Betadine 100 mg/ml Antiseptic Paint

Land: Ierland

Taal: Engels

Bron: HPRA (Health Products Regulatory Authority)

Werkstoffen:

Iodinated povidone

Beschikbaar vanaf:

Ayrton Saunders Ltd

ATC-code:

D08AG; D08AG02

INN (Algemene Internationale Benaming):

Iodinated povidone

Dosering:

100 milligram(s)/millilitre

farmaceutische vorm:

Cutaneous solution

Prescription-type:

Product not subject to medical prescription

Therapeutisch gebied:

Iodine products; povidone-iodine

Autorisatie-status:

Not marketed

Autorisatie datum:

1978-03-15

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine 100 mg/ml Antiseptic Paint
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 10% w/v (yielding 1.1% w/v available iodine).
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
Glass bottle with applicator brush containing a brown coloured
solution with an odour of alcohol.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic in the prevention and treatment of topical
cutaneous infections.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply to the affected area once or twice daily or as directed.
Apply directly to the affected area and allow to dry. Cover with a
dressing if desired.
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.
Allow to dry after use and avoid exposure to sources of ignition.
If local irritation and hypersensitivity develop, then discontinue
treatment. Refer to section 4.8 for further information.
Betadine Antiseptic Paint
can permanently discolour white gold jewellery and it
is recommended that
this type of
jewellery should be removed before using Betadine Antiseptic Paint.
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