CEFAZOLIN 2 g Powder

Contents of the leaflet

1. PATIENT INFORMATION LEAFLET
2. Leaflet accompanying the packaging: patient information
3. Cefazolin Dali Pharma, 2 g, powder for solution for infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet
4. What Cefazolin Dali Pharma is and what it is used for
5. Important information before using Cefazolin Dali Pharma
   1. When not to use Cefazolin Dali Pharma
   2. Warnings and precautions
   3. Children
   4. Cefazolin Dali Pharma and other medicines
   5. Pregnancy, breastfeeding, and fertility
   6. Driving and using machines
   7. Cefazolin Dali Pharma contains sodium
6. How to use Cefazolin Dali Pharma
   1. Recommended dose
   2. Adults and adolescents (over 12 years old and weighing ≥ 40 kg)
   3. Use in children and adolescents
   4. Premature infants and newborns under 1 month old
   5. Children over 1 month old
   6. Use in elderly patients
   7. Special dosage recommendations
   8. Duration of treatment
   9. Using a higher dose of Cefazolin Dali Pharma than recommended
   10. Missing a dose of Cefazolin Dali Pharma
   11. Stopping or prematurely ending treatment with Cefazolin Dali Pharma
7. Possible side effects
   1. Stop taking the medicine and contact your doctor immediately if you experience any of the following symptoms:
   2. The following side effects may also occur when using products containing cefazolin:
   3. Reporting side effects
8. How to store Cefazolin Dali Pharma
9. Contents of the packaging and other information
   1. What Cefazolin Dali Pharma 2 g contains
   2. What Cefazolin Dali Pharma 2 g looks like and what the packaging contains
   3. Marketing authorization holder:
   4. Importer:
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   7. Date of last revision of the leaflet:
   8. Information intended for healthcare professionals only:
   9. DOSAGE GUIDELINES FOR CHILDREN
   10. Dosage in children
   11. INCOMPATIBILITIES
   12. INSTRUCTIONS FOR DISPOSAL OF THE MEDICINAL PRODUCT
   13. PREPARATION OF THE SOLUTION
   14. Instructions for reconstitution and (or) dilution:
   15. Intravenous infusion
   16. SPECIAL PRECAUTIONS FOR STORAGE

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: patient information

Cefazolin Dali Pharma, 2 g, powder for solution for infusion

Cefazolin

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

• Keep this leaflet, so you can read it again if you need to.
• 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 tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Cefazolin Dali Pharma contains the active substance cefazolin (as cefazolin sodium).
Cefazolin is an antibiotic belonging to the group of cephalosporins, which have a bactericidal effect.
Cefazolin Dali Pharma is used to treat bacterial infections caused by bacteria sensitive to cefazolin. Cefazolin Dali Pharma is used to treat the following infections:

• Skin and soft tissue infections
• Bone and joint infections

Cefazolin Dali Pharma is also used before, during, or after surgery to prevent infections in patients.

2. Important information before using Cefazolin Dali Pharma

When not to use Cefazolin Dali Pharma

• If the patient is allergic to cefazolin sodium
• If the patient is allergic to any cephalosporin
• If the patient has had a severe allergic reaction (hypersensitivity) to any beta-lactam antibiotic (penicillins, monobactams, and carbapenems) in the past

Warnings and precautions

Before starting treatment with Cefazolin Dali Pharma, discuss it with your doctor or pharmacist

• if the patient has a tendency to allergies (e.g., hay fever or asthma), as the risk of severe allergic reactions to Cefazolin Dali Pharma is higher.
• if the patient has had an allergic reaction to other beta-lactam antibiotics (e.g., penicillins) in the past, as the risk of an allergic reaction to Cefazolin Dali Pharma is higher (see section 4).
• if the patient has kidney or liver function disorders.
• if the patient has bleeding disorders (e.g., hemophilia) or if the patient is currently at risk of bleeding disorders [due to parenteral nutrition, malnutrition, liver or kidney function disorders, decreased platelet count, which increases the risk of bleeding or bruising (thrombocytopenia), or the use of 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 Dali Pharma (see section 4). In such cases, contact your doctor immediately. Do not take medications that suppress intestinal motility without consulting your doctor.
• if the patient has hypertension, consider the sodium content in Cefazolin Dali Pharma

Cefazolin Dali Pharma must not be administered into the spinal canal (intrathecally), as severe central nervous system toxicity (including seizures) has been reported.
Prolonged use of Cefazolin Dali Pharma may cause superinfections. Your doctor will then prescribe appropriate treatment.
Cefazolin Dali Pharma may give false-positive results in some laboratory tests.

