Cefazolin mip pharma

Patient Information Leaflet

Cefazolin MIP Pharma powder for solution for injection / infusion
Cefazolinum
Please read this leaflet carefully before using this medicine, as it contains important information for you.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Cefazolin MIP Pharma is and what it is used for
2. Important information before using Cefazolin MIP Pharma
3. How to use Cefazolin MIP Pharma
4. Possible side effects
5. How to store Cefazolin MIP Pharma
6. Contents of the pack and other information

1. What Cefazolin MIP Pharma is and what it is used for

This medicine contains the active substance cefazolin, which is an antibiotic. Cefazolin MIP Pharma is used
in the treatment of bacterial infections caused by microorganisms sensitive to cefazolin, for example:

• skin and soft tissue infections
• bone and joint infections

Cefazolin may also be used before, during, or after surgery to prevent possible infections.

2. Important information before using Cefazolin MIP Pharma

When not to use Cefazolin MIP Pharma

• if the patient is allergic to any cephalosporin.
• if the patient has ever experienced a severe allergic reaction to any beta-lactam antibiotic (penicillins, monobactams, and carbapenems).

Warning and precautions
Before starting treatment with Cefazolin MIP Pharma, discuss this with your doctor.

• if the patient has a tendency towards allergies (e.g. hay fever or bronchial asthma), the risk of severe allergic reactions to Cefazolin MIP Pharma increases.
• if the patient has previously been diagnosed with hypersensitivity to beta-lactam antibiotics (e.g. penicillins), there is also a risk of allergy to Cefazolin MIP Pharma.
• if the patient has been diagnosed with impaired kidney or liver function.
• if the patient has been diagnosed with blood clotting disorders (e.g. haemophilia) or if the patient may currently have blood clotting disorders due to parenteral nutrition, malnutrition, impaired liver or kidney function, low platelet count (thrombocytopenia), which increases the risk of bleeding or bruising, or due to the use of anticoagulant drugs (e.g. heparin).
• if the patient has been diagnosed with conditions causing bleeding (e.g. gastric or duodenal ulcers).
• if the patient has experienced severe, persistent diarrhoea during or after treatment with Cefazolin MIP Pharma. In such a case, contact your doctor immediately. Do not take drugs that inhibit intestinal peristalsis without consulting your doctor.

Children

• Cefazolin should not be used in newborns and infants under 1 month of age, as the safety of the drug has not been established in this age group.

Cefazolin MIP Pharma and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Particular attention should be paid when using the following medicines concurrently:

• anticoagulants (drugs preventing blood clotting): Cefazolin may very rarely cause blood clotting disorders. Therefore, when cefazolin is used concomitantly with drugs that prevent blood clotting (e.g. heparin), caution is required and, if necessary, regular monitoring of coagulation parameters should be performed.
• probenecid (a drug used in the treatment of joint disease and gout).
• drugs with potentially harmful effects on the kidneys: Cefazolin may enhance the nephrotoxic effects of certain antibiotics (e.g. aminoglycosides) and diuretics (e.g. furosemide). When Cefazolin MIP Pharma is used concomitantly with the above-mentioned drugs, kidney function should be monitored regularly, especially in patients with impaired renal function.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Cefazolin crosses the placental barrier and may affect the unborn child. Therefore, cefazolin may be used during pregnancy only if absolutely necessary and after careful consideration by the doctor of the benefit-risk ratio.
Cefazolin passes into breast milk in small amounts. Therefore, breastfeeding should be discontinued during treatment with Cefazolin MIP Pharma.

Driving and operating machinery
Cefazolin MIP Pharma has no effect or has a negligible effect on the ability to drive vehicles and operate machinery.

The medicine contains 101.6 mg of sodium (the main component of table salt) in each vial. This corresponds to 5.1% of the maximum recommended daily dietary sodium intake for adults.

