Augmentin Pdr for Soln Inj/Inf 500mg/100mg

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

AMOXICILLIN, CLAVULANIC ACID

Tilgjengelig fra:

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

ATC-kode:

J01CR02

INN (International Name):

AMOXICILLIN 500 mg CLAVULANIC ACID 100 mg

Legemiddelform:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Sammensetning:

AMOXICILLIN 500 mg CLAVULANIC ACID 100 mg

Resept typen:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2006-03-28

Informasjon til brukeren

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PACKAGE LEAFLET
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PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN 500 MG/100 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
_ _
amoxicillin/clavulanic acid
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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Augmentin is and what it is used for
2.
What you need to know before you have Augmentin
3.
How Augmentin is given
4.
Possible side effects
5.
How to store Augmentin
6.
Contents of the pack and other information
1.
WHAT AUGMENTIN IS AND WHAT IT IS USED FOR
Augmentin is an antibiotic and works by killing bacteria that cause
infections. It contains two
different medicines called amoxicillin and clavulanic acid.
Amoxicillin belongs to a group of
medicines called “penicillins” that can sometimes be stopped from
working (made inactive). The
other active component (clavulanic acid) stops this from happening.
Augmentin is used in adults and children to treat the following
infections:
•
severe ear, nose and throat infections
•
respiratory tract infections
•
urinary tract infections
•
skin and soft tissue infections including dental infections
•
bone and joint infections
•
intra-abdominal infections
•
genital organ infections in women.
Augmentin is used in adults and children to prevent infections
associated with major surgical
procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE AUGMENTIN
YOU SHOULD NOT HAVE AUGMENTIN:
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other ingredients of
this medicine (listed in section 6).
•
if you have ever had a severe allergic reaction to any other
antibiotic. This can include a skin
rash or swelling of the face or throat.

Preparatomtale

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SUMMARY OF PRODUCT CHARACTERISTICS
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1.
NAME OF THE MEDICINAL PRODUCT
Augmentin 500 mg/100 mg powder for solution for injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains sodium amoxicillin equivalent to 500 mg amoxicillin
and potassium clavulanate
equivalent to 100 mg of clavulanic acid.
The sodium content of each vial is 31.4 mg (1.4 mmol).
The potassium content of each vial is 19.6 mg (0.5 mmol), which at
less than 39 mg (1 mmol) is
considered essentially ‘potassium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Vials containing a white to off-white sterile powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Augmentin is indicated for the treatment of the following infections
in adults and children (see
sections 4.2, 4.4 and 5.1):
•
Severe infections of the ear, nose and throat (such as mastoiditis,
peritonsillar infections,
epiglottitis, and sinusitis when accompanied by severe systemic signs
and symptoms)
•
Acute exacerbations of chronic bronchitis (adequately diagnosed)
•
Community acquired pneumonia
•
Cystitis
•
Pyelonephritis
•
Skin and soft tissue infections in particular cellulitis, animal
bites, severe dental abscess with
spreading cellulitis
•
Bone and joint infections, in particular osteomyelitis
•
Intra-abdominal infections
•
Female genital infections.
Prophylaxis against infections associated with major surgical
procedures in adults, such as those
involving the:
•
Gastrointestinal tract
•
Pelvic cavity
•
Head and neck
•
Biliary tract surgery.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
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4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Doses are expressed throughout in terms of amoxicillin/clavulanic acid
content except when doses
are stated in terms of an individual component.
The dose of Augmentin that is selected to treat an individual
infection should take into