AURO-CEFAZOLIN 0.5g cefazolin (as sodium) 0.5g powder for injection vial

Australia - English - Department of Health (Therapeutic Goods Administration)

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Active ingredient:
cefazolin sodium
Available from:
Strides Pharma Science Pty Ltd
INN (International Name):
cefazolin sodium
Authorization status:
Registered
Authorization number:
174066

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AURO-CEFAZOLIN

CONSUMER MEDICINE INFORMATION

Ver 1.3

Page 1 of 3

AURO-CEFAZOLIN 0.5g, 1g & 2g

Cephazolin (as sodium)

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions

about

AURO-

CEFAZOLIN. It does not contain all

the available information and does

not take the place of talking to your

doctor or pharmacist.

medicines

have

risks

benefits. Your doctor has weighed

risks

taking

AURO-

CEFAZOLIN

against

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

AURO-CEFAZOLIN is

used for

AURO-CEFAZOLIN

contains

cephazolin (as cephazolin sodium) as

active

ingredient.

Cephazolin

belongs

group

antibiotics

called cephalosporins.

AURO-CEFAZOLIN is used to treat

serious

infections,

caused

bacteria,

different

parts

body. It works by killing the bacteria

that

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

AURO-

CEFAZOLIN has been prescribed

for you.

Your doctor may have prescribed it

for another purpose

.

AURO-CEFAZOLIN

recommended for use in premature

infants

infants

under

month.

This medicine is only available with

a doctor’s prescription.

There

evidence

that

addictive.

Before you take

AURO-CEFAZOLIN

When

you

must

not

be

given

AURO-CEFAZOLIN

You

must

not

be

given

AURO-

CEFAZOLIN if you have a known

allergy to:

cephazolin

other

cephalosporin

antibiotic

or a major allergy to penicillin.

Signs

allergic

reaction

include

shortness

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

AURO-

CEFAZOLIN if the packaging is

torn or shows signs of tampering.

You

must

not

be

given

AURO-

CEFAZOLIN after the expiry date

printed on the pack.

If you are not sure whether you

should be given this medicine, talk

to your doctor.

Before you are given

AURO-CEFAZOLIN

Tell your doctor if you are allergic

to

any

other

medicines

or

any

foods, preservatives or dyes.

Tell your doctor if you have or

have had any medical conditions,

especially the following:

kidney disease

severe bowel condition/disease.

If you are scheduled to have any

laboratory

tests

e.g.

blood

or

urine, tell your doctor that you are

being given AURO-CEFAZOLIN.

Tell

your

doctor

if

you

are

pregnant

or

intend

to

become

pregnant.

The safety of this medicine during

pregnancy has not been established.

Tell your doctor if you are breast

feeding or plan to breast-feed.

If you have not told your doctor

about any of the above, tell them

before

you

start

being

given

AURO-CEFAZOLIN.

Taking other medicines

Tell your doctor if you are taking

any other medicines, including any

that

you

buy

without

a

prescription from your pharmacy,

supermarket or health food shop.

Some medicines may be affected by

AURO-CEFAZOLIN or may affect

how it works.

Your doctor has more information

on medicines to be careful with or to

avoid

while

being

given

AURO-

CEFAZOLIN.

AURO-CEFAZOLIN

CONSUMER MEDICINE INFORMATION

Ver 1.3

Page 2 of 3

How

AURO-CEFAZOLIN

is given

How much is given

Your doctor will decide what dose

you will receive. This depends on

various factors such as the condition

being treated (and your response to

the treatment), your weight and age

and whether or not you have a pre

existing kidney condition.

How it is given

AURO-CEFAZOLIN

sterile

powder

which

dissolved

diluted with suitable fluids.

After

reconstitution,

AURO-

CEFAZOLIN can be given either:

into a vein via a ‘drip’

as a slow injection directly into

a vein

deep

injection

into

large muscle.

Your doctor or nurse will prepare the

injection

AURO-CEFAZOLIN

for you.

If

you

are

given

too

much

(overdose)

As AURO-CEFAZOLIN is given to

you under the supervision of your

doctor, it is very unlikely that you

will receive too much.

However,

if

you

experience

any

side

effects

after

being

given

AURO-CEFAZOLIN,

tell

your

doctor immediately.

Symptoms

overdose

include:

pain

inflammation

injection site

dizziness and headaches

tingling

numbness

hands or feet.