3. How to use Cefazolin MIP Pharma

Method of administration:
This medicine should always be used as directed by a physician or pharmacist. If in doubt, consult your
physician. The medicine is administered as an injection or infusion (into a vein) after prior dissolution. The
physician will determine the duration and frequency of administration of Cefazolin MIP Pharma.
Recommended doses are as follows:
Adult patients with normal renal function
infections caused by bacteria sensitive to the medicine: 1 to 2 g per day divided into 2 or 3 doses.
infections caused by less sensitive bacteria: 3 to 4 g per day divided into 3 or 4 doses.
The daily dose of cefazolin may be increased up to 6 g given in 3 or 4 equal doses.
Use in children and adolescents
Newborns and infants below 1 month of age:
The safety of using the medicine has not been established in infants below 1 month of age.
Children above 1 month of age:
infections caused by bacteria sensitive to the medicine: 25 to 50 mg per kg of body weight per day divided
into 2 to 4 single doses every 6, 8 or 12 hours.
infections caused by less sensitive bacteria: up to 100 mg of cefazolin per kg of body weight per day
divided into 3 or 4 single doses every 6 to 8 hours.
Use of the medicine is not recommended in children below 1 month of age.
Use in elderly patients
Dosage adjustment is not necessary in elderly patients with normal renal function.
Special dosage recommendations
Prevention of infections during surgical procedures
1 g of cefazolin 30–60 minutes before surgery.
In case of prolonged operations (2 hours or longer), an additional dose of 0.5 to 1 g of cefazolin during
the procedure.
Patients with renal impairment
In patients with renal impairment, elimination of cefazolin is slowed. Therefore, the physician will adjust
the dosage according to the degree of renal impairment by reducing the maintenance dose or extending
the interval between doses.
Duration of treatment
The duration of treatment depends on the severity of the infection and the patient's recovery.
Missed dose of Cefazolin MIP Pharma
Do not administer a double dose to make up for a missed dose. A missed dose should only be administered
if there is sufficient time before the next scheduled dose.
Administration of a higher than recommended dose of Cefazolin MIP Pharma
Symptoms of overdose include headache, dizziness, skin burning or prickling sensation (paresthesia),
restlessness (irritability), involuntary muscle jerks or muscle group contractions (myoclonus), and seizures.
If any of these symptoms occur, contact your physician.
In emergency cases, immediate medical assistance is required to treat symptoms of overdose.
Discontinuation of Cefazolin MIP Pharma
Small doses, irregular dosing, or premature discontinuation of treatment may affect treatment outcome or
cause recurrence of infection, which may be significantly more difficult to treat. Follow your physician's
instructions.
If you have any further questions regarding the use of this medicine, consult your physician, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
You should stop taking the medicine immediately and contact your doctor if any of the following symptoms occur:

Uncommon adverse reactions (may occur in less than 1 in 100 patients):

• skin redness (erythema), extensive skin rash (erythema multiforme or rash), urticaria (red, itchy skin rash with wheals), fever, subcutaneous itching (angioedema) and/or lung tissue swelling with possible cough and breathing difficulties (interstitial pneumonia or pneumonia), as these adverse reactions may indicate an allergic reaction to the medicine.

Rare adverse reactions (may occur in less than 1 in 1000 patients):

• jaundice (yellowing of the skin and whites of the eyes)
• severe skin reactions with hot flushes, fever, blisters or ulcers (Stevens-Johnson syndrome), or severe rash with redness, skin peeling and swelling resembling burns (toxic epidermal necrolysis).

Very rare adverse reactions (may occur in less than 1 in 10,000 patients):

• severe allergic reaction (anaphylactic shock) with breathing difficulties, swelling of the throat, face, eyelids or lips, tachycardia and drop in blood pressure. This reaction may start shortly after the first dose of the medicine or later.

Frequency unknown (cannot be estimated from available data):

• severe and frequent diarrhoea, sometimes with blood, as this may be a sign of a more serious condition (pseudomembranous colitis).

The following adverse reactions may also occur during treatment with products containing
cefazolin:

Common adverse reactions, may occur in less than 1 in 10 patients:

• mild gastrointestinal disturbances (loss of appetite, diarrhoea, nausea, vomiting, severe and frequent diarrhoea). These symptoms usually resolve within a few days.
• intramuscular injection may cause pain at the injection site, sometimes accompanied by hardening of the skin and soft tissue at the site.

Uncommon adverse reactions, may occur in less than 1 in 100 patients:

• oral thrush (thick, white or creamy coating in the mouth and on the tongue).
• seizures or convulsions in patients with kidney dysfunction.
• vein swelling due to thrombus formation after intramuscular injection (thrombophlebitis).

Rare adverse reactions, may occur in less than 1 in 1000 patients:

• bacterial infection of male or female genital organs with symptoms such as itching, redness, swelling and discharge (genital candidiasis, yeast infection, vaginitis).
• increased or decreased blood glucose levels (hyperglycaemia or hypoglycaemia).
• transient blood disorders involving decreased or increased numbers of red or white blood cells (leukopenia, granulocytopenia, neutropenia, thrombocytopenia, leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia and eosinophilia), which may cause bleeding, easy bruising and/or skin discoloration (confirmed by blood test).
• dizziness, feeling of fatigue and general malaise.
• chest pain, fluid accumulation in the lungs, breathing difficulties, cough, nasal congestion (rhinitis).
• liver function disorders (such as alkaline phosphatase increase or transient hepatitis) with symptoms such as increased liver enzyme activity (alanine aminotransferase (AlAT), aspartate aminotransferase (AspAT), gamma-glutamyl transferase (gamma GT) and lactate dehydrogenase (LDH)) and bilirubin (a breakdown product of blood cells) in bile or urine (diagnosed in blood tests).
• kidney function disorders (nephrotoxicity, interstitial nephritis, nephropathy of undefined cause, proteinuria) with symptoms such as kidney swelling and increased nitrogen concentration in the body, detectable in urine tests, usually occurring only in patients receiving cefazolin simultaneously with other nephrotoxic drugs.

