Amoxicillin/Clavulanic Acid Normon 1000mg/200mg, Powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM

Available from:

Laboratorios Normon S.A Ronda DE Valdecarrizo 6, 28760 Tres Cantos Madrid, Spain

ATC code:

J01CR02

INN (International Name):

AMOXICILLIN SODIUM 1000 mg CLAVULANATE POTASSIUM 200 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

AMOXICILLIN SODIUM 1000 mg CLAVULANATE POTASSIUM 200 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Authorization date:

2019-09-13

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
AMOXICILLIN/CLAVULANIC ACID NORMON 1,000 MG/200 MG POWDER FOR SOLUTION
FOR INJECTION AND FOR
INFUSION
AMOXICILLIN/CLAVULANIC ACID
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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.
−
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
−
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 Amoxicillin/Clavulanic acid Normon is and what it is used for
2.
What you need to know before you use Amoxicillin/Clavulanic acid
NORMON
3.
How to use Amoxicillin/Clavulanic acid NORMON
4.
Possible side effects
5.
How to store Amoxicillin/Clavulanic acid NORMON
6.
Contents of the pack and other information
1.
WHAT AMOXICILLIN/CLAVULANIC ACID NORMON IS AND WHAT IT IS USED FOR
Amoxicillin/Clavulanic acid NORMON 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 NORMON is used in adults and children to
treat the following infections:
•
severe ear, nose and throat infections
ANTIBIOTICS ARE USED TO TREAT BACTERIAL INFECTIONS AND DO NOT SERVE TO
TREAT VIRAL INFECTIONS SUCH AS FLU
OR CATARRH.
IT IS IMPORTANT THAT YOU FOLLOW THE INSTRUCTIONS RELATED TO DOSES,
INTAKE AND DURATION OF TREATMENT
INDICATED BY YOUR DOCTOR.
DO NOT STORE OR REUSE THIS MEDICINE. IF ONCE TREATMENT IS COMPLETED
YOU HAVE ANTIBIOTIC LEFT, BRING IT
BACK TO THE PHARMACY

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Amoxicillin/Clavulanic acid NORMON 1,000 mg/200 mg powder for solution
for injection and for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1000 mg amoxicillin (as sodium amoxicillin) and 200
mg clavulanic acid (as potassium
clavulanate).
Amoxicillin/clavulanic acid NORMON 1,000 m/20 mg powder for solution
for injection and for infusion
contains:
Sodium: 62.9 mg (2.7 mmol) per vial.
Potassium: 39.2 mg (1 mmol) per vial.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection and for infusion.
Vials containing a sterile white to off-white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Amoxicillin/Clavulanic acid NORMON is indicated in 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 exacerbation 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.
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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 NORMON that is selected to
treat an in