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

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

Fresenius Kabi Deutschland GmbH

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

1000 mg/200 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

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

Authorization status:

Marketed

Authorization date:

2014-02-28

Patient Information leaflet

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV 1000 MG/200 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
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 have Co-amoxiclav
3.
How Co-amoxiclav is given
4.
Possible side effects
5.
How to store Co-amoxiclav
6.
Content 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 "penicillin’s" 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 used in adults and children to prevent infections
associated with major
surgical procedures.
2. WHAT YOU NEED TO KNOW BEFORE YOU HAVE CO·AMOXICLAV
You should not have Co-amoxiclav
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other
ingredients of Co-amoxiclav (listed in section 6)
•
if you have ever had a severe allergic (hypersensitive) reaction to
any other antibiot

Summary of Product characteristics

Health Products Regulatory Authority
04 September 2023
CRN00DFVN
Page 1 of 14
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)

The severity and the site of the infection

The age, weight and renal funct