BETADINE VAGINAL CLEANSING KIT
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
POVIDONE-IODINE
Available from:
Seton Healthcare Group PLC
Dosage:
10%w/v %w/v
Pharmaceutical form:
Vaginal Solution
Authorization date:
1993-04-01
Summary of Product characteristics
PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Betadine Vaginal Cleansing Kit.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Povidone Iodine 10% w/v
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Concentrate for vaginal solution
A dark brown coloured solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
As an antiseptic for use in
the management of pre-operative disinfection
of vaginitis due to organisms sensitive to the
iodine and in pre-operative preparation of the vagina.
4.2 POSOLOGY AND METHOD OF ADMINSTRATION
For intravaginal administration.
Betadine Vaginal Cleansing concentrate should be diluted 1:10 and
used according to the patient instruction leaflet
provided.
Use once a day (preferably in the morning) for 14
consecutive days. If menstruation occurs during
the treatment it is
important to continue treatment during the days of the period.
4.3 CONTRAINDICATIONS
1.
Use in patients hypersensitive to iodine.
2.
Use in pregnancy.
3.
Regular use is contraindicated in patients and users with thyroid
disorders (in particular nodular colloid goitre,
endemic goitre and Hashimoto’s thyroiditis).
4.
Use in pre-pubertal children
4.4 SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
1.
If local irritation, redness or swelling
develops discontinue treatment. Iodine is absorbed
from the vagina and
following prolonged use, thyroid dysfunction may
develop. The product may be spermicidal and should not be
used when conception is desired.
2.
If no improvement occurs the doctor should be consulted.
3.
Special caution is needed when regular applications to inflamed
or broken vaginal mucosa are made to patients
with pre existing renal insufficiency.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Issued 24/10/2005_
_CRN 2016032_
_
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