Co-Amoxiclav TEVA 500 mg/100 mg Powder for Solution for Injection/Infusion

Država: Irska

Jezik: engleski

Izvor: HPRA (Health Products Regulatory Authority)

Aktivni sastojci:

Amoxicillin; Clavulanic acid

Dostupno od:

Teva Pharma B.V.

ATC koda:

J01CR; J01CR02

INN (International ime):

Amoxicillin; Clavulanic acid

Doziranje:

500 mg/100 milligram(s)

Farmaceutski oblik:

Powder for solution for injection/infusion

Tip recepta:

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

Područje terapije:

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

Status autorizacije:

Marketed

Datum autorizacije:

2006-08-04

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
CO-AMOXICLAV TEVA 500 MG/100 MG POWDER FOR SOLUTION FOR
INJECTION/INFUSION
CO-AMOXICLAV TEVA 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 Co-Amoxiclav TEVA is and what it is used for
2.
What you need to know before you are given Co-Amoxiclav TEVA
3.
How Co-Amoxiclav TEVA is given
_ _
4.
Possible side effects
5.
How to store Co-Amoxiclav TEVA
6.
Contents of the pack and other information
1.
WHAT CO-AMOXICLAV TEVA 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
“penicillins” 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 ARE GIVEN CO-AMOXICLAV TEVA
DO NOT USE CO-AMOXICLAV TEVA
•
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 s

Svojstava lijeka

Health Products Regulatory Authority
16 August 2023
CRN00DFK0
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Co-Amoxiclav TEVA 500 mg/100 mg Powder for Solution for
Injection/Infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 500 mg amoxicillin (as the sodium salt) and 100 mg
clavulanic acid (as the potassium salt).
The sodium content of each vial is 1.7 mmol. The potassium content of
each vial is 0.5 mmol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
Powder for solution for infusion.
White or almost white crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Co-Amoxiclav TEVA 500 mg/100 mg Powder for Solution for
Injection/Infusion 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