Kraj: Izrael
Język: angielski
Źródło: Ministry of Health
CETRIMIDE; CHLORHEXIDINE DIGLUCONATE
RAZ PHARMACEUTICS LTD, ISRAEL
D08AC52
SOLUTION
CETRIMIDE 0.15 %W/V; CHLORHEXIDINE DIGLUCONATE 0.015 %W/V
CUTANEOUS
Not required
MEDLOCK MEDICAL LIMITED, UK
CHLORHEXIDINE, COMBINATIONS
A broad spectrum antiseptic with detergent properties for swabbing in obstetrics and during dressing changes. For disinfecting and cleansing traumatic and surgical wounds and burns
2016-06-08
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS), 1986. This medicine is dispensed without a doctor’s prescription. STERETS® TISEPT SACHETS CUTANEOUS SOLUTION CHLORHEXIDINE GLUCONATE 0.015% W/V / CETRIMIDE 0.15% W/V For the list of inactive ingredients see section 6. CAREFULLY READ THE ENTIRE LEAFLET BEFORE USING THIS MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to your doctor or pharmacist. This medicine was prescribed to you. Do not pass it on to others. It may harm them, even if it seems that they have a similar medical condition. Use the medicine correctly. Ask your doctor if symptoms worsen or do not improve. The medicine is intended for adults and children. 1. WHAT IS THE MEDICINE INTENDED FOR? Sterets Tisept Sachets are used to help prevent infection from occurring during and after childbirth, and also in wounds and burns. THERAPEUTIC GROUP: Antiseptic solution. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE: - If you are allergic to Chlorhexidine gluconate, Cetrimide or to any of the other ingredients of this medicine (listed in section 6). If you are not sure if this applies to you, talk to your doctor or nurse before this medicine is used. - If the product could come into contact with the brain, meninges (the membranes surrounding the brain and spinal cord) or the inside of the ear. - In the internal cavities of the body. SPECIAL WARNINGS REGARDING THE USE OF THIS MEDICINE -Talk to your doctor or nurse before using Sterets Tisept sachets. -Avoid contact with the eyes and ears. -Household bleaches (which contain hypochlorites) may cause brown stains to appear on fabrics that have had contact with Sterets Tisept solution. -The product's effectiveness may be impaired if used with soap or detergents. CHILDREN Use with care in newborn babies, especially those born prematurely. Sterets Tisept may cause chemical skin burns. TELL YOUR DOCTOR OR PHARMACIST IF YOU ARE TAKING OR HAVE RECENTLY TAKEN ANY OT Przeczytaj cały dokument
STERETS TISEPT SACHETS PHYSICIAN'S LEAFLET 1. NAME OF THE MEDICINAL PRODUCT Sterets Tisept Sachets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Chlorhexidine Gluconate 0.015% w/v (incorporated as 20% w/v Chlorhexidine gluconate Solution) Cetrimide 0.15% w/v 3. PHARMACEUTICAL FORM Cutaneous solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A broad spectrum antiseptic with detergent properties for swabbing in obstetrics and during dressing changes. For disinfecting and cleansing traumatic and surgical wounds and burns. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Cutaneous. Use without further dilution. For topical administration only. 4.3 CONTRAINDICATIONS Known hypersensitivity to 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). Sterets Tisept should not come into contact with the brain, eyes, meninges or middle ear. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Sterets Tisept Sachets 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. Sterets Tisept Sachets should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8). The use of chlorhexidine solutions, both alcohol based and aqueous, for skin antisepsis prior to invasive procedures has been associated with chemical burns in neonates. Based on available case reports and the published literature, this risk appears to be higher in preterm infants, especially those born before 32 weeks of gestation and within the first 2 weeks of life. Remove any soaked materials, drapes or gowns before proceeding with the intervention. Do not use excessive quantities and do not allow the solution to pool in skin folds or under the patient or drip on sheets or other ma Przeczytaj cały dokument