BACTROBAN CREAM

国家: 马来西亚

语言: 英文

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

有效成分:

MUPIROCIN CALCIUM

可用日期:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN（国际名称）:

MUPIROCIN CALCIUM

每包单位数:

5gm mcg/mL; 15gm mcg/mL

厂商:

SMITHKLINE BEECHAM

资料单张

_ _
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
BACTROBAN
CREAM
_ _
_ _
Mupirocin (2% w/w)
1 WHAT IS IN THIS LEAFLET
1.
What Bactroban is used for
2.
How Bactroban works
3.
Before you use Bactroban
4.
How to use Bactroban
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Bactroban
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT BACTROBAN IS USED FOR
Bactroban is used to treat skin
infections caused by bacteria,
due to small lacerations, sutured
wounds or abrasions.
HOW BACTROBAN WORKS
Bactroban cream is an antibiotic
for use on your skin only.
BEFORE YOU USE BACTROBAN
-
_When you must not use it _
If you are allergic
(hypersensitive) to mupirocin or
any other ingredients of
Bactroban.
If you think this may apply to
you, don’t use Bactroban until
you have checked with your
doctor.
-
_Before you start to use it _
Bactroban may cause skin
irritation and allergic reactions.
Tell the doctor if you are
pregnant, or think you could be,
or if you are planning to become
pregnant. Do not use Bactroban
cream when pregnant unless the
doctor tells you to.
It is not known whether the
ingredients of Bactroban can
pass into breast milk. Tell the
doctor if you are breast feeding
your baby.
If you are applying Bactroban
cream to the cracked nipple
area, wash thoroughly before
breast feeding.
Bactroban cream is not suitable
for ophthalmic use and
intranasal use. Keep the cream
away from the eyes. If the cream
gets into your eyes accidentally,
wash them thoroughly with
water.
Don’t use the cream inside your
nose.
If prolonged or significant
diarrhea occurs or if you
experience abdominal cramps,
stop using this Bactroban cream
immediately and consult with
your doctor.
-
_Taking other medicines _
Tell your doctor or pharmacist if
you’re taking any other
medicines, if you’ve taken any
recently, or if you start taking
new ones. This includes
medicines you bought without a
prescription.
HOW TO USE BACTROBAN
-
_How much to use _
Follow the doctor’

产品特点

CONFIDENTIAL
BACTROBAN
®
TM CREAM
MUPIROCIN CALCIUM
QUALITATIVE AND QUANTITATIVE COMPOSITION
Mupirocin calcium equivalent to 2% w/w mupirocin free acid.
PHARMACEUTICAL FORM
White cream for topical administration in a multi-use tube.
CLINICAL PARTICULARS
INDICATIONS
_BACTROBAN_ cream is indicated for the topical treatment of
secondarily infected
traumatic lesions such as small lacerations, sutured wounds or
abrasions.
DOSAGE AND ADMINISTRATION
POPULATIONS
DOSAGE
_Adults/children/elderly _
3 times a day for up to 10 days, depending on the response.
_Hepatic impairment_: No dosage adjustment is necessary.
_Renal impairment:_ No dosage adjustment is necessary.
METHOD OF ADMINISTRATION
A small quantity of cream should be applied to the affected area with
a piece of clean
cotton wool or gauze swab.
The treated area may be covered by a dressing.
Do not mix with other preparations as there is a risk of dilution,
resulting in a reduction
in the antibacterial activity and potential loss of stability of the
mupirocin in the cream.
CONTRAINDICATIONS
_BACTROBAN_ cream should not be given to patients with a history of
hypersensitivity to
any of its constituents.
CONFIDENTIAL
WARNINGS AND PRECAUTIONS
In the rare event of a possible sensitisation reaction or severe local
irritation occurring
with the use of _BACTROBAN_ cream, treatment should be discontinued,
the product
should be washed off and appropriate alternative therapy for the
infection instituted.
As with other antibacterial products, prolonged use may result in
overgrowth of non-
susceptible organisms.
Pseudomembranous colitis has been reported with the use of antibiotics
and may range in
severity from mild to life-threatening. Therefore, it is important to
consider its diagnosis
in patients who develop diarrhoea during or after antibiotic use.
Although this is less
likely to occur with topically applied mupirocin, if prolonged or
significant diarrhoea
occurs or the patient experiences abdominal cramps, treatment should
be discontinued
immediately and the patient inve