Quốc gia: Malaysia
Ngôn ngữ: Tiếng Anh
Nguồn: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Povidone Iodine
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
Povidone Iodine
100 ml; 500 ml; 1000 ml; 200 ml; 250 ml; 100 ml; 200 ml; 250 ml
KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ _ _ UNIDINE POVIDONE IODINE SOLUTION 10% W/V Povidone Iodine (10% w/v) 1 WHAT IS IN THIS LEAFLET 1. What UNIDINE is used for 2. How UNIDINE works 3. Before you use UNIDINE 4. How to use UNIDINE 5. While you are using UNIDINE 6. Side effects 7. Storage and disposal of UNIDINE 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT UNIDINE IS USED FOR It is indicated as disinfectant and antiseptic for the treatment of contaminated wounds, cuts and burns and also for the pre-operative preparation of the skin and mucous membrane. HOW UNIDINE 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 _-When you must not use it _ It should not be used if you: had known to be hypersensitive to iodine, polyvinylpyrrolidone or to any components of the formulation. had history of abnormal thyroid function or goiter (swelling of the neck). on concurrent lithium therapy (for depression). Do not use in children under two years of age. _-Before you start to use it _ Use of this preparation may interfere with tests of thyroid function. Caution to individual with kidney insufficiency and impaired kidney 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 you Đọc toàn bộ tài liệu
UNIDINE POVIDONE IODINE SOLUTION 10% W/V NAME AND STRENGTH OF ACTIVE INGREDIENT: Povidone Iodine ………….. 10% w/v (Available Iodine 1% w/v) PRODUCT DESCRIPTION: A deep brown liquid. 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: Disinfectant and antiseptic for the treatment of contaminated wounds, cuts and burns and also for the pre- operative preparation of the skin and mucous membrane. RECOMMENDED DOSE: To be used undiluted. Apply directly to skin. Allow to dry before applying dress, drape or cast. ROUTE OF ADMINISTRATION: For topical administration. 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 skin may interfere with thyroid function tests. Contamination with povidone iodine of severa Đọc toàn bộ tài liệu