Cefazolin Phagecon

PACKAGE LEAFLET

Package leaflet: information for the user

Cefazolina Phagecon 1 g powder for injectable solution / for infusion

cefazolin
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Cefazolina Phagecon 1 g powder for injectable solution / for infusion is and what it is used for

2. What you need to know before using Cefazolina Phagecon 1 g powder for injectable solution / for infusion

3. How to use Cefazolina Phagecon 1 g powder for injectable solution / for infusion

4. Possible side effects

5. How to store Cefazolina Phagecon 1 g powder for injectable solution / for infusion

6. Contents of the pack and other information

7. What Cefazolina Phagecon 1 g powder for injectable solution / for infusion is and what it is used for

Cefazolina Phagecon contains the active substance cefazolin (as sodium cefazolin). Cefazolin belongs to a group of antibiotics called cephalosporins, which destroy bacteria.
Cefazolin is used when an infection is definitely or likely caused by bacteria sensitive to cefazolin. It is used in adults and children over 1 month of age 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 infections listed above.

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

2. What you need to know before using Cefazolin Phagecon 1 g powder for injectable/infusion solution

Do not use Cefazolin Phagecon 1 g powder for injectable/infusion solution

• if you are allergic to cefazolin or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe anaphylactic reaction (hypersensitivity) (for example, severe skin peeling, swelling of the face, hands, feet, lips, tongue or throat, difficulty swallowing or breathing) to any other type of beta-lactam antibiotics (penicillins, monobactams and carbapenems).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Cefazolin Phagecon 1 g powder for
injectable/infusion solution.

• if you have ever had a mild allergic reaction to penicillin or to similar antibiotics (for example, an itchy rash);
• if you suffer from allergies not already mentioned in this leaflet;
• if you have ever had intestinal problems, particularly inflammation of the intestine (colitis);
• if you have kidney problems;
• if you are on a low-sodium diet.

Risk factors causing vitamin K deficiency or risk factors affecting other blood coagulation mechanisms .
In rare cases, blood coagulation disorders may occur during treatment with cefazolin. Furthermore, blood coagulation may be impaired in patients with conditions that cause or exacerbate bleeding, such as haemophilia, gastric and intestinal ulcers. In such cases, blood coagulation will be monitored.
This medicine must not be administered by injection into the space around the spinal cord (intrathecal route), as central nervous system toxicity (including seizures) has been reported.
Cefazolin Phagecon 1 g powder for injectable/infusion solution must not be given to premature infants or infants during the first month of life.
Prolonged use of Cefazolin Phagecon 1 g powder for injectable/infusion solution may lead to secondary infections. Your doctor will monitor you closely and treat you if necessary.
Other medicines and Cefazolin Phagecon 1 g powder for injectable/infusion solution
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Cefazolin Phagecon 1 g powder for injectable/infusion solution may affect how some medicines work. Conversely, some medicines may affect how Cefazolin Phagecon 1 g powder for injectable/infusion solution works.
Inform your doctor if you are taking any of the following medicines, particularly:

• aminoglycosides or other antibiotics (for treatment of infections)
• probenecid (for treatment of gout)
• vitamin K
• anticoagulants (medicines used to thin the blood)
• furosemide (a diuretic)
• oral contraceptives ("the pill")

Also inform your doctor if blood tests or urine tests for glucose are to be performed.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.
Driving and using machines
Cefazolin Phagecon 1 g powder for injectable/infusion solution may impair your ability to drive or use machinery, particularly due to the possible occurrence of encephalopathy (see sections 3 and 4).
Cefazolin Phagecon 1 g powder for injectable/infusion solution contains sodium
This medicine contains 50.6 mg of sodium (the main component of table salt) per vial.
This corresponds to 2.53% of the maximum recommended daily dietary intake for an adult.

3. How to use Cefazolina Phagecon 1 g powder for injectable solution/for infusion

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Cefazolina Phagecon 1 g powder for injectable solution/for infusion will be administered to you by a healthcare professional via one of the following routes:

• as an injection into a muscle (e.g., into the muscle of the arm);
• as a slow injection into a vein, which may take 3–5 minutes;
• through a tube into a vein. This procedure is called “intravenous infusion”.

