Afazol® ( Cefazolin ) 1 g

Afazol®

Cefazolin

Powder for injection 250mg, 500 mg, 1 g

 

Read all of this leaflet carefully before you start taking 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

 

Afazol® is used to treat bacterial infections caused by cefazolin-susceptible bacteria, e.g:

• Infections of skin and soft tissue
• Infections of bones and joints
• Cefazolin can also be used before, during and after surgery to prevent possible infections.

 

Before use this drug, Do not use Cefazolin if you:

• are allergic (hypersensitive) to any cephalosporin antibiotics.
• have ever had a severe allergic (hypersensitive) reaction to any other type of betalactam antibiotic (penicillins, monobactams and carbapenems).

 

Children:

Cefazolin may not be used in newborn infants and infants below the age of 1 month as the safety of use has not yet been established in this group

 

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Cefazolin crosses the placenta and can affect the unborn child. Therefore, if you are pregnant, your doctor should only give you cefazolin if clearly necessary and after careful consideration of benefits and risks. Cefazolin passes in small amounts into breast milk. Therefore, breastfeeding should be discontinued during treatment with Cefazolin.

 

 

Warnings and precautions

Talk to your doctor before using Cefazolin if you

• are prone to allergic reactions (e.g. hay fever or bronchial asthma), since then the risk of severe allergic reactions to Cefazolin is increased.
• have had previously an allergic reaction to other beta-lactam antibiotics (e.g. penicillins), since then there is an increased risk of being allergic to Cefazolin as well.
• suffer from an impaired kidney or liver function.
• suffer from disorders of blood clotting (e.g. haemophilia) or your present condition can lead to such defects (parenteral feeding, malnutrition, liver or kidney diseases, reduction in blood platelets which increases risk of bleeding or bruising (thrombocytopenia), administration of medicines that prevent blood clotting (anticoagulants like heparin)).
• suffer from diseases which can cause bleedings (e.g. gastrointestinal ulcers).
• suffer from severe persistent diarrhoea during or after treatment with Cefazolin. In this case contact your doctor immediately. Do not take any anti-diarrhoea medicine without consulting your doctor
• you are on a low-sodium (low salt) diet. This medicinal product contains 48 mg sodium per gram.
• if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Includes:
• Anticoagulants (medicines that prevent blood clotting): Cefazolin may very rarely lead to disorders of blood clotting. Therefore, if you simultaneously receive cefazolin and medicines that prevent blood clotting (e. g. heparin), a careful and regular control of the coagulation factors is necessary.
• Probenecid (medicine for the treatment of joint disease and gout).
• Medicines potentially harmful to kidney: Cefazolin may intensify the harmful effect of certain antibiotics (aminoglycosides) and of medicines that cause increase in urination (diuretics, e.g. furosemide) on the kidney. Using Cefazolin and one of these medicines at the same time requires regular monitoring of the kidney function, especially in patients with kidney disease.

 

Driving and using machines

Cefazolin has no or negligible influence on the ability to drive and use machines.

 

Medical Tests

If you are diabetic or need to have your blood glucose level monitored you should not use certain blood glucose monitoring systems which may estimate blood glucose incorrectly while you are receiving cefazolin. If you use such systems check the instructions for use and tell your doctor, pharmacist or nurse.

Alternative testing methods should be used if necessary.

 

Method of administration

• Intramuscular administration

250mg or 500mg cefazolin should be dissolved in 2ml of Sterile Water for Injection.

1g cefazolin should be dissolved in 2.5ml of Sterile Water for Injection.

• Intravenous administration

Following reconstitution according to the above. further dilute vials with approximately 5 mL or 10 mL Sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids

• For i.v. infusion

Dilute reconstituted Cefazolin for Injection in 50 to 100 mL of one of the following solutions: Sodium Chloride %9 Injection or 5% Dextrose Injection.

 

The recommended dose

The medicine should be taken for the prescribed number of days.

Your doctor will decide the correct dose of Cefazolin for injection for you. The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working. The number of days or weeks that you are given Cefazolin for injection depends on what sort of infection you have. The recommended doses are:

 

Adult patients with normal kidney function

• Infections caused by bacteria susceptible to this medicine: 1-2 g daily, divided into 2-3 doses.
• Infections caused by bacteria less susceptible to this medicine: 3-4 g daily, divided into 3-4 doses.

An increase of the daily dose up to 6 g in three or four equal doses is possible.

 

Use in children and adolescents

Newborn infants and infants below the age of one month:

The safety in infants below the age of one month has not been determined

 

 

Children over the age of one month:

• Infections caused by bacteria susceptible to this medicine: 25 – 50 mg per kg body weight per day divided in 2-4 single doses, every 6, 8 or 12 hours.
• Infections caused by bacteria less susceptible to this medicine: Up to 100 mg cefazolin/kg body weight/day divided in 3-4 single doses, every 6-8 hours.