While

you

are

receiving

(being given)

AURO-CEFAZOLIN

Things you must do

Tell your doctor if the symptoms

of your infection do not improve

within

a

few

days

or

if

they

become worse.

If

you

get

severe

diarrhoea,

tell

your doctor, pharmacist or nurse

immediately.

Do

this

even

if

it

occurs several weeks after AURO-

CEFAZOLIN has been stopped.

Diarrhoea may mean that you have a

serious

condition

affecting

your

bowel.

need

urgent

medical care.

Do

not

take

any

diarrhoea

medicine

without

first

checking

with your doctor.

If you are about to be started on

any new medicine, tell your doctor

that

you

are

receiving

AURO-

CEFAZOLIN.

Tell

your

doctor

if

you

become

pregnant while you are receiving

AURO-CEFAZOLIN.

If you have to test your urine for

sugar while you are being given

AURO-CEFAZOLIN,

make

sure

your doctor knows which type of

test you use.

AURO-CEFAZOLIN may affect the

results of these tests.

Side Effects

Tell

your

doctor

as

soon

as

possible

if

you

do

not

feel

well

while you are being treated with

AURO-CEFAZOLIN.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Ask

your

doctor,

nurse

or

pharmacist

to

answer

any

questions you may have.

Tell

your

doctor,

nurse

or

pharmacist if you notice any of the

following and they worry you:

pain, swelling or red skin where

you had the injection

nausea and vomiting

mild diarrhoea.

These

more

common

side

effects of AURO-CEFAZOLIN and

are usually mild.

Tell

your

doctor

or

nurse

immediately if you notice any of

the following side effects:

watery

severe

diarrhoea,

which may also be bloody

severe

chills,

sore

throat

mouth ulcers

skin problems such as rash or

itchiness

bleeding or bruising more easily

than normal

signs

anaemia,

such

tiredness, being short of breath

and looking pale

jaundice, yellowing of the skin

and eyes

swelling of the face, lips, mouth

throat

which

cause

difficulty

swallowing

breathing

severe blisters and bleeding in

the lips, eyes, mouth, nose and

genitals.

These side effects are rare but may

be serious. You may need medical

attention.

After you have received

AURO-CEFAZOLIN

Tell your doctor immediately or go

to

Accident

and

Emergency

at

your nearest hospital if any of the

following

happen,

particularly

if

they

occur

several

weeks

after

stopping

treatment

with

AURO-

CEFAZOLIN:

severe

abdominal

cramps

stomach cramps

AURO-CEFAZOLIN

CONSUMER MEDICINE INFORMATION

Ver 1.3

Page 3 of 3

watery

severe

diarrhoea,

which may also be bloody

fever, in combination with one

or both of the above.

These

rare

serious

side

effects.

have

serious

condition affecting your bowel. You

may need urgent medical attention or

hospitalisation.

Tell

your

doctor

if

you

notice

anything else that is making you

feel unwell, even if you think the

problems are not connected with

this medicine and are not referred

to in this leaflet.

Other side effects not listed above

may occur in some people.

Do not be alarmed by this list of

possible side effects.

experience

them.

After using

AURO-CEFAZOLIN

Storage

AURO-CEFAZOLIN will be stored

in the pharmacy or on the ward. The

powder for injection is kept in a cool

place,

protected

from

light,

where the temperature stays below

Contains no antimicrobial agent. Use

in one patient on one occasion only.

reduce

microbiological

hazard,

soon

practicable

after

dilution.

Discard

residue.

storage is necessary hold at 2°-8°C

for not more than 24 hours.

Product Description

What it looks like

AURO-CEFAZOLIN 0.5g, 1g & 2g

comes in pack of 1 vial, 5 vials & 10

vials.

AURO-CEFAZOLIN

0.5g

(AUST R 174066)

White or almost white powder filled

in 10 mL moulded type I clear glass

vials with grey bromo butyl rubber

stoppers sealed with aluminium seal

having light rose colour PP disc.

AURO-CEFAZOLIN 1g

(AUST R 174072)

White or almost white powder filled

in 10 mL moulded type I clear glass

vials with grey bromo butyl rubber

stoppers sealed with aluminium seal

having violet colour PP disc.

AURO-CEFAZOLIN 2g

(AUST R 174073)

White or almost white powder filled

in 20 mL moulded type I clear glass

vials with grey bromo butyl rubber

stoppers sealed with aluminium seal

having violet colour PP disc.

