Bactroban 2% w/w Ointment

国家: 马耳他

语言: 英文

来源: Malta Medicines Authority

有效成分:

MUPIROCIN

可用日期:

Glaxo SmithKline Ireland Limited 12, Riverwalk, Citywest Business Campus, Dublin 24, Ireland

ATC代码:

D06AX09

INN（国际名称）:

MUPIROCIN 20 mg/g

药物剂型:

OINTMENT

组成:

MUPIROCIN 20 mg/g

处方类型:

POM

治疗领域:

ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE

授权状态:

Authorised

授权日期:

2005-11-24

资料单张

PACKAGE LEAFLET: INFORMATION FOR THE USER
BACTROBAN 2%W/W OINTMENT
mupirocin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, nurse or
pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor, nurse or pharmacist.
This includes any possible
side effects not listed in this leaflet. See section 4.
•
In this leaflet, Bactroban 2% w/w Ointment will be called Bactroban.
WHAT IS IN THIS LEAFLET
1
What Bactroban is and what it is used for
2
What you need to know before you use Bactroban
3
How to use Bactroban
4
Possible side effects
5
How to store Bactroban
6
Contents of the pack and other information
Bactroban contains the active substance mupirocin. Bactroban is an
antibiotic ointment.
It is used:
•
to treat skin infections on the skin such as
- infected hair follicles which form pimples containing pus
(“folliculitis”),
- an infectious skin infection with blistering and crusting known as
“impetigo”
- recurring boils (“furunculosis”)
•
This ointment is for external use on your skin only.
DO NOT USE BACTROBAN:
•
if you are allergic to mupirocin or any of the ingredients of this
medicine (listed in section 6).
•
if you have kidney problems as the ointment contains polyethylene
glycol.
WARNINGS AND PRECAUTIONS
* Only marketed pack size(s) will be shown.
•
Talk to your doctor or pharmacist before using Bactroban. Do not use
Bactroban in your nose or
eyes. If you are using Bactroban on your face, be careful not to use
it in or near your eyes or
nose. For infections of the inner nose, a different ointment will be
prescribed.
•
Do not put Bactroban into your mouth or swallow it.
•
If you are using Bactroban on your face, do not get it in your eyes.
If you get

产品特点

Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bactroban 2% w/w Ointment
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of ointment contains 20 mg mupirocin (2% w/w mupirocin free
acid).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Ointment in a white, translucent, water-soluble, macrogol base.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bactroban Ointment is indicated for the treatment of acute primary
bacterial skin
infections e.g. impetigo and folliculitis due to organisms sensitive
to the active
ingredient.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults (including elderly) and children: _
Bactroban Ointment should be applied to the affected area up to three
times a day for
up to 10 days, depending on the response. Dosage should not exceed ten
days.
The area may be covered with a dressing or occluded if desired.
Method of administration
Cutaneous use.
Do not mix with other preparations as there is a risk of dilution,
resulting in a
reduction of the antibacterial activity and potential loss of
stability of the mupirocin
in the ointment.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients
listed in section
6.1.
Page 2 of 7
4.4
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
In the rare event of a possible sensitisation reaction or severe local
irritation occur
with the use of the product, treatment should be discontinued, the
product should be
wiped 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 li