Land: Irland
Språk: engelska
Källa: HPRA (Health Products Regulatory Authority)
CETRIMONIUM BROMIDE CHLORHEXIDINE GLUCONATE
Novartis Consumer Health UK Limited
CETRIMONIUM BROMIDE CHLORHEXIDINE GLUCONATE
%v/v
Cutaneous Solution Concentrate
Product not subject to medical prescription
Authorised
0000-00-00
250ML _Antiseptic Liquid_ DIRECTIONS: DO NOT USE UNDILUTED ON THE SKIN. FOR FIRST AID TREATMENT add 2 capfuls (30ml) of the liquid Gently apply the diluted to 1 / 2 litre of warm water liquid to the affected area FOR PERSONAL HYGIENE add 2 capfuls (30ml) of the liquid to 1 / 2 litre of warm water • Keep out of eyes, ears and other mucosa • Treat accidental splashes into the eyes by washing open eyes with water for at least 10 minutes • Do not use if you are allergic to any of the ingredients • Benzyl benzoate maybe mildly irritant to the skin, eyes and mucous membranes • If skin irritation occurs, stop using and seek medical advice • If swallowed, wash out mouth, drink plenty of milk or water. Seek medical advice and show this container to a doctor • If symptoms persist or allergic reaction occurs, discontinue use and seek medical advice. • Keep out of the reach and sight of children. SAVLON ANTISEPTIC LIQUID gently cleanses and helps prevent infection, aiding in the natural healing of minor skin injuries. Savlon Antiseptic Liquid may also be used in bathing to help cleanse the skin. CAUTION: FOR EXTERNAL USE ONLY ACTIVE INGREDIENTS: Cetrimide 2.25% w/v and Chlorhexidine Gluconate 0.225% w/v. Also contains: Isopropyl alcohol, terpineol, liquid deodoriser, benzyl benzoate, d-gluconolactone, sodium hydroxide and purified water. Do not store above 25ºC. Do not use Savlon Antiseptic Liquid after the expiry date which is stated on the bottom of the bottle. Date of information: August 2013 Savlon is a registered trade mark. PA Holder and manufacturer: PA 30/28/1 Novartis Consumer Health, Horsham, RH12 5AB, UK Manufacturer: BCM Limited, Nottingham, NG90 2PR, UK FOR BATHING add 5 capfuls (75ml) to bath water .FOR FULL BENEFIT DO NOT MIX WITH SOAP OR DETERGENT N TV X 0 MM 1 0 2 0 3 0 4 0 5 0 6 0 7 0 8 0 9 0 100 110 120 130 140 150 160 170 180 190 200 210 220 230 240 250 260 270 280 CUSTOMER: Novartis CUSTOMER REF: NXTV0 ARA NO: 112 Läs hela dokumentet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Savlon Antiseptic Liquid. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Cetrimide 2.25 % w/v and Chlorhexidine Gluconate 0.225 % w/v. Excipients: also includes benzyl benzoate 0.056% w/v For a full list excipients, see Section 6.1. 3 PHARMACEUTICAL FORM Concentrate for Cutaneous Solution. A clear, colourless or almost colourless liquid with a pine-like odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS A topical antiseptic for prevention and management of infection or superficial skin trauma. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For cutaneous use. Two capfuls to ½ litre of warm water. 4.3 CONTRAINDICATIONS Hypersensitivity to chlorhexidine, cetrimide or to any of the excipients listed in Section 6.1. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If symptoms persist or condition worsens or if a skin reaction occurs, discontinue use and consult a doctor. For external use only. Avoid contact with the eyes, ears, mouth or other mucosa. If accidentally splashed into the eye, the open eye should be irrigated with water for at least 10 minutes. Savlon Antiseptic Liquid contains benzyl benzoate which may be mildly irritant to the skin, eyes and mucous membranes. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No interaction studies have been performed with the topical forms. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 09/09/2013_ _CRN 2119982_ _page number: 1_ 4.6 FERTILITY, PREGNANCY AND LACTATION PREGNANCY There are no adequate data from the use of chlorhexidine and cetrimide in pregnant women. The potential risk for humans is unknown but is most likely very low since chlorhexidine and cetrim Läs hela dokumentet