Ingredients

Active ingredient:

Cephazolin (as cephazolin sodium)

Each vial contains 0.5g, 1g or 2g of

Cefazolin as sodium.

Inactive ingredients:

There are no inactive ingredients in

AURO-CEFAZOLIN.

AURO-CEFAZOLIN

does

contain

lactose,

gluten,

sucrose,

tartrazine or any other azo dyes.

Sponsor

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

Date of Approval

19 December 2011

Read the complete document

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 1 of 9

PRODUCT INFORMATION

AURO-CEFAZOLIN 0.5g (0.5 g cephazolin as cephazolin sodium) powder for injection

AURO-CEFAZOLIN 1g (1 g cephazolin as cephazolin sodium) powder for injection

AURO-CEFAZOLIN 2g (2 g cephazolin as cephazolin sodium)

powder for injection

NAME OF THE MEDICINE

The name of the medicine is cephazolin as cephazolin sodium.

Chemical name:

Sodium (6

R

R

)-3-[[(5-methyl-1,3,4-thiadiazol-2-yl)sulphanyl]methyl]-8-oxo-

7-[(1

H

-tetrazol-1-ylacetyl)amino]-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.

Molecular Formula:

Molecular Weight:

476.5

CAS Registry Number: [27164-46-1]

DESCRIPTION

AURO-CEFAZOLIN is a semisynthetic cephalosporin antibiotic for parenteral administration

only. It is a white or almost white powder, very hygroscopic. It is freely soluble in water and

very slightly soluble in ethanol. It contains approximately 48 mg (2.1 mEq) of sodium per g of

cephazolin sodium

Microbiology: In vitro tests demonstrate that the bactericidal action of cephalosporins results

from inhibition of cell-wall synthesis. Cephazolin 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

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

Herellea

species) are almost uniformly resistant to cephazolin.

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 2 of 9

Pharmacology: The following table demonstrates the blood levels and duration of cephazolin

following intramuscular administration.

TABLE 1

SERUM CONCENTRATIONS AFTER INTRAMUSCULAR ADMINISTRATION

Serum Concentrations (μg/mL)

-------------------------------------

Dose

½ hr

250 mg

15.5

17.0

13.0

500 mg

36.2

36.8

37.9

15.5

1 g *

60.1

63.8

54.3

29.3

13.2

* 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 (using normal volunteers) of constant intravenous infusion with dosages of 3.5 mg/kg

for one hour (approximately 250 mg) and 1.5 mg/kg the next two hours (approximately 100 mg),

cephazolin produced a steady serum level at the third hour of approximately 28 μg/mL. The

following table shows the average serum concentration after I.V. injection of a single 1 g dose;

average half-life was 1.4 hours.

TABLE 2

SERUM CONCENTRATION AFTER 1 g INTRAVENOUS DOSE

Serum Concentrations (μg/mL)

-------------------------------------

5 min

15 min

30 min

1 hr

2 hr

4 hr

188.4

135.8

106.8

73.7

45.6

16.5

Controlled studies on adult normal volunteers receiving 1 g four times a day for ten days,

monitoring CBC, SGOT, SGPT, bilirubin, alkaline phosphatase, serum urea, creatinine, and

urinalysis, indicated no clinically significant changes attributed to cephazolin.

Cephazolin is excreted unchanged in the urine. Following intramuscular injection of 500 mg, 56

to 89 percent of the administered dose was recovered within six hours and 80 to nearly 100

percent was recovered in twenty-four hours. Cephazolin achieves peak urine concentrations

greater than 1000 μg/mL and 4000 μg/mL respectively following 500 mg and 1 g intramuscular

doses.

When cephazolin is administered to patients with unobstructed biliary tracts, high concentrations,

well over serum levels, occur in the gallbladder tissue and bile. In the presence of obstruction,

however, concentration of the antibiotic in bile is considerably lower than the serum level.

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 3 of 9

Cephazolin

readily

crosses

inflamed

synovial

membrane

concentration

antibiotic achieved in the joint space is comparable to levels measured in serum.

Cephazolin

readily

crosses

placental

barrier

into

cord

blood

amniotic

fluid.

Cephazolin is present in very low concentrations in the milk of nursing mothers.

Disc Susceptibility Tests: Quantitative methods that require measurement of zone diameters give

most

precise

estimates

antibiotic

susceptibility.

such

procedure

been

recommended for use with discs for testing susceptibility to cephalosporin-class antibiotics.