Recommended doses
Your doctor will determine the dose of Cefazolina Phagecon 1 g powder for injectable solution/for infusion based on your age, weight, severity of infection, and kidney function. Your doctor will explain this to you.
Adults, adolescents and elderly patients

• The dosage for treating an infection may range from 1 g to 6 g or 12 g per day, depending on the severity of the infection.
• If you are about to undergo surgery, you may be given a dose of 1 g, 30–60 minutes before the start of the procedure.
• In case of prolonged surgical procedures, an additional dose of 500 mg to 1 g may be administered during surgery. Treatment with Cefazolina Phagecon 1 g powder for injectable solution/for infusion may continue for 24 hours after surgery to prevent infections.

Use in children and infants (aged 1 month and older)
The dosage will be calculated by the doctor based on the child's body weight. For children, the daily dose may range from 25 mg to 50 mg per kg of body weight. Depending on the severity of the infection, the dose may be increased to 100 mg per kg of body weight.
Data are insufficient to recommend a dosage regimen for children under 1 month of age.
Adults and children with kidney problems
If you have kidney problems, you may receive a lower dose. Blood tests may be performed to ensure you are receiving the appropriate dose.
If you use more Cefazolina Phagecon 1 g powder for injectable solution/for infusion than you should
Seek advice from your doctor.
As with all antibiotics belonging to this therapeutic class, administration of this medicine, particularly in case of overdose, may carry a risk of encephalopathy (which may cause confusion, disturbances of consciousness, seizures, or abnormal movements). If such symptoms occur, seek immediate medical advice from your doctor or pharmacist (see sections 2 and 4).
If you forget to use Cefazolina Phagecon 1 g powder for injectable solution/for infusion
If you have missed a dose, contact your doctor or pharmacist immediately.

4. Possible side effects

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

Severe allergic reactions (very rare: may affect up to 1 in 10,000 people)
If you notice a severe allergic reaction, contact a doctor immediately. Signs may include:

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

Other possible side effects

Common (may affect up to 1 in 10 people)

• Rash
• Nausea and vomiting
• Diarrhoea
• Loss of appetite
• Flatulence
• Abdominal pain
• Pain and hardening at the injection site

Uncommon (may affect up to 1 in 100 people)

• Increase in the number of a certain type of blood cells
• Low white blood cell count
• Low count of cells involved in blood clotting
• Inflammation of veins
• Severe hypersensitivity reactions, drug fever
• Skin redness, skin itching, joint pain, skin lesions, widespread rash, urticaria
• Transient increase in liver function test values

Rare (may affect up to 1 in 1,000 people)

• Blood may take longer than normal to clot. You may notice this if you have nosebleeds or if you cut yourself.
• Kidney problems

Very rare (may affect up to 1 in 10,000 people)

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

Not known (frequency cannot be estimated from the available data)

• Candida (a yeast infection of the vagina, mouth or present in skin folds); your doctor can provide treatment for thrush.
• Headache
• Dizziness
• Unpleasant bodily sensations, sometimes painful, with tingling, numbness, limbs feeling "asleep", disturbances in the perception of cold and heat
• Agitation affecting the central nervous system
• Involuntary muscle contractions
• Seizures
• Inflammation of the large intestine (colon). Signs include diarrhoea, usually with blood and mucus, abdominal pain and fever.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefazolin Phagecon 1 g powder for injectable/infusion solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.". The expiry date refers to the last day of that month.
Before opening: this medicine requires no special storage conditions.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C and 24 hours at 2-8 °C in Water for Injections. From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 8 hours at 25 °C and 24 hours at 2-8 °C.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Cefazolina Phagecon 1 g powder for injectable/infusion solution contains

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

Description of the appearance of Cefazolina Phagecon 1 g powder for injectable/infusion solution
and contents of the pack
Cefazolina Phagecon 1 g powder for injectable/infusion solution is presented as a white or almost white powder.
Cefazolina Phagecon 1 g powder for injectable/infusion solution is available in vials containing 1 g of Cefazolin as the sodium salt, closed with a chlorobutyl rubber stopper and sealed with an aluminum and polypropylene cap.
Cefazolina Phagecon 1 g powder for injectable/infusion solution is packaged in boxes containing 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
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 Lourenço Ferreira, lots 8, 15 and 16
3450-232 Mortágua
Portugal

