Cefazolin Phagecon

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: Information for the user

Cefazolin Phagecon, 1 g, powder for solution for injection/infusion

Cefazolin sodium

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

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

Cefazolin Phagecon contains the active substance cefazolin (as cefazolin sodium). Cefazolin belongs to a group of antibiotics called cephalosporins, which kill bacteria. Cefazolin is used when an infection is known or suspected to be caused by bacteria sensitive to cefazolin. It is used to treat the following infections:

• respiratory tract infections;
• kidney and urinary tract infections;
• skin infections;
• bone and joint infections;
• endocarditis (inflammation of the inner lining of the heart or heart valves).

Cefazolin Phagecon may also be given before surgery or after surgery to prevent infections.

2. Important information before using Cefazolin Phagecon

When not to use Cefazolin Phagecon

Warnings and precautions

Before starting treatment with Cefazolin Phagecon, the patient should discuss it with their doctor, pharmacist, or nurse.

Factors that may cause a deficiency of vitamin K or other blood clotting disorders
Blood clotting disorders.
In rare cases, during treatment with cefazolin, blood clotting disorders may occur.
Additionally, blood clotting may be impaired in patients with conditions that may cause or exacerbate bleeding, such as hemophilia, stomach or duodenal ulcers. In such cases, the patient's blood clotting system will be monitored.
This medicine should not be administered by injection into the space surrounding the spinal cord (intrathecally), as it has been reported to cause toxic effects on the central nervous system (including seizures).
Cefazolin Phagecon should not be used in premature infants or newborns under 1 month of age.
Prolonged use of Cefazolin Phagecon may cause superinfection. The doctor will carefully monitor the patient and, if necessary, prescribe appropriate treatment.

Cefazolin Phagecon and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Cefazolin Phagecon may affect the action of some medicines, and some medicines may affect the action of Cefazolin Phagecon.
The patient should tell their doctor if they are taking any of the following medicines, in particular:

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

The patient should also tell their doctor if they are having urine tests for glucose or blood tests.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

Cefazolin Phagecon 1 g powder for solution for injection/infusion has a significant effect on the ability to drive and use machines, particularly due to the possibility of encephalopathy (see sections 3 and 4).

Cefazolin Phagecon contains sodium

The medicine contains 48.3 mg of sodium (the main component of common salt) per gram. This corresponds to 2.5% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account for patients controlling their sodium intake.

3. How to use Cefazolin Phagecon

This medicine should always be used exactly as prescribed by the doctor. In case of doubts, the patient should consult their doctor or pharmacist.
Cefazolin Phagecon will be administered to the patient by a doctor 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 an intravenous infusion.

Recommended doses

The doctor will determine the dose of Cefazolin Phagecon based on the patient's age, body weight, severity of the infection, and kidney function. The doctor will explain this to the patient.
Adults and adolescents and elderly patients

• In the case of infection, 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 planned surgery, the patient will receive a dose of 1 g, 30-60 minutes before the start of surgery.
• In the case of longer operations, the patient may receive an additional 500 mg to 1 g of the medicine during the operation. Administration of Cefazolin Phagecon may be continued for 24 hours after surgery to prevent the risk of infection.

Use in children and infants (over 1 month of age)
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. This dose may be increased to 100 mg per kilogram of body weight, depending on the severity of the infection.
There is not enough data to recommend dosing in children under 1 month of age.
Adults and children with kidney problems
If the patient has kidney problems, the dose of the medicine may be reduced. It may be necessary to perform blood tests to determine if the patient is receiving the correct dose.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Severe allergic reactions(very rare, may occur in less than 1 in 10,000 people) If the patient experiences a severe allergic reaction, they should tell their doctor immediately.
Symptoms may include:

• Sudden swelling of the face, throat, lips, or mouth; may cause difficulty breathing or swallowing.
• Sudden swelling of the hands, feet, or ankles.

