This medicine contains the active substance cefazolin, which is an antibiotic. Zolecin is used to treat bacterial infections caused by cefazolin-susceptible bacteria, e.g:

• Infections of skin and soft tissue
• Infections of bones and joints

Zolecin can also be used before, during and after surgery to prevent possible infections.

Do not use Zolecin

• If you are allergic to cefazolin or any of the other ingredients of this medicine (listed in section 6).
• If you are allergic (hypersensitive) to any cephalosporin antibiotics.
• Have ever had a severe allergic (hypersensitive) reaction to any other type of beta lactam antibiotic (penicillins, monobactams and carbapenems).

Warning and precautions
Talk to your doctor or pharmacist before using Zolecin if you:

• Are prone to allergic reactions (e.g. hay fever or bronchial asthma), since then the risk of severe allergic reactions to Zolecin 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 Zolecin 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 Zolecin. In this case contact your doctor immediately.

Do not take any anti-diarrhoea medicine without consulting your doctor.

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.

Other medicines and Zolecin
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines available without prescription.

Your doctor will take special care if you are using any of the following medicines:

• 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.

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 or pharmacist for advice before taking this medicine.

Pregnancy
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.

Breast-feeding
Cefazolin passes in small amounts into breast milk. Therefore, breastfeeding should be discontinued during treatment with cefazolin.

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

Zolecin contains sodium
Zolecin contains sodium. Each vial of Zolecin 1000 mg Powder for Solution for Injection/Infusion contains 50.6 mg sodium (main component of cooking/table salt). This is equivalent to 2.53% of the maximum daily dietary intake of sodium for an adult

Administration
Zolecin is always administered by healthcare personnel. It will be given as an injection or infusion (into a vein) after being dissolved, or into a muscle (intramuscularly) as a deep IM injection. Your doctor will inform you about the necessary duration and frequency of administration of Zolecin.

The recommended doses are:
Adult patients with normal kidney function

• Infections caused by bacteria susceptible to this medicine: 1000 – 2000 mg daily, divided into 2 – 3 doses.
• Infections caused by bacteria less susceptible to this medicine: 3000 – 4000 mg daily, divided into 3 – 4 doses.

An increase of the daily dose up to 6000 mg in three or four equal doses is possible.

Use in children and adolescents
Prematures 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/kg body weight/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/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.

Special dosage recommendations
Prevention of infections during surgical procedures
1000 mg Zolecin 30 - 60 minutes before surgery.

In case of long surgical procedures (2 hours or more), additional 500 mg - 1000 mg cefazolin during the operation.

Patients with impaired kidney function
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.

Duration of treatment
The treatment duration depends on the severity of the infection as well as on your recovery from your illness.

If you are given more Zolecin than you should
Since the medicine will be given to you by a doctor or nurse, it is unlikely that you will be given too much.

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). If these symptoms occur talk to your doctor immediately.

In emergencies, your physician must take the necessary measures for the treatment of symptoms of overdose.

If you miss a dose of Zolecin
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 the treatment with Zolecin is interrupted or discontinued too early
Low dosage, irregular administration or stopping the treatment too early can compromise the outcome of the therapy or lead to a relapse, that is more difficult to treat. Please follow the instructions of your doctor.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

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:
Uncommon: may affect up to 1 in 100 people

• Redness of the skin (erythema), widespread skin rash (erythema multiforme or exanthema), hives (red, itchy, bumpy skin rash) on the surface of the skin (urticaria), fever, swelling beneath the skin (angioedema) and/or swelling of the lung tissue possibly with a cough and breathing difficulties (interstitial pneumonia or pneumonitis), as these side effects may indicate an allergic reaction to this medicine.

Rare: may affect up to 1 in 1,000 people

•  Jaundice (yellow colour in the skin and whites of the eyes)
• Severe skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis).

Very rare: may affect up to 1 in 10,000 people

• A severe allergic reaction (anaphylactic shock) with breathing difficulty, swelling of the throat, face, eyelids or lips, increased heart rate and falling blood pressure. This reaction may start soon after you first take the medicine, or it might start later.

The following side effect has been reported but its frequency of occurrence is unknown:

• Severe and frequent diarrhoea, sometimes containing blood, as this may indicate a more serious condition (pseudomembranous colitis).

The following side effects may also occur during the use of cefazolin containing products:
Common: may affect up to 1 in 10 people

• 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: may affect up to 1 in 100 people

• 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: may affect up to 1 in 1000 people

• Bacterial infection of male or female genitals with symptoms such as itching, redness, swelling and female discharge (genital candidiasis, monoliasis, vaginitis).
• Increase or decrease in blood glucose concentration (hyperglycaemia or hypoglycaemia).
• 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 transient elevation of alkaline phosphatase or transient hepatitis) with symptoms such as an increase in liver enzymes (alanine transaminase (ALT), aspartate transaminase (AST), gamma glutamyl transpeptidase (gamma GT) and lactate dehydrogenase (LDH)) and bilirubin (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: may affect up to 1 in 10,000 people

• 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 (see section 2).
• 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).

Not known: frequency cannot be estimated from the available data

• Long-term or repeated treatment with cefazolin may lead to further infection by cefazolin resistant fungi or bacteria (superinfection).

Keep this medicine out of the sight and reach of children.

Store below 30°C.

Store in the original package in order to protect from light.

After reconstitution/dilution:
Chemical and physical stability has been demonstrated for 12 hours at 25°C and for up to 24 hours in a refrigerator (2–8°C).

From a microbiological point of view, unless the method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than the times stated above for the chemical and physical in-use stability.

Do not use this medicine after the expiry date which is stated on the package after “EXP”. The expiry date refers to the last day of that month.

Do not use this medicine if you notice any visible signs of deterioration.

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.