Consumer medicine information

CEFAZOLIN-AFT

Cefazolin

BRAND INFORMATION

Brand name

Cefazolin-AFT Powder for injection

Active ingredient

Cefazolin

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using CEFAZOLIN-AFT.

What is in this leaflet

This leaflet answers some common questions about Cefazolin-AFT.

It does not contain all the available information. It 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 using Cefazolin-AFT against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Cefazolin-AFT is used for

Cefazolin-AFT is an antibiotic used to treat infections in different parts of the body caused by bacteria.

Cefazolin-AFT will not work against infections caused by viruses such as colds or the flu.

Cefazolin-AFT belongs to a group of antibiotics called cephalosporins. These antibiotics work by killing the bacteria that are causing your infection.

Ask your doctor if you have any questions about why Cefazolin-AFT has been prescribed for you. Your doctor may have prescribed Cefazolin-AFT for another reason.

Cefazolin-AFT is available only with a doctor's prescription. It is not addictive.

Before you are given Cefazolin-AFT

When you must not be given Cefazolin-AFT

Do not use Cefazolin-AFT if:

  1. you have an allergy to the active ingredient, cefazolin sodium, or to any other cephalosporins. Some of the symptoms of an allergic reaction may include asthma, wheezing, shortness of breath, swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing, skin rash, itching or hives.
  2. you have had a serious allergic reaction to any penicillins.
    You may be more likely to have an allergic reaction to Cefazolin-AFT if you are allergic to penicillin medicines.

Do not use Cefazolin-AFT if the packaging is torn or shows signs of tampering.

Do not use Cefazolin-AFT after the expiry date on the pack has passed.

If you are not sure whether you should be given Cefazolin-AFT, talk to your doctor or nurse.

Before you are given Cefazolin-AFT

Tell your doctor if:

  1. you have had any type of allergic reaction to any cephalosporin or penicillin medicines. You may have an increased chance of being allergic to Cefazolin-AFT if you are allergic to any cephalosporins or penicillins.
  2. you have any allergies to:
  • any other medicines
  • any other substances, such as foods, preservatives or dyes.
  1. you are pregnant, or intend to become pregnant. Cefazolin-AFT may affect your developing baby if you use it during pregnancy. Your doctor will discuss the risks and benefits of using Cefazolin-AFT during pregnancy.
  2. you are breast-feeding or intend to breast-feed.
    Cefazolin-AFT passes into breast milk and may affect your baby. Your doctor will discuss the risks and benefits of using Cefazolin-AFT when breast-feeding.
  3. if you have or have had any medical conditions, including:
  • kidney disease
  • stomach or bowel problems.

If you have not told your doctor about any of the above, tell them before you are given Cefazolin-AFT.

Use in Children

Cefazolin-AFT is not recommended for use in premature infants or infants under one month of age. The safety of Cefazolin-AFT in premature infants and infants under one month of age has not been established.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Cefazolin-AFT. These include:

  • probenecid, a medicine used to treat gout
  • warfarin, a medicine used to prevent blood clots
  • other antibiotics such as amikacin, gentamicin, tobramycin
  • typhoid vaccine.

These medicines may be affected by Cefazolin-AFT, or may affect how well it works. You may need to use different amounts of your medicine, or you may need to use different medicines. Your doctor will advise you.

Talk to your doctor about the need for an additional method of contraception while using Cefazolin-AFT. Some antibiotics may decrease the effectiveness of some birth control pills.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while using Cefazolin-AFT.

How Cefazolin-AFT is given

Cefazolin-AFT must only be given by a doctor or nurse.

Cefazolin-AFT can be given:

  • into a vein via a drip
  • as a slow injection into a vein
  • as a deep injection into a large muscle.

Your doctor will decide what dose and how long you will receive Cefazolin-AFT. This depends on your condition and whether you are taking any other medicines. For most infections, Cefazolin-AFT is usually given in divided doses throughout the day.

Sometimes only a single dose of Cefazolin-AFT is required for the treatment of certain infections.

If you are given too much (overdose)

In the unlikely event of an overdose, your treating physician will know what to do.

If you are given too much Cefazolin-AFT you may experience redness, pain or inflammation where the injection was given, stomach upset, headaches, chills, dizziness, tingling or numbness of the hands and feet or seizures.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26 in Australia, or call 0800 764 766 in New Zealand) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Cefazolin-AFT. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

While you are using Cefazolin-AFT

Things you must do

If the symptoms of your infection do not improve within a few days, or if they become worse, tell your doctor.

