Cefazolin Phagecon

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: Information for the user

Cefazolin Phagecon, 2 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 them, even if their symptoms are the same as yours.
• 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 the infection is certainly or probably 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);
• bacteremia associated with or suspected to be associated with the above infections.

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

2. Important information before using Cefazolin Phagecon

When not to use Cefazolin Phagecon

• if the patient is allergic to cefazolin or any of the other ingredients of this medicine (listed in section 6).
• if the patient has ever had a severe anaphylactic reaction (hypersensitivity) (e.g., severe peeling, facial swelling, hand, foot, lip, tongue, or throat swelling, difficulty swallowing or breathing) in response to any other type of beta-lactam antibiotics (penicillins, monobactams, and carbapenems).

Warnings and precautions

Before starting to use Cefazolin Phagecon, discuss it with your doctor, pharmacist, or nurse.
Allergic reactions
Any allergic symptoms (skin rash, itching, etc.) during treatment should be reported to the doctor immediately. In case of a severe and sudden allergic reaction, the administration of Cefazolin Phagecon should be stopped immediately. Before using this medicine, tell your doctor if you have had a history of hives or other skin rashes, itching, angioedema (sudden swelling of the face and neck of allergic origin) during previous antibiotic treatment.
Caution should be exercised when using this medicine in case of allergies, asthma, or hay fever.
Diarrhea
Onset of diarrhea during antibiotic therapy should not be treated without consulting a doctor.
Diarrhea may occur during or after the use of antibiotics, including cefazolin. If it becomes severe or persistent, or if the patient notices blood or mucus in the stool, THEY MUST IMMEDIATELY INFORM THEIR DOCTOR, as this may be life-threatening. Do not take medications that stop or slow down bowel movements.
Neurological disorders
Similar to all antibiotics in this therapeutic group, the administration of this medicine, especially in case of overdose or improper dose adjustment in patients with renal impairment, may be associated with the risk of encephalopathy (which can lead to confusion, consciousness disorders, seizures, or abnormal movements). In case of such disorders, the patient should immediately consult a doctor or pharmacist (see sections 2 and 4).
Kidney function
INFORM YOUR DOCTORin case of kidney failure, due to the need to adjust the treatment. The doctor will monitor the patient's kidney function in case of concomitant use of nephrotoxic drugs or diuretics.
Other
Solutions reconstituted with lidocaine should not be administered intravenously.
There is no data on the safety of cefazolin in premature infants and newborns under 1 month of age.
Biological analyses
Taking these medicines may affect the results of laboratory tests.
Factors that may cause vitamin K deficiency or other blood clotting disorders
mechanisms.
Rarely, during cefazolin treatment, blood clotting disorders may occur.
Additionally, blood clotting may be impaired in patients with diseases that can 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 have toxic effects on the central nervous system (including seizures).
This medicine should not be used in premature infants or newborns under 1 month of age.
Prolonged use of Cefazolin Phagecon may lead to superinfection. The doctor will carefully monitor the patient and, if necessary, prescribe appropriate treatment.

Cefazolin Phagecon and other medicines

Tell your doctor about all the medicines you are taking or have recently taken, as well as any medicines you plan to take.
Cefazolin Phagecon may affect the action of some medicines, and some medicines may affect the action of Cefazolin Phagecon.
Tell your doctor if you 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").

You should also tell your doctor if you are having urine tests for glucose or blood tests.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a baby, ask your doctor for advice before using this medicine.
Pregnancy
Cefazolin Phagecon can be used during pregnancy only after consulting a doctor.
If you become pregnant while using Cefazolin Phagecon, consult your doctor, as only they can assess the need to continue using this medicine.
Breastfeeding
It is possible to breastfeed while using this medicine.
If the newborn experiences problems, such as diarrhea, allergy, skin rash, tell your doctor, who will advise what to do, as these symptoms in the child may be caused by the medicine.

Driving and using machines

Cefazolin Phagecon has a significant impact 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 table 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 in patients controlling their sodium intake.

3. How to use Cefazolin Phagecon

This medicine should always be used as directed by your doctor. In case of doubts, consult your doctor or pharmacist.
Cefazolin Phagecon will be administered to you by your doctor in one of the following ways:

• by intramuscular injection (e.g., into the arm muscle)
• by slow injection into one of the veins. The injection will last from 3 to 5 minutes
• through a small tube inserted into one of the veins. This is called "intravenous infusion".

Recommended doses

Your doctor will determine the dose of Cefazolin Phagecon based on your age, body weight, severity of the infection, and kidney function. Your doctor will explain this to you.
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. The administration of Cefazolin Phagecon may be continued for 24 hours after the operation 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 insufficient data to recommend dosing in children under 1 month of age.
Adults and children with renal impairment
In patients with renal failure, the dose should be adjusted by the doctor (see table).

