Meropenem Pdr for Soln Inj/Inf 1g

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

MEROPENEM

Available from:

Accord Healthcare Limited

ATC code:

J01DH02

INN (International Name):

MEROPENEM

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

MEROPENEM 1 g

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Authorization status:

Authorised

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER MEROPENEM 0.5 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION MEROPENEM 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Meropenem
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.

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 Meropenem infusion is and what it is used for
2.
What you need to know before you use Meropenem infusion
3.
How to use Meropenem infusion
4.
Possible side effects
5.
How to store Meropenem infusion
6.
Contents of the pack and other information.
1.
WHAT MEROPENEM INFUSION IS AND WHAT IT IS USED FOR
Meropenem infusion contains the active substance meropenem and belongs
to a group of
medicines called carbapenem antibiotics. It works by killing bacteria,
which can cause serious
infections.
Meronem is used to treat the following in adults and children aged 3
months and older:

Infection affecting the lungs (pneumonia)

Lung and bronchial infections in patients suffering from cystic
fibrosis

Complicated urinary tract infections

Complicated infections in the abdomen

Infections that you can catch during or after the delivery

Complicated skin and soft tissues infections

Acute bacterial infection of the brain (meningitis)
Meropenem infusion may be used in the management of neutropenic
patients with fever that
is suspected to be due to a bacterial infection.
Meropenem infusion may be used to treat bacterial infection of the
blood which might be
associated with a type of infection mentioned above.
2.
WHAT YOU NEED TO KNOW BEFORE Y

Summary of Product characteristics

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1
NAME OF THE MEDICINAL PRODUCT
Meropenem 0.5 g Powder for solution for injection or infusion
Meropenem 1 g Powder for solution for injection or infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem 0.5 g
Each vial contains 500 mg anhydrous meropenem (as meropenem
trihydrate).
Meropenem 1 g
Each vial contains 1 g anhydrous meropenem (as meropenem trihydrate).
Excipient(s) with known effect:
Meropenem 0.5 g
Each vial contains approximately 45.1 mg sodium.
Meropenem 1 g
Each vial contains approximately 90.2mg sodium.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to light yellow powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem is indicated for the treatment of the following infections
in adults and children aged 3
months and older (see sections 4.4 and 5.1):
•
Severe pneumonia, including hospital and ventilator-associated
pneumonia.
•
Broncho-pulmonary infections in cystic fibrosis
•
Complicated urinary tract infections
•
Complicated intra-abdominal infections
•
Intra- and post-partum infections
•
Complicated skin and soft tissue infections
•
Acute bacterial meningitis
Meropenem may be used in the management of neutropenic patients with
fever that is suspected to
be due to a bacterial infection.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be
associated with, any of the infections listed above.
Consideration should be given to official guidance on the appropriate
use of antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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Posology
The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duration of treatment
should take into account the
type of infection to be treated, including its severity, and the
clinical response.
A dose of up to 2 g three times daily in adults and adolescents and a
dose of up to 40 mg/kg three
times daily in children may be particularly appropriate w