Children

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

Cefazolin Dali 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. This includes medicines available without a prescription.
Pay special attention if you are taking any of the following medicines:

• Antibiotics that inhibit bacterial growth, such as tetracyclines, sulfonamides, erythromycin, and chloramphenicol.
• Probenecid (used to treat joint disease and gout), as the level of cefazolin in the patient's blood may increase.
• Anticoagulant medications (medicines that prevent blood clotting, such as warfarin or heparin), as their concurrent use with cephalosporins may rarely lead to coagulation disorders. Therefore, during concurrent use of cefazolin and anticoagulant medications, coagulation should be monitored.
• Certain diuretics (e.g., furosemide), as their concurrent use with cefazolin may increase the toxic effect on the kidneys. Kidney function should be monitored during concurrent use of cefazolin and these types of medications.
• Medicines that are potentially toxic to the kidneys. Cefazolin may increase the toxic effect on the kidneys of certain antibiotics (aminoglycosides) and diuretics (e.g., furosemide). Concurrent use of Cefazolin Dali Pharma and one of the above-mentioned medicines requires regular monitoring of kidney function, especially in patients with kidney function disorders.
• Oral contraceptives (birth control pills), as antibiotics reduce their effectiveness.

Cephalosporins like cefazolin may interfere with the conversion and utilization of vitamin K1 in the body, especially in patients with vitamin K1 deficiencies. During treatment with Cefazolin Dali Pharma, your doctor may recommend vitamin K1 supplementation.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, consult your doctor before using this medicine.
Pregnancy
Cefazolin crosses the placental barrier and may affect the unborn child. Therefore, cefazolin should only be used during pregnancy if it is absolutely necessary and after careful consideration by your doctor of the benefit-to-risk ratio.
Breastfeeding
Cefazolin passes into human milk in small amounts. Therefore, breastfeeding should be discontinued during treatment with Cefazolin Dali Pharma.
Fertility
In animal studies, no effect on fertility has been observed.

Driving and using machines

Cefazolin has no influence or negligible influence on the ability to drive and use machines. However, during treatment, side effects (e.g., allergic reactions, non-systemic dizziness) may occur that can affect these activities (see also section 4).

Cefazolin Dali Pharma contains sodium

Cefazolin Dali Pharma contains 101.2 mg of sodium (the main component of table salt) per 2 g dose.
This corresponds to 5.1% of the maximum recommended daily sodium intake in the diet for adults. This should be taken into account in patients on a sodium-restricted diet.

3. How to use Cefazolin Dali Pharma

This medicine should be administered to the patient by a qualified person, i.e., a doctor or nurse. This medicine should always be used as directed by your doctor. In case of doubts, consult your doctor.
Cefazolin Dali Pharma 2 g, after reconstitution, is administered intravenously in the form of an infusion. Your doctor will inform you about the required duration of treatment and the frequency of Cefazolin Dali Pharma administration.

Recommended dose

The recommended dose of Cefazolin Dali Pharma is determined by your doctor based on the severity of the infection, body weight, and age, as well as kidney function.

Adults and adolescents (over 12 years old and weighing ≥ 40 kg)

• Infections caused by bacteria sensitive to the medicine: 1 to 2 g per day divided into 2-3 equal doses (1 dose every 8 or 12 hours).
• Infections caused by bacteria less sensitive to the medicine: 3 to 4 g per day divided into 3-4 equal doses (1 dose every 6 or 8 hours).
• The daily dose of cefazolin can be increased to 6 g divided into 3 or 4 equal doses (1 dose every 6 or 8 hours).

