Cefazolin Tzf

Leaflet attached to the packaging: Patient information

Cefazolin TZF, 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.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

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

Cefazolin TZF contains the active substance cefazolin (as sodium salt). Cefazolin belongs to a group of antibiotics called cephalosporins, which have a bactericidal effect on susceptible bacteria.
Cefazolin is used to treat infections caused by bacteria that are susceptible to cefazolin. It is used to treat the following infections:

• respiratory tract infections
• kidney, urinary tract, and genital infections
• skin and soft tissue infections
• septicemia (a specific reaction of the body to infection)
• biliary tract infections
• bone and joint infections
• endocarditis (inflammation of the inner layer of the heart or heart valves) Cefazolin TZF can also be given before or after surgery to prevent infections.

2. Important information before using Cefazolin TZF

When not to use Cefazolin TZF

Warnings and precautions

Before using Cefazolin TZF, consult your doctor, pharmacist, or nurse:

Factors that may cause vitamin K deficiency or other coagulation disorders.

In rare cases, during cefazolin treatment, bleeding disorders may occur. The risk of these disorders is higher in patients with vitamin K deficiency or other factors that lead to coagulation disorders (parenteral nutrition, nutritional deficiencies, liver and kidney dysfunction, thrombocytopenia [reduced platelet count, which increases the risk of bleeding or bruising]). The cause of coagulation disorders may also be concomitant diseases (e.g., hemophilia[coagulation disorders] , gastric or duodenal ulcer), which cause or exacerbate bleeding. In patients with these diseases, coagulation will be monitored by the doctor.
Do not administer this medicine by injection into the space surrounding the spinal cord (intrathecally), as severe toxic effects on the central nervous system (including seizures) have been reported.
Do not use Cefazolin TZF in premature infants or newborns under 1 month of age.
Prolonged use of cefazolin may cause superinfection. The doctor will carefully monitor the patient for signs of superinfection and, if necessary, prescribe appropriate treatment.

Cefazolin TZF and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or might take, including those obtained without a prescription and herbal medicines. Cefazolin TZF may affect the action of other medicines. Some medicines may also affect the action of Cefazolin TZF.
In particular, tell your doctor or nurse if you are taking any of the following medicines:

• aminoglycosides or other antibiotics (used to treat infections).
• probenecid (used to treat gout).
• vitamin K.
• anticoagulant medicines (blood thinners).
• furosemide (a diuretic).
• oral contraceptives.

You should also tell your doctor or nurse if you are having any urine tests for glucose or blood tests (including newborns whose mothers have received cephalosporins).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
The medicine may be used during pregnancy only after careful consideration by the doctor of the benefit to risk ratio.
Breastfeeding
A small amount of cefazolin passes into breast milk. In breastfed babies, this may cause allergic reactions, diarrhea, or thrush. In such cases, the doctor will advise to stop breastfeeding during treatment.

Driving and using machines

Cefazolin does not affect the ability to drive and use machines. However, side effects may occur (e.g., dizziness), which may affect the ability to drive and use machines (see section 4).

Cefazolin TZF contains sodium

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

3. How to use Cefazolin TZF

Cefazolin TZF is administered by a doctor or nurse.
Cefazolin TZF will be administered in one of the following ways:

• by intramuscular injection (e.g., into the arm muscle);
• by slow injection into a vein. The injection will take 3 to 5 minutes;
• through a small tube inserted into a vein. This is called intravenous infusion.

Recommended dose

The dose of Cefazolin TZF is determined by the doctor based on age, body weight, and severity of infection, as well as the patient's kidney function. The doctor will provide explanations on this.

Adolescents over 12 years, adults, and elderly patients with normal kidney function

• In the case of infections, the dose may be 1 g to 6 g or 12 g per day, depending on the severity of the infection.
• In the case of surgery, the patient will receive a dose of 1 g 30-60 minutes before the start of surgery.
• In the case of longer surgeries, the patient may receive an additional 0.5 g to 1 g of the medicine during surgery. Administration of Cefazolin TZF may be continued for 24 hours after surgery or, in the case of surgeries where infection is a particular risk, for 3 to 5 days, to prevent the risk of infection.

