Ország: Írország
Nyelv: angol
Forrás: HPRA (Health Products Regulatory Authority)
Zinc oxide; Dimeticone 350
Ayrton Saunders Ltd
D02AB
Zinc oxide; Dimeticone 350
12.5%w/w + 1.04 percent weight/weight
Cutaneous spray, solution
Product not subject to medical prescription
Zinc products
Marketed
1996-05-21
1. WHAT SPRILON IS USED FOR Sprilon is used for the prevention and treatment of pressure sores, and skin damage from contact with body fluids, e. g. around the perineum, fistulae, colostomies, ileostomies eczematous areas etc. It is also used for the protection and treatment of fissures and leg ulcers, and the protection of skin beneath plaster casts. 2. BEFORE YOU USE SPRILON Do not use Sprilon and talk to your doctor if: • You are allergic (hypersensitive) to zinc oxide, dimeticone, wool fat or any of the other ingredients. • You are sensitive to cetostearyl alcohol. Ask your doctor for advice before taking any medicine if you are pregnant or breast-feeding. Warnings and precautions Do not smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. 3. HOW TO USE SPRILON For external use only. Avoid inhalation or contact with the eyes. Shake the can well. Hold the can 20cm (8”) away from the skin surface, at a right angle. Gently press the nozzle to apply a thin even layer. Two to three seconds of spraying should be sufficient to cover an area the size of the buttocks. A mild cooling sensation may be experienced. Re-apply as often as necessary. Frequent, repeated application to the same area could lead to skin irritation. Other skin preparations may disrupt the Sprilon film if applied to the same area. If you accidentally spray into your eyes, bathe them throughly in water and talk to your doctor. 4. POSSIBLE SIDE EFFECTS Like all medicines, Sprilon can cause side effects, although not everybody gets them. Stop use and talk to your doctor or pharmacist if: AYRTON SAUNDERS LTD. 115G 12.5%W/W / 1.04%W/W CUTANEOUS SPRAY SUSPENSION ZINC OXIDE / DIMETICONE NON-IRRITANT PROTECTIVE WATER-REPELLENT SPRAY OINTMENT PA501/5/1 MA Holder: Ayrton Saunders Ltd., 9 Arkwright Road, Astmoor Industrial Estate, Ru Olvassa el a teljes dokumentumot
Health Products Regulatory Authority 25 July 2019 CRN009732 Page 1 of 4 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sprilon 12.5 % Zinc Oxide and 1.04 % Dimeticone Cutaneous Spray, Suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Zinc Oxide 12.5 % w/w Dimeticone 350 1.04 % w/w _ Excipients_ Wool Fat 5.19 % w/w Cetostearyl Alcohol 0.519 % w/w 3 PHARMACEUTICAL FORM Cutaneous Spray, Suspension. White, water-repellant, viscous ointment suspended in a propellant. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prevention and treatment of pressure sores, and skin damage from contact with body fluids e.g. around the perineum, fistulae, colostomies, ileostomies, eczematous areas etc. Protection and treatment of fissures and leg ulcers. Protection of skin beneath plaster casts. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Shake can well. Spray surfaces at right angles from a distance of 20 cm (8”). Two to three seconds should be sufficient for the area the size of the buttocks. Sprilon can be re-applied as often as necessary. 4.3 CONTRAINDICATIONS Do not use on patients with known sensitivity to wool fats. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Health Products Regulatory Authority 25 July 2019 CRN009732 Page 2 of 4 Avoid inhalation or contact with the eyes. Keep out of the reach and sight of children. If condition is aggravated, discontinue use and consult the doctor. Instruct patients not to smoke or go near naked flames – risk of severe burns. Fabric (clothing, bedding, dressings etc.) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Other topical preparations may disrupt the Sprilon film. 4.6 FERTILITY, PREGNANCY AND LACTATION The safety of Sprilon during pregnancy and lactation has not been established, but useof the product is not considered to be contraindicated during t Olvassa el a teljes dokumentumot