البلد: أيرلندا
اللغة: الإنجليزية
المصدر: HPRA (Health Products Regulatory Authority)
Benzocaine; Mepyramine maleate
GR Lane Health Products Ltd
D04AA; D04AA02
Benzocaine; Mepyramine maleate
0.5%w/w +1 percent weight/weight
Cutaneous spray, solution
Product not subject to medical prescription
Antihistamines for topical use; mepyramine
Not marketed
1996-07-09
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Wasp-eze Spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _For full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Cutaneous spray, solution. Clear, colourless solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the treatment of all insect bites and stings, nettle stings and jellyfish stings. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: For cutaneous use. ADULTS, THE ELDERLY AND CHILDREN: Hold nozzle approximately five inches from the skin and spray once for 2-3 seconds. Stop spraying immediately if a white deposit or ‘frost’ appears. Repeat once after 15 minutes if necessary. If pain persists, seek medical advice. 4.3 CONTRAINDICATIONS Do not apply to large areas of skin, eczematous, sunburnt, infected or broken skin. Do not use the spray on the face. Do not use if you are sensitive to benzocaine, any chemically related anaesthetics (butylcaine and tetracaline) or mepyramine maleate. Do not use if you are sensitive to any of the excipients or to PABA, parabens or paraphenylenediamine or to commercial hair dyes as there is cross-sensitivity between these products. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Patients with any known allergy should seek medical advice. If pain persists, seek medical advice. Do not use near the mouth or eyes or under conditions in which significant inhalation is likely. Not for repeated or prolonged use. For external use only. Keep out of the reach and sight of children. Flammable. Do not use near fire or flame. Pressurised container. Protect from sunlight and do not expose to temperatures exceeding 50 ° C. Do not pierce or burn, even after use. Do not spray on a naked flame or any incandescent material. Do not use near or place container on polished or painted surfaces. Methaemoglobinaemia has been reported with benzocaine use. Benzocaine 1.0% w/w Mepyramine maleate 0.5% w/w Excipients: Propylene glycol (E1520) 2.2% w/w H E A L T H P R O D U C T S R E G U L A T O اقرأ الوثيقة كاملة