Meropenem 1g powder for solution for injection vials

Riik: Suurbritannia

keel: inglise

Allikas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Toimeaine:

Meropenem trihydrate

Saadav alates:

Milpharm Ltd

ATC kood:

J01DH02

INN (Rahvusvaheline Nimetus):

Meropenem trihydrate

Annus:

1gram

Ravimvorm:

Powder for solution for injection

Manustamisviis:

Intravenous

Klass:

No Controlled Drug Status

Retsepti tüüp:

Valid as a prescribable product

Toote kokkuvõte:

BNF: 05010202; GTIN: 8901175025169

Infovoldik

PACKAGE LEAFLET: INFORMATION FOR THE USER
MEROPENEM 500 MG
POWDER FOR SOLUTION FOR INJECTION OR INFUSION
MEROPENEM 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 is and what it is used for
2.
What you need to know before you take Meropenem
3.
How to take Meropenem
4.
Possible side effects
5.
How to store Meropenem
6.
Contents of the pack and other information
Meropenem belongs to a group of medicines called carbapenem
antibiotics. It works by killing bacteria, which can cause serious
infections.
•
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 is suspected to be due to a bacterial
infection.
Meropenem may be used to treat bacterial infection of the blood
which might be associated with a type of infection mentioned
above.
DO NOT TAKE MEROPENEM
•
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 or

Toote omadused

OBJECT 1
MEROPENEM 1 G POWDER FOR SOLUTION FOR INJECTION
OR INFUSION
Summary of Product Characteristics Updated 02-Aug-2017 | Aurobindo
Pharma - Milpharm Ltd.
1. Name of the medicinal product
Meropenem 1 g 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 is indicated for the treatment of the following infections
in adults and children over 3 months
of age (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
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 suspected to 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
infection to be treated, including its severity, and the clinical
response.
A dose of up to 2 g