This medicinal product is authorized in the Member States of the European Economic Area under the following names:
Portugal Cefazolina Basi
Belgium Cefazolin Phagecon 1 g Powder for solution for injection/infusion
Cefazolin Phagecon 1 g poeder voor oplossing voor injectie/infusie
Cefazolin Phagecon 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Italy Cefazolina Phagecon
Czech Republic Cefazolin Phagecon
Poland Cefazolin Phagecon

WHAT YOU NEED TO KNOW ABOUT ANTIBIOTICS?
Antibiotics are effective in fighting infections caused by bacteria. They are not effective against infections caused by viruses.
Moreover, your doctor has chosen to prescribe this antibiotic because it is appropriate for you and your current illness.
Bacteria have the ability to survive or reproduce despite the action of an antibiotic. This phenomenon is called resistance: it renders certain antibiotic treatments ineffective.
Resistance has increased due to the excessive or inappropriate use of antibiotics.
You risk promoting the emergence of resistant bacteria, thereby delaying your recovery or even rendering this medicine ineffective, if you do not comply with:

• the prescribed dose,
• the timing of administration,
• and the duration of treatment.

Therefore, to maintain the effectiveness of this medicine:
1- Use an antibiotic only when prescribed by a doctor.
2- Strictly follow the doctor's instructions.
3- Do not reuse an antibiotic without a medical prescription, even if you believe you are treating a similar illness.
4- Never give your antibiotic to another person; it may not be suitable for their condition.
5- At the end of treatment, return all opened packages to the pharmacist for proper and appropriate disposal of this medicine.

---

The following information is intended exclusively for physicians or healthcare professionals:
Cefazolina Phagecon can be administered by intramuscular or intravenous route. In both cases, the total daily doses are the same. The dosage and route of administration depend on the site and severity of the infection, as well as the clinical and bacteriological course.
Adults and adolescents (over 12 years of age and ≥ 40 kg body weight):

• Infections caused by susceptible microorganisms: 1 g–2 g of Cefazolin per day, divided into 2–3 equal doses.
• Infections caused by moderately susceptible microorganisms: 3 g–4 g of Cefazolin per day, divided into 3–4 equal doses.

In severe infections, doses up to 6 g per day may be administered in three or four equal doses (one dose every 6 or 8 hours).
For perioperative prophylaxis: to prevent postoperative infections in contaminated or potentially contaminated surgical procedures, the recommended dose is: 1 g of Cefazolin administered 30–60 minutes before surgery.
Paediatric population
Children and infants over 30 months of age (intramuscular route):
25 to 50 mg/kg every 24 hours (divided into three or four equal doses).
For severe infections, the total daily dose may be increased to 100 mg/kg body weight.
The use of Cefazolin in premature infants and infants under one month of age is not recommended, as safety for use in these patients has not been established.
Patients with renal impairment
In patients with renal impairment, dosage must be adjusted by the physician according to creatinine clearance or serum creatinine levels (see table).

• Severe or very severe infection:

• Mild or moderate infection:

Prevention of postoperative infections in surgery: should be of short duration, most often limited to the duration of the procedure, sometimes 24 hours, but never exceeding 48 hours.

• 2 g administered intravenously at induction of anesthesia,
• followed by repeated 1 g injections every 4 hours throughout the duration of the procedure. If administration continues beyond the intraoperative period, a further 1 g injection should be given every 8 hours. In cardiac surgery with extracorporeal circulation (ECC), an additional 1 g injection should be administered after ECC connection. In cesarean sections, the injection must be given after clamping of the umbilical cord.

Administration method
Cefazolina Phagecon may be administered intravenously, either by direct injection or by continuous or intermittent infusion.
For direct intravenous injection, this medicinal product should be injected slowly into a vein over 3–5 minutes.
The solution of this medicinal product may also be administered as a slow intravenous infusion.
Cefazolin may be administered by deep intramuscular injection.
Intramuscular administration: this dosage form must not be used in children under 30 months of age (due to the solvent containing lidocaine hydrochloride).