If you get severe diarrhoea, tell your doctor, pharmacist or nurse immediately. Do this even if it occurs several weeks after Cefazolin-AFT has been stopped. Diarrhoea may mean that you have a serious condition affecting your bowel. You may need urgent medical care. Do not take any diarrhoea medicine without first checking with your doctor.

If you get a sore white mouth or tongue while using or soon after stopping Cefazolin-AFT, tell your doctor. Also tell your doctor if you get vaginal itching or discharge. This may mean you have a fungal infection called thrush. Sometimes the use of Cefazolin-AFT allows fungi to grow and the above symptoms to occur. Cefazolin-AFT does not work against fungi.

If you become pregnant while you are using Cefazolin-AFT, tell your doctor immediately.

If you are about to start taking any new medicine, tell your doctor and pharmacist that you are using Cefazolin-AFT. Also tell all the doctors, dentists and pharmacists who are treating you that you are using Cefazolin-AFT.

If you have to test your urine for sugar while you are being given Cefazolin-AFT, make sure your doctor knows which type of test you use. Cefazolin-AFT may affect the results of some of these tests.

Things to be careful of

Be careful driving or operating machinery until you know how Cefazolin-AFT affects you. Cefazolin-AFT may cause dizziness in some people. Make sure you know how you react to Cefazolin-AFT before you drive a car, operate machinery or do anything else that may be dangerous if you are affected.

Side effects

Tell your doctor, nurse or pharmacist as soon as possible if you do not feel well after you are given Cefazolin-AFT. 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 or pharmacist to answer any questions you may have.

While using Cefazolin-AFT

Tell your doctor or nurse if you notice any of the following and they worry you:

  • oral thrush - white, furry, sore tongue and mouth
  • vaginal thrush - sore and itchy vagina and/or discharge
  • diarrhoea
  • nausea or vomiting
  • pain, redness and swelling where the injection was given.

These are the more common side effects of Cefazolin-AFT. These side effects are usually mild.

Tell your doctor or nurse immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever
  • skin rash, itching or hives
  • swelling of the face, lips or tongue which may cause difficulty swallowing or breathing
  • wheezing or shortness of breath
  • bleeding or bruising more easily than normal
  • signs of frequent infections such as fever, severe chills, sore throat or mouth ulcers.

These are serious side effects. You may need urgent medical attention. These serious side effects are rare.

After finishing Cefazolin-AFT

Tell your doctor immediately if you notice any of the following side effects, even if they occur several weeks after stopping treatment with Cefazolin-AFT:

  • severe abdominal cramps or stomach cramps
  • watery and severe diarrhoea, which may also be bloody
  • fever, in combination with one or both of the above.

These are rare but serious side effects. You may have a serious condition affecting your bowel. Therefore, you may need urgent medical attention. However, this side effect is rare.

Do not take any diarrhoea medicine without first checking with your doctor.

Tell your doctor if you notice anything else that is making you fell unwell. Other side effects not listed above may also occur in some patients.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

After using Cefazolin-AFT

Storage

Cefazolin-AFT will be stored in the pharmacy or on the ward.

The powder for injection is kept in a cool, dry place, protected from light, where the temperature stays below 25 °C.

Product Description

What it looks like

Cefazolin-AFT is a white to off-white powder. It is reconstituted before being injected.

Ingredients

Each vial contains cefazolin sodium equivalent to cefazolin 500 mg or 1 g powder for injection.

Cefazolin-AFT does not contain gluten, lactose, sucrose, tartrazine or any other azo dyes.

Sponsor

AFT Pharmaceuticals Pty Ltd
113 Wicks Road
North Ryde
NSW 2113
Australia

Australian Registration Numbers

Cefazolin-AFT, cefazolin sodium equivalent to cefazolin 500 mg AUST R 171534

Cefazolin-AFT, cefazolin sodium equivalent to cefazolin 1 AUST R 171582

This leaflet was prepared on 24 August 2015

BRAND INFORMATION

Brand name

Cefazolin-AFT Powder for injection

Active ingredient

Cefazolin

Schedule

S4

 

1 Name of Medicine

Cefazolin sodium.

6.7 Physicochemical Properties

Chemical name: sodium (6R, 7R)-3-[[5-methyl-1,3,4- thiadiazol-2-yl)sulphanyl]methyl]-8- oxo-7-[(1H-tetrazol-1-ylacetyl)amino]-5- thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate.
Molecular formula: C14H13N8NaO4S3.
Molecular weight: 476.5.

Chemical structure.


CAS number.

27164-46-1.

