Co-amoxiclav 1000mg/200mg powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin sodium; Clavulanic acid (in the form of potassium clavulanate)

Available from:

Fresenius Kabi Limited

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin sodium; Clavulanic acid (in the form of potassium clavulanate)

Dosage:

1000/200 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Combinations of penicillins, incl. beta-lactamase inhibitors; amoxicillin and enzyme inhibitor

Authorization status:

Not marketed

Authorization date:

2014-02-28

Patient Information leaflet

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Anexo 6.00 do PT.G.087

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 1000mg/200mg powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg of amoxicillin as amoxicillin sodium and
200 mg clavulanic acid as potassium clavulanate.
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 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):
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.
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 Co-amoxiclav 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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