Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
Povidone-iodine
GlaxoSmithKline Consumer Healthcare (Ireland) Limited
D08AG; D08AG02
Povidone-iodine
1.14 percent weight/weight
Cutaneous spray, powder
Product not subject to medical prescription
Iodine products; povidone-iodine
Not marketed
1986-05-12
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Savlon Dry Antiseptic. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Spray powder containing 1.14% w/w of Povidone Iodine with an available iodine content of 5% w/w in the powder. _For full list of excipients, see section 6.1_ 3 PHARMACEUTICAL FORM Cutaneous spray, powder. Pressurised Cutaneous Spray. Orange/brown micronised powder and propellants. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the topical prophylaxis and treatment of superficial infections or injuries of skin. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Apply to the affected area by spraying from a distance of 15 to 22 cm. Special populations; _Children:_ There are no special dosage recommendations for children. However, povidone-iodine is not recommended for regular use in neonates and is contra-indicated in very low birth weight infants (below 1500g). _Renal Impairment:_ Avoid regular application to inflammed or broken skin. 4.3 CONTRAINDICATIONS Savlon Dry is contraindicated in patients with thyroid disorders, in particular overactive thyroid (hyperthyroidism), nodular colloid goitre, endemic goitre and Hashimoto’s thyroiditis. Hypersensitivity to povidone iodine or any other ingredient of the spray. Povidone iodine containing products are contra-indicated for preterm neonates gestational age under 32 weeks. Use near nose or mouth. Scheduled radioiodine therapy. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Iodine absorption may interfere with tests of thyroid function. Application to extensive areas of broken skin may lead to excessive absorption of iodine. Regular or prolonged use should be avoided in patients receiving lithium therapy (refer to section 4.5). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ Leggi il documento completo