Special precautions for disposal and handling

• Direct intravenous injection: Reconstitute the vial of Cefazolina powder with 5 mL of water for injections (WFI) and inject slowly over 3–5 minutes directly into a vein or into an infusion set.
• Deep intramuscular injection: Reconstitute the vial of Cefazolina powder with 4 mL of 1% lidocaine solution or with 5 mL of water for injections (WFI), and administer by deep intramuscular injection.
• Intravenous infusion: Dilute the primary solution of Cefazolina in 50 mL of water for injections or in one of the following intravenous solutions:
  • 0.9% sodium chloride,
  • 5% or 10% glucose,
  • 5% glucose with 0.9% sodium chloride,
  • 5% glucose with 0.2% or 0.45% saline,
  • Ringer's solution,
  • Ringer lactate solution,
  • 5% glucose with Ringer lactate solution.

Do not use for intrathecal administration.

• Reconstitution: Cefazolina Phagecon 1 g powder for injectable solution/for infusion must be reconstituted with water for injections: 1 g is stable in 2 mL. Cefazolina Phagecon 1 g powder for injectable solution/for infusion is highly soluble; for intravenous use, it is preferable to add 5 mL of WFI to the 1 g vials. Shake to dissolve and withdraw the entire contents of the vial into a syringe. For intramuscular administration, Cefazolina Phagecon 1 g powder for injectable solution/for infusion may be reconstituted with 1% lidocaine solution: 1 g is stable in 4 mL. Shake to dissolve and withdraw the entire contents of the vial into a syringe. Intramuscular administration: this dosage form must not be used in children under 30 months of age (solvent containing lidocaine hydrochloride). After reconstitution, the solution may appear yellow, which is normal.
• Dilution: The reconstituted solution must be diluted with one of the solvents listed above: 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 medicinal product and waste material derived from this medicinal product must be disposed of in accordance with local regulations.

Shelf life
3 years.
The physicochemical stability of the reconstituted solution has been demonstrated for 8 hours at 25 °C and for 24 hours at a temperature between 2 °C and 8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 8 hours at 25 °C and 24 hours at 2–8 °C.
PACKAGE LEAFLET

Package leaflet: information for the user

Cefazolin Phagecon 2 g powder for injectable/infusion solution

cefazolin
Please read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Cefazolin Phagecon 2 g powder for injectable/infusion solution is and what it is used for

2. What you need to know before using Cefazolin Phagecon 2 g powder for injectable/infusion solution

3. How to use Cefazolin Phagecon 2 g powder for injectable/infusion solution

4. Possible side effects

5. How to store Cefazolin Phagecon 2 g powder for injectable/infusion solution

6. Contents of the pack and other information

7. What Cefazolin Phagecon 2 g powder for injectable/infusion solution is and what it is used for

Cefazolin Phagecon contains the active substance cefazolin (as cefazolin sodium). Cefazolin belongs to a group of antibiotics called cephalosporins, which destroy bacteria.
Cefazolin is used when an infection is definitely or probably caused by bacteria sensitive to cefazolin. It is used in adults and children over 1 month of age 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-mentioned infections