Interpretations correlate diameters of the disc test with MIC values for cephazolin. With this

procedure, a report from the laboratory of "susceptible" indicates that the infecting organism is

likely to respond to therapy. A report of "resistant" indicates that the infecting organism is not

likely to respond to therapy. A report of "intermediate susceptibility" suggests that the organism

would be susceptible if high dosage is used or if the infection is confined to tissues and fluids

(e.g. urine) in which high antibiotic levels are attained.

INDICATIONS

AURO-CEFAZOLIN 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.

AURO-CEFAZOLIN is effective in the eradication of streptococci from the nasopharynx;

however, data establishing the efficacy of AURO-CEFAZOLIN in the subsequent prevention of

rheumatic fever are not available at present.

Genitourinary tract infections due to

Esch. coli, Pr. mirabilis, Klebsiella

species, and some strains

Enterobacter

and enterococci.

Skin and skin structure infections due to

Staph. aureus

(penicillin-sensitive and penicillin-

resistant), and Group A beta-haemolytic streptococci and other strains of streptococci.

Bone and joint infections due to

Staph. aureus.

Septicaemia due to

S. pneumoniae, Staph. aureus (penicillin-sensitive and

penicillin-resistant),

Pr. mirabilis, Esch. coli

Klebsiella

species.

Endocarditis due to

Staph. aureus

(penicillin-sensitive and penicillin-resistant), and Group A

beta-haemolytic streptococci.

Appropriate culture and susceptibility studies should be performed to determine susceptibility of

the causative organism to AURO-CEFAZOLIN.

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 4 of 9

CONTRAINDICATIONS

AURO-CEFAZOLIN is contraindicated in patients with known allergy to the cephalosporin

group of antibiotics or who have previously experienced a major allergy to penicillin (

see

PRECAUTIONS).

PRECAUTIONS

Before cephazolin therapy is instituted, careful inquiry should be made concerning previous

hypersensitivity reactions to cephalosporins and penicillin. Cephalosporin C derivatives should

be given cautiously in penicillin-sensitive patients.

Serious acute hypersensitivity reactions may require adrenaline and other emergency measures.

There is some clinical and laboratory evidence of partial cross-allergenicity of the penicillins and

cephalosporins.

Patients

have

been

reported

have

severe

reactions

(including

anaphylaxis) to both drugs.

Antibiotics, including cephazolin, should be administered cautiously to any patient who has

demonstrated some form of allergy, particularly to drugs.

If an allergic reaction to cephazolin occurs, the drug should be discontinued and the patient

treated

with

usual

agents

(e.g.,

adrenaline

other

pressor

amines,

antihistamines,

corticosteroids).

Antibiotic

associated

pseudomembranous

colitis

been

reported

with

many

antibiotics

including cephazolin. A toxin produced with

Clostridium difficile

appears to be the primary

cause. The severity of the colitis may range from mild to life threatening. It is important to

consider this diagnosis in patients who develop diarrhoea or colitis in association with antibiotic

use (this may occur up to several weeks after cessation of antibiotic therapy). Mild cases usually

respond to drug discontinuation alone. However, in moderate to severe cases appropriate therapy

with a suitable oral antibacterial agent effective against

C. difficile

should be considered. Fluids,

electrolytes and protein replacement should be provided when indicated.

Drugs which delay peristalsis, e.g. opiates and diphenoxylate with atropine (Lomotil) may

prolong and/or worsen the condition and should not be used.

Prolonged use of cephazolin may result in the overgrowth of non-susceptible organisms. Careful

clinical observation of the patient is essential. If superinfection occurs during therapy, appropriate

measures should be taken.

When cephazolin is administered to patients with low urinary output because of impaired renal

function, lower daily dosage is required (see dosage instructions).

The intrathecal administration of cephazolin is not an approved route of administration for this

antibiotic; in fact, there have been reports of severe central nervous system (CNS) toxicity

including seizures when cephazolin was administered in this manner.

Laboratory Test Interactions - A false-positive reaction for glucose in the urine may occur with

Benedict's or Fehling's solution or with Clinitest tablets but not with Tes-Tape (urine sugar

analysis paper, Lilly).

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 5 of 9

Use in Pregnancy - Pregnancy Category B1 -

Safety of this product for use during pregnancy has not been established.

