Amoxicillin/clavulanic acid AptaPharma 1000 mg/200 mg powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMOXICILLIN, CLAVULANIC ACID

Available from:

Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN 1000 mg CLAVULANIC ACID 200 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

AMOXICILLIN 1000 mg CLAVULANIC ACID 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:

2021-01-20

Patient Information leaflet

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN/CLAVULANIC ACID APTAPHARMA 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 or pharmacist or
nurse. This includes
any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Amoxicillin/clavulanic acid AptaPharma is and what it is used for
2.
What you need to know before you have Amoxicillin/clavulanic acid
AptaPharma
3.
How Amoxicillin/clavulanic acid AptaPharma is given
4.
Possible side effects
5.
How to store Amoxicillin/clavulanic acid AptaPharma
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN/CLAVULANIC ACID APTAPHARMA IS AND WHAT IT IS USED FOR
Amoxicillin/clavulanic acid AptaPharma 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 AptaPharma 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 AptaPharma is used in adults and children
to prevent
infections associated with major surgical procedures.
2.
WHAT YOU NEED TO KNOW BEFORE YOU HAVE
AMOXICILLIN/CLAVULANIC ACID APTAPHARMA YOU SHOULD NOT
HAVE AMOXICILLIN/CLAVULANIC AC

Summary of Product characteristics

Page
1
of
16
SUMMARY OF PRODUCT CHARACTERISTICS
Page
2
of
16
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicillin/clavulanic acid AptaPharma 1000 mg/200 mg powder for
solution for injection/infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains sodium amoxicillin equivalent to 1000 mg
amoxicillin and potassium clavulanate
equivalent to 200 mg of clavulanic acid.
1 ml of reconstituted solution contains 50 mg of amoxicillin and 10 mg
of clavulanic acid.
Excipients with known effect
Sodium 62.9 mg (2.7 mmol) per vial. Potassium
39.1 mg (1.0 mmol) per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to almost white sterile powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin/clavulanic acid AptaPharma 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.
Page
3
of
16
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 AptaP