Meropenem 500mg powder for solution for injection vials

País: Reino Unido

Idioma: inglés

Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)

Ingredientes activos:

Meropenem trihydrate

Disponible desde:

Pfizer Ltd

Código ATC:

J01DH02

Designación común internacional (DCI):

Meropenem trihydrate

Dosis:

500mg

formulario farmacéutico:

Powder for solution for injection

Vía de administración:

Intravenous

clase:

No Controlled Drug Status

tipo de receta:

Valid as a prescribable product

Resumen del producto:

BNF: 05010202; GTIN: 0304090012883 5015997106418

Información para el usuario

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Page 1 of 9
PACKAGE LEAFLET: INFORMATION FOR THE USER
Meropenem 500 mg and 1 g Powder for Solution for Injection or 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 is and what it is used for
2.
What you need to know before you use Meropenem
3.
How to use Meropenem
4.
Possible side effects
5.
How to store Meropenem
6.
Contents of the pack and other information
1.
WHAT MEROPENEM 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.

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 delivery

Complicated skin and soft tissue 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 bacterial infection.
Meropenem 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 USE MEROPENEM
DO NOT USE MEROPENEM IF

you are allergic to meropenem or any of the other ingredients of
Meropenem
(listed in Section 6)

you are allergic (hypersensitive) to other antibiotics such as
penicillins,
cephalosporins, or carbapenems as you

Ficha técnica

OBJECT 1
MEROPENEM 500 MG POWDER FOR SOLUTION FOR
INJECTION OR INFUSION
Summary of Product Characteristics Updated 13-Sep-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Meropenem 500 mg Powder for Solution for Injection or Infusion
2. Qualitative and quantitative composition
Each vial contains meropenem trihydrate equivalent to 500 mg anhydrous
meropenem.
When reconstituted with 10 ml sterile Water for Injections, each ml
contains 50 mg meropenem.
Excipients(s) with known effect:
Each 500 mg vial contains 104 mg sodium carbonate which equates to
approximately 2.0 mEq of sodium
(approximately 45 mg).
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 powder.
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
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 tim