Other possible side effects

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

• Rash
• Nausea and vomiting
• Diarrhea
• Lack of appetite
• Bloating
• Abdominal pain
• Pain and hardening at the injection site

Uncommon(may occur in less than 1 in 100 people)

• Increased number of a certain type of blood cell
• Low white blood cell count
• Low platelet count
• Phlebitis
• Severe allergic reactions, drug fever
• Redness of the skin, itching, joint pain, skin changes, generalized rash, hives
• Transient increase in liver function parameters

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

• Blood clotting may take longer than usual. This can be observed with nosebleeds or cuts.
• Kidney problems

Very rare(may occur in less than 1 in 10,000 people)

• Yellowing of the skin or whites of the eyes (jaundice)

Unknown(frequency cannot be estimated from the available data)

• Fungal infections (thrush of the vagina, mouth, or skin folds); the doctor may prescribe treatment for thrush.
• Headache
• Dizziness
• Unpleasant, sometimes painful sensations with tingling, numbness, tingling of the limbs, disturbances of cold and heat perception
• Central nervous system stimulation
• Involuntary muscle contractions
• Seizures
• Colitis (inflammation of the colon). Symptoms include: diarrhea, usually with blood and mucus, abdominal pain, and fever.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety 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.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Cefazolin Phagecon

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton: "Expiry date".
The expiry date refers to the last day of the month stated.
Before opening: this medicinal product does not require any special storage conditions.
To protect from light, the vial should be stored in the outer carton.
After reconstitution:
The chemical and physical stability of the solution after reconstitution has been demonstrated for 8 hours at 25°C and 24 hours at 2-8°C. From a microbiological point of view, the product should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions prior to administration, and the storage time should not normally exceed 8 hours at 25°C and 24 hours at 2-8°C.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Cefazolin Phagecon contains

The active substance is cefazolin.
Each vial contains 1.048 g of cefazolin sodium, equivalent to 1 g of cefazolin.

What Cefazolin Phagecon looks like and contents of the pack

Cefazolin Phagecon is a white or almost white powder.
Cefazolin Phagecon is available in a vial containing 1 g of cefazolin as sodium salt, with a rubber stopper and an aluminum-polypropylene cap, in a cardboard box.
Cefazolin Phagecon is packaged in cardboard boxes of 10 or 100 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Phagecon – Serviços e Consultoria Farmacêutica Lda.
Avenida Jose Malhoa n 2 Edificio Malhoa Plaza 3º Piso Escritorio 3.7
1070-325 Lisbon
Portugal

Manufacturer

LDP-LABORATORIOS TORLAN, S.A.
Ctra de Barcelona, 135-B
08290 Cerdanyola del Vallès
Barcelona
Spain
Laboratórios Basi Indústria Farmacêutica S.A.
Parque Industrial Manuel Lourenco Ferreira 8, 15 and 16
Mortagua
3450-232 Viseu
Portugal

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

Portugal
Cefazolina Phagecon
Belgium
Cefazolin Phagecon 1 g Poudre pour solution injectable/pour perfusion
Cefazolin Phagecon 1 g poeder voor oplossing voor injectie/infusie
Cefazolin Phagecon 1 g Pulver zur Herstellung einer Injektions-
/Infusionslösung
Italy
Cefazolin Phagecon
Czech Republic
Cefazolin Phagecon
Poland
Cefazolin Phagecon

Date of last revision of the leaflet:

WHAT YOU SHOULD KNOW ABOUT ANTIBIOTICS?

Antibiotics are effective against bacterial infections. They are not effective against viral infections.
Moreover, the doctor has decided to prescribe this antibiotic because it is suitable for the patient and their illness.
Bacteria have the ability to survive or multiply despite the action of antibiotics. This phenomenon is called resistance: it makes some antibiotics ineffective.
Resistance increases with the excessive or improper use of antibiotics.
The patient risks contributing to the emergence of resistant bacteria, and thus delaying recovery or even making the medicine ineffective, if they do not follow the instructions regarding:

• dose to be taken,
• time of taking the dose,
• and duration of treatment. Therefore, to maintain the effectiveness of this medicine:

1 – Antibiotics should only be used when prescribed by a doctor.

