Meropenem Steriscience 1000 mg powder for solution for injection/infusion

Country: Malta

Language: English

Source: Medicines Authority

Available from:

Steriscience B.V. Kingsfordweg 151 1043GR Amsterdam , Netherlands

ATC code:

J01DH02

INN (International Name):

MEROPENEM 1000 mg

Pharmaceutical form:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Composition:

MEROPENEM 1000 mg

Prescription type:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2022-08-11

Patient Information leaflet

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Package leaflet: Information for the user
Meropenem 500 mg powder for solution for injection/infusion
Meropenem 1 g powder for solution for injection/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 contains the active substance meropenem and belongs to a
group of medicinescalled
carbapenem antibiotics. It works by killing bacteria, which can cause
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

Infections that you can catch during or after the delivery

Complicated skin and soft tissues infections

Acute bacterial infection of the brain (meningitis)
Meropenem may be used in the management of neutropenic patients with
fever that issuspected
to be due to a bacterial infection.
Meropenem may be used to treat bacterial infection of the blood which
might beassociated
with a type of infection mentioned above.
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2. What you need to know before you use Meropenem
Do not use Meropenem:

if you are allergic to
Meropene

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Meropenem Steriscience 500 mg powder for solution for
injection/infusion
Meropenem Steriscience 1000 mg powder for solution for
injection/infusion
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Meropenem Steriscience 500 mg powder for solution for
injection/infusion
Each vial contains meropenem trihydrate equivalent to 500 mg
meropenem.
Excipient with known effect: Each vial contains 45 mg sodium (as
sodium carbonate)
.
Meropenem Steriscience 1000 mg powder for solution for
injection/infusion
Each vial contains meropenem trihydrate equivalent to 1000 mg
meropenem.
Excipient with known effect: Each vial contains 90 mg sodium (as
sodium carbonate).
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
A White to pale yellow powder and free from visual agglomerates
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Meropenem is indicated for the treatment of the following infections
in adults and children aged3
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
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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 suspectedto 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
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 infecti