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PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Antiseptic Swab
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each cotton swab contains 1g of solution, each ml of the solution contains 10% w/v povidone iodine, which contains 3
parts per million of free iodine.
For excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Swab impregnated with a cutaneous solution.
Sachet containing a folded 100% surgical grade cotton swab impregnated with a clear golden brown iodinated solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for cleansing and preparation of sites.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical use only.
Swab area thoroughly. Use swab once only. Use as required.
4.3 CONTRAINDICATIONS
Use in patients with a known hypersensitivity to iodine. Use in children under 2 years of age. Use in patients with
thyroid disorders.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Use of this preparation may interfere with tests of thyroid function. Special caution is needed when regular applications
to broken skin are made in patients with pre-existing renal insufficiency. Regular use should be avoided in patients on
concurrent lithium therapy. If used for prolonged periods, thyroid function tests should be preformed.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
None known.
4.6 PREGNANCY AND LACTATION
Regular use should be avoided in pregnant or lactating women as absorbed iodine can cross the placental barrier and
can be secreted in breast milk.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 20/07/2006_
_CRN 2025767_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Not applicable.
4.8 UNDESIRA
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