Augmentin Intravenous 500mg/100mg powder for solution for injection or infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Amoxicillin sodium; Clavulanic acid

Disponibil de la:

GlaxoSmithKline (Ireland) Limited

Codul ATC:

J01CR; J01CR02

INN (nume internaţional):

Amoxicillin sodium; Clavulanic acid

Dozare:

500 mg/100 milligram(s)

Forma farmaceutică:

Powder for solution for injection/infusion

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

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

Statutul autorizaţiei:

Not marketed

Data de autorizare:

1985-07-01

Prospect

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 AUGMENTIN
YOU SHOULD NOT HAVE AUGMENTIN:
•
if you are allergic to amoxicillin, clavulanic acid, penicillin or any
of the other ingredients of this
medicine (listed in section 6).
•
if you have ever had a severe allergic reaction to any other
antibiotic. This can include a

Caracteristicilor produsului

Health Products Regulatory Authority
15 April 2020
CRN009DRH
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Augmentin Intravenous 500mg/100mg powder for solution for injection or
infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains sodium amoxicillin equivalent to 500 mg amoxicillin
and potassium clavulanate equivalent to 100 mg of
clavulanic acid.
The sodium content of each vial is 31.4 mg (1.4 mmol).
The potassium content of each vial is 19.6 mg (0.5 mmol), which at
less than 39 mg (1 mmol) is considered essentially
'potassium-free'.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
Vials 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.
Health Products Regulatory Authority
15 April 2