IMETOXIM

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

CEFOTAXIME

Disponível em:

Novocat Farma S.A.

Código ATC:

J01DD01

DCI (Denominação Comum Internacional):

CEFOTAXIME

Dosagem:

1 Grams

Forma farmacêutica:

Pdr+Solv for soln for inf/inj

Tipo de prescrição:

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

Área terapêutica:

cefotaxime

Status de autorização:

Not Marketed

Data de autorização:

2018-04-06

Folheto informativo - Bula

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMETOXIM 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION
Cefotaxime
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 or pharmacist.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Imetoxim 1g Powder for Solution for Injection or Infusion is and
what it is used for
2.
What you need to know before you use Imetoxim 1g Powder for Solution
for Injection or Infusion
3.
How to use Imetoxim 1g Powder for Solution for Injection or Infusion
4.
Possible side effects
5.
How to store Imetoxim 1g Powder for Solution for Injection or Infusion
6.
Contents of the pack and other information
1.
WHAT IMETOXIM 1G POWDER FOR SOLUTION FOR INJECTION OR INFUSION IS AND
WHAT IT IS USED FOR
Imetoxim contains a medicine called Cefotaxime. This belongs to a
group of medicines called antibiotics.
It works by killing the bacteria that cause infections.
Imetoxim is used for infections of the:
-
Respiratory tract such as chest and lungs
-
The urinary tract
-
The skin and soft tissues
-
The bones and joints
-
Genital tract in women - including infections of the uterus, fallopian
tubes and ovaries that can happen
pre, post and during pregnancy
-
Gonorrhoea - a type of sexually transmitted disease
-
The brain (meningitis)
Imetoxim 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 IMETOXIM 1G POWDER FOR SOLUTION
FOR INJECTION OR
INFUSION
DO NOT USE IMETOXIM:
-
If you are allergic to cefotaxime or any of the other ingredients of
this medicine (listed in section 6)
-
If you are allergic to certain other antibiotics (e.g. penicillins,
cephalosporins)
WARNINGS AND PRECAUTIONS
Talk to your doct

Características técnicas

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imetoxim 1g Powder for solution for injection or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains cefotaxime sodium equivalent to 1 g cefotaxime
base.
Each gram of cefotaxime contains approximately 48 mg (2.09 mmol) of
sodium.
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-white crystalline powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Imetoxim is active in vitro against
Gram-negative organisms
sensitive or
resistant
to first
or
second generation
cephalosporins. It is similar to other cephalosporins in activity
against Gram-positive organisms.
Imetoxim is indicated in the treatment
of
the following infections either
before the infecting organism has been
identified or when caused by bacteria of established sensitivity (see
sections 4.4 and 5.1).
-
Acute and chronic bronchitis ,
-
Infected bronchiectasis,
-
Lung abscess
-
Post-operative chest infections.
-
Nosocomial pneumonia
-
Complicated urinary tract infections
-
Complicated skin and soft tissue infections.
-
Bone and Joint Infections such as osteomyelitis, septic arthritis.
-
Obstetric and Gynaecological Infections such as pelvic inflammatory
disease.
-
Gonorrhoea particularly when penicillin has failed or is unsuitable.
-
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 and prescription of antibacterial agents.
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