CEFAZOLIN 1 g Powder

Contents of the leaflet

1. Leaflet accompanying the packaging: patient information
2. Cefazolin AptaPharma, 1 g, powder for solution for injection/infusion
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
3. What is Cefazolin AptaPharma and what is it used for
4. Important information before using Cefazolin AptaPharma
   1. When not to use Cefazolin AptaPharma
   2. Warnings and precautions
   3. Children
   4. Cefazolin AptaPharma and other medicines
   5. Pregnancy and breastfeeding
   6. Driving and using machines
   7. Cefazolin AptaPharma contains sodium
5. How to use Cefazolin AptaPharma
   1. Dosage
   2. What to do if too much Cefazolin AptaPharma is used
   3. What to do if a dose of Cefazolin AptaPharma is missed
   4. Stopping treatment with Cefazolin AptaPharma
6. Possible side effects
   1. Stop using the medicine and contact your doctor immediately if any of the following symptoms occur:
   2. Common side effects, may occur in less than 1 in 10 patients:
   3. Uncommon side effects, may occur in less than 1 in 100 patients:
   4. Rare side effects, may occur in less than 1 in 1,000 patients:
   5. Very rare side effects, may occur in less than 1 in 10,000 patients:
   6. Unknown (frequency cannot be estimated from available data)
   7. Reporting side effects
7. How to store Cefazolin AptaPharma
8. Contents of the packaging and other information
   1. What Cefazolin AptaPharma contains
   2. What Cefazolin AptaPharma looks like and contents of the packaging
   3. Marketing authorization holder
   4. Manufacturer
   5. This medicinal product is authorized in the Member States of the European Economic Area under the following names:
   6. Country
   7. Date of last revision of the leaflet:
   8. Information intended for healthcare professionals only:
   9. Preparation of the solution
   10. Intramuscular injection
   11. Intravenous injection
   12. Children and adolescents with renal impairment
   13. Method of administration
   14. Duration of treatment

Leaflet accompanying the packaging: patient information

Cefazolin AptaPharma, 1 g, 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, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist, or nurse.
• If the patient experiences any side effects, including those not listed in this leaflet, inform the doctor or pharmacist. See section 4.

Table of contents of the leaflet:

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

1. What is Cefazolin AptaPharma and what is it used for

The medicine contains the active substance cefazolin, which is an antibiotic. Cefazolin is used to treat bacterial infections caused by bacteria sensitive to cefazolin:

• skin and soft tissue infections
• bone and joint infections Cefazolin may also be used before, during, or after surgery, or to prevent potential infections.

2. Important information before using Cefazolin AptaPharma

When not to use Cefazolin AptaPharma

• if the patient is allergic (hypersensitive) to cefazolin or any of the other ingredients of this medicine (listed in section 6);
• 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 AptaPharma, discuss with your doctor or pharmacist if:

• the patient has a tendency to allergies (e.g., hay fever or asthma) increases the risk of severe allergic reactions to Cefazolin AptaPharma;
• the patient has previously been diagnosed with hypersensitivity to beta-lactam antibiotics (e.g., penicillins), there is also a risk of allergy to Cefazolin AptaPharma;
• the patient has kidney or liver function disorders;
• the patient has bleeding disorders (e.g., hemophilia) or currently has bleeding disorders (as a result of parenteral nutrition, malnutrition, liver or kidney dysfunction, decreased platelet count, which increases the risk of bleeding or bruising [thrombocytopenia], or the use of anticoagulant medications [e.g., heparin]);
• the patient has diseases that cause bleeding (e.g., gastrointestinal ulcers);
• the patient has had severe, persistent diarrhea during or after treatment with Cefazolin AptaPharma. In such a case, contact your doctor immediately. Do not take medications that slow down bowel movements without consulting your doctor;
• prolonged or repeated treatment with cefazolin may lead to further fungal or bacterial infections resistant to cefazolin (superinfection).

Children

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

Cefazolin AptaPharma and other medicines

Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, including those available without a prescription. The doctor will exercise particular caution if the patient is taking any of the following medicines:

• Anticoagulant medications (medicines that prevent blood clotting): Cefazolin may very rarely cause blood clotting disorders. For this reason, when using Cefazolin AptaPharma and anticoagulant medications (e.g., heparin) together, caution is required and regular monitoring of coagulation parameters is necessary.
• Probenecid (a medicine used to treat joint and gout diseases).
• Medicines with potentially harmful effects on the kidneys: Cefazolin AptaPharma may increase the harmful effects of some antibiotics (e.g., aminoglycosides) and diuretic medications (e.g., furosemide) on the kidneys. When using Cefazolin AptaPharma and the above-mentioned medicines together, regular monitoring of kidney function is necessary, especially in patients with kidney function disorders.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult her doctor before using this medicine.

