Meropenem AptaPharma 500mg Powder for solution for injection/infusion

Maa: Malta

Kieli: englanti

Lähde: Medicines Authority

Aktiivinen ainesosa:

MEROPENEM

Saatavilla:

Apta Medica Internacional d.o.o Likozarjeva Ulica 6, 1000 Ljubljana, , Slovenia

ATC-koodi:

J01DH02

INN (Kansainvälinen yleisnimi):

MEROPENEM 500 mg

Lääkemuoto:

POWDER FOR SOLUTION FOR INFUSION OR INJECTION

Koostumus:

MEROPENEM 500 mg

Prescription tyyppi:

POM

Terapeuttinen alue:

ANTIBACTERIALS FOR SYSTEMIC USE

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2018-12-14

Pakkausseloste

1
PACKAGE LEAFLET
2
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM APTAPHARMA
500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
MEROPENEM APTAPHARMA
1000 MG 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 AptaPharma is and what it is used for
2.
What you need to know before you use Meropenem AptaPharma
3.
How to use Meropenem AptaPharma
4.
Possible side effects
5.
How to store Meropenem AptaPharma
6.
Contents of the pack and other information
1.
WHAT MEROPENEM APTAPHARMA
IS AND WHAT IT IS USED FOR
Meropenem AptaPharma contains the active substance meropenem which
belongs to a group of
medicines called carbapenem antibiotics. It works by killing bacteria,
which can cause serious infections.
Meropenem AptaPharma 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 AptaPharma may be used in the management of neutropenic
patients with fever that is
suspected to be due to a bacterial infection.
Meropenem AptaPharma may be used to treat bacterial infection of the
blood which might be associated
with a type of infe

Valmisteyhteenveto

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Meropenem AptaPharma 500 mg powder for solution for injection/infusion
Meropenem AptaPharma 1000 mg powder for solution for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Meropenem AptaPharma 500 mg: _
Each vial contains 570 mg meropenem trihydrate equivalent to 500 mg
anhydrous meropenem.
_Meropenem AptaPharma 1000 mg: _
Each vial contains 1140 mg meropenem trihydrate equivalent to 1000 mg
anhydrous meropenem.
Excipients with known effect:
Each vial of Meropenem AptaPharma 500 mg contains 104 mg sodium
carbonate, corresponding to 45 mg (1,96
mmol) sodium.
Each vial of Meropenem AptaPharma 1000 mg contains 208 mg sodium
carbonate, corresponding to 90 mg
(3,92 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection/infusion.
White to pale yellow crystalline powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem AptaPharma 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 AptaPharma may be used in the management of neutropenic
patients with fever that is suspected to
be due to a bacterial infection.
Treatment of patients with bacteraemia that occurs in association
with, or is suspected to be associated with, any
of the infections listed above.
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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 a