Cefazolin Mip Pharma

Leaflet accompanying the packaging: patient information

Cefazolin MIP Pharma powder for solution for injection / infusion

Cefazolin

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Cefazolin MIP Pharma and what is it 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 packaging and other information

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

The medicine contains the active substance cefazolin, which is an antibiotic. Cefazolin MIP Pharma is used to treat bacterial infections caused by microorganisms sensitive to cefazolin, such as:

• skin and soft tissue infections
• bone and joint infections

Cefazolin may also be used before, during, or after surgery to prevent potential 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 had a severe allergic reaction to any beta-lactam antibiotic (penicillins, monobactams, and carbapenems).

Warnings and precautions

Before starting treatment with Cefazolin MIP Pharma, discuss it with your doctor.

• if the patient has a tendency to allergies (e.g., hay fever or 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 kidney or liver dysfunction.
• if the patient has bleeding disorders (e.g., hemophilia) or is currently at risk of bleeding due to parenteral nutrition, malnutrition, liver dysfunction, or kidney disease, decreased platelet count, which increases the risk of bleeding or bruising (thrombocytopenia), or is taking anticoagulant medications (e.g., heparin).
• if the patient has diseases that cause bleeding (e.g., stomach and duodenal ulcers).
• if the patient experiences severe, persistent diarrhea during or after treatment with Cefazolin MIP Pharma. In such cases, contact a doctor immediately. Do not take medications that slow down bowel movements without consulting a doctor.

Children

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

Cefazolin MIP Pharma and other medicines

Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Be particularly careful when taking the following medicines:

• anticoagulants (blood thinners):Cefazolin may rarely cause bleeding disorders. Therefore, when taking cefazolin and anticoagulants (e.g., heparin) together, be cautious and monitor blood clotting parameters regularly if necessary.
• probenecid(a medicine used to treat joint and gout diseases).
• medicines with potential nephrotoxic effects: Cefazolin may increase the nephrotoxic effects of some antibiotics (e.g., aminoglycosides) and diuretics (e.g., furosemide). When taking Cefazolin MIP Pharma and the above-mentioned medicines together, regularly monitor kidney function, especially in patients with kidney dysfunction.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Cefazolin MIP Pharma has no or negligible influence on the ability to drive and use machines.
The medicine contains 101.6 mg of sodium (the main component of table salt) per vial, which corresponds to 5.1% of the maximum recommended daily sodium intake in the diet for adults.

3. How to use Cefazolin MIP Pharma

Method of administration:

This medicine should always be used as directed by your doctor or pharmacist. If you have any doubts, consult your doctor. The medicine is administered by injection or infusion (into a vein) after prior dissolution. The doctor will decide on the duration and frequency of Cefazolin MIP Pharma administration.

Recommended doses are as follows:

Adult patients with normal kidney function

infections caused by bacteria sensitive to the medicine: 1 to 2 g per day divided into 2 or 3 doses.
infections caused by bacteria less sensitive to the medicine: 3 to 4 g per day divided into 3 or 4 doses.
It is possible to increase the daily dose of cefazolin to 6 g administered in 3 or 4 equal doses.

Use in children and adolescents

Newborns and infants under 1 month:

The safety of the medicine in infants under 1 month has not been established.

Children over 1 month:

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 bacteria less sensitive to the medicine: 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.
Cefazolin should not be used in children under 1 month of age.

Use in elderly patients

No dose adjustment is necessary in elderly patients with normal kidney function.

Special dosage recommendations

Prevention of infections during surgical procedures
1 g of cefazolin 30-60 minutes before the surgical procedure.
In the 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, cefazolin excretion is slowed down. Therefore, the doctor will adjust the dosage according to the degree of renal impairment by reducing the maintenance dose or prolonging the interval between doses.

Duration of treatment

The duration of treatment depends on the severity of the infection and the patient's recovery.

Missing a dose of Cefazolin MIP Pharma

Do not take a double dose to make up for a missed dose. A missed dose should only be taken if the time before the next regular dose is long enough.

Using a higher dose of Cefazolin MIP Pharma than recommended

Symptoms of overdose include headache, dizziness, burning or tingling sensation on the skin (paresthesia), restlessness (irritation), involuntary muscle contractions or muscle group contractions (myoclonus), and seizures. If you experience any of these symptoms, contact your doctor.
In emergency situations, immediate medical attention is required to treat overdose symptoms.

Stopping treatment with Cefazolin MIP Pharma

Small doses, irregular dosing, or premature discontinuation of treatment may affect the outcome of treatment or cause a relapse of the infection, which may be more difficult to treat. Follow your doctor's instructions.
If you have any further doubts about using this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

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

Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms:

Uncommon side effects(may occur in less than 1 in 100 patients):

• redness of the skin (rash), widespread skin rash (erythema multiforme or rash), hives (red, itchy skin rash with blisters) on the skin surface, fever, itching under the skin (angioedema), and (or) swelling of lung tissue with possible cough and difficulty breathing (interstitial pneumonia or pneumonia), as these side effects may indicate an allergic reaction to the medicine.

Rare side effects(may occur in less than 1 in 1000 patients):

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

Very rare side effects(may occur in less than 1 in 10,000 patients):

• severe allergic reaction (anaphylactic shock) with difficulty breathing, throat swelling, face, eyelid, or lip swelling, tachycardia, and blood pressure drop. This reaction may start soon after the first administration of the medicine or later.

Frequency not known(cannot be estimated from the available data):

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

The following side effects may also occur when using products containing cefazolin:

Common side effects, may occur in less than 1 in 10 patients:

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

Uncommon side effects, 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 function disorders.
• vein swelling caused by blood clot formation after intramuscular injection (phlebitis).

