Standardised Betadine Antiseptic 100 mg/ml Cutaneous Solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Iodinated povidone

Disponible depuis:

Mundipharma Pharmaceuticals Limited

Code ATC:

D08AG; D08AG02

DCI (Dénomination commune internationale):

Iodinated povidone

Dosage:

100 milligram(s)/millilitre

forme pharmaceutique:

Cutaneous solution

Domaine thérapeutique:

Iodine products; povidone-iodine

Statut de autorisation:

Not marketed

Date de l'autorisation:

1983-04-01

Résumé des caractéristiques du produit

Health Products Regulatory Authority
09 July 2019
CRN0091J5
Page 1 of 3
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Standardised Betadine Antiseptic 100 mg/ml Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of cutaneous solution contains 100 mg Iodinated Povidone (10%
w/v) yielding 10 mg/ml (1% w/v) of available iodine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A dark brown coloured cutaneous solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic for the local management of minor skin trauma,
and in the preparation of skin for surgical procedures.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply locally to affected area.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidone or to any excipient.
History of abnormal thyroid function or goitre (in particular
nodular colloid goitre, endemic goitre and Hashimoto's thyroiditis).
Use in children under two years of age. Regular use should
be avoided in patients on concurrent lithium therapy.
4.4 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 in the blood, particularly in patients with renal
insufficiency. If symptoms occur suggesting changes in thyroid
function, these should be investigated. In patients with
impaired renal function, blood levels of iodine should be monitored.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Standardised Betadine Antiseptic Solution can permanently discolour
white gold jewellery and it is recommended that this type
of jewellery should be removed before using Standardised Betadine
Antiseptic Solution.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF
INTERACTIONS
Use with concurrent lithium therap