Meropenem Infomed 1g powder for solution for injection/infusion

Ország: Málta

Nyelv: angol

Forrás: Medicines Authority

Aktív összetevők:

MEROPENEM TRIHYDRATE

Beszerezhető a:

Infomed Fluids Srl Blvd. Theodor Pallady 50, Sector 3 032266 Bucharest , Romania

ATC-kód:

J01DH02

INN (nemzetközi neve):

MEROPENEM TRIHYDRATE 1 g

Gyógyszerészeti forma:

POWDER FOR SOLUTION FOR INJECTION/INFUSION

Összetétel:

MEROPENEM TRIHYDRATE 1 g

Recept típusa:

POM

Terápiás terület:

ANTIBACTERIALS FOR SYSTEMIC USE

Termék összefoglaló:

Licence number in the source country: NOT APPLICAPABLE

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2021-10-11

Betegtájékoztató

PAGE 1 OF 7
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM INFOMED 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
MEROPENEM INFOMED 1 G POWDER FOR SOLUTION FOR INJECTION/INFUSION
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 Infomed is and what it is used for
2.
What you need to know before you use Meropenem Infomed
3.
How to use Meropenem Infomed
4.
Possible side effects
5.
How to store Meropenem Infomed
6.
Contents of the pack and other information
1.
WHAT MEROPENEM INFOMED IS AND WHAT IT IS USED FOR
Meropenem Infomed belongs to a group of medicines called carbapenem
antibiotics. It works by
killing bacteria, which can cause the following serious infections:
Meropenem 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 (stomach)
•
Infections that you can catch during or after giving birth
•
Complicated skin and soft tissue infections
•
Acute bacterial infection of the brain (meningitis)
Meropenem Infomed may be used in the management of neutropenic
patients (patients with low levels
of white blood cells) with fever that is suspected to be due to a
bacterial infection.
Meropenem Infomed may be used to treat bacterial infection of the
blood which might be associated
with one of the infections mentioned above.
2.
WHAT YO

Termékjellemzők

PAGE 1 OF 15
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Meropenem Infomed 500 mg powder for solution for injection/infusion
Meropenem Infomed 1 g powder for solution for injection/infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
vial
contains
meropenem
trihydrate
equivalent
to
500
mg
anhydrous
meropenem.
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
Excipients 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/infusion.
A white to light yellow powder.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem Infomed 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 Infomed may be used in the management of neutropenic
patients with
fever that is suspected to be due to a bacterial infection
Meropenem Infomed may be used in the treatment of patients with
bacteraemia that
occurs in association with, or is suspected to be associated with, any
of the infections
listed above.
PAGE 2 OF 15
Consideration
should
be
given
to
official
guidance
on
the
appropriate
use
of
antibacterial agents.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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, includi