Cefotaxime Netpharmalab 1g Powder for solution for injection or infusion

Country: Ireland

Bahasa: Inggeris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Cefotaxime

Boleh didapati daripada:

Netpharmalab Consulting Services S. L.

Kod ATC:

J01DD; J01DD01

INN (Nama Antarabangsa):

Cefotaxime

Dos:

1 gram(s)

Borang farmaseutikal:

Powder for solution for injection/infusion

Jenis preskripsi:

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

Kawasan terapeutik:

Third-generation cephalosporins; cefotaxime

Status kebenaran:

Not marketed

Tarikh kebenaran:

2018-04-06

Risalah maklumat

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEFOTAXIME NETPHARMALAB 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 Cefotaxime Netpharmalab 1g Powder for Solution for Injection or
Infusion is and what it is
used for
2.
What you need to know before you use Cefotaxime Netpharmalab 1g Powder
for Solution for
Injection or Infusion
3.
How to use Cefotaxime Netpharmalab 1g Powder for Solution for
Injection or Infusion
4.
Possible side effects
5.
How to store Cefotaxime Netpharmalab 1g Powder for Solution for
Injection or Infusion
6.
Contents of the pack and other information
1.
WHAT CEFOTAXIME NETPHARMALAB 1G POWDER FOR SOLUTION FOR INJECTION OR
INFUSION IS AND WHAT
IT IS USED FOR
Cefotaxime Netpharmalab contains a medicine called Cefotaxime. This
belongs to a group of medicines
called antibiotics. It works by killing the bacteria that cause
infections.
Cefotaxime Netpharmalab 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)
Cefotaxime Netpharmalab 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 CEFOTAXIME NETPHARMALAB 1G POWDER
FOR SOLUTION FOR
INJECTION OR INFUSION
DO NOT USE CEFOTAXIME NETPHARMALAB:
-
If you are allergic to cefotaxime or any of the other ingredients of

Ciri produk

Health Products Regulatory Authority
25 November 2022
CRN00D8KH
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Cefotaxime Netpharmalab 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
Cefotaxime Netpharmalab 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.
Cefotaxime Netpharmalab 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.
Health Products Regulatory Authority
25 November 2022
CRN00D8KH
Page 2 of 11
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Cefotaxime Netpharmalab may be administered intravenously or by slow
injection or infusion or intramuscularly. The dosage,