Use in children and adolescents

Premature infants and newborns under 1 month old

The safety of the medicine in premature infants and newborns under 1 month old has not been established.

Children over 1 month old

• Infections caused by bacteria sensitive to the medicine: 25-50 mg/kg body weight per day divided into 2-4 equal doses (1 dose every 6, 8, or 12 hours).
• Infections caused by bacteria less sensitive to the medicine: up to 100 mg of cefazolin per kg body weight per day divided into 3 or 4 equal doses (1 dose every 6 or 8 hours).

Use in elderly patients

Dose adjustment is not necessary in elderly patients with normal kidney function

Special dosage recommendations

Surgical prophylaxis
1 g of cefazolin 30-60 minutes before surgery. In cases of prolonged operations (2 hours or longer), an additional dose of 0.5-1 g of cefazolin during surgery.
Patients with renal impairment
In patients with renal impairment, cefazolin excretion is slowed down. Therefore, your 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.

Using a higher dose of Cefazolin Dali Pharma than recommended

Contact your doctor or nurse immediately if you think you have been given a higher dose than recommended.
Since the medicine is administered by a doctor or nurse, it is unlikely that the patient will be given a higher dose than recommended. Symptoms of overdose include systemic dizziness, feeling of pricking, itching, or tingling without an apparent cause (paresthesia) and (or) headache.
In patients with kidney disease, seizures may occur. Contact your doctor immediately if you experience any of the above symptoms! In emergency cases, immediate medical attention is required to treat overdose symptoms.

Missing a dose of Cefazolin Dali Pharma

Contact your doctor immediately if you think you have missed a dose of the medicine.
Missed doses should still be administered. Do not take a double dose to make up for a missed dose. Missed doses should only be administered if the time before the next regular dose is long enough.

Stopping or prematurely ending treatment with Cefazolin Dali Pharma

Small doses of the medicine, irregular dosing, or premature termination of treatment may affect the treatment outcome or cause a relapse of the infection, which is more difficult to treat. Follow your doctor's instructions.
In case of any further doubts related to the use of this medicine, consult your doctor.

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:

Uncommonside effects (may occur in less than 1 in 100 patients, but more than 1 in 1,000 patients):

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

Rareside effects (may occur in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):

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

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

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

Commonside effects (may occur in less than 1 in 10 patients, but more than 1 in 100 patients):

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

Uncommonside effects (may occur in less than 1 in 100 patients, but more than 1 in 1,000 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).

Rareside effects (may occur in less than 1 in 1,000 patients, but more than 1 in 10,000 patients):

• bacterial infection 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).
• non-systemic dizziness, feeling of fatigue, and general malaise.
• chest pain, excess fluid in the lungs, breathing difficulties, cough, nasal congestion (runny nose).
• liver function disorders (such as alkaline phosphatase or transient hepatitis) with symptoms such as increased liver enzyme activity [alanine aminotransferase (ALT), aspartate aminotransferase (AspAT), gamma-glutamyltransferase (gamma GT), and lactate dehydrogenase (LDH)] and bilirubin (a breakdown product of red 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 Dali Pharma concurrently with other medicines that cause kidney function disorders.
• sleep disorders, including nightmares and insomnia.
• feeling of nervousness and anxiety, drowsiness, weakness, hot flashes, vision disturbances, non-systemic dizziness, and seizures (involuntary, rapid, and repetitive muscle contractions and relaxations).

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

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

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to: Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
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 the medicine.

5. How to store Cefazolin Dali Pharma

Store the medicine out of sight and reach of children.
Do not use this medicine after the expiration date stated on the outer packaging and label after EXP. The expiration date refers to the last day of the month stated.
This medicinal product does not require any special storage conditions. Store the vials in the outer packaging to protect them from light.
From a microbiological point of view, the prepared solution should be used immediately after preparation. If the solution is not used immediately, the person administering the medicine is responsible for the storage conditions and the time after opening, which usually should not exceed 24 hours at a temperature of 2-8°C, unless the reconstitution and (or) dilution took place in controlled and validated aseptic conditions.
Do not use Cefazolin Dali Pharma if you notice any visible signs of degradation, such as solid particles and discoloration.
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 Dali Pharma 2 g contains

The active substance of the medicine is cefazolin. Each vial contains 2 g of cefazolin (as cefazolin sodium).
The medicinal product does not contain any other ingredients besides the active substances.