• Severe or very severe infection:

• Mild or moderate infection:

How to use Cefazolin Phagecon

Cefazolin can be administered intramuscularly or intravenously.
Intramuscular administration: Dissolve 1 g of powder by diluting it in 4 ml of 1% lidocaine solution or in 5 ml of water for injections. Shake the vial vigorously until the contents are completely dissolved, the solution after reconstitution should be clear and free from visible particles. The solution after reconstitution may have a yellow color, which is normal. Perform a deep intramuscular injection.
Intravenous administration: Cefazolin can be administered as a direct injection or as a continuous or intermittent infusion.
Instructions for reconstitution and dilution of the medicine before administration, see section Information intended for healthcare professionals.

Use of a higher than recommended dose of Cefazolin Phagecon

Consult a doctor.
Similar to all antibiotics in this therapeutic group, the administration of this medicine, especially in case of overdose, may be associated with the risk of encephalopathy (which can lead to confusion, consciousness disorders, seizures, or abnormal movements). In case of such disorders, the patient should immediately consult a doctor or pharmacist (see sections 2 and 4).

Missing a dose of Cefazolin Phagecon

Do not take a double dose to make up for a missed 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 must immediately tell their doctor.
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

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

• Skin 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 number of blood cells involved in blood clotting
• Phlebitis
• Severe hypersensitivity reactions, drug fever
• Redness of the skin, itching of the skin, 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)

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

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, 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 Phagecon

Keep the medicine out of the 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:
Chemical and physical stability of the 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 use, and the storage time should usually not exceed 8 hours at 25°C and 24 hours at 2-8°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

What Cefazolin Phagecon contains

The active substance of the medicine is cefazolin.
Each vial contains 2.096 g of cefazolin sodium, which corresponds to 2 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 2 g of cefazolin in the form of 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 2 g Poudre pour solution injectable/pour perfusion
Cefazolin Phagecon 2 g poeder voor oplossing voor injectie/infusie
Cefazolin Phagecon 2 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 in fighting bacterial infections. They are not effective in the case of viral infections.
Moreover, your doctor has decided to prescribe you this antibiotic because it is suitable for you and your disease.
Bacteria have the ability to survive or multiply despite the action of the antibiotic. This phenomenon is called resistance: it makes some antibiotics inactive.
Resistance increases as a result of excessive or improper use of antibiotics.
You risk contributing to the emergence of resistant bacteria, and thus delaying your recovery or even making this medicine inactive, if you do not follow the recommendations regarding:

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

1 – You should only use antibiotics when prescribed by a doctor.

2 – You should strictly follow the instructions given on the prescription.

3 – You should never reuse an antibiotic without a doctor's prescription, even if you think you have the same illness.

4 – You should never give your antibiotic to another person, it may not be suitable for their illness.

5 – After completing the treatment, you should return any opened packaging to the pharmacist for proper and safe 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).
Use in the prevention of postoperative infections: the recommended dose for the prevention 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 newborns 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 dose should be adjusted by the doctor according to the creatinine clearance or serum creatinine concentration (see table).

• Severe or very severe infection:

• Mild or moderate infection:

Prevention 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,
then a repeat injection of 1 g every 4 hours during the operation.
In the case of administration outside 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, in a direct injection or as a 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 as a 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 use

• Direct intravenous injection: The vial of cefazolin powder should be reconstituted with 5 ml of water for injections and injected slowly over three to five 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 injections and injected deep intramuscularly.

• Intravenous infusion: The reconstituted cefazolin solution should be diluted with 50 ml of water for injections or one of the following intravenous solutions:
• sodium chloride 0.9%,
• glucose 5% or 10%,
• mixed solution of glucose 5% and sodium chloride 0.9%,
• glucose 5% with 0.2% or 0.45% saline solution,
• Ringer's solution,
• lactated Ringer's solution,
• mixed solution of glucose 5% and lactated Ringer's solution,

Do not administer intrathecally.

• - ReconstitutionCefazolin Phagecon should be reconstituted with water for injections: 1 g is stable in 2 ml. Although Cefazolin Phagecon is very soluble, it is beneficial to add 5 ml of water for injections to vials of 1 g. Shake to dissolve, withdraw the entire contents of the vial into a syringe. For intramuscular administration, Cefazolin Phagecon can be reconstituted with 1% lidocaine solution: 1 g is stable in 4 ml. Shake to dissolve, withdraw the entire contents of the vial into a syringe. Intramuscular administration: this form of the medicine should not be used in children under 30 months of age (lidocaine hydrochloride solvent). The solution after reconstitution may have a yellow color, which is normal.
• - DilutionThe reconstituted solution should be diluted with the solvents listed above in section
• 6.6: add approximately 45 ml of solvent 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.
Chemical and physical 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 use, and the storage time should usually not exceed 8 hours at 25°C and 24 hours at 2-8°C.