KEFZOL 1g powder for injection

Land: Australië

Taal: Engels

Bron: Department of Health (Therapeutic Goods Administration)

Werkstoffen:

cefazolin, Quantity: 1 g

Beschikbaar vanaf:

Aspen Pharmacare Australia Pty Ltd

farmaceutische vorm:

Injection, powder for

Samenstelling:

Excipient Ingredients:

Toedieningsweg:

Intramuscular, Intravenous

Eenheden in pakket:

1 X 1g vial, 10 x 1g vials

Prescription-type:

(S4) Prescription Only Medicine

therapeutische indicaties:

The treatment of susceptible gram positisve gram negative infections of the respiratory tract, genitourinary tract, bones and joints, bloodstream (including endocarditis and septicaemia), skin and soft tissue. Appropriate culture and sensitivity studies should be performed. INDICATIONS AS AT 26 July 1995: Kefzol is indicated in the treatment of the following serious infections due to susceptible organisms: Respiratory tract infections due to S. pneumoniae, Klebsiella species, H. influenzae, Staph. aureus (penicillin-sensitive and penicillin- resistant), and Group A beta-haemolytic streptococci. Injectable benzathine penicillin is considered to be the drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Kefzol is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Kefzol in the subsequent prevention of rheumatic fever are not available at present. Genitourinary tract infections due to

Product samenvatting:

Visual Identification: A white to off-white lyophilised plug; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius

Autorisatie-status:

Registered

Autorisatie datum:

1991-09-05

Bijsluiter

KEFZOL CMI- 150410
Page 1 of 3
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Kefzol. It does not
contain all the available information and
does not take the place of talking to your
doctor or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of you
taking Kefzol against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT BEING
GIVEN THIS MEDICINE ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT KEFZOL IS USED FOR
Kefzol contains cephazolin (as
cephazolin sodium) as the active
ingredient. Cephazolin belongs to a
group of antibiotics called
cephalosporins.
Kefzol is used to treat serious infections,
caused by bacteria, in different parts of
the body. It works by killing the bacteria
that are causing your infection, including
infections of the:
•
respiratory tract (throat, tonsils, chest
and lungs)
•
nose
•
skin and soft tissue
•
genitourinary tract (kidney and
bladder)
•
bone and joint
•
blood.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY KEFZOL HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it for
another purpose
.
Kefzol is not recommended for use in
premature infants and in infants under
one month.
This medicine is only available with a
doctor’s prescription.
There is no evidence that it is addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN IT _
_ _
YOU MUST NOT BE GIVEN KEFZOL IF YOU
HAVE A KNOWN ALLERGY TO:
•
cephazolin
•
any other cephalosporin antibiotic
•
or a major allergy to penicillin.
Signs of an allergic reaction may include
shortness of breath, wheezing or
difficulty in breathing; swelling of the
face, lips, tongue or other parts of the
body; rash, itching or hives on the skin.
YOU MUST NOT BE GIVEN KEFZOL IF THE
PACKAGING IS TORN OR SHOWS SIGNS OF
TAMPERING.
YOU MUST NOT BE GIVEN KEFZOL AFTER THE
EXPIRY DATE PRINTED ON THE PACK.
IF YOU ARE NOT SURE WHETHER YOU
SHOULD BE GIVEN THIS MEDICINE, TALK TO
YOUR DOCT

Productkenmerken

KEFZOL PI - (marketed)
Page 1 of 9
PRODUCT INFORMATION
KEFZOL
(cephazolin, as cephazolin sodium)
DESCRIPTION
Kefzol (cephazolin sodium) is a semisynthetic cephalosporin for
parenteral administration. It
is the sodium salt of 3-[[(5-methyl-1,3,4-thiadiazol-2-yl)-thio]
methyl]-7-
[2-(1H-tetrazol-1-yl)acetamido]-3-cephem-4-carboxylic acid. The sodium
content is 48.3 mg
per g of cephazolin sodium.
Cephazolin sodium is a white to off-white crystalline powder with a
solubility of
≥
100mg/mL in water.
The structural formula is as follows :-
ACTIONS
Microbiology -- In vitro tests demonstrate that the bactericidal
action of cephalosporins
results from inhibition of cell-wall synthesis. Kefzol is active
against the following
organisms in vitro:
_Staphylococcus aureus _
(penicillin-sensitive and penicillin-resistant).
Group A beta-haemolytic streptococci and other strains of streptococci
(many strains of
enterococci are resistant).
_Streptococcus pneumoniae _
_ _
_Klebsiella species_
_Escherichia coli _
_ _
_ _
_Enterobacter aerogenes_
_Proteus mirabilis _
_ _
_ _
_Haemophilus influenzae_
KEFZOL PI - (marketed)
Page 2 of 9
Most strains of
_Enterobacter cloacae _
and indole-positive
_Proteus (Pr. vulgaris, Pr. morganii, _
_Pr. rettgeri) _
are resistant. Methicillin-resistant staphylococci,
_Serratia, Pseudomonas, _
_Acinetobacter calcoaceticus _
(formerly
_Mima _
and
_Herellea _
species) are almost uniformly
resistant to cephazolin.
Human Pharmacology -- The following table demonstrates the blood
levels and duration of
cephazolin following intramuscular administration.
TABLE 1
SERUM CONCENTRATIONS AFTER INTRAMUSCULAR ADMINISTRATION
Serum Concentrations (
µ
g/mL)
Dose
½ hr
1 hr
2 hr
4 hr
6 hr
8 hr
250 mg
15.5
17.0
13.0
5.1
2.5
500 mg
36.2
36.8
37.9
15.5
6.3
3.0
1 g *
60.1
63.8
54.3
29.3
13.2
7.1
* Average of two studies
Clinical pharmacology studies in patients hospitalised with infections
indicate that cephazolin
produces mean peak serum levels approximately equivalent to those seen
in normal
volunteers.
In a study (usin