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

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Istituto Biochimico Italiano G. Lorenzini S.p.A Via Fossignano 2, Aprilia (LT), Italy

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN SODIUM 2000 mg CLAVULANATE POTASSIUM 200 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Composition:

AMOXICILLIN SODIUM 2000 mg CLAVULANATE POTASSIUM 200 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-05-24

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV IBISQUS 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 Ibisqus is and what it is used for
2.
What you need to know before you are given Co-amoxiclav Ibisqus
3.
How Co-amoxiclav Ibisqus is given
4.
Possible side effects
5.
How to store Co-amoxiclav Ibisqus
6.
Contents of the pack and other information
1.
WHAT CO-AMOXICLAV IBISQUS IS AND WHAT IT IS USED FOR
Co-amoxiclav Ibisqus 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 Ibisqus 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 Ibisqus 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 IBISQUS
YOU SHOULD NOT HAVE CO-AMOXICLAV IBISQUS
•
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 fa

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Co-amoxiclav Ibisqus 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 Ibisqus 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 Co-amoxiclav Ibisqus 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 below
The use of alter