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

2. What you should know before using Cefazolin Phagecon 2 g powder for injectable/infusion solution

Do not use Cefazolin Phagecon 2 g powder for injectable/infusion solution

• if you are allergic to cefazolin or to any of the other ingredients of this medicine (listed in section 6).
• if you have ever had a severe anaphylactic reaction (hypersensitivity) (for example, severe skin peeling, swelling of the face, hands, feet, lips, tongue or throat, difficulty swallowing or breathing) to any other type of beta-lactams (penicillins, monobactams and carbapenems).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Cefazolin Phagecon 2 g powder for
injectable/infusion solution.
Allergic reactions
Any allergic manifestation (skin rash, itching sensation, etc.) during treatment
must be immediately reported to your doctor. In case of a severe and sudden allergic reaction, treatment with Cefazolin Phagecon 2 g powder for injectable/infusion solution must be immediately discontinued. Before taking this treatment, inform your doctor if, during a previous antibiotic treatment, you experienced hives or other skin rashes, itching, angioedema (sudden swelling of the face and neck of allergic origin).
Use this medicine with caution if you have allergies, bronchial asthma or hay fever.
Diarrhea
The onset of diarrhea during antibiotic treatment must not be treated without consulting your
doctor. Diarrhea may occur even after taking antibiotics, including cefazolin, or after stopping them. If the condition becomes severe or persistent, or if you notice blood or mucus in your stools, INFORM YOUR DOCTOR IMMEDIATELY, as this may be life-threatening. Do not take medicines that block or slow intestinal movements.
IF IN DOUBT, IT IS ESSENTIAL TO SEEK ADVICE FROM YOUR DOCTOR OR
PHARMACIST.
Nervous system disorders
As with all antibiotics belonging to this therapeutic class, administration of this
medicine, particularly in cases of overdose or inadequate dose adjustment in patients with renal dysfunction, may pose a risk of encephalopathy (which may cause confusion, disturbances of consciousness, seizures or abnormal movements). If such conditions occur, seek immediate advice from your doctor or pharmacist (see sections 3 and 4).
Renal function
In case of renal impairment, INFORM YOUR DOCTOR, as treatment adjustment is required. Your doctor will monitor renal function if this medicine is used concomitantly with nephrotoxic medicines or diuretics.
Other
For solutions reconstituted with lidocaine, do not inject intravenously.
There are no data on the safety of cefazolin in premature infants and infants under one month of age.
Biological tests
Laboratory test results may be affected by taking this medicine.
Risk factors causing vitamin K deficiency or risk factors affecting other blood coagulation mechanisms
In rare cases, blood coagulation disorders may occur during treatment with cefazolin. Furthermore, blood coagulation may be impaired in patients with a disease that causes or exacerbates bleeding, such as haemophilia, gastric and intestinal ulcers. In these cases, blood coagulation will be monitored.
This medicine must not be administered by injection into the space around the spinal cord (intrathecal route), as central nervous system toxicity (including seizures) has been reported.
Cefazolin Phagecon 2 g powder for injectable/infusion solution must not be administered to premature infants and infants during the first month of life.
Prolonged use of Cefazolin Phagecon 2 g powder for injectable/infusion solution may lead to secondary infections. Your doctor will closely monitor you and treat you if necessary.
Other medicines and Cefazolin Phagecon 2 g powder for injectable/infusion solution
Inform your doctor if you are currently taking, have recently taken or might take any other medicines.
Cefazolin Phagecon 2 g powder for injectable/infusion solution may affect how some medicines work. Conversely, some medicines may affect how Cefazolin Phagecon 2 g powder for injectable/infusion solution works.
Inform your doctor if you are taking any of the following medicines, particularly:

• aminoglycosides or other antibiotics (for treatment of infections)
• probenecid (for treatment of gout)
• vitamin K
• anticoagulants (medicines used to thin the blood)
• furosemide (a diuretic)
• oral contraceptives ("the pill")

Also inform your doctor if blood tests or urine tests for glucose are scheduled.
Pregnancy, breastfeeding and fertility
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor for advice before using this medicine.
Pregnancy
Cefazolin Phagecon 2 g powder for injectable/infusion solution may be used during pregnancy only on the advice of your doctor.
If you find out you are pregnant while taking Cefazolin Phagecon 2 g powder for injectable/infusion solution, consult your doctor, who is the only one able to assess whether it is necessary to continue taking this medicine.
Breastfeeding
Breastfeeding is possible while taking this medicine.
If the newborn experiences problems such as diarrhea, allergy or skin rash, inform your doctor, who will advise you on what to do, as these effects in the infant may be due to the medicine.
Driving and use of machines
Cefazolin Phagecon 2 g powder for injectable/infusion solution may impair the ability to drive vehicles and operate machinery, particularly due to the possible occurrence of encephalopathy (see sections 3 and 4).
Cefazolin Phagecon 2 g powder for injectable/infusion solution contains sodium
This medicine contains 101.1 mg of sodium (the main component of table salt) per vial. This corresponds to 5.055% of the maximum daily recommended dietary intake for an adult.

