Meropenem Aurobindo 1g Powder for solution for injection or infusion

Страна: Ирландия

Език: английски

Източник: HPRA (Health Products Regulatory Authority)

Активна съставка:

Meropenem

Предлага се от:

Aurobindo Pharma (Malta) Limited

АТС код:

J01DH; J01DH02

INN (Международно Name):

Meropenem

дозиране:

1 gram(s)

Лекарствена форма:

Powder for solution for injection/infusion

Вид предписание :

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

Терапевтична област:

Carbapenems; meropenem

Статус Оторизация:

Marketed

Дата Оторизация:

2016-03-11

Листовка

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM AUROBINDO 500 MG POWDER FOR SOLUTION FOR INJECTION OR
INFUSION
MEROPENEM AUROBINDO 1 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
meropenem
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 your 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 Aurobindo is and what it is used for
2.
What you need to know before you take Meropenem Aurobindo
3.
How to take Meropenem Aurobindo
4.
Possible side effects
5.
How to store Meropenem Aurobindo
6.
Contents of the pack and other information
1.
WHAT MEROPENEM AUROBINDO
IS AND WHAT IT IS USED FOR
Meropenem belongs to a group of medicines called carbapenem
antibiotics. It works by killing bacteria,
which can cause serious infections.
Meropenem Aurobindo 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 Aurobindo may be used in the management of neutropenic
patients with fever that is
suspected to be due to a bacterial infection.
Meropenem Aurobindo 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 TAKE MEROPENEM AUROBINDO
DO NOT TAKE MEROPENEM

Данни за продукта

Health Products Regulatory Authority
30 July 2021
CRN009VWS
Page 1 of 12
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem Aurobindo 1g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder for solution for injection or infusion contains
1141.56 mg meropenem trihydrate equivalent to 1 g
anhydrous meropenem.
Excipients with known effect: Each vial contains 208 mg sodium
carbonate approximately 4.0 mmol of sodium (approximately
90 mg).
Each ml of reconstituted solution contains 50 mg Meropenem.
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 crystalline powder.
pH of the product after reconstitution is 7.3 to 8.3
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Meropenem Aurobindo 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 Aurobindo 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.
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, including its severity, and the clinical response.
Health Products Regulatory Authority
30 Ju