2 Qualitative and Quantitative Composition

Cefazolin sodium is a white to off-white crystalline powder with a solubility in water of greater than or equal to 100 mg/mL. Cefazolin-AFT powder for injection contains cefazolin sodium as a single ingredient.
The sodium content is 48 mg/g of cefazolin sodium.
For the full list of excipients, see Section 6.1.

3 Pharmaceutical Form

White to almost white powder for injection which reconstitutes with Sterile Water for Injection to give a colourless solution.
This powder for injection is supplied in vials containing cefazolin sodium equivalent to 500 mg and 1 g cefazolin.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Microbiology.

In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell wall synthesis. Cefazolin 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, Escherichia coli, Proteus mirabilis, Klebsiella sp., Enterobacter aerogenes, Haemophilus influenzae. Most strains of E. cloacae and indole positive proteus (P. vulgaris, P. morganii, P. rettgeri) are resistant. Methicillin resistant Staphylococci, Serratia, Pseudomonas, Acinetobacter calcoaceticus (formerly mima and herellea sp.) are almost uniformly resistant to cefazolin.

Disc susceptibility tests.

Quantitative methods that require measurements of zone diameters give the most precise estimates of antibiotic susceptibility. One such procedure has been recommended for use with discs for testing susceptibility to cephalosporin class antibiotics. Interpretations correlate diameters of the disc test with minimum inhibitory concentration (MIC) values for cefazolin. 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.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Table 4 demonstrates the blood levels and duration of cefazolin following intramuscular administration.
Clinical pharmacology studies in patients hospitalised with infections indicate that cefazolin 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 for the next two hours (approximately 100 mg) cefazolin produced a steady serum level at the third hour of approximately 28 microgram/mL.
Table 5 shows the average serum concentration after intravenous injection of a single 1 g dose; average half-life was 1.4 hours.

Distribution.

Cefazolin readily crosses an inflamed synovial membrane and the concentration of the antibiotic achieved in the joint space is comparable to levels measured in serum. Cefazolin readily crosses the placental barrier into the cord blood and amniotic fluid. Cefazolin is present in very low concentrations in the milk of breastfeeding mothers.

Metabolism.

Controlled studies on adult normal volunteers receiving 1 g four times daily for ten days, monitoring complete blood count, AST, ALT, bilirubin, alkaline phosphatase, serum urea, creatinine and urinalysis, indicated no clinically significant changes attributed to cefazolin.

Excretion.

Cefazolin is excreted unchanged in the urine. Following intramuscular injection of 500 mg, 56 to 89% of the administered dose was recovered within six hours and 80 to nearly 100% was recovered in 24 hours. Cefazolin achieves peak urine concentrations greater than 1,000 microgram/mL and 4,000 microgram/mL, respectively, following 500 mg and 1 g intramuscular doses. When cefazolin is administered to patients with unobstructed biliary tracts, high concentrations, well over serum levels, occur in the gall bladder tissue and bile. In the presence of obstruction, however, concentration of the antibiotic in bile is considerably lower than the serum level.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

Long-term studies in animals to determine the carcinogenic potential of cefazolin have not been performed.

4 Clinical Particulars

4.1 Therapeutic Indications

Treatment of the following serious infections due to susceptible organisms.
Respiratory tract infections due to Strep. pneumoniae, Klebsiella sp., 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 E. coli, P. mirabilis, Klebsiella sp. 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 Strep. pneumoniae, Staph. aureus (penicillin sensitive and penicillin resistant), P. mirabilis, E. coli and Klebsiella sp.
Endocarditis due to Staph. aureus (penicillin sensitive and penicillin resistant) and group A beta-haemolytic Streptococci.

4.3 Contraindications

Known allergy to the cephalosporin group of antibiotics or previous experience of a major allergy to penicillin (see Section 4.4 Special Warnings and Precautions for Use).

