Meropenem Hospira 500mg Powder for Solution for Injection or Infusion

Land: Malta

Sprog: engelsk

Kilde: Medicines Authority

Aktiv bestanddel:

MEROPENEM

Tilgængelig fra:

Pfizer Hellas S.A. 243 Messoghion Ave., Neo Psychiko 15451, Athens, Greece

ATC-kode:

J01DH02

INN (International Name):

MEROPENEM 50 mg/ml

Lægemiddelform:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Sammensætning:

MEROPENEM 50 mg/ml

Recept type:

POM

Terapeutisk område:

ANTIBACTERIALS FOR SYSTEMIC USE

Autorisation status:

Withdrawn

Autorisation dato:

2011-01-31

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Meropenem 500 mg and 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 is and what it is used for
2.
What you need to know before you use Meropenem
3.
How to use Meropenem
4.
Possible side effects
5.
How to store Meropenem
6.
Contents of the pack and other information
1.
WHAT MEROPENEM IS AND WHAT IT IS USED FOR
Meropenem belongs to a group of medicines called carbapenem
antibiotics. It works
by killing bacteria, which can cause serious infections.

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 delivery

Complicated skin and soft tissue infections

Acute bacterial infection of the brain (meningitis)
Meropenem may be used in the management of neutropenic patients with
fever that is
suspected to be due to bacterial infection.
Meropenem 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 YOU USE MEROPENEM
DO NOT USE MEROPENEM IF

you are allergic to meropenem or any of the other ingredients of
Meropenem
(listed in Section 6)

you are allergic (hypersensitive) to other antibiotics such as
penicillins,
cephalosporins, or carbapenems as you

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Meropenem Hospira 500 mg Powder for Solution for Injection or Infusion
Meropenem Hospira 1 g Powder for Solution for Injection or Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous
meropenem.
When reconstituted with 10 ml sterile Water for Injections, each ml
contains
50 mg meropenem.
Each
vial
contains
meropenem
trihydrate
equivalent
to
1
g
anhydrous
meropenem.
When reconstituted with 20 ml sterile Water for Injections, each ml
contains
50 mg meropenem.
Excipients(s) with known effect:
Each 500 mg vial contains 104 mg sodium carbonate which equates to
approximately 2.0 mEq of sodium (approximately 45 mg).
Each 1 g vial contains 208 mg sodium carbonate which equates to
approximately 4.0 mEq of sodium (approximately 90 mg).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder for solution for injection or infusion.
A white to pale yellow powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem is indicated for the treatment of the following infections
in adults
and children over 3 months of age (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
Treatment of patients with bacteraemia that occurs in association
with, or is
suspected to be associated with, any of the infections listed above.
Meropenem may be used in the management of neutropenic patients with
fever that is suspected to be due to a bacterial infection.
Consideration should be given to official guidance on the appropriate
use of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The tables below provide general recommendations for dosing.
The dose of Meropenem adm