MEDICIANZ MUPIROCIN OINTMENT mupirocin 2%w/w, tube

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

mupirocin, Quantity: 20 mg/g

Available from:

Medsurge Pharma Pty Ltd

INN (International Name):

Mupirocin

Pharmaceutical form:

Ointment

Composition:

Excipient Ingredients: macrogol 400; macrogol 3350

Administration route:

Topical

Units in package:

5g x 1, 15g x 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Medicianz Mupirocin Ointment is indicated for the topical treatment of mild impetigo.

Product summary:

Visual Identification: Homogenous off-white ointment; Container Type: Tube; Container Material: Epoxy-coated Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-07-06

Patient Information leaflet

MEDICIANZ MUPIROCIN OINTMENT 2%W/W CMI V0.1
1
MEDICIANZ MUPIROCIN
OINTMENT
_MUPIROCIN _
CONSUMER MEDICINE INFORMATION
_WHAT IS IN THIS LEAFLET _
Please read this leaflet carefully
before you use Medicianz
Medicianz MUPIROCIN
Ointment.
This leaflet answers some
common questions about
Medicianz MUPIROCIN
Ointment. It does not contain all
the available information
It does not take the place of talking
to your doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed
the risks of you using
the
Medicianz MUPIROCIN
Ointment
against the benefits
they expect it will have for you.
If you are helping someone else to
use Medicianz MUPIROCIN
Ointment, read this leaflet before
applying the first application.
IF YOU HAVE ANY CONCERNS
ABOUT BEING TREATED WITH
MEDICIANZ MUPIROCIN
OINTMENT, ASK YOUR DOCTOR OR
PHARMACIST.
This leaflet was last updated on
the date at the end of this
leaflet. More recent information
may be available. The latest
Consumer Medicine
Information is available from
your pharmacist, doctor, or
from www.tga.gov.au and may
contain important information
about the medicine and its use
of which you should be aware.
KEEP THIS LEAFLET WITH THE
MEDICINE
.
You may need to read it again.
_WHAT MEDICIANZ _
_MUPIROCIN OINTMENT _
_IS USED FOR _
Medicianz MUPIROCIN
Ointment contains mupirocin
(2% w/w) as the active
ingredient.
MUPIROCIN belongs to a
group of medicines called
antibiotics.
Antibiotics work by killing
bacteria which can cause
infection.
Medicianz MUPIROCIN
Ointment is used for the
treatment of mild impetigo
(school sores).
Medicianz MUPIROCIN
Ointment is for use on your
skin only.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you.
Your doctor may have
prescribed Medicianz
MUPIROCIN Ointment for
another reason.
Medicianz MUPIROCIN
Ointment is not addictive.
_BEFORE YOU USE _
_MEDICIANZ _
_MUPIROCIN OINTMENT _
_WHEN YOU SHOULD NOT _
_BE GIVEN IT _
You must not be given
Medicianz MUPIROCIN
Ointment if you have an
allergy to:

any medicin

Summary of Product characteristics

MEDICIANZ MUPIROCIN OINTMENT
PRODUCT INFORMATION
Edition 2.0 –February 2021
Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION
MEDICIANZ MUPIROCIN OINTMENT
MUPIROCIN 20 MG/G (2 % W/W) OINTMENT TUBE
1
NAME OF THE MEDICINE
Mupirocin
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Medicianz Mupirocin Ointment contains mupirocin 2% w/w equivalent to
20 mg/g mupirocin
as the active ingredient.
Mupirocin is a naturally occurring antibiotic, produced by
fermentation of the organism
Pseudomonas fluorescens.
Each gram of Medicianz Mupirocin Ointment contains 20 milligrams of
mupirocin. Medicianz
Mupirocin Ointment also contains Polyethylene glycol (macrogol) 400
and Polyethylene glycol
(macrogol) 3350.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Ointment.
Medicianz Mupirocin Ointment is a white, translucent, water-soluble,
polyethylene glycol based,
homogeneous off-white ointment, which is odourless or nearly
odourless.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Medicianz Mupirocin Ointment is indicated for the topical treatment of
mild impetigo.
4.2
D
OSE AND METHOD OF ADMINISTRATION
A small amount of Medicianz Mupirocin Ointment should be applied to
the affected area three
times daily. The area treated may be covered with a gauze dressing if
desired. Usually treatment
should not continue for more than 10 days.
Any product remaining at the end of treatment should be discarded.
MEDICIANZ MUPIROCIN OINTMENT
PRODUCT INFORMATION
Edition 2.0 –February 2021
Page 2 of 8
_Renal impairment _
For use in renal impairment, please refer to section 4.4 SPECIAL
WARNINGS AND
PRECAUTIONS FOR USE.
4.3
C
ONTRAINDICATIONS
Medicianz Mupirocin Ointment is contraindicated in patients who have
demonstrated
hypersensitivity to mupirocin or any components of the formulations.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
If a reaction suggesting sensitivity or chemical irritation should
occur with the use of Medicianz
Mupirocin Ointment, treatment should be discontinued, the product
should be wiped o