Co-amoxiclav 400mg/57mg/5 ml powder for oral suspension

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

AMOXICILLIN, CLAVULANIC ACID

Dostupno od:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC koda:

J01CR02

INN (International ime):

AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml

Farmaceutski oblik:

POWDER FOR ORAL SUSPENSION

Sastav:

AMOXICILLIN 400 mg/5ml CLAVULANIC ACID 57 mg/5ml

Tip recepta:

POM

Područje terapije:

ANTIBACTERIALS FOR SYSTEMIC USE

Status autorizacije:

Authorised

Datum autorizacije:

2013-01-17

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV 400 MG/57 MG/5 ML POWDER FOR ORAL SUSPENSION
amoxicillin/clavulanic acid
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 or 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 signs of illness are the same as your
child’s.
-
If your child gets any side effects, talk to your doctor or pharmacist
or nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Co-amoxiclav is and what it is used for
2.
What you need to know
before you use Co-amoxiclav
3.
How to use Co-amoxiclav
4.
Possible side effects
5.
How to store Co-amoxiclav
6.
Contents of the pack and other information
1.
WHAT CO-AMOXICLAV IS AND WHAT IT IS USED FOR
Co-amoxiclav 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.
Co-amoxiclav 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.
2.
WHAT YOU NEED TO KNOW
BEFORE YOU USE CO-AMOXICLAV
DO NOT GIVE YOUR CHILD CO-AMOXICLAV:
•
if they are allergic to amoxicillin, clavulanic acid, penicillin or
any of the other ingredients of
this medicine (listed in section 6)
•
if they have ever had a severe allergic reaction to any other
antibiotic. This can include a skin
rash or swelling of the face or throat
•
if they hav

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 400 mg/57 mg/5 ml powder for oral suspension 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: aspartame (E951).
Every ml of oral suspension contains 2.26 mg aspartame (E951)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral suspension.
White to off-white granular powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Co-amoxiclav 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
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 Co-amoxiclav that is selected to treat an individual
infection should take into account:
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•
The expected pathogens and their likely susceptibility to
antibacterial agents (see
section 4.4)
•
The severity and the site of the infection
•
The age, weight and renal function of the patient as shown below.
The use of alternative presentations of Co-amoxiclav (e.g. those that
provide higher doses of
amoxicillin and/or different ratios of amoxicillin to clavulanic acid)
should be considered as
necessary (see sections 4.4 and 5.1).
For child