Use in children and infants (over 1 month of age) with normal kidney function

The doctor will determine the appropriate dose based on the child's body weight. In children, the daily dose may be 25 mg to 50 mg per kilogram of body weight. The dose may be increased to 100 mg per kilogram of body weight, depending on the severity of the infection.

Adults and children with impaired kidney function

If the patient has impaired kidney function, the dose of the medicine may be reduced. It may be necessary to perform blood tests to determine the correct dose.

Use of a higher than recommended dose of Cefazolin TZF

If you suspect that you have used too much Cefazolin TZF, tell your doctor or nurse.

Missing a dose of Cefazolin TZF

Do not use a double dose to make up for a missed dose.
If you have any further questions about using this medicine, ask your doctor or nurse.

4. Possible side effects

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

Severe side effects

• Severe allergic reactions. These occur very rarely (may occur in less than 1 in 10,000 people) Symptoms may include:
• sudden swelling of the face, throat, lips, or mouth, causing difficulty breathing or swallowing,
• sudden swelling of the hands, feet, and ankles,
• redness of the skin, itching, joint pain, skin changes, widespread rash, hives, drug fever.
• Transient hepatitis and jaundice (yellowing of the skin or whites of the eyes). This occurs very rarely (may occur in less than 1 in 10,000 people)
• Pseudomembranous colitis (severe diarrhea). Symptoms include severe or prolonged diarrhea, possibly with blood or mucus in the stool, abdominal pain, and fever. The frequency is unknown (cannot be estimated from available data)

➢ If you experience any of the above symptoms, stop using the medicine and contact your doctor or go to the emergency room of your nearest hospital.

Other possible side effects:

Frequently(may occur in less than 1 in 10 people)

• Allergic reactions such as rash, hives, and itching
• Nausea and vomiting
• Diarrhea
• Loss of appetite
• Bloating
• Abdominal pain
• Pain and induration at the injection site.

Less frequently(may occur in less than 1 in 100 people)

• Increased number of certain blood cells
• Decreased number of white blood cells
• Abnormal breakdown of red blood cells
• Decreased number of blood cells involved in blood clotting
• Transient increase in liver function test values
• Phlebitis, thrombophlebitis.

Rarely(may occur in less than 1 in 1,000 people)

• Bleeding disorders. Nosebleeds or bleeding after injury are longer.
• Kidney function disorders.

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

• Candidiasis (fungal infection of the vagina, mouth, or skin folds), the doctor may prescribe appropriate treatment.
• Headache
• Dizziness
• Unpleasant, sometimes painful sensation of tingling, numbness, or burning of the limbs, disturbances in sensation of cold and heat, nervous excitement
• Involuntary muscle twitching and cramps
• Seizures.

Reporting side effects

If you experience any side effects, including any not listed in the leaflet, please tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefazolin TZF

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date (EXP) stated on the label and carton. The expiry date refers to the last day of the month.
Store below 25°C. Store the vial in the outer carton to protect from light.
Instructions for storage and preparation of the solution are at the end of the leaflet in the subsection "Information intended for healthcare professionals only:"
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What Cefazolin TZF contains

The active substance is cefazolin (as sodium salt).
1 vial contains 1 g of cefazolin (as sodium salt).
This medicine does not contain any excipients.

What Cefazolin TZF looks like and contents of the pack

White or almost white powder, very hygroscopic.

Packaging

1 vial in a cardboard box with patient leaflet.

Marketing authorization holder and importer

Tarchomińskie Zakłady Farmaceutyczne "Polfa" Spółka Akcyjna
ul. A. Fleminga 2
03-176 Warsaw
Phone number: 22 811-18-14
In order to obtain more detailed information on this medicine, please contact the marketing authorization holder.

Date of last revision of the leaflet:

Information intended for healthcare professionals only:

Please refer to the summary of product characteristics for Cefazolin TZF, 1 g, powder for solution for injection/infusion to obtain full information.
Dosage
The dose, route of administration, and dosing interval depend on the severity of the infection, the susceptibility of the causative organism, age, weight, and the patient's condition (e.g., renal function).