4.4 Special Warnings and Precautions for Use

Before cefazolin 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 the cephalosporins. Patients have been reported to have had severe reactions (including anaphylaxis) to both drugs.
Antibiotics, including cefazolin, should be administered cautiously to any patient who has demonstrated some form of allergy, particularly to drugs. If an allergic reaction to cefazolin occurs, the drug should be discontinued and the patient treated with the usual agents (e.g. adrenaline or other pressor amines, antihistamines or corticosteroids).
Prolonged use of cefazolin may result in the overgrowth of nonsusceptible organisms. Careful clinical observation of the patient is essential. If superinfection occurs during therapy, appropriate measures should be taken.
Antibiotic associated pseudomembranous colitis has been reported with many antibiotics including cefazolin. A toxin produced by 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 Cl. difficile should be considered. Fluids, electrolytes and protein replacement should be provided when indicated.
Drugs that delay peristalsis, e.g. opiates and diphenoxylate with atropine (e.g. Lomotil), may prolong and/or worsen the condition and should not be used.
Encephalopathy has been reported with the use of cefazolin in patients with renal failure (see Section 4.8 Adverse Effects (Undesirable Effects)). When cefazolin is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required (see Section 4.2 Dose and Method of Administration).
The intrathecal administration of cefazolin is not an approved route of administration for this antibiotic; in fact, there have been reports of severe CNS toxicity including seizures when cefazolin was administered in this manner.
The intrathecal administration of cefazolin is not an approved route of administration for this antibiotic; in fact there have been reports of tremulousness, headache, agitation, lightheadedness and sensations of seeing flashing lights when cefazolin was administered in this manner for the treatment of infected ventricular shunts.

History of gastrointestinal disease.

Cefazolin, as with all cephalosporins, should be prescribed with caution in individuals with a history of gastrointestinal disease.

Severe cutaneous adverse reactions.

Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in patients taking beta-lactam antibiotics. When SCAR is suspected, Cefazolin-AFT should be discontinued immediately and an alternative treatment should be considered.

Use in renal impairment.

When cefazolin is administered to patients with low urinary output because of impaired renal function, lower daily dosage is required (see Section 4.2 Dose and Method of Administration). The dose of cefazolin should be reduced or the dosing interval increased in patients with renal failure.

Use in the elderly.

No data available.

Paediatric use.

Safety for use in premature infants and infants under 1 month of age has not been established.

Effects on laboratory tests.

A false positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution or with Clinitest tablets, but not with enzyme based tests, such as Clinistix and Tes-Tape. Positive direct and indirect antiglobulin (Coombs) tests have occurred; these may also occur in neonates whose mothers received cephalosporins before delivery.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Probenecid.

Probenecid may decrease renal tubular secretion of cephalosporins when used concurrently, resulting in increased and more prolonged cephalosporin blood levels.

Aminoglycoside antibodies.

Additive nephrotoxicity has been reported following the concomitant administration of cephalosporins and aminoglycoside antibiotics.

Live typhoid vaccine.

Antibiotics which possess bacterial activity against Salmonella typhi organisms may interfere with the immunological response to the live typhoid vaccine. Allow 24 hours or more to elapse between the administration of the last dose of the antibiotic and the live typhoid vaccine.

Warfarin.

Cefazolin may produce hypoprothrombinemia and may enhance the anticoagulant effect of warfarin.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category B1)
This category specifies drugs which have been taken only by 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 foetus having been observed. Cefazolin readily crosses the placental barrier into the cord blood and amniotic fluid.
Studies in animals have not shown evidence of an increased occurrence of foetal damage. Nevertheless, safety of the product for use during pregnancy has not been established.

Cefazolin is present in very low concentrations in the milk of breastfeeding mothers. Safety for use in lactating women has not been established.

4.8 Adverse Effects (Undesirable Effects)

The following reactions have been reported.

Hypersensitivity.

Drug fever, skin rash, vulvar pruritus, eosinophilia, itching and Stevens-Johnson syndrome have occurred.

Haematological.

The most common blood disorder associated with cefazolin has been eosinophilia. Neutropenia, leucopenia, thrombocythaemia, thrombocytopenia and positive direct and indirect Coombs' tests have occurred.

Hepatic and renal.

Isolated transient rise in AST, ALT, 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 cefazolin (see Section 4.4 Special Warnings and Precautions for Use).

Skin and other subcutaneous tissue disorders.

Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalised exanthematous pustulosis (AGEP) have been reported in beta-lactam antibiotics.

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 candidiasis and vaginitis.
Encephalopathy has been reported with the use of cefazolin in patients with renal failure. The symptoms include tonic-clonic seizures, lethargy, disorientation, memory loss, asterixis and multifocal myoclonus. Toxicity has been attributed to increased cefazolin serum levels and increased permeability of the blood brain barrier caused by uraemia. Therefore when cefazolin sodium is administered to patients with renal failure, lower daily dosage is required (see Section 4.2 Dose and Method of Administration).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at https://www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Dose.

Adults.

Usual dosage for mild Gram positive infections is cefazolin 250 to 500 mg every eight hours.
In mild to moderate infections of the respiratory tract caused by Strep. pneumoniae, or mild to moderate infections of the genitourinary tract caused by susceptible organisms, a dosage of 500 mg to 1 g every 12 hours may be used.
In moderate or severe infections, the usual adult dosage is cefazolin 500 mg to 1 g every six to eight hours. Cefazolin has been administered in dosages of 6 g/day in serious infections such as endocarditis.