Australian categorisation definition of Category B1:

Drugs which have been taken by only a

limited number of pregnant women and women of childbearing age, without an increase in the

frequency of malformation or other direct or indirect harmful effects on the human fetus having

been observed. Studies in animals have not shown evidence of an increased occurrence of fetal

damage.

Use in Infants: Safety for use in prematures and infants under one month of age has not been

established.

ADVERSE EFFECTS

The following reactions have been reported:

Hypersensitivity: Drug fever, skin rash, vulvar pruritus, eosinophilia, itching and Stevens-

Johnson syndrome have occurred.

Blood: Neutropenia, leukopenia, thrombocythaemia, thrombocytopenia and positive direct and

indirect Coombs tests have occurred.

Hepatic and Renal: Isolated transient rise in SGOT, SGPT, serum urea and alkaline phosphatase

levels has been observed without evidence of renal or hepatic impairment.

Gastrointestinal: Nausea, anorexia, vomiting, diarrhoea, and oral candidiasis (oral thrush) have

been reported. As with other broad-spectrum antibiotics, colitis, including rare instances of

pseudomembranous colitis, has been reported in conjunction with therapy with cephazolin (see

PRECAUTIONS).

Other: Pain at the site of injection after intramuscular administration has occurred, some with

induration. Phlebitis at the site of injection has been noted. Other reactions have included genital

and anal pruritus, genital moniliasis, and vaginitis.

DOSAGE AND ADMINISTRATION

Cephazolin may be administered intramuscularly or intravenously after reconstitution.

The intrathecal administration of cephazolin is not an approved route of administration for this

antibiotic; in fact, there have been reports of severe CNS toxicity including seizures when

cephazolin was administered in this manner.

Intramuscular

Administration:

Reconstitute

with

Sterile

Water

Injection

percent

Sodium Chloride Injection according to the dilution table below. Shake well until dissolved. To

facilitate putting the product into solution, the vial should be warmed in the hands while shaking.

Do not use the reconstituted injection solution if there is any sign of turbidity. Cephazolin should

be injected into a large muscle mass.

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 6 of 9

TABLE 3

DILUTION TABLE

Vial Size

Diluent to

be added

Approximate available

volume

Approximate

average

concentration

2.5 mL

3 mL

330 mg/mL

Intravenous Administration: Cephazolin may be administered by direct intravenous injection or

by intermittent or continuous infusion. Total daily dosages are the same as with intramuscular

injection.

Direct Intravenous Injection: Dilute the reconstituted 1 g cephazolin in a minimum of 10 mL of

Sterile

Water

Injection.

Inject

solution

slowly

over

three

five

minutes.

administered directly into a vein or through the tubing for a patient receiving one of the following

intravenous solutions:

0.9% Sodium Chloride Injection

5% or 10% Glucose Injection

5% Glucose in Lactated Ringer's Injection

5% Glucose and 0.9% Sodium Chloride Injection

(also may be used with 5% Glucose and 0.4% or 0.2% Sodium Chloride Injection)

Lactated Ringer's Injection

5% or 10% Invert Sugar in Sterile Water for Injection

Ringer's Injection

Intermittent

Intravenous

Infusion:

Cephazolin

administered

along

with

primary

intravenous fluid management programmes in a volume control set or in a separate, secondary

I.V. bottle. Reconstituted 1 g cephazolin may be diluted in 50 to 100 mL of Sterile Water for

Injection or one of the above parenteral fluids, and infused over a period of three to five minutes.

If a Y-type administration set is used, it is desirable to discontinue the other solution during the

infusion of the solution containing cephazolin.

Continuous Intravenous Infusion: The total daily dose of cephazolin, diluted and well mixed with

at least 50 mL of Sterile Water for Injection, may be added to an I.V. bottle containing one of the

above parenteral fluids. The choice of saline or glucose solution and the volume to be employed

are dictated by fluid and electrolytic management.

Dosage: In adults, usual dosage for mild gram-positive infections is 250 to 500 mg of cephazolin

every

eight

hours.

mild

moderate

infections

respiratory

tract

caused

S.

pneumoniae,

or mild to moderate infections of the genitourinary tract caused by susceptible

organisms, a dosage of 500 mg to 1 g every twelve hours may be used. In moderate or severe

infections, the usual adult dosage is 500 mg to 1 g of cephazolin every six to eight hours.

