Augmentin Intravenous 1000mg/200mg powder for solution for injection or infusion

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Amoxicillin; Clavulanic acid

Available from:

GlaxoSmithKline (Ireland) Limited

ATC code:

J01CR; J01CR02

INN (International Name):

Amoxicillin; Clavulanic acid

Dosage:

1000 mg/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:

1985-07-01

Patient Information leaflet

Reason for update: Type IB variation to align to the EU excipient
guidelines and other admin updates
(updated post submission of Brexit CMC change)
Market: IE
Agency Approval Date: TBC
Text Date: 29/03/2019
Text Issue and Draft No.: Issue 7 Draft 2 (combines issues 5 and 6)
PACKAGE LEAFLET: INFORMATION FOR THE USER
AUGMENTIN INTRAVENOUS 500 MG/100 MG POWDER FOR SOLUTION FOR
INJECTION/INFUSION
AUGMENTIN INTRAVENOUS 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.
WHAT IS IN THIS LEAFLET
1.
What Augmentin is and what it is used for
2.
What you need to know before you have Augmentin
3.
How Augmentin is given
4.
Possible side effects
5.
How to store Augmentin
6.
Contents of the pack and other information
1.
WHAT AUGMENTIN IS AND WHAT IT IS USED FOR
Augmentin 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.
Augmentin 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.
Augmentin is used in adults and children to prevent infections
associated with major surgical
procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE A

Summary of Product characteristics

Health Products Regulatory Authority
16 January 2020
CRN009DRL
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin Intravenous 1000mg/200mg powder for solution for injection
or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial or bottle contains sodium amoxicillin equivalent to 1000 mg
amoxicillin and potassium clavulanate equivalent to
200 mg of clavulanic acid.
The sodium content of each vial or bottle is 62.9 mg (2.7 mmol).
The potassium content of each vial or bottle is 39.3 mg (1.0 mmol).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
Vials or bottles containing a white to off-white sterile powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Augmentin 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 Augmentin that is selected to treat an individual
infection should take