BETADINE Pressurised aerosol spray (2015)
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Περιεχόμενα
Name of the medicinal product
Betadine Dry Powder Spray.
Qualitative and quantitative composition
Povidone iodine 2.5 %w/w. For excipients, see section 6.1.
Pharmaceutical form
Pressurised aerosol spray.
Therapeutic indications
Antiseptic for the treatment and prevention of infection in wounds including ulcers, burns, cuts and other minor injuries.
Posology and method of administration
For topical use only. Adults and children aged 2 years and older Shake the can well before use. Spray the required area from a distance of 6-10 inches (15-25cm) until a dusting of powder is deposited. ...
Contraindications
Hypersensitivity to iodine, polyvinylpyrrolidine or to any excipient. History of abnormal thyroid function or goitre (in particular nodular colloid goitre, endemic goitre and Hashimotos thyroiditis). Use ...
Special warnings and precautions for use
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 ...
Interaction with other medicinal products and other forms of interaction
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 ...
Pregnancy and lactation
Iodine freely crosses the placenta and is secreted in breast milk. Thyroid function disorders have been reported in the offspring of mothers exposed to pharmacological doses of iodine. Povidone iodine ...
Effects on ability to drive and use machines
None.
Undesirable effects
Local irritation, skin burns and sensitivity reactions have been reported rarely. Anaphylactic reactions, anaphylactoid reactions and anaphylactic shock have been reported uncommonly with products containing ...
Overdose
Deliberate or accidental ingestion of large quantities of povidone iodine will result in high blood concentrations of iodine and gastrointestinal corrosive effects including vomiting, diarrhoea and abdominal ...
Pharmacodynamic properties
Antiseptics and disinfectants ATC code: D08AG02 Povidone iodine is a complex of iodine, which retains the broad-spectrum germicidal activity of the elemental iodine without its disadvantages. The germicidal ...
Pharmacokinetic properties
Not applicable.
Preclinical safety data
None stated.
List of excipients
Isopropyl myristate N-pentane Butane 40 Soya lecithin
Incompatibilities
None known.
Shelf life
36 months unopened.
Special precautions for storage
Do not store above 25°C.
Nature and contents of container
Aerosol cans, containing 50, 100 or 150ml of product. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
None.
Marketing authorization holder
Ayrton Saunders Ltd, 9 Arkwright Road, Astmoor Industrial Estate, Runcorn, Cheshire, WA7 1NU, UK
Marketing authorization number(s)
PL 16431/0190
Date of first authorization / renewal of the authorization
19 April 2006
Date of revision of the text
24/09/2015
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