MEROPENEM HOSPIRA

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

MEROPENEM TRIHYDRATE

Fáanlegur frá:

Hospira UK Limited

ATC númer:

J01DH02

INN (Alþjóðlegt nafn):

MEROPENEM TRIHYDRATE

Skammtar:

1 Grams

Lyfjaform:

Pdr for Soln Inj/Inf

Gerð lyfseðils:

Product subject to prescription which may not be renewed (A)

Lækningarsvæði:

meropenem

Leyfisstaða:

Not marketed

Leyfisdagur:

2010-11-12

Upplýsingar fylgiseðill

_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
Meropenem Hospira 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 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 you doctor or nurse. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Meropenem Hospira is and what it is used for
2.
What you need to know before you use Meropenem Hospira
3.
How to use Meropenem Hospira
4.
Possible side effects
5.
How to store Meropenem Hospira
6.
Contents of the pack and other information
1.
WHAT MEROPENEM HOSPIRA IS AND WHAT IT IS USED FOR
Meropenem Hospira 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 Hospira 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
HOSPIRA
DO NOT USE MEROPENEM
HOSPIRA
_ _

if you are allergic to meropenem or any of the other ingredients of
Meropenem
Hospira (listed in Section 6)

if you are allergic (hypersensitive) to other antibiotic

Vara einkenni

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem Hospira 1 g powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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.
Excipient(s) with known effect:
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 administered and the duration of treatment
should take into account the type of infection to be
treated, including its severity, and the clinical response.
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___