Rare side effects, may occur in less than 1 in 1000 patients:

• bacterial or fungal infections of the male or female genital organs with symptoms such as itching, redness, swelling, and discharge (genital candidiasis, thrush, vaginitis).
• increased or decreased blood glucose levels (hyperglycemia or hypoglycemia).
• transient blood disorders, including decreased or increased red or white blood cell count (leukopenia, granulocytopenia, neutropenia, thrombocytopenia, leukocytosis, granulocytosis, monocytosis, lymphocytopenia, basophilia, and eosinophilia), which may cause bleeding, easy bruising, and (or) skin discoloration (confirmed by blood tests).
• dizziness, feeling of fatigue, and general malaise.
• chest pain, excess fluid in the lungs, difficulty breathing, cough, and nasal congestion (rhinitis).
• liver function disorders (such as alkaline phosphatase or transient hepatitis) with symptoms such as increased liver enzyme activity (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyltransferase (gamma GT), and lactate dehydrogenase (LDH)) and bilirubin (a breakdown product of blood cells) in bile or urine (diagnosed by blood tests).
• kidney function disorders (nephrotoxicity, interstitial nephritis, nephropathy of unknown cause, proteinuria) with symptoms such as kidney swelling and increased nitrogen levels in the body, which can be diagnosed by urine tests, usually occurring only in patients taking cefazolin together with other nephrotoxic medicines.

Very rare side effects, may occur in less than 1 in 10,000 patients:

• anal or genital itching.
• blood clotting disorders, which may cause increased bleeding. The above resolves after increasing vitamin K intake, which should be confirmed by blood tests (see section 2).

Frequency not known (frequency cannot be estimated from the available data)

• prolonged or repeated treatment with cefazolin may lead to further fungal or bacterial infections resistant to cefazolin (superinfection)
• sleep disorders, including nightmares and insomnia.
• feeling of nervousness and restlessness, drowsiness, weakness, hot flashes, vision disturbances, dizziness, and seizures (involuntary, rapid, and repeated muscle contractions and relaxations).

If any side effect worsens or if you experience any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. This includes any side effects not listed in this leaflet.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides:
Al. Jerozolimskie 181C,
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of this medicine.

5. How to store Cefazolin MIP Pharma

Keep the medicine out of 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 given month.
Do not store above 30°C. Store the vials in the outer packaging to protect them from light.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Cefazolin MIP Pharma contains

The active substance of the medicine is cefazolin. Each vial contains 2 g of cefazolin (as cefazolin sodium).
Other ingredients: 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 of colorless glass type I, closed with a rubber stopper made of chlorobutyl rubber, sealed with an aluminum flip-off cap, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

MIP Pharma GmbH

Kirkeler Str. 41
66440 Blieskastel
Germany
Phone: +49 (0) 6842 9609 0
Fax: +49 (0) 6842 9609 355

Manufacturer Importer

MIP Pharma GmbH

Kirkeler Str. 41
66440 Blieskastel
Germany

Date of last revision of the leaflet: 01.04.2023

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Information intended for healthcare professionals only:

Method of administration

Cefazolin MIP Pharma for injection and infusion can be administered as a slow intravenous injection or, after dilution, as an intravenous infusion.
In the case of any administration route, refer to the information in the table, which presents additional volumes and concentrations of solutions that may be useful in situations where divided doses are required.
Intravenous injection:
2 g of powder should be dissolved in at least 10 ml of water for injection or in one of the solvents listed below.

Cefazolin should be injected slowly into a vein over 3-5 minutes. Injections lasting less than 3 minutes are contraindicated. Injections should be administered directly into a vein or into a set through which the patient is receiving intravenous solutions.
Single doses greater than 1 g should be administered as an intravenous infusion over 30 to 60 minutes.
Intravenous infusion
2 g of powder should be dissolved in 8 ml of water for injection and diluted with a compatible solvent to a volume of 50-100 ml.

If smaller doses are required, it is recommended to use half of the dissolved solution (about 4 ml from 1 g of cefazolin, i.e., half of the vial content) and add a compatible solvent to the target volume of 100 ml (resulting concentration of about 10 mg/ml). The required amount of such a diluted solution can then be administered to the patient over a specified period.
Compatibility with intravenous fluids
The following solvents are suitable for preparing the solution:

• water for injection
• 9 mg/ml (0.9%) sodium chloride solution
• 50 mg/ml (5%) glucose solution

The dissolved solution is clear, light yellow, and should be protected from light.
Only use clear solutions without contaminants.

Storage after dissolution

Shelf life of the prepared infusion solution
The prepared solution shows chemical and physical stability for 12 hours at 25°C and for 24 hours at 2-8°C. From a microbiological point of view, the prepared solution should be used immediately after preparation. If the solution is not used immediately, the time and conditions of storage after opening are the responsibility of the healthcare professional.
The dissolved product is only suitable for single use. Any unused product or waste material should be disposed of in accordance with local regulations.

Adults with renal impairment

Dosing guidelines for children

The contents of 1 vial (2000 mg of cefazolin) are dissolved in 10 ml of a compatible solvent (i.e., a concentration of about 200 mg/ml). The following table shows the appropriate volume of this solution to be used along with the dose in mg.

Children with renal impairment

Children with renal impairment (like adults) may require lower doses to avoid accumulation of the medicine.
A lower dose can be selected based on blood test results. If this is not possible, the dose can be determined based on creatinine clearance according to the following guidelines.
In children with moderate renal impairment (creatinine clearance 40-20 ml/min), it is sufficient to use 25% of the usual daily dose divided into doses every 12 hours.
In children with severe renal impairment (creatinine clearance 20-5 ml/min), it is sufficient to use 10% of the usual daily dose divided into doses every 24 hours.
All of the above guidelines apply after the initial dose.