Fucidin 30mg/100cm2 impregnated dressing

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Sodium fusidate

متاح من:

LEO Pharma A/S

ATC رمز:

D09AA; D09AA02

INN (الاسم الدولي):

Sodium fusidate

جرعة:

30 milligram(s)

الشكل الصيدلاني:

Impregnated dressing

طريقة التعاطي:

cutaneous use

الوحدات في الحزمة:

10 or 50 impregnated dressings (10 cm x 10 cm)

نوع الوصفة الطبية :

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

المصنعة من قبل:

LEO Laboratories Ltd

المجموعة العلاجية:

Medicated dressings with antiinfectives

المجال العلاجي:

Medicated dressings with antiinfectives; fusidic acid

الخصائص العلاجية:

Fucidin is indicated for the treatment of skin infections caused by bacteria susceptible to sodium fusidate in children from 1 year of age and adults. Consideration should be given to official guidance on the appropriate use of antibacterial agents. Prescribers should consider local resistance and susceptibility.

الوضع إذن:

Not marketed

تاريخ الترخيص:

2015-09-11

نشرة المعلومات

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
FUCIDIN 30 MG/100 CM
2
IMPREGNATED DRESSING
sodium fusidate
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 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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Fucidin is and what it is used for
2.
What you need to know before you use Fucidin
3.
How to use Fucidin
4.
Possible side effects
5.
How to store Fucidin
6.
Contents of the pack and other information
1.
WHAT FUCIDIN IS AND WHAT IT IS USED FOR
The active substance of Fucidin is sodium fusidate which is an
antibiotic. Fucidin is used for skin infections
caused by bacteria sensitive to sodium fusidate in children from 1
year of age and adults.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUCIDIN
DO NOT USE FUCIDIN:
-
if you are allergic to sodium fusidate or any of the other ingredients
of this medicine (listed in section
6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before using Fucidin.
If you use this product regularly or during a long period, there is a
risk that the bacteria against which this
product is active become resistant to sodium fusidate. Therefore, it
is possible that this product does not
work properly for you after prolonged use.
When Fucidin is used on the face, care should be taken to avoid
contact with the eyes as the excipients in
the impregnated dressing may cause eye irritation.
Fucidin must not be used on severely injured skin.
Talk to you doctor or pharmacist before using Fucidin if you are
taking statins (medicines to lower blood
cholesterol).
OTHER MEDICINES AND FUCIDIN
Tell your doctor or pharmacist if you are

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Fucidin 30mg/100cm
2
impregnated dressing
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each impregnated dressing contains 30 mg/100 cm
2
sodium fusidate in a dressing size of 10 cm x 10 cm.
Excipients with known effect:
Each impregnated dressing contains not more than 9 mcg
butylhydroxytoluene (E321), 6 mg cetyl alcohol and 69 mg
wool fat.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Impregnated dressing
The impregnated dressing consists of a 10 cm x 10 cm piece of cotton
gauze impregnated with ointment. The ointment
is off-white to white in colour.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Fucidin is indicated for the treatment of skin infections caused by
bacteria susceptible to sodium fusidate in children
from 1 year of age and adults. For information on susceptible
bacteria, refer to section 5.1.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents. Prescribers should
consider local resistance and susceptibility.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and children from 1 year of age: Fucidin should be applied once
daily for up to 14 days.
Special Populations
_Elderly_
No specific risks for elderly patients have been identified for
Fucidin. No special precautions or dosage adjustment is
necessary.
_Renal impairment_
No specific risks for patients with renal impairment have been
identified for Fucidin. No special precautions or dosage
adjustment is necessary.
_Hepatic impairment_
No specific risks for patients with hepatic impairment have been
identified for Fucidin. No special precautions or
dosage adjustment is necessary.
Method of administration
Fucidin is for cutaneous use only.
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