GULF CEFOTAXIME 1 g INJECTION

Pajjiż: Afrika t’Isfel

Lingwa: Ingliż

Sors: South African Health Products Regulatory Authority (SAHPRA)

Disponibbli minn:

Gulf Drug Company (Pty) Ltd

Dożaġġ:

See ingredients

Għamla farmaċewtika:

INJECTION

Kompożizzjoni:

EACH VIAL CONTAINS CEFOTAXIME SODIUM EQUIVALENT TO CEFOTAXIME 1,0 g

L-istatus ta 'awtorizzazzjoni:

Registered

Data ta 'l-awtorizzazzjoni:

2013-06-09

Fuljett ta 'informazzjoni

PATIENT INFORMATION LEAFLET
_READ THE ENTIRE LEAFLET CORRECTLY BEFORE YOU START RECEIVING GULF
CEFOTAXIME 1 G _

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor or your
pharmacist.

Gulf Cefotaxime has been prescribed for only you and you should not
share your medicine with other
people. It may harm them, even if their symptoms are the same as
yours.
SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
GULF CEFOTAXIME 1 g (Sterile Powder for Injection)
WHAT GULF CEFOTAXIME 1 G CONTAINS:
Gulf Cefotaxime 1g: Each vial contains cefotaxime sodium equivalent to
1 g cefotaxime
WHAT GULF CEFOTAXIME 1 G IS USED FOR:
Indicated in the treatment of infections caused by sensitive strains
of organisms in the following common
infections:

Upper respiratory tract infections

Urinary tract infections

Gastro-intestinal infections

Inflammation of the meninges (bacterial infection of the membranes
covering the brain and spinal cord)

Inflammation of the bladder (cystitis)

During operations to reduce the incidence of post-operative infections
BEFORE YOU ARE GIVEN GULF CEFOTAXIME 1 G:
YOU SHOULD NOT BE GIVEN GULF CEFOTAXIME 1 G IF:

You are sensitive or ever had a harmful reaction to cefotaxime or
cephalosporin antibiotics

Hypersensitivity to penicillin and other beta-lactam antibiotics
SPECIAL CARE SHOULD BE TAKEN:

If you are on sodium restriction

If you develop abdominal or stomach cramps, abdominal tenderness,
severe and watery diarrhoea and
fever

If you have a history of gastro-intestinal disease

If you have renal function impairment

If you suffer from porphyria
Since Gulf Cefotaxime 1 g is given through the vein or muscle, food
does not have an effect on the
bioavailability of Gulf Cefotaxime 1 g.
IF YOU ARE TAKING MEDICINES ON A REGULAR BASIS, INCLUDING
COMPLEMENTARY AND TRADITIONAL MEDICINES,
USING
GULF
CEFOTAXIME
1
G
AT
THE
SAME
TIME
WITH
ANOTHER
MEDICINE
MAY
CAUSE
UNDESIRABLE
INTERACTIONS. PLEASE CONSULT Y

Karatteristiċi tal-prodott

SCHEDULING STATUS: S4
PROPRIETARY NAME AND DOSAGE FORM:
GULF CEFOTAXIME 1 g (Sterile Powder for Injection)
COMPOSITION:
Gulf Cefotaxime 1 g: Each vial contains cefotaxime sodium equivalent
to 1 g cefotaxime
PHARMACOLOGICAL CLASSIFICATION:
A 20.1.1 Broad and medium spectrum antibiotics
PHARMACOLOGICAL ACTION:
Cefotaxime is a bactericidal semi-synthetic third-generation
cephalosporin. The antibacterial action results
from inhibition of bacterial cell wall synthesis by binding to
essential target proteins in bacterial cytoplasmic
membranes. Cefotaxime has activity against a wide range of bacterial
organisms (gram-positive and gram-
negative), including beta-lactamase producing strains.
PHARMACOKINETICS:
Cefotaxime is metabolised in the liver to both active and inactive
metabolites, and is approximately 90 %
excreted in the urine. Approximately 30 % of the dose of cefotaxime is
excreted unchanged, while 15 %-25 %
is excreted as the desacetyl derivative, the major active metabolite.
The mean terminal half-life is about 80
minutes.
IM INJECTION:
Peak plasma levels are reached 30 minutes after IM injection of 0,25
g; 0,5 g and 1 g doses. The peak
plasma level attained is dose dependent – approximately 24 µg/ml
after the 1 g injection. Urinary excretion is
50 % to 60 % of the administered dose within 24 hours after injection
(44 % to 55 % within the first six hours).
Cefotaxime crosses the blood brain barrier.
IV INJECTION:
Initial phase half lives for whole blood and plasma are 4,5 and 8
minutes respectively. Terminal phase half
lives for whole blood and plasma are 1,3 and 2,2 hours respectively.
Most of the dose is excreted within 4
hours of dosing. The elimination half life is prolonged with renal
impairment. Between 85 % and 90 % of the
administered dose is excreted in the urine and 7 % to 9,5 % is
excreted in the faeces. Cefotaxime is
metabolised in the liver to active and inactive metabolites.
Approximately 20 % to 36 % of an IV dose is
excreted as unchanged cefotaxime, while 15 % to 25 % is excreted as
the desa