Cephazolin has been administered in dosages of 6 g per day in serious infections such as

endocarditis. In patients with renal impairment, cephazolin is not readily excreted. After a loading

dose of 500 mg, the following recommendations for maintenance dosage may be used as a guide.

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 7 of 9

TABLE 4

MAINTENANCE DOSAGE OF CEPHAZOLIN IN ADULTS WITH

REDUCED RENAL FUNCTION

Renal Half-

Life Function

Serum

Urea*

(mg%)

Creatinine

Clearance

(mL/min)

Serum

Creatinine

(mmol/L)

Dosage

Serum

Half-Life

(hours)

Mild to

Moderate

Infection

Moderate to

Severe

Infection

Mild

Impairment

20-34

70-40

115-180

250 to 500mg

q 12 h

500mg to 1.25g

q 12 h

Moderate

Impairment

35-49

40-20

181-310

125 to 250mg

q 12 h

250 to 600mg

q 12 h

6-12

Severe

Impairment

50-75

20-5

311-620

75 to 150mg

q 24 h

150 to 400mg

q 24 h

15-30

Essentially No

Function

>75

<5

>620

37.5 to 75mg

q 24 h

75 to 200mg

q 24 h

30-40

* If used to estimate degree of renal impairment, concentrations should reflect a steady state of

renal azotaemia.

In children, a total daily dosage of 25 to 50 mg per kg of body weight, divided into three or four

equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be

increased to 100 mg per kg of body weight for severe infections. In children with mild to

moderate impairment of renal function (creatinine clearance of 70-40 mL/min) 60% of the normal

daily dose given in divided doses q 12 h should be sufficient. In patients with moderate

impairment (creatinine clearance of 40-20 mL/min) 25% of the normal daily dose given in

divided doses q 12 h should be sufficient. In children with marked impairment (creatinine

clearance of 20-5 mL/min) 10% of the normal daily dose given q 24 h should be adequate. All

dosage recommendations apply after an initial loading dose.

Since safety for use in premature infants and in infants under one month has not been established,

the use of cephazolin in these patients is not recommended.

TABLE 5

PAEDIATRIC DOSAGE GUIDE

Part A

Weight

25 mg/kg/day

Divided into 3 Doses

25 mg/kg/day

Divided into 4 Doses

Approximate

Single Dose

(mg q 8 h)

Vol. (mL)

Needed with

Dilution of

125 mg/mL

Approximate

Single Dose

(mg q 6 h)

Vol. (mL)

Needed with

Dilution of

125 mg/mL

40 mg

0.35 mL

30 mg

0.25 mL

75 mg

0.6 mL

55 mg

0.45 mL

13.6

115 mg

0.9 mL

85 mg

0.7 mL

18.1

150 mg

1.2 mL

115 mg

0.9 mL

22.7

190 mg

1.5 mL

140 mg

1.1 mL

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 8 of 9

Part B

Weight

50 mg/kg/day

Divided into 3 Doses

50 mg/kg/day

Divided into 4 Doses

Approximate

Single Dose

(mg q 8 h)

Vol. (mL)

Needed with

Dilution of

225 mg/mL

Approximate

Single Dose

(mg q 6 h)

Vol. (mL)

Needed with

Dilution of

225 mg/mL

75 mg

0.35 mL

55 mg

0.25 mL

150 mg

0.7 mL

110 mg

0.5 mL

13.6

225 mg

1 mL

170 mg

0.75 mL

18.1

300 mg

1.35 mL

225 mg

1 mL

22.7

375 mg

1.7 mL

285 mg

1.25 mL

OVERDOSAGE

Signs and Symptoms

: Toxic signs and symptoms following an overdose of cephazolin may

include pain, inflammation and phlebitis at the injection site.

administration

inappropriately

large

doses

parenteral

cephalosporins

cause

dizziness, paraesthesias and headaches. Seizures may occur following overdosage with some

cephalosporins, particularly in patients with renal impairment in whom accumulation is likely to

occur.

Laboratory abnormalities that may occur after an overdose include elevations in creatinine, serum

urea, liver enzymes and bilirubin, a positive Coombs' test, thrombocytosis, thrombocytopenia,

eosinophilia, leukopenia and prolongation of the prothrombin time.

Treatment

managing

overdosage,

consider

possibility

multiple

drug

overdoses,

interaction among drugs and unusual drug kinetics in your patient.

