UNIDINE Povidone Iodine Solution 10% wv

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Povidone Iodine

Boleh didapati daripada:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

Povidone Iodine

Unit dalam pakej:

100 ml; 500 ml; 1000 ml; 200 ml; 250 ml; 100 ml; 200 ml; 250 ml

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
UNIDINE POVIDONE IODINE SOLUTION 10% W/V
Povidone Iodine (10% w/v)
1
WHAT IS IN THIS LEAFLET
1.
What UNIDINE is used for
2.
How UNIDINE works
3.
Before you use UNIDINE
4.
How to use UNIDINE
5.
While you are using UNIDINE
6.
Side effects
7.
Storage and disposal of UNIDINE
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT UNIDINE IS USED FOR
It
is
indicated
as
disinfectant
and
antiseptic
for
the
treatment
of
contaminated
wounds,
cuts
and
burns
and also for the pre-operative preparation
of the skin and mucous membrane.
HOW UNIDINE WORKS
UNIDINE
contains
povidone
iodine
which is a broad spectrum antiseptic for
topical application in the treatment and
prevention of wound infection.
BEFORE YOU USE UNIDINE
_-When you must not use it _
It should not be used if you:

had
known
to
be
hypersensitive
to
iodine, polyvinylpyrrolidone or to any
components of the formulation.

had
history
of
abnormal
thyroid
function
or
goiter
(swelling
of
the
neck).

on
concurrent
lithium
therapy
(for
depression).
Do not use in children under two years of
age.
_-Before you start to use it _

Use of this preparation may interfere
with tests of thyroid function.

Caution
to
individual
with
kidney
insufficiency
and
impaired
kidney
function.
_ _
_Pregnancy and lactation_
Talk to you doctor before taking this
medicine
if
you
are
pregnant,
might
become pregnant or are breastfeeding.
Iodine freely crosses the placenta and is
secreted in breast milk. Therefore it is
recommended that breastfeeding should
stop
during
treatment,
unless
no
alternative is possible.
Thyroid
function
disorders
have
been
reported
in
the
offspring
of
mothers
exposed
to
pharmacological
doses
of
iodine. Povidone iodine should not be
used regularly during pregnancy unless
there
is
no
alternative
treatment
available.
_ _
_-Taking other medicines _
Inform your doctor or pharmacist before
taking this medicines, including any that
you get without a prescription from you

Ciri produk

UNIDINE
POVIDONE IODINE SOLUTION 10% W/V
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Povidone Iodine ………….. 10% w/v (Available Iodine 1% w/v)
PRODUCT DESCRIPTION:
A deep brown liquid.
PHARMACODYNAMICS:
Povidone iodine is a complex of iodine, which shows all the broad
spectrum germicidal activity of
elemental iodine. The germicidal activity is maintained in the
presence of blood, pus, serum and necrotic
tissue.
PHARMACOKINETICS:
Povidone Iodine is slightly absorbed when applied to the skin. Iodides
are excreted mainly in the urine,
with smaller amounts appearing in the faeces, saliva and sweat.
INDICATIONS:
Disinfectant and antiseptic for the treatment of contaminated wounds,
cuts and burns and also for the pre-
operative preparation of the skin and mucous membrane.
RECOMMENDED DOSE:
To be used undiluted. Apply directly to skin. Allow to dry before
applying dress, drape or cast.
ROUTE OF ADMINISTRATION:
For topical administration.
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.
WARNING AND PRECAUTIONS:
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.
INTERACTIONS WITH OTHER MEDICAMENTS:
Use with concurrent lithium therapy has been shown to exhibit additive
hypothyroidic effects. Absorption
of iodine from povidone iodine through either intact skin or broken
skin may interfere with thyroid
function tests. Contamination with povidone iodine of severa