Renal impairment.

In patients with renal impairment, cefazolin is not readily excreted. After a loading dose of 500 mg, the recommendations in Table 1 for maintenance dosage may be used as a guide.

Children.

A total daily dosage of 25 to 50 mg/kg bodyweight, 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/kg bodyweight for severe infections.
Since safety for use in premature infants and in infants aged under one month has not been established, the use of cefazolin in these patients is not recommended (see Table 2).

Renal impairment.

In children with mild to moderate impairment of renal function (creatinine clearance of 70 to 40 mL/minute), 60% of the normal daily dose given in divided doses every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/minute), 25% of the normal daily dose given in divided doses every 12 hours should be sufficient. In children with marked impairment (creatinine clearance of 20 to 5 mL/minute), 10% of the normal daily dose given every 24 hours should be adequate. All dosage recommendations apply after an initial loading dose.

Method of administration.

Cefazolin may be administered intramuscularly or intravenously after reconstitution. The intrathecal administration of cefazolin is not an approved route of administration for this antibiotic; in fact, there have been reports of severe CNS toxicity including seizures when cefazolin was administered in this manner.

Intramuscular administration.

Reconstitute with water for injections or sodium chloride 0.9% injection according to the dilution table (see Table 3). 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. Cefazolin should be injected into a large muscle mass.

Intravenous administration.

Cefazolin 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 500 mg or 1 g Cefazolin-AFT Sodium for injection in 5 mL of water for injections and then dilute to 10 mL. Inject solution slowly over three to five minutes. It may be administered directly into a vein or via the giving line for a patient receiving a compatible IV solution. Cefazolin sodium has been reported to be compatible with the following IV fluids: 0.9% sodium chloride intravenous infusion; 5% or 10% glucose intravenous infusion; 5% glucose and 0.9% sodium chloride injection; lactated Ringer's injection.

Intermittent intravenous infusion.

Cefazolin sodium can be administered along with primary IV fluid management programmes in a volume control set or in a separate, secondary IV infusion bag. Reconstituted 500 mg or 1 g Cefazolin-AFT Sodium for injection may be diluted in 50 to 100 mL of water for injections or a compatible parenteral fluid, and infused over a period of 10 to 15 minutes. If a Y-type administration set is used, it is desirable to discontinue the other solution during the infusion of the solution containing cefazolin sodium.

Continuous intravenous infusion.

The total daily dose of cefazolin, diluted and well mixed with at least 50 mL of water for injections, may be added to an intravenous bottle containing one of the previously listed parenteral fluids. The choice of saline or glucose solution and the volume to be employed are dictated by fluid and electrolyte management.

Stability.

Reconstituted Cefazolin-AFT injection and dilutions of Cefazolin-AFT injection in the recommended IV fluids are stable for 24 hours at room temperature and for 96 hours if stored under refrigeration (5°C). However, to minimise the risk of microbial contamination and growth, the preferred practice is to use the reconstituted product as soon as practical after reconstitution and to discard any remaining residue. If storage of the reconstituted solution is necessary, hold at 2 to 8°C for not more than 24 hours.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Signs and symptoms.

Toxic signs and symptoms following an overdose of cefazolin may include pain, inflammation and phlebitis at the injection site.
The administration of inappropriately large doses of parenteral cephalosporins may 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 may include elevations in creatinine, serum urea, liver enzymes and bilirubin, a positive Coombs' test, thrombocytosis, thrombocytopenia, eosinophilia, leucopenia and prolongation of the prothrombin time.

Treatment.

In managing overdosage, the possibility of multiple drug overdoses, interaction among drugs and unusual drug kinetics should be considered.
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.

7 Medicine Schedule (Poisons Standard)

S4.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cefazolin-AFT powder for injection contains cefazolin sodium as a single ingredient.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Powder: Store below 25 °C. Protect from light.
Reconstituted solution: Store at 2°C to 8°C. Refrigerate. Do not freeze. (Use within 24 hours after initial reconstitution.) To reduce microbiological hazard, use as soon as practicable after dilution. If storage is necessary, hold at 2-8°C for not more than 24 hours. Product is for single use in one patient only. Discard any residue.

6.5 Nature and Contents of Container

This powder for injection is supplied in vials containing cefazolin sodium equivalent to 500 mg and 1 g cefazolin.
Available in packs of 1, 5 and 10 vials.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes