País: Malasia
Idioma: inglés
Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Povidone Iodine
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
Povidone Iodine
15 gm; 30 gm; 250 gm; 500 gm
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ UNIDINE POVIDONE IODINE 5%W/W OINTMENT Povidone Iodine (5%w/w) 1 WHAT IS IN THIS LEAFLET 1. What UNIDINE Povidone Iodine is used for 2. How UNIDINE Povidone Iodine works 3. Before you use UNIDINE Povidone Iodine 4. How to use UNIDINE Povidone Iodine 5. While you are using UNIDINE Povidone Iodine 6. Side effects 7. Storage and disposal of UNIDINE Povidone Iodine 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT UNIDINE POVIDONE IODINE IS USED FOR UNIDINE Povidone Iodine is a topical antiseptic treating minor burns, wounds, cut and abrasions, as well to treat viral, fungus and bacterial skin infection. HOW UNIDINE POVIDONE IODINE WORKS UNIDINE contains povidone iodine which is a broad spectrum antiseptic for topical application in the treatment and prevention of wound infection. BEFORE YOU USE UNIDINE POVIDONE IODINE _-When you must not use it _ It should not be used if you: • had known to be hypersensitive to povidone-iodine, or to any of the excipient listed in the leaflet. • had history of abnormal thyroid function or goitre (swelling of the neck). • on scheduled radioiodine & concomitant therapy. _-Before you start to use it _ • Use of this preparation may interfere with tests of thyroid function. _ _ _Pregnancy and lactation_ Talk to you doctor before taking this medicine if you are pregnant, might become pregnant or are breastfeeding. Iodine freely crosses the placenta and is secreted in breast milk. Therefore, it is recommended that breastfeeding should stop during treatment, unless no alternative is possible. Thyroid function disorders have been reported in the offspring of mothers exposed to pharmacological doses of iodine. Povidone iodine should not be used regularly during pregnancy unless there is no alternative treatment available. _ _ _-Taking other medicines _ Inform your doctor or pharmacist before taking this medicines, including any that you get without a prescription from your pharmacy, s Leer el documento completo
UNIDINE POVIDONE IODINE 5% W/W OINTMENT NAME AND STRENGTH OF ACTIVE INGREDIENT: Povidone Iodine …………………5% w/w PRODUCT DESCRIPTION: A brown viscous ointment . PHARMACODYNAMICS: Povidone iodine is a complex of iodine, which shows all the broad spectrum germicidal activity of elemental iodine. The germicidal activity is maintained in the presence of blood, pus, serum and necrotic tissue. PHARMACOKINETICS: Povidone Iodine is slightly absorbed when applied to the skin. Iodides are excreted mainly in the urine, with smaller amounts appearing in the faeces, saliva and sweat. INDICATIONS: UNIDINE Povidone Iodine is a topical antiseptic treating minor burns, wounds, cut and abrasions, as well to treat viral, fungus and bacterial skin infection. RECOMMENDED DOSE: i) Minor burn, wounds, cuts and abrasions: Apply a small amount at the affected area, 2-3 times daily. May be bandaged, taped or otherwise occluded. ii) Viral, fungal and bacterial skin infections: Apply 2-3 times daily. ROUTE OF ADMINISTRATION: For topical use. CONTRAINDICATIONS: Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis). Use in children under two years of age. Regular use should be avoided in patients on concurrent lithium therapy. WARNING 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 levels of iodine in the blood, particularly in patients with renal insufficiency. If symptoms occur suggesting changes in thyroid function, these should be investigated. In patients with impaired renal function, blood levels of iodine should be monitored. 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 Leer el documento completo