3. How to use Cefazolin Phagecon 2 g powder for injectable/infusion solution

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your
doctor or pharmacist.
Cefazolin Phagecon 2 g powder for injectable/infusion solution will be administered to you by a
doctor via one of the following routes:

• as an injection into a muscle (e.g., into the muscle of the arm);
• as a slow injection into a vein, which may take 3–5 minutes;
• through a tube into a vein. This procedure is called “intravenous infusion”.

Recommended doses
Your doctor will determine the dose of Cefazolin Phagecon 2 g powder for injectable/infusion solution based on your age, body weight, severity of infection, and kidney function. Your doctor will explain this to you.
Adults, adolescents, and elderly patients

• The dosage for treating an infection may range from 1 g to 6 g or 12 g per day, depending on the severity of the infection.
• If you are about to undergo surgery, you may be given a dose of 1 g, 30–60 minutes before the start of the procedure.
• In the case of prolonged surgical procedures, an additional dose of 500 mg to 1 g may be administered during surgery. Treatment with Cefazolin Phagecon 2 g powder for injectable/infusion solution may continue for 24 hours after surgery to prevent infections.

Use in children and infants (aged 1 month and older)
The dosage will be calculated by the doctor based on the child's body weight. For children, the daily dose may range from 25 mg to 50 mg per kg of body weight. Depending on the severity of the infection, the dose may be increased to 100 mg per kg of body weight.
There are insufficient data to recommend dosing in children under 1 month of age.
Adults and children with kidney problems
In patients with renal impairment, the dosage must be adjusted by the doctor (see table).

• Severe or very severe infection:

• Mild or moderate infection:

How to use Cefazolin Phagecon 2 g powder for injectable/infusion solution
Cefazolin may be administered by deep intramuscular or intravenous route.
Intramuscular administration: Dissolve 1 g of powder by dilution in 4 mL of 1% lidocaine solution or in 5 mL of water for injections (p.p.i.). Shake the vial vigorously until the contents are completely dissolved; the reconstituted solution must be clear and free from visible particles. Once reconstituted, the solution may have a yellow coloration, which is normal. Administer by deep intramuscular injection.
Intravenous administration: Cefazolin may be administered either by direct injection or by continuous or intermittent infusion.
For instructions on reconstitution and dilution of the medicinal product prior to administration, see the section “The following information is intended exclusively for physicians or healthcare professionals”.

If you use more Cefazolin Phagecon 2 g powder for injectable/infusion solution than you should
Consult your doctor.
As with all antibiotics belonging to this therapeutic class, administration of this medicinal product, particularly in case of overdose, may pose a risk of encephalopathy (which may cause confusion, disturbances in consciousness, seizures, or abnormal movements). If such symptoms occur, seek immediate advice from your doctor or pharmacist (see sections 2 and 4).

If you forget to use Cefazolin Phagecon 2 g powder for injectable/infusion solution
If you have missed a dose, contact your doctor or pharmacist immediately.

4. Possible side effects

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

Severe allergic reactions (very rare, may affect up to 1 in 10,000 people)
If you notice a severe allergic reaction, contact a doctor immediately. Signs may include:

• Sudden swelling of the face, neck, lips or mouth. This may cause difficulty in breathing or swallowing.
• Sudden swelling of the hands, feet or ankles.

Other possible side effects

Common (may affect up to 1 in 10 people)

• Rash
• Nausea and vomiting
• Diarrhoea
• Loss of appetite
• Flatulence
• Abdominal pain
• Pain and hardening at the injection site

Uncommon (may affect up to 1 in 100 people)

• Increase in the number of a certain type of blood cells
• Low number of white blood cells
• Low number of cells involved in blood clotting
• Inflammation of the veins
• Severe hypersensitivity reactions, drug fever
• Skin redness, skin itching, joint pain, skin lesions, widespread rash, urticaria
• Transient increase in liver function test values

Rare (may affect up to 1 in 1,000 people)

