Bactroban 2% w/w Ointment

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Mupirocin

제공처:

GlaxoSmithKline (Ireland) Limited

ATC 코드:

D06AX; D06AX09

INN (국제 이름):

Mupirocin

복용량:

2 percent weight/weight

약제 형태:

Ointment

처방전 유형:

Product subject to prescription which may not be renewed (A)

치료 영역:

Other antibiotics for topical use; mupirocin

승인 상태:

Marketed

승인 날짜:

1986-04-29

환자 정보 전단

Reason for update:
Type Iain Project Pine CMC update (Pzn address is grey shaded
therefore no live artwork
impacted thus no change to date in PIL)
Agency Approval Date: 30/06/2022 (imp date for Type IAIN)
Text Date: 10/06/2022
Text Issue and Draft No.: Issue 8 draft 1
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
1
WHAT BACTROBAN IS AND WHAT IT IS USED FOR
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.
2
WHAT YOU NEED TO KNOW BEFORE YOU USE BACTROBAN
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

Talk to your doctor or pharmacist before using Bactroban. Do not use
Bactroban in your n

제품 특성 요약

Health Products Regulatory Authority
08 October 2019
CRN009D41
Page 1 of 6
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 (2.0% w/w) as mupirocin
free acid.
For the full list 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 in 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.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
In the rare event of a possible sensitisation reaction or severe local
irritation occurring 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 af