Meropenem ACS Dobfar 1 g powder for solution for injection/infusion

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Meropenem

Dostopno od:

ACS Dobfar S.p.A.

Koda artikla:

J01DH02

INN (mednarodno ime):

Meropenem

Farmacevtska oblika:

Powder for solution for injection/infusion

Terapevtsko območje:

meropenem

Status dovoljenje:

Not marketed

Datum dovoljenje:

2021-05-07

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM ACS DOBFAR 500 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION
MEROPENEM ACS DOBFAR 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 ACS Dobfar is and what it is used for
2.
What you need to know before you use Meropenem ACS Dobfar
3.
How to use Meropenem ACS Dobfar
4.
Possible side effects
5.
How to store Meropenem ACS Dobfar
6.
Contents of the pack and other information
1.
WHAT MEROPENEM ACS DOBFAR IS AND WHAT IT IS USED FOR
Meropenem ACS Dobfar 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 ACS Dobfar 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 ACS Dobfar may be used to treat bacterial infection of the
blood which might be
associated with one of the infections mentioned

Lastnosti izdelka

Health Products Regulatory Authority
19 January 2023
CRN00DD41
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Meropenem ACS Dobfar 1 g powder for solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains meropenem trihydrate equivalent to 1 g anhydrous
meropenem.
Excipients with known effect:
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
ACS Dobfar
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 ACS Dobfar may be used in the management of neutropenic
patients with fever that is suspected to be due to a
bacterial infection
Meropenem ACS Dobfar 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.
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.
A dose of up to 2 g three times daily in adults and adolescents and a
dose of up to 40 mg/kg three times daily in children may
be particularly appropriate when treati