2 – The guidelines provided on the prescription should be strictly followed.

3 – The antibiotic should not be used again without the doctor's recommendation, even if the patient thinks they have a similar illness.

4 – The patient should never give their antibiotic to another person, as it may not be suitable for their illness.

5 – After completing the treatment, the patient should return all opened packages to the pharmacist for proper disposal of the medicine.

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Information intended for healthcare professionals only:

Cefazolin Phagecon can be administered intramuscularly or intravenously. In both cases, the total daily doses are the same. The dosage, as well as the method of administration, depend on the location and severity of the infection, as well as the clinical and bacteriological progression.
Adults and adolescents (over 12 years of age and weighing ≥ 40 kg):

• Infections caused by susceptible microorganisms: 1 g to 2 g of cefazolin per day divided into 2-3 equal doses.
• Infections caused by moderately susceptible microorganisms: 3 g to 4 g of cefazolin per day divided into 3-4 equal doses.

In severe infections, doses of up to 6 g per day can be administered, divided into three or four equal doses (one dose every 6 or 8 hours).
Prophylaxis of postoperative infections: the recommended dose for prophylaxis of postoperative infections in potentially contaminated surgical procedures is: 1 g of cefazolin 30-60 minutes before surgery.
Children and adolescents
Children and infants over 30 months (im.):
25 to 50 mg/kg body weight every 24 hours (divided into three or four equal doses).
In the case of severe infections, the total daily dose can be increased to 100 mg/kg body weight.
Cefazolin is not recommended for use in premature infants and infants under 1 month of age, as its safety has not been established in these patients.
Patients with renal impairment
In patients with renal impairment, the dosage should be adjusted by the doctor based on the creatinine clearance or serum creatinine concentration (see table).

• Severe or very severe infection:

• Mild or moderate infection:

Prophylaxis of postoperative infections in surgery:administration should be short-term, usually limited to the duration of the procedure, sometimes 24 hours, but never more than 48 hours.
2 g ivat the induction of anesthesia,
followed by a repeat injection of 1 g every 4 hours during the operation.
If administration is continued beyond the perioperative period, a repeat injection of 1 g should be given every 8 hours.
In cardiothoracic surgery with extracorporeal circulation (ECC), an additional injection of 1 g should be given after the start of ECC.
In cesarean sections, the injection should be given after the umbilical cord is clamped.

Method of administration

Cefazolin Phagecon can be administered intravenously, either by direct injection or by continuous or intermittent infusion.
In the case of direct injection into a vein, this medicinal product can be injected slowly into a vein over 3 to 5 minutes.
The solution of this medicinal product can also be administered by slow intravenous infusion.
Cefazolin can be administered deep intramuscularly.
Intramuscular administration: this form of the medicine should not be used in children under 30 months of age (lidocaine hydrochloride solvent).

Special precautions for disposal and preparation of the medicinal product for administration

• Direct intravenous injection: The vial of cefazolin powder should be reconstituted with 5 ml of water for injection and injected slowly over 3 to 5 minutes, directly into a vein or into an infusion set.
• Deep intramuscular injection:

The vial of cefazolin powder should be reconstituted with 4 ml of 1% lidocaine solution or 5 ml of water for injection and injected deep intramuscularly.

• Intravenous infusion: The reconstituted cefazolin solution should be diluted with the diluents listed above in section 6.6: add approximately 45 ml of diluent to the reconstituted solution to obtain a final volume of 50 ml. After reconstitution/dilution, use immediately. Any unused product or waste material should be disposed of in accordance with local requirements.

Shelf life

3 years.
The physicochemical stability of the reconstituted solution has been demonstrated for 8 hours at 25°C and 24 hours at 2-8°C.
From a microbiological point of view, the product should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions prior to administration, and the storage time should not normally exceed 8 hours at 25°C and 24 hours at 2-8°C.