Adults and adolescents over 12 years with normal kidney function

Infections caused by very susceptible organisms:
Usual adult dosage is 1 g to 2 g per day in two or three equal doses (one dose every 8 or 12 hours).
Infections caused by less susceptible organisms:
Usual adult dosage is 3 g to 4 g per day in three or four equal doses (one dose every 6 or 8 hours).
In the case of severe and life-threatening infections, doses of 6 to 12 g per day may be administered in three or four equal doses (one dose every 6 to 8 hours).
Surgical prophylaxis: for adults and adolescents, the following dosing is recommended:
a) 1 g intravenously or intramuscularly 30 minutes to 1 hour before surgery
b) during longer surgical procedures (e.g., 2 hours or longer), 0.5 g to 1 g intravenously or intramuscularly during surgery (administration adjusted to the duration of surgery)
c) 0.5 g to 1 g intravenously or intramuscularly every 6 to 8 hours for 24 hours after surgery or, in the case of surgeries where infection is a particular risk, for 3 to 5 days.
It is essential to administer the preoperative dose just before the start of the surgical procedure (30 minutes to 1 hour), to achieve adequate antibiotic concentrations in serum and tissues at the time of the initial surgical incision, and to administer cefazolin, if necessary, at appropriate intervals during surgery, to ensure adequate antibiotic concentrations at the anticipated times of greatest risk of infection.

Adult patients with impaired kidney function

Adult patients with impaired kidney function may require a lower dose to avoid accumulation of the medicine. The dose should be adjusted based on the results of cefazolin concentration measurements in the blood. If this is not possible, the dose can be determined based on creatinine clearance.
In the case of impaired kidney function, an appropriate initial dose should be administered. Subsequent doses should be adjusted accordingly, taking into account the degree of impaired kidney function, the severity of the infection, and the susceptibility of the pathogen.
In patients undergoing hemodialysis, the treatment schedule depends on the dialysis conditions.

*Daily dose for adults with normal kidney function

Infants (over 1 month) and children

Recommended total daily dose, in moderately severe infections - 25–50 mg/kg body weight, divided into 3 to 4 single doses.
In severe infections, the total daily dose can be increased to 100 mg/kg body weight.

Children with impaired kidney function

Children with impaired kidney function may (like adults) require a lower dose to avoid accumulation of the medicine. A lower dose should be adjusted based on the results of cefazolin concentration measurements in the blood. If this is not possible, the dose can be determined based on creatinine clearance.
In the case of impaired kidney function, an appropriate initial dose should be administered. Subsequent doses should be adjusted accordingly, taking into account the degree of impaired kidney function, the severity of the infection, and the susceptibility of the pathogen.

Premature infants and young children under 1 month of age

Since the safety of cefazolin in premature infants and children under 1 month of age has not been confirmed, cefazolin is not recommended for these patients. See also section 4.4.

Elderly patients

In elderly patients with normal kidney function, dose adjustment is not necessary.

Preparation of solutions for injection and infusion

Before administration, check the appearance of the solution. The color of the solution may be light yellow to yellow.
The solution can only be administered if it is clear and practically free from visible particles.
Intramuscular injection
Add 4 ml of water for injection or 0.9% sodium chloride solution to the vial, shake until completely dissolved.
The product should be administered deep into a large muscle. Intramuscular administration of cefazolin rarely causes pain.
Intravenous injection
Dissolve the contents of the vial in at least 10 ml of water for injection.
The product should be injected very slowly, not less than 3 minutes.
Intravenous infusion
Cefazolin should be reconstituted initially and then diluted to 50 ml or 100 ml of one of the following solutions:
water for injection,
0.9% sodium chloride solution,
5% glucose solution,
10% glucose solution,
5% glucose solution with 0.9% sodium chloride 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 sodium lactate.
Prepared solutions
Cefazolin solution prepared with the above solvents is physically and chemically stable for 24 hours at 25°C and in the refrigerator (2°C - 8°C).
From a microbiological point of view, the product should be used immediately. If not used immediately, the user is responsible for the storage conditions and storage time, which should not exceed 24 hours at 2°C to 8°C (refrigerator).

Incompatibilities

The medicine must not be mixed with other medicines, except those mentioned in the section "Method of administration and preparation of solutions".