Betadine Surgical Scrub 75 mg/ml Cutaneous Solution

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Iodinated povidone

Commercializzato da:

Ayrton Saunders Ltd

Codice ATC:

D08AG; D08AG02

INN (Nome Internazionale):

Iodinated povidone

Dosaggio:

75 milligram(s)/millilitre

Forma farmaceutica:

Cutaneous solution

Tipo di ricetta:

Product subject to prescription which may be renewed (B)

Area terapeutica:

Iodine products; povidone-iodine

Stato dell'autorizzazione:

Not marketed

Data dell'autorizzazione:

1983-04-01

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Surgical Scrub 75 mg/ml Cutaneous Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 75 mg/ml (7.5% w/v).
This yields approx 8 mg/ml (0.8% w/v) of available iodine.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Cutaneous solution
Clear, dark brown colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic in pre- and post-operative treatment of skin. As a
pre-operative surgical preparation.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For topical administration.
Apply to the appropriate area as a pre-operative antiseptic skin
cleanser.
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.
Betadine Surgical Scrub can permanently discolour white gold jewellery
and it is recommended that this type of
jewellery should be removed before using Betadine Surgical Scrub.
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