APO-MUPIROCIN mupirocin 20mg/g ointment tube

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

mupirocin, Quantity: 20 mg/g

Prieinama:

Southern Cross Pharma Pty Ltd

INN (Tarptautinis Pavadinimas):

Mupirocin

Vaisto forma:

Ointment

Sudėtis:

Excipient Ingredients: macrogol 3350; macrogol 400

Vartojimo būdas:

Topical

Vienetai pakuotėje:

15 gram tube

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

APO-MUPIROCIN is indicated for the topical treatment of mild impetigo.

Produkto santrauka:

Visual Identification: white, semi-transparent homogenous preparation; Container Type: Tube; Container Material: Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorizacija statusas:

Licence status A

Leidimo data:

2017-04-12

Pakuotės lapelis

APO-Mupirocin
1
APO-MUPIROCIN
_Contains the active ingredient mupirocin _
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _
WHAT IS IN THIS LEAFLET
READ THIS LEAFLET CAREFULLY BEFORE
TAKING YOUR MEDICINE.
This leaflet answers some common
questions about mupirocin ointment.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
The information in this leaflet was
last updated on the date listed on the
last page. More recent information on
this medicine may be available.
ASK YOUR DOCTOR OR PHARMACIST:
•
if there is anything you do not
understand in this leaflet,
•
if you are worried about taking
your medicine, or
•
to obtain the most up-to-date
information.
You can also download the most up
to date leaflet from
www.apotex.com.au.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
Pharmaceutical companies cannot
give you medical advice or an
individual diagnosis.
Keep this leaflet with your medicine.
You may want to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is APO-
Mupirocin. It contains the active
ingredient mupirocin.
It is used to treat mild impetigo
(school sores).
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you. Your
doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
_HOW IT WORKS _
APO-Mupirocin is for use on your
skin only. APO-Mupirocin belongs
to a group of medicines called
antibiotics. Antibiotics work by
killing bacteria which can cause
infection.
There is no evidence that this
medicine is addictive.
_USE IN CHILDREN _
This medicine should not be used in
children under two years of age.
BEFORE YOU USE THIS
MEDICINE
_WHEN YOU MUST NOT USE IT _
DO NOT USE THIS MEDICINE IF:
•
YOU ARE HYPERSENSITIVE TO, OR
HAVE HAD AN ALLERGIC REACTION TO,
MUPIROCIN OR AN

Prekės savybės

AUSTRALIAN PRODUCT INFORMATION
APO-MUPIROCIN, 20 MG/G (2% W/W) OINTMENT
_ _
1. NAME OF THE MEDICINE
Mupirocin
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of mupirocin ointment contains 20 mg of mupirocin (2% w/w)
as the active ingredient.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
APO-Mupirocin ointment is a white, semi-transparent, homogeneous
ointment.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
APO-Mupirocin is indicated for the topical treatment of mild impetigo.
4.2. DOSE AND METHOD OF ADMINISTRATION
APO-Mupirocin is intended for topical application only.
A small amount of mupirocin ointment should be applied to the affected
area three times daily. The area
treated may be covered with 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.
4.3. CONTRAINDICATIONS
APO-Mupirocin
is
contraindicated
in
patients
who
have
demonstrated
hypersensitivity
to
mupirocin,
mupirocin calcium, or any components of the formulation.
4.4. SPECIAL WARNINGS AND PRECAUTIONS FOR USE
If a reaction suggesting sensitivity or chemical irritation should
occur with the use of APO-Mupirocin,
treatment should be discontinued, the product should be wiped off and
appropriate alternative therapy for
the infection instituted.
APO-Mupirocin is not suitable for ophthalmic use, intranasal use or
application to other mucosal surfaces.
Avoid contact with eyes. If contaminated, the eyes should be
thoroughly irrigated with water until the residues
have been removed.
APO-Mupirocin is not suitable for application to the site of
cannulation or for use in conjunction with cannulae.
APO-Mupirocin – AUSTRALIAN PRODUCT INFORMATION
2
As with other antibacterial products, prolonged use may result in
overgrowth of nonsusceptible organisms,
including fungi. Appropriate measures should be taken if this occurs.
Pseudomembranous colitis has been reported with the use of antibiotics
and may range in