Betadine Alcoholic 100 mg/ml Cutaneous Solution

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Iodinated povidone

Disponible depuis:

Ayrton Saunders Ltd

Code ATC:

D08AG; D08AG02

DCI (Dénomination commune internationale):

Iodinated povidone

Dosage:

100 milligram(s)/millilitre

forme pharmaceutique:

Cutaneous solution

Type d'ordonnance:

Product subject to prescription which may be renewed (B)

Domaine thérapeutique:

Iodine products; povidone-iodine

Statut de autorisation:

Not marketed

Date de l'autorisation:

1983-04-01

Résumé des caractéristiques du produit

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Alcoholic 100 mg/ml Cutaneous Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of cutaneous solution contains 100 mg of Iodinated Povidone
(10% w/v).
This yields 10 mg/ml of available Iodine (1% w/v).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
A dark brown coloured solution with an odour of alcohol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for pre- and post-operative treatment of skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply directly as required.
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.
This preparation contains alcohol and is flammable.
When used prior to a procedure which involves the use of an
electrosurgical unit, do not allow pooling of the fluid to occur, and
ensure that the skin and surrounding drapes are dry
to reduce the risk of fires and burns.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Betadine Alcoholic Solution can permanently discolour white gold
jewellery and it is recommended that this type of
jewellery should be removed before using Betadine Alcoholic Solution