Bactroban 2% w/w Nasal Ointment

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Mupirocin calcium

Доступна с:

GlaxoSmithKline (Ireland) Limited

код АТС:

D06AX; D06AX09

ИНН (Международная Имя):

Mupirocin calcium

дозировка:

2.0 percent weight/weight

Фармацевтическая форма:

Nasal ointment

Тип рецепта:

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

Терапевтические области:

Other antibiotics for topical use; mupirocin

Статус Авторизация:

Marketed

Дата Авторизация:

1989-07-17

тонкая брошюра

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)
Market: Ireland
Agency Approval Date: 30/06/2022
Text Date: 10/06/2022
Text Issue and Draft No.: Issue 8 draft 1
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BACTROBAN 2.0% W/W NASAL 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 2.0% w/w Nasal 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 as mupirocin
calcium. Bactroban is an antibiotic
ointment.
It is used:

to kill a group of bacteria in the nose called ‘Staphylococci’

this group includes MRSA (Methicillin Resistant _Staphylococcus
aureus_)

this ointment is for use in your nose 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 other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Bactroban

Do not put Bactroban into your mouth or swallow it.

Do not put Bactroban in your eyes. If you get it in your eyes, wash it
out immediately.

If you develop a severe skin reaction or

Характеристики продукта

Health Products Regulatory Authority
21 January 2021
CRN00C34F
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bactroban 2% w/w Nasal Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each gram of nasal ointment contains 20 mg mupirocin (2.0% w/w) as
mupirocin calcium.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Nasal ointment.
An off white smooth ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bactroban Nasal Ointment is indicated for the treatment of nasal
carriage of staphylococci, including methycillin resistant
_staphylococcus aureus _(MRSA).
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults:_
Bactroban Nasal Ointment should be applied to the anterior nares two
to three times a day, as follows:
A small amount of the ointment about the size of a match head is
placed on the little finger and applied to the inside of each
nostril. The nostrils are closed by pressing the sides of the nose
together; this will spread the ointment throughout the nares. A
cotton bud may be used instead of the little finger for the
application in particular to infants or patients who are very ill.
Nasal carriage should normally clear within 5-7 days of commencing
treatment.
Method of administration
Topical
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