AUGMENTIN SUSPENSION 400 MG5 ML

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

AMOXICILLIN AS TRIHYDRATE; CLAVULANIC ACID AS POTASSIUM SALT

Dostępny od:

GLAXO SMITH KLINE (ISRAEL) LTD

Kod ATC:

J01CR02

Forma farmaceutyczna:

POWDER FOR SUSPENSION

Skład:

CLAVULANIC ACID AS POTASSIUM SALT 57 MG / 5 ML; AMOXICILLIN AS TRIHYDRATE 400 MG / 5 ML

Droga podania:

PER OS

Typ recepty:

Required

Wyprodukowano przez:

SMITHKLINE BEECHAM LIMITED, UK

Grupa terapeutyczna:

AMOXICILLIN AND ENZYME INHIBITOR

Dziedzina terapeutyczna:

AMOXICILLIN AND ENZYME INHIBITOR

Wskazania:

Augmentin is indicated for the treatment of the following infections in adults and children: • 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.• Recurrent tonsillitis

Data autoryzacji:

2012-09-30

Ulotka dla pacjenta

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
AUGMENTIN SUSPENSION 400 MG/5 ML
EACH 5 ML OF SUSPENSION CONTAINS:
400 MG AMOXICILLIN (AS TRIHYDRATE)
57 MG CLAVULANIC ACID (AS POTASSIUM SALT)
List of the additional ingredients is detailed in section 6.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This
leaflet contains concise information about the medicine. If you have
further questions, refer to the physician or pharmacist.
This medicine has been prescribed for you/your child. Do not pass
it on to others. It may harm them even if it seems to you that their
medical condition is similar.
1. WHAT IS THE MEDICINE INTENDED FOR?
Augmentin is used in adults, children and babies 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.
∙
recurrent tonsil infections.
There is no clinical data about patients under two months of age.
Augmentin is an antibiotic that 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” whose action can sometimes be stopped (become
inactive). The other active component (clavulanic acid) prevents this
from happening.
THERAPEUTIC GROUP
Amoxicillin: Penicillin antibiotic group
Clavulanic acid: Beta-lactamase enzyme inhibitors
2. BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE IF:
∙
you or your child are/is sensitive (allergic) to amoxicillin,
clavulanic
acid, penicillin or any of the additional ingredients contained in
the medicine (listed in section 6)
∙
you or your child have/has ever had a severe allergic reaction
to any other antibiotic. This can include a skin rash or swelling
of the face or throat
∙
you or your child have/has ever had liver

Charakterystyka produktu

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Augmentin 500 mg Tablets
SUMMARY OF PRODUCT CHARACTERISTICS
Augmentin 500 mg Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to
500 mg amoxicillin and
potassium clavulanate equivalent to 125 mg of clavulanic acid.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
White to off-white, oval film-coated tablets debossed with ‘AC’
and a score line on one side.
The score line is only to facilitate breaking for ease of swallowing
and not to divide into equal doses.
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
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 account:
•
The expected pathogens and their likely susceptibility to
antibacterial agents (see section 4.4)
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•
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 Augmentin (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 adults and children
≥
40 kg,