Very rare adverse reactions, may occur in less than 1 in 10,000 patients:

• itching of the anus or genital organs.
• blood coagulation disorders, which may lead to increased bleeding. The above resolves with increased vitamin K intake, which should be confirmed by blood tests (see section 2).

Frequency unknown (frequency cannot be estimated from available data):

• prolonged or repeated treatment with cefazolin may lead to further infection with fungi or bacteria resistant to cefazolin (superinfection).
• sleep disorders, including nightmares and inability to sleep (insomnia).
• feelings of nervousness and anxiety, drowsiness, weakness, hot flushes, colour vision disturbances, dizziness and seizures (involuntary, rapid and repetitive muscle contractions and relaxations).

If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor, pharmacist or nurse. This applies to any adverse reactions not mentioned in this leaflet.

Reporting of adverse reactions

If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:

Al. Jerozolimskie 181C,
02-222 Warszawa
Tel: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cefazolin MIP Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer packaging and
label after "Expiry date". The expiry date refers to the last day of the indicated month.
Do not store above 30 °C. Store the vials in the original outer packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Cefazolin MIP Pharma contains
The active substance is cefazolin. Each vial contains 2 g of cefazolin (as cefazolin sodium).
Other components: none.

What Cefazolin MIP Pharma looks like and contents of the pack
White or almost white powder.
Cefazolin MIP Pharma is available in packs containing 1, 5 or 10 vials made of colourless type I glass, closed with a chlorobutyl rubber stopper, sealed with an aluminium flip-off cap, and placed in a cardboard box. Not all pack sizes may be marketed.

Marketing Authorisation Holder Manufacturer Importer
MIP Pharma GmbH MIP Pharma GmbH
Kirkeler Str. 41 Mühlstraße 50
66440 Blieskastel 66386 St. Ingbert
Germany Germany
Tel.: +49 (0) 6842 9609 0
Faks: +49 (0) 6842 9609 355

Information intended exclusively for healthcare professionals:

Method of administration
Cefazolin MIP Pharma for injections and infusions can be administered as a slow intravenous injection or, after dilution, as an intravenous infusion.
For each route of administration, refer to the table below providing additional solution volumes and concentrations that may be useful when divided doses are required.
Intravenous injection:
2 g of powder should be dissolved in at least 10 ml of water for injections or in one of the following solvents.
Table containing data necessary for dissolving the powder for intravenous injection

Cefazolin should be administered intravenously slowly over 3–5 minutes. Injections lasting less than 3 minutes are contraindicated. The injection should be given directly into a vein or into an intravenous infusion set being used for intravenous solutions in the patient.
Single doses exceeding 1 g should be administered by intravenous infusion over 30 to 60 minutes.
Intravenous infusion
2 g of powder should be dissolved in 8 ml of water for injections and further diluted with a compatible solvent to a final volume of 50–100 ml.
Table containing data necessary for dissolving the powder in the case of intravenous infusion

If lower doses are required, it is recommended to use half of the reconstituted solution (approximately 4 ml from 1 g of cefazolin, i.e. half the vial contents) and add a compatible diluent to a final volume of 100 ml (resulting in a concentration of approximately 10 mg/ml). The required amount of this diluted solution can then be administered to the patient over a specified period of time.
Compatibility with intravenous fluids
The following diluents are suitable for preparing the solution:

• Water for injections
• 9 mg/ml (0.9%) sodium chloride solution (normal saline)
• 50 mg/ml (5%) glucose solution

The reconstituted solution is clear, light yellow, and should be protected from light.
Only clear solutions without particulate matter or discoloration should be used.
Storage after reconstitution
Shelf life of the prepared infusion solution
The prepared solution is chemically and physically stable for 12 hours at 25°C and for 24 hours at 2–8°C. From a microbiological standpoint, the solution should be used immediately after preparation. If not used immediately, the responsibility for storage conditions and duration after opening lies with the person preparing the solution.
The reconstituted product is intended for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.
Adults with renal impairment

Paediatric dosing guidelines
The contents of 1 vial (2000 mg cefazolin) should be dissolved in 10 ml of a compatible solvent (i.e. concentration of approximately 200 mg/ml). The appropriate volume of this solution to be used, together with the dose in mg, is shown in the table below.
The medicinal product may also be administered by intravenous infusion using the diluted solution (10 mg/ml) prepared as described above.

Children with renal impairment
Children with renal impairment (similar to adults) may require a lower dose to avoid drug accumulation.
The lower dose can be determined based on blood test results. If this is not possible, the dose can be established according to creatinine clearance following the guidelines below.
In children with moderate renal impairment (creatinine clearance 40–20 mL/min), administration of 25% of the usual daily dose, divided into doses every 12 hours, is sufficient.
In children with severe renal impairment (creatinine clearance 20–5 mL/min), administration of 10% of the usual daily dose, divided into doses every 24 hours, is sufficient.
All the above guidelines apply after the initial dose.