Betadine Solution

Texto original en francés.

Producto de salud natural autorizado en Canadá

Titular

iNova Pharmaceuticals (Australia) Pty Limited

NPN o DIN-HM

00158348

Estado

Licencia activa

Fecha de licencia

16 de noviembre de 2009

Fecha de revisión

7 de enero de 2025

Forma

Solution

Vía de administración

Topique

Tipo de solicitud

DIN de transition

Composición

Ingredientes no medicinales

Glycérine, Eau purifiée, Pareth-25-9, Acid citrique, Phosphate de disodium anhydre, Acide citrique anhydre, Hydroxyde de sodium

Dosis recomendadas en Canadá

Usos autorizados en Canadá

Film-forming, non-staining and water-soluble. Dependable microbicide for situations such as: ¿ pre-operative skin preparation of the operative site ¿ disinfection of wounds, skin, genital and oropharangeal mucosa ¿ anti-infective prophylaxis during hospital and office procedures (i.e., injections) For topical use only. Use full strength for pre- and post-operative skin and mucus membrane antisepsis, prophylaxis and treatment of wounds, lacerations and burns, bacterial and mycotic infections of the skin, trichomonal, monilial and non-specific vaginitis, cervicitis, oral infections and dental procedures.

Texto original en inglés.

Un uso autorizado en Canadá no es una declaración de propiedades saludables autorizada en la Unión Europea. Consulte el registro de declaraciones de propiedades saludables.

Advertencias en Canadá

Known Adverse Reactions : The adverse reactions are classified by body system according to their incidence (common or uncommon). Common adverse reactions have an incidence of grater or equal of 1% and uncommon adverse reactions have an incidence of < 1%. Immune system disorders Uncommon: Anaphylactic reaction and hypersensitivity Endocrine disorders Uncommon: Hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness)* and hypothyroidism*** Metabolism and nutrition Uncommun: Electrolyte imbalance** and metabolic acidosis** Respiratory, thoracic and mediastinal disorders; Uncommon: Pneumonitis***** Skin and subcutaneous disorders Uncommon: Angioedema and contact dermatitis (with symptoms such as erythema, small blisters and pruritus). Renal and urinary disorders Uncommon: Acute renal failure** and blood osmolarity abnormal** Injury poisoning and procedural complications Uncommon: Chemical burn of skin*** *In patients with a history of thyroid disease (see under Special Warnings and Special Precautions for Use) following a notable uptake of iodine e.g. following long-term use of povidone-iodine solution for the treatment of wounds and burns over extensive areas of the skin. **May occur following absorption of large amounts of povidone-iodine during the exposure of large skin or mucosal areas(e.g. in the treatment of burns) ***Following prolonged or extensive use of povidone-iodine ****May occur due to "pooling" beneath the patient in pre-operative preparation *****Complication of aspiration, see Cautions and Warnings

Texto original en inglés.

Contra-Indications : Contraindicated in: - Patients with known hypersensitivity to iodine or povidone - Hyperthyroidism - Other manifest thyroid disease (i.e., non-acute) - Other acute thyroid diseases - Before and after radioactive iodine therapy - Do not use within 4 weeks of radioactive iodine treatments or if using products containing mercury.

Texto original en inglés.

Cautions and Warnings : Drug Interactions and Other Forms of Interactions: The PVP-iodine complex is effective at pH values of between 2.0 and 7.0. It has to be expected that the complex will react with protein and other unsaturated organic compounds, leading to impairment of its effectiveness. The concomitant use of wound-treatment preparations containing enzymatic components leads to a weakening of the effects of both substances. Products containing mercury, silver, hydrogen peroxide, alkali, tannic acid, and taurolidine may interact with povidone-iodine and should not be used concomitantly. Povidone-iodine products when used concomitantly or immediately after application of octenidine containing antiseptics in the same or adjacent sites may lead to transient dark discolorations in the areas involved. Due to the oxidative effect of povidone-iodine preparations various diagnostic agents can show false-positive lab results (e.g. tests with toluidine or gum guaiac for the determination of haemoglobin or glucose in the stool or the urine). Absorption of iodine from povidone-iodine products may lower the iodine uptake of the thyroid; this can lead to interference with various investigations (thyroid scintigraphy, determination of PBI [protein-bound iodine, radioiodine diagnostics) and can make a planned treatment of the thyroid with iodine (radioiodine therapy) impossible. After the end of the treatment, 4 weeks should be allowed before a new scintigram is carried out. It should not be used prior to or after radioiodine scintigraphy or radioiodine treatment of thyroid carcinoma. Fertility, Pregnancy and Lactation: During pregnancy and lactation, povidone-iodine solution should only be used if strictly indicated and its use should be kept to the absolute minimum. Because of the ability of iodine to pass through the placenta and be secreted in breast milk, and because of the increased sensitivity of the fetus and newborn to iodine, no large amounts of povidone-iodine should be administered during pregnancy and lactation. Moreover, iodine is concentrated in the breast milk, as compared with the serum. Povidone-iodine use may induce transient hypothyroidism with elevation of TSH (thyroid stimulating hormone) in the fetus or in the newborn. A check of the newborn's thyroid function may be necessary. Any possible oral ingestion of the solution by the infant must be absolutely avoided. In case of overdose: Call a Regional Poison Control Centre and/or your doctor and/or your local emergency number immediately, or go to your local hospital emergency, even if you do not notice any signs or symptoms. Overdose: Acute iodine toxicity is manifested by abdominal symptoms, anuria, circulatory collapse, pulmonary edema and metabolic abnormalities. Treatment is symptomatic and supportive.

Texto original en inglés.

Fuente

Ficha oficial de Health Canada, licencia 00158348

Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias, consultado el 27 de octubre de 2026.

Contient des informations visées par la Licence du gouvernement ouvert – Canada (Santé Canada, BDPSNH)

Texto original en francés.

La fórmula vendida en Europa con el mismo nombre puede ser diferente. Esta información no sustituye el consejo de un médico o farmacéutico.

Lista en la revisión oficial del 7 de enero de 2025 (registro: Base de datos de productos de salud natural autorizados (BDPSNH), Health Canada: productos autorizados, ingredientes, dosis, usos y advertencias).

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