Betadine 10% w/w Ointment

Country: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

IODINATED POVIDONE PH.EUR.

Fáanlegur frá:

Ayrton Saunders Ltd

ATC númer:

D08AG; D08AG02

INN (Alþjóðlegt nafn):

IODINATED POVIDONE PH.EUR.

Skammtar:

10 percent weight/weight

Lyfjaform:

Ointment

Gerð lyfseðils:

Product not subject to medical prescription

Lækningarsvæði:

Iodine products; povidone-iodine

Leyfisstaða:

Not marketed

Leyfisdagur:

1983-04-01

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine 10% w/w Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Iodinated Povidone 10% w/w (yielding 1% w/w available iodine)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Ointment
Smooth, uniform, dark brown ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As a topical antiseptic for management of minor trauma or infection of
the skin.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Apply to the affected area, once or twice daily for a maximum of 14
days.
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, “Undesirable effects”
for further information.
Betadine Ointment can permanently discolour white gold jewellery and
it is recommended that this type of jewellery
should be removed before using Betadine Ointment.
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