What Cefazolin Dali Pharma 2 g looks like and what the packaging contains

Cefazolin Dali Pharma, 2 g, is a white or almost white powder in a 20-mL vial made of colorless glass, closed with a gray stopper and a red cap.
The packaging contains 10 vials.

Marketing authorization holder:

Dali Pharma GmbH
Brehmstraße 56
40239 Düsseldorf
Germany
Email: [email protected]

Importer:

Health-Med sp. z o.o. sp.j.
ul. Chełmska 30/34
00-725 Warsaw

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Germany
Cefazolin Dali Pharma 2 g Pulver zur Herstellung einer Infusionslösung
Poland
Cefazolin Dali Pharma

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

This leaflet contains practical information about the preparation and (or) handling of the medicinal product. Read the leaflet carefully before administering the medicine to the patient.
Note:this leaflet does not contain all the necessary information for this medicine. When deciding on the suitability of the medicine for a specific patient, the prescribing doctor should consult the Summary of Product Characteristics (SmPC).

DOSAGE GUIDELINES FOR CHILDREN

Infections caused by microorganisms very sensitive to cefazolin:
The recommended total daily dose is 25-50 mg/kg body weight in 2-4 divided equal doses (1 dose every 6, 8, or 12 hours).
Infections caused by microorganisms less sensitive to cefazolin:
The recommended total daily dose may be increased to 100 mg/kg body weight in 3-4 divided equal doses (1 dose every 6-8 hours).

Dosage in children

INCOMPATIBILITIES

Do not mix cefazolin solutions with other medicines, except for those listed in the section on solution preparation.
The following active substances or solutions for reconstitution and (or) dilution should not be administered simultaneously: amikacin sulfate, sodium amobarbital, ascorbic acid, bleomycin sulfate, calcium glucoheptonate, calcium gluconate, cimetidine hydrochloride, colistin sulfate methanesulfonate, erythromycin glucoheptonate, kanamycin sulfate, oxytetracycline hydrochloride, sodium pentobarbital, polymyxin B sulfate, and tetracycline hydrochloride.

INSTRUCTIONS FOR DISPOSAL OF THE MEDICINAL PRODUCT

Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

PREPARATION OF THE SOLUTION

Reconstitution/dilution of the product should be carried out under aseptic conditions. Before administration, the solution should be visually inspected for the presence of solid particles and discoloration.
Only use clear, colorless, or almost colorless solutions that are free from solid particles.
In cooled solutions, a precipitate may form, which dissolves again upon reaching room temperature. Before using the solution, ensure that the precipitate has completely dissolved.

Instructions for reconstitution and (or) dilution:

Information on the volume and compatibility of solvents that can be used for dilution/reconstitution is provided below.

Intravenous infusion

The dry powder should be reconstituted in 5 mL of water for injection or in one of the following solutions. Further dilution should be carried out with one of the following compatible solvents in accordance with the dilution table below:

• physiological saline solution,
• 5% or 10% glucose solution,
• 5% glucose solution with Ringer's solution with lactates,
• 5% glucose solution with physiological saline solution,
• 5% glucose solution with 0.45% sodium chloride solution,
• 5% glucose solution with 0.2% sodium chloride solution,
• Ringer's solution,
• Ringer's solution with lactates,
• water for injection with 5% or 10% invert sugar solution.

Table containing the necessary data for reconstituting the powder in the case of intravenous infusion.

SPECIAL PRECAUTIONS FOR STORAGE

This medicinal product does not require any special storage conditions. Store the vials in the outer packaging to protect them from light.
Shelf life of the solution after reconstitution
The prepared solution shows chemical and physical stability for 12 hours at a temperature of ≤ 25°C and for 24 hours at a temperature of 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 person administering the medicine is responsible for the storage conditions and the time after opening, which usually should not exceed 24 hours at a temperature of 2-8°C, unless the reconstitution and (or) dilution took place in controlled and validated aseptic conditions.