Страна: Малайзія
мова: англійська
Джерело: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Povidone Iodine
Top Biopharma Sdn Bhd
Povidone Iodine
10 gm
Macrophar Co.,Ltd
Page 1 of 2 PACKAGE INSERT 1. Product Name: B IO-B ACTEDENE GEL 10%w/w 2. Name and strength of active ingredients (S): Povidone -Iodine 10g/100g (equivalent to iodine 1g). 3. Product Description: Brown gel 4. Indication: B io-B actedene is used for prevention of infection in cuts, abrasions, burns and use for pre-operative disinfection of the skin. 5. Pharmacodynamics Povidone – iodine is a complex of Iodine which retains the broad-spectrum germicidal activity of elemental iodine without its disadvantages. The germicidal activity is maintained in the presence of bloods, pus, serum and necrotic tissues. 6. Pharmacokinetics B io-B actedene is applied topically to the affected area. 7. Recommended Dose: Apply 2-3 times daily. 8. Mode of Administration: Topical 9. Contraindication -Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. - History of abnormal thyroid function or goiter (in particular nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis). -Regular use should be avoided in patients on concurrent lithium therapy. 10. Warnings and Precautions -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 level of iodine in the blood, particularly patients with renal insufficiency. If symptoms occur suggesting changes in thyroid function, these should investigated. - In patients with impaired renal function, blood levels of iodine should be monitored. - If local irritation and hypersensitivity develop, then discontinue treatment. 11. Interactions with Other Medicaments - Use with concurrent lithium therapy has been shown to exhibit additive hypothyroidic effects. - Absorption of iodine from povidone iodine through either intact skin or broken skin may interfere with thyroid function tests. - Contamination with povidone iodine of several types of tests for the detection of occult blood in faeces or blood in urine may produce false-positive results. Page 2 Прочитайте повний документ