Meropenem Aptapharma 2000 mg powder for solution for infusion

Country: মাল্টা

ভাষা: ইংরেজি

সূত্র: Medicines Authority

থেকে পাওয়া:

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

এটিসি কোড:

J01DH02

INN (International Name):

MEROPENEM 2000 mg

ফার্মাসিউটিকাল ফর্ম:

POWDER FOR SOLUTION FOR INFUSION

রচনা:

MEROPENEM 2000 mg

প্রেসক্রিপশন টাইপ:

POM

Therapeutic area:

ANTIBACTERIALS FOR SYSTEMIC USE

পণ্য সারাংশ:

Licence number in the source country: NOT APPLICAPABLE

অনুমোদন অবস্থা:

Authorised

অনুমোদন তারিখ:

2022-12-15

তথ্য লিফলেট

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM APTAPHARMA 2000 MG POWDER FOR SOLUTION FOR INFUSION
meropenem
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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.
-
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 are given 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:
•
Lung and bronchial infections in patients suffering from cystic
fibrosis.
•
Acute bacterial infection of the brain (meningitis).
Meropenem Aptapharma 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 ARE GIVEN MEROPENEM APTAPHARMA
DO NOT USE MEROPENEM APTAPHARMA
•
If you are allergic to meropenem or any of the other ingredients of
this medicine (listed in section 6).
•
If you are allergic to other antibiotics such as penicillins,
cephalosporins or carbapenems as you may
also be allergic to meropenem.
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Meropenem
Aptapharma.
•
If you have health problems, such as liver or kidney problems.
•
If you have had severe diarrhoea after taking other antibiotics.
You may develop a posit

পণ্য বৈশিষ্ট্য

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Meropenem Aptapharma 2000 mg powder for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 2000 mg meropenem (as 2280 mg meropenem
trihydrate).
Excipients with known effect:
Each vial of Meropenem Aptapharma 2000 mg contains 416 mg sodium
carbonate, corresponding to 180
mg (7,85 mmol) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White to pale yellow crystalline powder.
The solution has a pH in range 7.3 – 8.3.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Meropenem Aptapharma 2000 mg is indicated for the treatment of the
following infections in adults,
children aged 3 months and older and adolescents (see sections 4.4 and
5.1):
•
Broncho-pulmonary infections in cystic fibrosis
•
Acute bacterial meningitis
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 2000 mg 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 treating
some types of infections, such as
2
infections due to less susceptible bacterial species (e.g.
_Enterobacteriaceae, Pseudomonas aeruginosa, _
_Acinetobacter_
spp.), or very severe infections.
Additional considerations for dosing are needed when treating patients
with renal insufficiency (see
further below).
Adults and adolescents
INFECTION
DOSE TO BE ADMINISTERED EVERY 8 HOURS
Broncho-pulmonary infections in cystic fibrosis
2000 mg
Ac