If seizures occur, the drug should be discontinued promptly; anticonvulsant therapy may be

administered if clinically indicated. Protect the patient's airway and support ventilation and

perfusion. Meticulously monitor and maintain, within acceptable limits, the patient's vital signs,

blood gases, serum electrolytes, etc.

In cases of severe overdosage, especially in a patient with renal failure, combined haemodialysis

and haemoperfusion may be considered if response to more conservative therapy fails. However,

no data supporting such therapy are available.

Contact the Poisons Information Centre on 131126 for management of overdose

PRESENTATION AND STORAGE CONDITIONS

AURO-CEFAZOLIN, powder for injection containing cephazolin (as sodium) 0.5g, 1g & 2g in

packs of 1 vial, 5 vials & 10 vials.

Product Information:

AURO-CEFAZOLIN (Cephazolin for Injection 0.5g, 1g & 2g)

Ver 1.4

Page 9 of 9

AURO-CEFAZOLIN 0.5g (AUST R 174066)

White or almost white powder filled in 10 mL moulded type I clear glass vials with grey bromo

butyl rubber stoppers sealed with aluminium seal having light rose colour PP disc.

AURO-CEFAZOLIN 1g (AUST R 174072)

White or almost white powder filled in 10 mL moulded type I clear glass vials with grey bromo

butyl rubber stoppers sealed with aluminium seal having violet colour PP disc.

AURO-CEFAZOLIN 2g (AUST R 174073)

White or almost white powder filled in 20 mL moulded type I clear glass vials with grey bromo

butyl rubber stoppers sealed with aluminium seal having violet colour PP disc.

STORAGE

Store below 30°C and protected from light.

Contains

antimicrobial

agent.

patient

occasion

only.

reduce

microbiological hazard, use as soon as practicable after dilution. Discard any residue. If storage is

necessary hold at 2°-8°C for not more than 24 hours.

POISON SCHEDULE OF THE MEDICINE

Schedule 4 (Prescription only medicine)

NAME AND ADDRESS OF THE SPONSOR

Aurobindo Pharma Australia Pty Ltd

Unit 3, North Rydelink

277-283 Lane Cove Road

Macquarie Park

NSW 2113

Australia

REFERENCES

* Bauer, A.W., Kirby, W.M.M., Sherris, J.C., and Turck, M.: Antibiotic Susceptibility Testing by

a Standardized Single Disc Method. Am. J. Clin. Path., 45:493, 1966; Standardized Disc

Susceptibility Test, Federal Register, 37:20527-29, 1972; 39:19182-19184, 1974.

DATE OF TGA APPROVAL

19 December 2011

Read the complete document

Public Summary

Summary for ARTG Entry:

174066

AURO-CEFAZOLIN 0.5g cefazolin (as sodium) 0.5g powder for injection vial

ARTG entry for

Medicine Registered

Sponsor

Aurobindo Pharma Australia Pty Ltd

Postal Address

5 / 148 Spit Road,Mosman, NSW, 2088

Australia

ARTG Start Date

23/12/2011

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. AURO-CEFAZOLIN 0.5g cefazolin (as sodium) 0.5g powder for injection vial

Product Type

Single Medicine Product

Effective date

23/12/2011

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Cefazolin 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.,Cefazolin is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of Cefazolin in the

subsequent prevention of rheumatic fever are not available at present.,Genitourinary tract infections due to Esch. coli, Pr. mirabilis, Klebsiella species,

and some strains of Enterobacter and enterococci.,Skin and skin structure infections due to Staph. aureus (penicillin-sensitive and penicillin- resistant),

and Group A beta-haemolytic streptococci and other strains of streptococci.,Bone and joint infections due to Staph. aureus.,Septicaemia due to S.

pneumoniae, Staph. aureus (penicillin-sensitive and penicillin-resistant), Pr. mirabilis, Esch. coli and Klebsiella species.,Endocarditis due to Staph.

aureus (penicillin-sensitive and penicillin-resistant), and Group A beta-haemolytic streptococci.,Appropriate culture and susceptibility studies should be

performed to determine susceptibility of the causative organism to cefazolin.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

12 Months

Store below 30

degrees Celsius

Not recorded

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

1.

Dosage Form

Injection, powder for

Route of Administration

Intravenous

Intramuscular

Visual Identification

White or almost white powder filled in 10 ml clear glass vials with grey

rubber stoppers sealed with aluminium seal having light rose PP disc

Active Ingredients

cefazolin sodium

524 mg

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 29.11.2017 at 03:38:14 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

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