Land: Verenigd Koninkrijk
Taal: Engels
Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calamine; Zinc oxide; Glycerol; Bentonite; Sodium citrate; Phenol liquefied
Vantage
n/a
Calamine; Zinc oxide; Glycerol; Bentonite; Sodium citrate; Phenol liquefied
150mg/1ml ; 50mg/1ml ; 50mg/1ml ; 30mg/1ml ; 5mg/1ml ; 5mg/1ml
Cutaneous liquid
Cutaneous
No Controlled Drug Status
Valid as a prescribable product
BNF: 13030000
Calamine lotion BP _ 200ML_ SOOTHING PROTECTIVE LOTION ABOUT THIS PRODUCT: Vantage Calamine Lotion BP is applied to the skin to relieve minor irritation and sunburn. DIRECTIONS FOR USE: Liquid for topical use (application to the skin). Shake the bottle thoroughly before use. Adults and children: Apply to the affected area with cotton wool. If you accidentally swallow Vantage Calamine Lotion it should not cause any problems, but if you notice anything consult your doctor or pharmacist. WARNINGS: For external use only Do not use if you allergic to any of the ingredients with symptoms of itching, rashes or difficulty breathing. Do not use on broken skin. This product is safe to use if you are pregnant or breast- feeding. Avoid contact with the eyes, mucous membranes and other sensitive parts of the body. If you have an allergic reaction or notice any other side effects discontinue use and consult your doctor or pharmacist. ACTIVE INGREDIENTS: Calamine 15%w/v and Zinc Oxide 5%w/v. OTHER INGREDIENTS: Bentonite E558, Sodium Citrate E331, Phenol, Glycerol, E422 and Purified Water. STORAGE: _Manufacturer and Product _ _Licence Holder: _ BELL, SONS & CO (DRUGGISTS) LTD., SOUTHPORT, PR9 9AL. _Packed for:_ AAH PHARMACEUTICALS LTD., COVENTRY CV2 2TX. C71-0758 VER A REVISED SEP 2010. KEEP OUT OF THE REACH AND SIGHT OF CHILDREN VAN1562L PL 3105/0011 5025903020776 _200ml_ CALAMINE AND ZINC OXIDE 100m 100y 100M PMS 286 Crease CMYK Template JOB NO DATE 00736 21.10.10 ITEM Vantage Calamine Lotion WIDTH HEIGHT SCALE XXX mm XXX mm 100% ARTWORKER EC Barcode: 5025903020776 VAN: VAN1562L blue. brand creative ltd ground floor studios, 23 charis avenue, bristol bs10 5jd tel: +44 (0) 789 495 2452 www.bluebrandcreative.eu FRONT _169 MM_ _Workstation: _ _Operator: _ _Version _ _Date: _ _Time: _ _Comments: Illustrator CS3_ _Dimensions: 169mm x 65mm_ _Proof required: _ _Outside Print_ _Inside Print_ _Litho_ _Flexo_ _Gravure_ _Mock-up_ _ Telephone: 0151 4229054 _ _• _ _Mobile • 07798677162 • Email • andy.taylor@anagraphics.co.uk_ _Job Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Calamine Lotion BP 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients % w/v Calamine BP 15 Zinc Oxide Ph Eur 5 3 PHARMACEUTICAL FORM Lotion 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the relief of minor skin rashes and irritation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults, children and elderly To be applied when required to the affected area. For topical application. 4.3 CONTRAINDICATIONS Hypersensitivity to any of the ingredients. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Shake the bottle. For external use only. Keep all medicines out of the reach of children. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION No clinically significant interactions known. May mask x-ray pictures under certain circumstances. 4.6 FERTILITY, PREGNANCY AND LACTATION The safety of Calamine Lotion during pregnancy and lactation has not been established but used during these periods is not considered to constitute a hazard. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES No adverse effects known. 4.8 UNDESIRABLE EFFECTS Occasional hypersensitivity or irritant reactions. REPORTING OF SUSPECTED ADVERSE REACTIONS Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. 4.9 OVERDOSE If ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only. 5 PHARMACOLOGICAL PROPERTIES 5.1 PHARMACODYNAMIC PROPERTIES Calamine has a mild astringent action on the skin. 5.2 PHARMACOKINETIC PROPERTIES None known. 5.3 PRECLINICAL SAFETY DATA There are no preclinical data of relevance to the prescriber which are additional to that already included. 6 PHARMACEUTICAL PARTICULARS 6.1 LIST O Lees het volledige document