Augmentin-Duo 400/57

מדינה: מלטה

שפה: אנגלית

מקור: Medicines Authority

מרכיב פעיל:

amoxicillin 400 mg/5ml, clavulanic acid 57 mg/5ml

זמין מ:

Smithkline Beecham PLC

קוד ATC:

J01CR02

INN (שם בינלאומי):

amoxicillin, clavulanic acid

טופס פרצבטיות:

powder for oral suspension

מצב אישור:

Authorised

תאריך אישור:

2006-03-28

עלון מידע

READ ALL OF THIS LEAFLET CAREFULLY BEFORE 
YOU START GIVING YOUR CHILD THIS MEDICINE 
BECAUSE IT CONTAINS IMPORTANT 
INFORMATION FOR THEM.
•  Keep this leaflet. You may need to read it
again.
•  If you have any further questions, ask your
doctor, pharmacist, or nurse.
•  This medicine is usually prescribed for a
baby or child. Do not pass it on to others. It
may harm them, even if their symptoms are
the same as your child’s.
•  If your child gets 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 give
Augmentin
3  How to give Augmentin
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 babies and children to
treat the following infections:
•  middle ear and sinus infections
•  respiratory tract infections
•  urinary tract infections
•  skin and soft tissue infections including
dental infections
•  bone and joint infections.
PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN-DUO
®
 400/57 
CO-AMOXICLAV (AMOXICILLIN AND CLAVULANIC ACID)
2   WHAT YOU NEED TO KNOW BEFORE 
YOU GIVE AUGMENTIN

DO NOT GIVE YOUR CHILD AUGMENTIN:
•  if they are allergic to amoxicillin, clavulanic
acid or any of the other ingredients of
Augmentin (listed in section 6)
•  if they have ever had a severe allergic
(hypersensitive) reaction to any other
antibiotic. This can include a skin rash or
swelling of the face

מאפייני מוצר

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SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT 

Augmentin
®
-Duo 400/57 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

When reconstituted, every ml of oral suspension contains
amoxicillin trihydrate equivalent to 80 mg amoxicillin 
and potassium clavulanate equivalent
to 11.4 mg of clavulanic acid. 
Excipients with known effect:  
Contains 3.32 mg of aspartame (E951) per ml.  
Contains maltodextrin (glucose). 

For the full list of excipients, see section 6.1. 

3. PHARMACEUTICAL 
FORM 

Powder for oral suspension.   
Off-white 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): 

 
Acute bacterial sinusitis (adequately diagnosed) 
 
Acute otitis media 
 
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. 

Consideration should be given to official guidance
on the appropriate use of antibacterial agents. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

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 account: 

 
The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4) 
 
The severity and the site of the infection  
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 
The age, weight and renal function of the patient as shown
below.