UNIDINE Povidone Iodine 5% ww Ointment

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:

15 gm; 30 gm; 250 gm; 500 gm

Dikeluarkan oleh:

KCK PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
UNIDINE POVIDONE IODINE 5%W/W OINTMENT
Povidone Iodine (5%w/w)
1
WHAT IS IN THIS LEAFLET
1.
What UNIDINE Povidone Iodine is
used for
2.
How UNIDINE Povidone Iodine
works
3.
Before you use UNIDINE Povidone
Iodine
4.
How to use UNIDINE Povidone
Iodine
5.
While you are using UNIDINE
Povidone Iodine
6.
Side effects
7.
Storage and disposal of UNIDINE
Povidone Iodine
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT UNIDINE POVIDONE IODINE
IS
USED FOR
UNIDINE Povidone Iodine is a topical
antiseptic treating minor burns, wounds,
cut and abrasions, as well to treat viral,
fungus and bacterial skin infection.
HOW
UNIDINE
POVIDONE
IODINE
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
POVIDONE
IODINE
_-When you must not use it _
It should not be used if you:
•
had
known
to
be
hypersensitive
to
povidone-iodine,
or
to
any
of
the
excipient listed in the leaflet.
•
had
history
of
abnormal
thyroid
function
or
goitre
(swelling
of
the
neck).
•
on
scheduled
radioiodine
&
concomitant therapy.
_-Before you start to use it _
•
Use of this preparation may interfere
with tests of thyroid 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 your
pharmacy, s

Ciri produk

UNIDINE
POVIDONE IODINE 5% W/W OINTMENT
NAME AND STRENGTH OF ACTIVE INGREDIENT:
Povidone Iodine …………………5% w/w
PRODUCT DESCRIPTION:
A brown viscous ointment
.
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:
UNIDINE Povidone Iodine is a topical antiseptic treating minor burns,
wounds, cut and abrasions, as well
to treat viral, fungus and bacterial skin infection.
RECOMMENDED DOSE:
i)
Minor burn, wounds, cuts and abrasions: Apply a small amount at the
affected area, 2-3 times
daily. May be bandaged, taped or otherwise occluded.
ii)
Viral, fungal and bacterial skin infections: Apply 2-3 times daily.
ROUTE OF ADMINISTRATION:
For topical use.
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