Co-amoxiclav 2000 mg/200 mg powder for solution for infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

Instituto Biochimico Italiano G. Lorenzini S.p.A.

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

2000 mg/200 milligram(s)

Pharmaceutical form:

Powder for solution for infusion

Therapeutic area:

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

Authorization status:

Not marketed

Authorization date:

2019-11-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV 2000 MG/200 MG POWDER FOR SOLUTION FOR INFUSION
Amoxicillin/Clavulanic acid
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor, pharmacist or
nurse.
•
If you get 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 Co-amoxiclav is and what it is used for
2.
What you need to know before you are given Co-amoxiclav
3.
How Co-amoxiclav is given
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 adults and children to treat the following
infections:
•
severe ear, nose and throat infections
•
respiratory tract infections
•
urinary tract infections
•
skin and soft tissue infections including dental infections
•
bone and joint infections
•
intra-abdominal infections
•
genital organ infections in women
Co-amoxiclav is also used in adults and children to prevent infections
associated with major surgical
procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CO-AMOXICLAV
YOU SHOULD NOT HAVE CO-AMOXICLAV
•
if you are allergic to amoxicillin, clavulanic acid or penicillin.
•
if you 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 you have ever had liver problems or jaundice (yellowing of the
ski

Summary of Product characteristics

Health Products Regulatory Authority
20 October 2023
CRN00DRZ5
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav 2000 mg/200 mg powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2000 mg amoxicillin (as amoxicillin sodium) and 200
mg clavulanic acid (as potassium clavulanate)
Each vial contains 5.5 mmol (125.9 mg) of sodium
Each vial contains 1 mmol (39.3 mg) of potassium
3 PHARMACEUTICAL FORM
Powder for solution for infusion
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
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 amoxicillin/clavulanic acid 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, weight and renal function of the patient as shown bel