excipients listed in _section 6.1_ . 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Avoid any contact with eyes and mucous membranes. Apply only to intact skin. Flammable (flash point: 21° C). Keep away from any flame or source of ignition. No smoking. Do not ingest. For external use only 4.5 INTERACTIONS WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTIONS No interaction study was performed. 4.6 FERTILITY, PREGNANCY AND BREASTFEEDING Pregnancy Given that the product is only applied locally to intact skin and that the absorption of alcohol by the skin is negligible, Softa-Man ViscoRub can be used in the recommended manner for hand disinfection during pregnancy. Alcohol is a known teratogenic agent in case of systemic absorption during the use of the product. In alcohol-dependent mothers, foetal alcohol syndrome was observed in which babies had specific characteristics and abnormalities such as microcephaly, low body weight, and facial abnormalities, with Lugege kogu dokumenti