Betadine Solution
Prodotto naturale per la salute autorizzato in Canada
- Titolare
- iNova Pharmaceuticals (Australia) Pty Limited
- NPN o DIN-HM
- 00158348
- Stato
- Licenza attiva
- Data della licenza
- 16 novembre 2009
- Data di revisione
- 7 gennaio 2025
- Forma
- Solution
- Via di somministrazione
- Topique
- Tipo di domanda
- DIN de transition
L’analisi delle dosi orali non si applica senza una via esclusivamente orale accertata.
Composizione
| Ingrediente medicinale e fonte | Per unità posologica, secondo la fonte |
|---|---|
| Povidone iodée Fonte : Synthétique Potenza : 1 % Iodine | 10 % |
Ingredienti non medicinali
Glycérine, Eau purifiée, Pareth-25-9, Acid citrique, Phosphate de disodium anhydre, Acide citrique anhydre, Hydroxyde de sodium
Dosi raccomandate in Canada
| Popolazione | Età | Quantità per assunzione | Frequenza |
|---|---|---|---|
Sottopopolazione S/O Tradotto automaticamente dal francese. Vedi l’originaleSous-population S/O | Non precisata Tradotto automaticamente dal francese. Vedi l’originaleNon précisée | Non precisata Tradotto automaticamente dal francese. Vedi l’originaleNon précisée | Non precisata Tradotto automaticamente dal francese. Vedi l’originaleNon précisée |
Usi autorizzati in Canada
Traduzione non disponibile. Testo originale, lingua: inglese.
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.Un uso autorizzato in Canada non è un’indicazione sulla salute autorizzata nell’Unione europea. Consulti il registro delle indicazioni sulla salute.
Avvertenze in Canada
Traduzione non disponibile. Testo originale, lingua: inglese.
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 WarningsTraduzione non disponibile. Testo originale, lingua: inglese.
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.Traduzione non disponibile. Testo originale, lingua: inglese.
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.Fonte
Scheda ufficiale Health Canada, licenza 00158348
Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze, consultato il 27 ottobre 2026.
Contient des informations visées par la Licence du gouvernement ouvert – Canada (Santé Canada, BDPSNH)
Licence du gouvernement ouvert – Canada 2.0 (OGL-Canada 2.0)
La formula venduta in Europa con lo stesso nome può essere diversa. Queste informazioni non sostituiscono il parere di un medico o farmacista.
Elenco nella revisione ufficiale del (registro: Banca dati dei prodotti naturali per la salute autorizzati (BDPSNH), Health Canada: prodotti autorizzati, ingredienti, dosi, usi e avvertenze).
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