Meropenem Hospira 1g Powder for Solution for Injection or Infusion

Država: Malta

Jezik: angleščina

Source: Medicines Authority

Aktivna sestavina:

MEROPENEM

Dostopno od:

Hospira UK Limited

Koda artikla:

J01DH02

INN (mednarodno ime):

MEROPENEM

Farmacevtska oblika:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Sestava:

MEROPENEM 1 g

Tip zastaranja:

POM

Terapevtsko območje:

ANTIBACTERIALS FOR SYSTEMIC USE

Status dovoljenje:

Authorised

Datum dovoljenje:

2011-01-31

Navodilo za uporabo

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Page 1 of 9
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

Lastnosti izdelka

Page 1 of 30
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
Page 2 of 30
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.