This product is not recommended for children under 1 month of life.

 

Elderly patients

No dosage adjustment is required for elderly patients with normal renal function.

 

Prevention of infections during surgical procedures

1 g cefazolin 30 – 60 minutes before surgery. In case of long surgical procedures (2 hours or more), additional 0.5 g – 1 g cefazolin during the operation.

 

People with liver and kidney problems

In patients with impairment of the kidney function, the elimination of cefazolin is slower. For this reason, your doctor will adjust the dosage according to the severity of the kidney impairment by reducing the maintenance dose or prolongation of the dosage intervals.

 

If you are given more Cefazolin for injection than you should

Symptoms of overdose are headache, dizziness (vertigo), sensation of pricking or tingling on the skin (paraesthesia), restlessness (agitation), involuntary twitching of a muscle or a group of muscles (myoclonia) and cramps (convulsions). Contact your physician if these symptoms occur! In emergencies, your physician must take the necessary measures for the treatment of symptoms of overdose.

 

If you forget to use Cefazolin for injection

A double dose must not be given to make up for a forgotten dose. A forgotten dose should only be given before the next regular dose if the time until the next regular dose is long enough.

 

If you stop using Cefazolin for injection

Do not stop taking Cefazolin for injection unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor or nurse.

 

Adverse reactions

Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

You must stop taking the medicine and speak to your doctor straight away if you notice any of these symptoms:

Common side effects, occurring in 1 to 10 out of 100 treated patients:

• mild gastrointestinal disturbances ( loss of appetite, diarrhoea, nausea, vomiting, severe and frequent diarrhoea). These side effects usually resolve after a few days.
• injection into the muscle may cause pain at the location of the injection which may sometimes include hardening of the skin and soft tissue at the same site.

 

Uncommon side effects, occurring in 1 to 10 out of 1,000 treated patients:

• oral thrush (thick white or cream-coloured deposits in the mouth and tongue).
• fits/convulsions in patients with kidney problems.
• swelling of a vein caused by a blood clot forming following injection into the muscle (thrombophlebitis).

 

Rare side effects, occurring in 1 to 10 out of 10,000 treated patients:

• bacterial infection of male or female genitals with symptoms such as itching, redness, swelling and female discharge (genital candidasis, monoliasis, vaginitis).
• increase or decrease in blood glucose concentration (hyperglycemia or hypoglycemia).
• reversible blood abnormalities including the reduction or increase in the number of red and white blood cells (leukopenia, granulocytopenia, neutropenia, thrombocytopenia, leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia and eosinophilia) which may cause bleeding, easy bruising and/or skin discolouration (confirmed by blood test).
• feelings of dizziness, tiredness and a general feeling of being unwell.
• chest pain, excess fluid in the lungs, shortness of breath, cough, stuffy nose (rhinitis).
• liver problems (such as alkaline phosphatise or transient hepatitis) with symptoms such as an increase in liver enzymes (alanine transaminase (ALT), aspartate transaminase (AST), gammaglutamyl transpeptidase (gamma GT) and lactate dehydrogenase (LDH)) and bilrubin (a product of the breakdown of blood cells) in bile or urine (diagnosed by blood test).
• kidney problems (nephrotoxicity, interstitial nephritis, undefined nephropathy, proteinuria) with symptoms such as kidney swelling and an increase of nitrogen in the body that may be diagnosed by urine tests, usually only occurring in patients taking cefazolin at the same time as other medicines that can cause kidney problems.

 

Very rare side effects, occurring in less than 1 out of 10,000 treated patients:

• itching of the anus or genitalia (pruritus).
• blood not clotting properly which may result in increased bleeding. This may be resolved by increasing vitamin K intake and should be confirmed by blood test

 

Side effects with unknown frequency

• long-term or repeated treatment with Cefazolin may lead to further infection by Cefazolin resistant fungi or bacteria (superinfection).
• sleep disorders including nightmares and being unable to sleep (insomnia).
• feelings of nervousness or anxiety, drowsiness, weakness, hot flushes, disturbed colour vision, vertigo and epileptic seizures (involuntary rapid and repeated muscle contraction and relaxation).

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not listed in this leaflet.

 

Special precautions for storage

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date that is stated on the outer carton and the label after ”EXP“. The expiry date refers to the last day of that month.
• Do not store above 30°C. Keep the vial in the outer carton in order to protect from light.
• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment

Afazol®

Each vial contains:

Cefazolin (as sodium) 250 mg, 500 mg, 1 g

Manufacture by Afa chemie pharmaceutical co. Tehran-Iran.