CO-AMOXICLAV PFIZER
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-04-2024
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Active ingredient:
AMOXICILLIN TRIHYDRATE POTASSIUM CLAVULANATE, DILUTED (WITH MICROCRYSTALLINE CELLULOSE IN A RATIO OF 1:1)
Available from:
Pfizer Healthcare Ireland
Dosage:
875/125 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-08-26
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav Pfizer 875mg / 125mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains amoxicillin trihydrate equivalent to 875mg amoxicillin with potassium clavulanate
equivalent to 125mg clavulanic acid.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film coated tablet.
Co-amoxiclav Pfizer 875mg/125mg tablets are white, capsule shaped, film-coated tablets inscribed with ‘A’ on one
side and with a score line in between ‘6’ and ‘5’ on the other 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
Co-amoxiclav Pfizer 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 abcess 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 Amoxicillin/Clavulanic acid Pfizer 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
•
The age,
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