Amoxicillin and clavulanic acid Ivowen 500 mg/100 mg powder for solution for injection/infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

Ivowen Limited

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

500/100 milligram(s)

Pharmaceutical form:

Powder for solution for injection/infusion

Therapeutic area:

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

Authorization date:

2019-11-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN/CLAVULANIC ACID IVOWEN 500 MG/100 MG POWDER FOR SOLUTION
FOR INJECTION/INFUSION
AMOXICILLIN/CLAVULANIC ACID IVOWEN 1000 MG/200 MG POWDER FOR SOLUTION
FOR INJECTION/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.
IN THIS LEAFLET:
1.
What Amoxicillin/clavulanic acid Ivowen is and what it is used for
2.
What you need to know before you are given Amoxicillin/clavulanic acid
Ivowen
3.
How Amoxicillin/clavulanic acid Ivowen is given
4.
Possible side effects
5.
How to store Amoxicillin/clavulanic acid Ivowen
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN/CLAVULANIC ACID IVOWEN IS AND WHAT IT IS USED FOR
Amoxicillin/clavulanic acid Ivowen 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.
Amoxicillin/clavulanic acid Ivowen 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
Amoxicillin/clavulanic acid Ivowen 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 AMOXICILLIN/CLAVULANIC ACID
IVOWEN
DO

Summary of Product characteristics

Health Products Regulatory Authority
22 November 2019
CRN008LJL
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Amoxicillin and clavulanic acid Ivowen 500 mg/100 mg powder for
solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg amoxicillin (as amoxicillin sodium) and 100
mg clavulanic acid (as clavulanate potassium)
Each vial contains 1.4 mmol (31.4 mg) of sodium
Each vial contains 0.5 mmol (19.6 mg) of potassium
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion
White powder
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Amoxicillin/clavulanic acid Ivowen 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 infe