• Blood may take longer than normal to clot. You may notice this if you have nosebleeds or if you cut yourself.
• Kidney problems

Very rare (may affect up to 1 in 10,000 people)

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

Not known (frequency cannot be estimated from the available data)

• Candida (a yeast infection of the vagina, mouth or present in skin folds); your doctor can provide treatment for thrush.
• Headache
• Dizziness
• Unpleasant bodily sensations, sometimes painful, with tingling, numbness, limbs going to sleep, disturbances in the perception of cold and heat
• Agitation states in the central nervous system
• Involuntary muscle contractions
• Seizures
• Inflammation of the large intestine (colon). Signs include diarrhoea, usually with blood and mucus, abdominal pain and fever.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Cefazolin Phagecon 2 g powder for injectable/infusion solution

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the last day of that month.
Before opening: this medicine requires no special storage conditions.
After reconstitution:
Chemical and physical in-use stability has been demonstrated for 8 hours at 25 °C and 24 hours at 2-8 °C in water for injections. From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration of in-use storage and the conditions prior to use are the responsibility of the user and should normally not exceed 8 hours at 25 °C and 24 hours at 2-8 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Cefazolina Phagecon 2 g powder for injectable/infusion solution contains

• The active substance is Sodium Cefazolin.
• Each vial contains 2.096 g of Sodium Cefazolin, equivalent to 2 g of Cefazolin.

Description of the appearance of Cefazolina Phagecon 2 g powder for injectable/infusion solution
and package contents
Cefazolina Phagecon 2 g powder for injectable/infusion solution is a white or almost white powder.
Cefazolina Phagecon 2 g powder for injectable/infusion solution is available in vials containing 2 g of
Cefazolin as the sodium salt, closed with a chlorobutyl rubber stopper and sealed with an aluminum and
polypropylene cap.
Cefazolina Phagecon 2 g powder for injectable/infusion solution is packaged in 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
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 Lourenço Ferreira, lots 8, 15 and 16
3450-232 Mortágua
Portugal

This medicinal product is authorized in the European Economic Area Member States under the
following names:
Portugal Cefazolina Basi
Belgium Cefazolin Phagecon 2 g Powder for solution for injection/infusion
Cefazolin Phagecon 2 g poeder voor oplossing voor injectie/infusie
Cefazolin Phagecon 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Italy Cefazolina Phagecon
Czech Republic Cefazolin Phagecon
Poland Cefazolin Phagecon

WHAT YOU SHOULD KNOW ABOUT ANTIBIOTICS?
Antibiotics are effective in fighting infections caused by bacteria. They are not effective against infections caused by viruses.
Moreover, your doctor has chosen to prescribe this antibiotic because it is appropriate for you and your current illness.
Bacteria have the ability to survive or reproduce despite the action of an antibiotic. This phenomenon is called resistance: it renders certain antibiotic treatments ineffective.
Resistance is increased by the excessive or inappropriate use of antibiotics.
You risk promoting the emergence of resistant bacteria, thereby delaying your recovery or even rendering this medicine ineffective, if you do not comply with:

• the prescribed dose,
• the timing of administration,
• and the duration of treatment.

Therefore, to maintain the effectiveness of this medicine:
1- Use an antibiotic only when prescribed by a doctor.
2- Strictly follow the doctor's instructions.
3- Do not reuse an antibiotic without medical prescription, even if you believe you are treating a similar illness.
4- Never give your antibiotic to another person; it may not be suitable for their condition.
5- At the end of treatment, return all opened packages to the pharmacist for proper and appropriate disposal of this medicine.

---

The following information is intended exclusively for physicians or healthcare professionals:
Cefazolina Phagecon can be administered by intramuscular or intravenous route. In both cases, the total daily doses are the same. The dosage and route of administration depend on the site and severity of the infection, as well as on the clinical and bacteriological course.
Adults and adolescents (over 12 years of age and ≥ 40 kg body weight):

• Infections caused by susceptible microorganisms: 1 g–2 g of Cefazolin per day, divided into 2–3 equal doses.
• Infections caused by moderately susceptible microorganisms: 3 g–4 g of Cefazolin per day, divided into 3–4 equal doses.

