Betaiodine solution mouthwash

Land: Armenië

Taal: Engels

Bron: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Werkstoffen:

povidone-iodine

Beschikbaar vanaf:

Arpimed LLC

ATC-code:

D08AG02

INN (Algemene Internationale Benaming):

povidone-iodine

Dosering:

10mg/ml

farmaceutische vorm:

solution mouthwash

Eenheden in pakket:

100ml and 120ml glass bottle

Prescription-type:

OTC

Autorisatie-status:

Registered

Autorisatie datum:

2018-10-30

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
BETAIODINE
1% MOUTHWASH SOLUTION
POVIDONE IODINE
1.1 NAME OF THE MEDICAL PRODUCT – BETAIODINE
1.2 INTERNATIONAL NON-PROPERTY NAME – POVIDONE IODINE
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of Betaiodine, 1% mouthwash solution contains povidone iodine
– 10 mg
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Mouthwash solution.
A dark brown colored liquid having a characteristic menthol odor.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This solution is used for the treatment of Acute Mucosal Infections of
the mouth and
pharynx e.g. gingivitis, mouth ulcers, for oral hygiene prior to,
during, and after dental and oral
surgery.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Route of administration: Oral, as a gargle and mouthwash. The product
should not be swallowed.
Adults, the elderly and children over 6 years of age: Use undiluted
with an equal volume of
warm water. Gargle or rinse with up to 10mls for up to 30 seconds
without swallowing. Repeat
up to four times daily, for up to 14 consecutive days, or as directed.
Not to be used in children of 6 years and under.
4.3 CONTRAINDICATIONS
Hypersensitivity to iodine, polyvinylpyrrolidine or to any excipient.
History of abnormal thyroid
function or goitre (in particular nodular colloid goitre, endemic
goitre and Hashimoto’s
thyroiditis). Regular use should be avoided in patients on concurrent
lithium therapy. Do not use
in children of 6 years and under.
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.
Do not use for more than 14 days.
If local irritation and hyper