Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
Dimeticone 350; Zinc oxide
Ayrton Saunders (Ireland) Limited
D02AB
Dimeticone 350; Zinc oxide
12.5%w/w + 1.04 percent weight/weight
Cutaneous spray, suspension
Zinc products
Not marketed
1996-05-21
AYRTON SAUNDERS (IRELAND) LTD. SPRILON ® 12.5%W/W / 1.04%W/W CUTANEOUS SPRAY SUSPENSION ZINC OXIDE / DIMETICONE 115G NON-IRRITANT PROTECTIVE WATER-REPELLENT SPRAY OINTMENT PA22906/001/001 MA HOLDER: Ayrton Saunders (Ireland) Limited, 8A Sandyford Business Centre, Blackthorn Avenue, Sandyford, Dublin 18, Ireland. MANUFACTURER: MIAS Pharma Limited, Suite 1, Stafford House, Strand Road, Portmarnock, Co. Dublin, Ireland. Fire hazard. Do not smoke or go near naked flames; clothing & bedding with this product dried on them can catch fire easily. ® Registered trademark Ayrton Saunders Ltd. 1. WHAT SPRILON IS AND WHAT IT IS USED FOR Sprilon contains Zinc Oxide and Dimeticone. 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. WHAT YOU NEED TO KNOW BEFORE YOU USE SPRILON DO NOT USE SPRILON AND TALK TO YOUR DOCTOR IF: • You are allergic to zinc oxide, dimeticone, wool fat or any of the other ingredients. • You are sensitive to cetostearyl alcohol. Cetostearyl alcohol and wool fat may cause local skin reactions (e.g. contact dermatitis). Ask your doctor for advice before taking any medicine if you are pregnant or breast-feeding. WARNINGS AND PRECAUTIONS AVOID INHALATION OR CONTACT WITH THE EYES. If condition is aggravated, discontinue use and consult doctor. 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. 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 sp Կարդացեք ամբողջական փաստաթուղթը
Health Products Regulatory Authority 09 July 2021 CRN00C073 Page 1 of 3 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 with known effect Wool Fat 5.19 % w/w Cetostearyl Alcohol 0.519 % w/w For the full list of excipients, see section 6.1. 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 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. This product contains wool fat and cetostearyl alcohol which may cause local skin reactions (eg. contact dermatitis). 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTIONS Other topical preparations may disrupt the Sprilon film. Health Products Regulatory Authority 09 July 2021 CRN00C073 Page 2 of 3 4.6 F Կարդացեք ամբողջական փաստաթուղթը