Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
Povidone-iodine
Ayrton Saunders Ltd
D08AG; D08AG02
Povidone-iodine
25 milligram(s)/gram
Cutaneous spray, powder
Product not subject to medical prescription
Iodine products; povidone-iodine
Not marketed
1986-01-17
Pharmaserve N W est 24pp Kleerform Bookle t 30x98m m 30x70mm(folded), 30x138mm(unfolded) Ashton 24.05.2017 24 For information in large print, audio CD or braille please contact the Marketing Authorisation Holder. This leaflet was last revised: July 2017 _Betadine is a registered trademark._ _PA/501/006/004_ 4 1. WHAT BETADINE DRY POWDER SPRAY IS AND WHAT IT IS USED FOR Betadine Dry Powder Spray contains povidone iodine, which kills a wide range of germs, including bacteria, viruses, fungi and simple organisms. Betadine Dry Powder Spray is used as an antiseptic for the treatment and prevention of infection in minor skin trauma including burns, cuts and other minor injuries. 20 5. HOW TO STORE BETADINE DRY POWDER SPRAY Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is printed on the bottom of the aerosol can.The expiry date refers to thelast day of that month. Do not store above 25°C. Store away from direct heat and sunlight. Do not puncture, break or burn the can even if apparently empty. Do not expose to temperatures exceeding 50°C. Do not throw away any medicines via wastewater or household waste. 8 as using Betadine Dry Powder Spray in these circumstances may cause toxic levels of iodine to be absorbed into your blood. • If you currently have or have ever had a kidney problem as using Betadine Dry Powder Spray in these circumstances may cause toxic levels of iodine to be absorbed into your blood. 16 • Allergic-type reactions, including difficulty breathing or swallowing, a rash, swelling of the face, lips, throat or tongue. You may also experience the following side effects: • Betadine Dry Powder Spray could also cause itching and burns on your skin (rarely). • local irritation 12 • Betadine Dry Powder Spray can permanently discolour white gold jewellery and it is recommended that this type of jewellery should be removed before using this product. 3. HOW TO USE BETADINE DRY POWDER SPRAY Always use this medicine exactly as described in Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Betadine Dry Powder 25 mg/g cutaneous spray 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each gram of powder contains 25mg povidone-iodine For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Cutaneous spray, powder. A reddish-brown powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Antiseptic for the treatment and prevention of infection in minor skin trauma including burns, cuts and other minor injuries. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION For topical use only. Adults and children aged 2 years and older Shake the can well before use. Spray the required area from a distance of 6-10 inches (15-25cm) until a dusting of powder is deposited. If necessary, the treated area may be covered with a dressing. Not to be used in children under 2 years of age, see section 4.3. 4.3 CONTRAINDICATIONS Hypersensitivity to iodine, polyvinylpyrrolidone or any of the excipients. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroditis). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy. Avoid inhaling or spraying into eyes. Betadine Dry Powder Spray should not be used in serous cavities. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE If no improvement occurs a doctor should be consulted. Use in the management of severe burns or denuded skin will lead to systemic absorption and may result in systemic effects such as metabolic acidosis, thyroid dysfunction or renal impairment. Use of this preparation may interfere with tests of thyroid function. Iodine is absorbed through burns and broken skin and to a lesser extent through intact skin and may lead to toxic levels of iodine in the blood, particularly in patients with renal insufficiency. In patients with impaired renal function, blood levels of iodine should be monitored. If symptoms occur suggesting changes in thyroid function, these should be investigated Lees het volledige document