Pregnancy

Cefazolin passes through the placental barrier and may affect the unborn child. For this reason, Cefazolin AptaPharma may only be used during pregnancy if, in the doctor's opinion, it is absolutely necessary and after careful consideration of the benefit-to-risk ratio.

Breastfeeding

Cefazolin passes into human milk in small amounts. Therefore, during treatment with Cefazolin AptaPharma, breastfeeding should be discontinued.

Driving and using machines

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

Cefazolin AptaPharma contains sodium

This medicine contains 50.6 mg of sodium (the main component of common salt) in each 1 g. This corresponds to 2.53% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Cefazolin AptaPharma

Cefazolin AptaPharma is always administered by medical personnel. The medicine is administered by injection or infusion (into a vein) or into a muscle (intramuscularly) in the form of a deep intramuscular injection, after prior dissolution. The doctor will inform the patient about the necessary duration and frequency of administration of Cefazolin AptaPharma.

Dosage

Adult patients with normal kidney function

• Infections caused by bacteria sensitive to this medicine: 1 to 2 g per day divided into 2 or 3 doses.
• Infections caused by bacteria less sensitive to this 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

Preterm infants and infants under 1 month of age:

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

Children over 1 month of age:

• Infections caused by bacteria sensitive to this medicine: 25 to 50 mg per kilogram 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 this medicine: up to 100 mg of cefazolin per kilogram of body weight per day divided into 3 or 4 single doses, every 6 to 8 hours. It is not recommended to use the medicine in children under 1 month of age.

Use in elderly patients

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

Special dosage recommendations

Surgical prophylaxis

• 1 g of cefazolin 30-60 minutes before surgery.
• In long-lasting 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, the elimination of cefazolin 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.

What to do if too much Cefazolin AptaPharma is used

Since the medicine will be administered by a doctor or nurse, it is unlikely that too much will be given.

Symptoms of overdose are headache, dizziness (central), dizziness (peripheral), burning or tingling sensation on the skin (paresthesia), restlessness (agitation), involuntary muscle contractions or muscle groups (myoclonus) and convulsions (seizures). If any of these symptoms occur, contact your doctor immediately.

In emergency cases, immediate medical help is necessary to treat the symptoms of overdose.

What to do if a dose of Cefazolin AptaPharma is missed

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

Stopping treatment with Cefazolin AptaPharma

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 the doctor's instructions.

If you have any further doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Stop using the medicine and contact your doctor immediately if any of the following symptoms occur:

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 1,000 patients):

• jaundice (yellowing of the skin and whites of the eyes)
• severe skin reactions with heat strokes, fever, blisters, or ulcers (Stevens-Johnson syndrome) or severe rash with redness, peeling, and swelling of the skin, resembling burns [(toxic epidermal necrolysis (Lyell's syndrome)].

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

• severe allergic reaction (anaphylactic shock) with difficulty breathing, swelling of the throat, face, eyelids, or lips, rapid heartbeat, and low blood pressure. This reaction may start soon after the first administration of the medicine or later.
• severe and frequent diarrhea, sometimes with blood, as this 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 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.

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

• 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 injection into a vein (phlebitis).

Rare side effects, may occur in less than 1 in 1,000 patients:

• bacterial or fungal infections of the male or female genital organs with symptoms such as itching, redness, swelling, and discharge (genital candidiasis, thrush, vulvitis).

Discharge.

• 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 (central), feeling of fatigue, and general malaise.
• sleep disorders, including nightmares and insomnia.
• feeling of nervousness and restlessness, drowsiness, weakness, hot flashes, color vision disturbances, dizziness (peripheral), confusion, and seizures (involuntary, rapid, and repeated contraction and relaxation of muscles).
• chest pain, fluid accumulation in the lungs, difficulty breathing, cough, nasal congestion (runny nose).
• liver function disorders (such as increased levels of alkaline phosphatase or transient hepatitis) with symptoms such as increased enzyme activity in the liver (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 undefined 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 medicines that cause kidney function disorders.

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).
• decreased hemoglobin and (or) hematocrit levels, anemia, decreased granulocyte count (agranulocytosis), insufficient production or increased breakdown of red blood cells (aplastic or hemolytic anemia), very low count of all blood cells (pancytopenia).

Unknown (frequency cannot be estimated from available data)

• regarding intramuscular administration (into the muscle): systemic reactions to lidocaine (if the solvent contains lidocaine).

Reporting side effects

If any side effects occur, including those not listed in this leaflet, inform your doctor or nurse.

Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration 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.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefazolin AptaPharma

Store the medicine out of sight and reach of children.

Do not store above 25°C.

Store the vials in the outer packaging to protect from light.

The solution after reconstitution/dilution should be administered immediately after preparation.

Do not use this medicine after the expiry date stated on the outer packaging and label after "EXP". The expiry date refers to the last day of the month.

