Meropenem Actavis 500mg powder for solution for injection or infusion

Country: Malta

Bahasa: Inggeris

Sumber: Medicines Authority

Bahan aktif:

MEROPENEM

Boleh didapati daripada:

Actavis Group PTC ehf Revkjavikurvegi 76-78, 220 Hafnarfjordur, Iceland

Kod ATC:

J01DH02

INN (Nama Antarabangsa):

MEROPENEM 500 mg

Borang farmaseutikal:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Komposisi:

MEROPENEM 500 mg

Jenis preskripsi:

POM

Kawasan terapeutik:

ANTIBACTERIALS FOR SYSTEMIC USE

Status kebenaran:

Withdrawn

Tarikh kebenaran:

2013-08-06

Risalah maklumat

Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM ACTAVIS 500 MG POWDER FOR SOLUTION FOR INJECTION OR INFUSION
MEROPENEM ACTAVIS 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 Actavis is and what it is used for
2.
What you need to know before you use Meropenem Actavis
3.
How to use Meropenem Actavis
4.
Possible side effects
5.
How to store Meropenem Actavis
6.
Contents of the pack and other information
1.
WHAT MEROPENEM ACTAVIS IS AND WHAT IT IS USED FOR
Meropenem Actavis 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 the delivery
-
Complicated skin and soft tissues infections
-
Acute bacterial infection of the brain (meningitis).
Meropenem Actavis may be used in the management of neutropenic
patients with fever that is
suspected to be due to a bacterial infection.
Meropenem Actavis 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 ACTAVIS
DO NOT USE MEROPENEM ACTAVIS:
-
if you are allergic to meropenem or any of the other ingredients of
this medicine listed

Ciri produk

Page 1 of 14
1.
NAME OF THE MEDICINAL PRODUCT
Meropenem Actavis 500 mg powder for solution for injection or infusion
Meropenem Actavis 1 g powder for solution for injection or infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Meropenem Actavis_
_500 mg powder for solution for injection or infusion: _
Each vial contains 570 mg meropenem trihydrate, equivalent to 500 mg
of anhydrous meropenem.
Excipient(s) with known effect: Each vial contains 1.95 mmol sodium
(45 mg) as anhydrous
sodium carbonate.
_Meropenem Actavis 1 g powder for solution for injection or infusion _
Each vial contains 1,140 mg meropenem trihydrate, equivalent to 1,000
mg of anhydrous
meropenem.
Excipient(s) with known effect: Each vial contains 3.9 mmol sodium (90
mg) as anhydrous sodium
carbonate.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection or infusion
_ _
White to slightly yellowish, crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem Actavis is indicated for the treatment of the following
infections in adults and children
older than 3 months (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,
_ _
-
Intrapartum and postpartum 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 Actavis 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.
Page 2 of 14
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tables below provide general recommendations for dosing.
The dose of meropenem administered and the duratio