In severe infections, doses up to 6 g per day may be administered in three or four equal doses (one dose every 6 or 8 hours).
For perioperative prophylaxis: to prevent postoperative infections in contaminated or potentially contaminated surgical procedures, the recommended dose is: 1 g of Cefazolin 30–60 minutes before surgery.
Paediatric population
Children and infants over 30 months of age (intramuscular route):
25 to 50 mg/kg every 24 hours (divided into three or four equal doses).
In severe infections, the total daily dose may be increased to 100 mg/kg body weight.
The use of Cefazolin in premature infants and infants under one month of age is not recommended, as safety for use in these patients has not been established.
Patients with renal impairment
In patients with renal impairment, the dosage must be adjusted by the physician according to creatinine clearance or serum creatinine levels (see table).

• Severe or very severe infection:

• Mild or moderate infection:

Prevention of postoperative infections in surgery: should be of short duration, most often limited to the duration of the procedure, sometimes 24 hours, but never exceeding 48 hours.

• 2 g intravenously at induction of anesthesia,
• followed by repeated 1 g doses every 4 hours throughout the duration of the procedure. If administration extends beyond the intraoperative period, a further 1 g dose should be given every 8 hours. In cardiac surgery with extracorporeal circulation (ECC), an additional 1 g dose should be administered after ECC connection. In cesarean sections, the injection must be given after clamping of the umbilical cord.

Method of administration
Cefazolina Phagecon may be administered intravenously, either by direct injection or by continuous or intermittent infusion.
For direct intravenous injection, this medicinal product should be injected slowly over 3–5 minutes into a vein.
The solution of this medicinal product may also be administered as a slow intravenous infusion.
Cefazolin can be administered by deep intramuscular injection.
Intramuscular administration: this dosage form must not be used in children under 30 months of age (due to the solvent containing lidocaine hydrochloride).

Special precautions for disposal and handling

• Direct intravenous injection: Reconstitute the vial of Cefazolin powder with 5 mL of water for injections and inject slowly over 3–5 minutes directly into a vein or into an infusion set.
• Deep intramuscular injection: Reconstitute the vial of Cefazolin powder with 4 mL of 1% lidocaine solution or with 5 mL of water for injections and administer by deep intramuscular injection.
• Intravenous infusion: Dilute the primary solution of Cefazolin in 50 mL of water for injections or in one of the following intravenous solutions:
  • 0.9% sodium chloride,
  • 5% or 10% glucose,
  • mixed solution of 5% glucose and 0.9% sodium chloride,
  • 5% glucose with 0.2% or 0.45% saline,
  • Ringer's solution,
  • Ringer's lactate solution,
  • mixed solution of 5% glucose and Ringer's lactate.

Do not use for intrathecal administration.

• Reconstitution: Cefazolina Phagecon 2 g powder for solution for injection/infusion should be reconstituted with water for injections: 1 g is stable in 2 mL. Cefazolina Phagecon 2 g powder for solution for injection/infusion is highly soluble; for intravenous use, it is preferable to add 5 mL of water for injections to 1 g vials. Shake to dissolve, then draw up the entire contents of the vial into a syringe. For intramuscular administration, Cefazolina Phagecon 2 g powder for solution for injection/infusion may be reconstituted with 1% lidocaine solution: 1 g is stable in 4 mL. Shake to dissolve, then draw up the entire contents of the vial into a syringe. Intramuscular administration: this dosage form must not be used in children under 30 months of age (due to the solvent containing lidocaine hydrochloride). After reconstitution, the solution may appear yellow, which is normal.
• Dilution: The reconstituted solution should be diluted with one of the solvents listed above: add approximately 45 mL of solvent to the reconstituted solution to achieve a final volume of 50 mL. After reconstitution/dilution, use immediately. Any unused medicinal product and waste material should be disposed of in accordance with local regulations.

Shelf life
3 years.
The physico-chemical stability of the reconstituted solution has been demonstrated for 8 hours at 25 °C and for 24 hours at a temperature between 2 °C and 8 °C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and should normally not exceed 8 hours at 25 °C and 24 hours at 2–8 °C.