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 AptaPharma contains

The active substance of the medicine is cefazolin. Cefazolin AptaPharma contains 1.048 g of cefazolin sodium, which corresponds to 1 g of cefazolin.

What Cefazolin AptaPharma looks like and contents of the packaging

Cefazolin AptaPharma is available in vials of 10 mL of colorless glass (type III) with a bromobutyl rubber stopper (type I) and an aluminum flip-off cap in a cardboard box.

Cefazolin AptaPharma is available in packs containing 10 vials of 1 g.

Marketing authorization holder

Apta Medica Internacional d.o.o.

Likozarjeva Ulica 6

1000 Ljubljana

Slovenia

Manufacturer

ACS Dobfar S.p.A

Nucleo Industriale S. Atto – S. Nicolò a Tordino

64100 Teramo

Italy

ACS Dobfar S.p.A.

Via A. Fleming, 2

37135 Verona

Italy

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

Country

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Preparation of the solution

In the case of any administration route, refer to the table, which presents additional volumes and concentrations of solutions that may be useful in situations where partial doses are needed.

Intramuscular injection

Cefazolin AptaPharma, 1 g, powder for solution for injection/infusion:

The medicinal product Cefazolin AptaPharma, 1 g, powder for solution for injection/infusion should be dissolved in one of the following solvents according to the table below:

• water for injection
• 10% glucose solution (100 mg/mL)
• 0.9% sodium chloride solution (9 mg/mL)
• 0.5% lidocaine hydrochloride solution (5 mg/mL)

Shake well until the contents of the vial are completely dissolved and inject deeply into the muscle.

Use of lidocaine:

When using a lidocaine solution as a solvent, cefazolin solutions should only be used for intramuscular injections. Before use, consider the contraindications, warnings, and other important information listed in the Lidocaine Product Characteristics.

Lidocaine solution should never be administered intravenously.

In children over 30 months of age, it is recommended to use intramuscular injection with lidocaine as a solvent.

Intravenous injection

The medicinal product Cefazolin AptaPharma, 1 g, powder for solution for injection/infusion should be dissolved in one of the following solvents according to the table below:

• water for injection
• 0.9% sodium chloride solution
• 5% glucose solution (50 mg/mL)
• 10% glucose solution (100 mg/mL)

Table containing information on dissolution in the case of intravenous injection

The medicinal product Cefazolin AptaPharma should be injected slowly over 3-5 minutes. In no case should the solution be injected for less than 3 minutes. This should be done directly into a vein or into a tube through which the patient is receiving intravenous solutions.

Single doses greater than 1 g should be administered by intravenous infusion over 30 to 60 minutes.

Guidelines for dosing in children and adolescents:

Intravenous injection

The contents of 1 vial (1000 mg of cefazolin) are dissolved in 4 mL of a compatible solvent (concentration of approximately 220 mg/mL). The appropriate volume of this solution for use with the dose in mg is presented in Table 1.

It is absolutely necessary to avoid intravenous administration of lidocaine solutions.

Table 1. Appropriate volumes of solution for intravenous and intramuscular injections in children and adolescents

* In the case of intramuscular administration, when the calculated volume of each individual administration exceeds 2 mL, it is recommended to choose a dosing schedule with more divided doses during the day (3 or 4) or to divide the administered volume into equal parts between two different injection sites.

In the case of volumes less than 1 mL, use a 0.5 mL syringe to achieve better dosing accuracy.

Intramuscular injection

The contents of 1 vial (1000 mg of cefazolin) are dissolved in 4 mL of a compatible solvent (concentration of approximately 220 mg/mL) and the appropriate volume (as indicated in Table 1) is taken from the reconstituted solution and administered by intramuscular injection.

In the case of administration to children under 30 months of age, cefazolin should not be dissolved in a lidocaine solution (see section 4.4 of the Product Characteristics).

Intravenous infusion

The dose can be administered in an intravenous infusion using the reconstituted product and then diluted solution (10 mg/mL) described in section 6.6 of the Product Characteristics.

Children and adolescents with renal impairment

Children with renal impairment (like adults) may need a lower dose to avoid accumulation of the medicine.

A lower dose should be chosen based on the results of blood tests for the medicine. 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 administered 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 the above guidelines apply after the initial dose. See also section 4.4 of the Product Characteristics.

Patients in old age:

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

Method of administration

Cefazolin AptaPharma can be administered by deep intramuscular injection or by slow intravenous injection or after dilution as an intravenous infusion.

The volume and type of solvent used to dissolve the powder depend on the method of administration.

Instructions for reconstitution of the medicinal product before administration, see section 6.6 of the Product Characteristics.

If lidocaine is used as a solvent, the resulting solution should never be administered intravenously (see section 4.3 of the Product Characteristics). Consider the information contained in the Lidocaine Product Characteristics.

Duration of treatment

The duration of treatment depends on the severity of the infection and the patient's clinical and bacteriological progress.