Cefazolin phagecon

Package leaflet: Information for the user

Cefazolin Phagecon, 2 g, powder for solution for injection/infusion
Cefazolin sodium
Please read all of this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. It may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

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

Cefazolin Phagecon contains the active substance cefazolin (in the form of cefazolin sodium). Cefazolin belongs to a group of antibiotics called cephalosporins, which kill bacteria.
Cefazolin is used when infection is definitely 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 related to the above infections.

Cefazolin Phagecon may also be administered before 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 experienced a severe anaphylactic reaction (hypersensitivity) (e.g. severe peeling of the skin, swelling of the face, hands, feet, lips, tongue or throat, difficulty swallowing or breathing) in response to any other type of beta-lactam antibiotics (penicillins, monobactams and carbapenems).

Warnings and precautions
Before starting treatment with Cefazolin Phagecon, discuss this with your doctor, pharmacist or
nurse.
Allergic reactions
Any allergic symptoms (skin rash, itching, etc.) occurring during treatment must be reported
immediately to the doctor. In case of a severe and sudden allergic reaction, administration of Cefazolin Phagecon must be stopped immediately. Before using this medicine, inform the doctor if the patient has previously experienced hives or other skin rashes, itching, or angioedema (sudden swelling of the face and neck of allergic origin) during previous antibiotic treatment.
Caution should be exercised when using this medicine in patients with allergies, bronchial asthma or
hay fever.
Diarrhoea
Diarrhoea occurring during antibiotic therapy should not be treated without medical advice.
Diarrhoea may occur during or after taking antibiotics, including cefazolin. If diarrhoea becomes severe or persistent, or if the patient notices blood or mucus in the stool, THE DOCTOR MUST BE INFORMED IMMEDIATELY, as this may be life-threatening. Do not take medications that stop or slow down bowel movements.
IF IN DOUBT, ALWAYS CONSULT A DOCTOR OR PHARMACIST FOR ADVICE.
Nervous system disorders
As with all antibiotics belonging to this therapeutic group, administration of this medicine, especially in cases of overdose or incorrect dose adjustment in patients with impaired kidney function, may carry a risk of encephalopathy (which may lead to confusion, altered consciousness, seizures or abnormal movements). If such disorders occur, seek immediate advice from a doctor or pharmacist (see sections 3 and 4).
Kidney function
INFORM THE DOCTOR if the patient has kidney failure, as treatment adjustment may be necessary. The doctor will monitor kidney function, especially if other nephrotoxic drugs or diuretics are used concomitantly.
Other
Solutions reconstituted with lidocaine must not be administered intravenously.
There are no data on the safety of cefazolin use in preterm infants and infants under 1 month of age.
Biological analyses
Taking this medicine may affect laboratory test results.
Risk factors causing vitamin K deficiency or risk factors causing other disturbances in blood coagulation mechanisms .
Rarely, treatment with cefazolin may lead to disturbances in blood coagulation.
Additionally, blood coagulation may be impaired in patients with diseases that may cause or exacerbate bleeding, such as haemophilia, gastric or duodenal ulcers. In such cases, the patient's coagulation system will be monitored.
This medicine must not be administered by intrathecal injection (into the space surrounding the spinal cord), as neurotoxic effects (including seizures) have been reported.
Cefazolin Phagecon must not be used in preterm infants or newborns under 1 month of age.
Prolonged use of Cefazolin Phagecon may lead to superinfection. The doctor will closely monitor the patient and, if necessary, recommend appropriate treatment.
Cefazolin Phagecon and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Cefazolin Phagecon may affect the action of certain medicines and, conversely, certain medicines may affect the way Cefazolin Phagecon works.
Inform the doctor if the patient is taking any of the following medicines, in particular:

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

Also inform the doctor if the patient is undergoing urine glucose tests or blood tests.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.
Pregnancy
Cefazolin Phagecon may be used during pregnancy only after consultation with a doctor.
If the patient discovers she is pregnant while taking Cefazolin Phagecon, she should consult her doctor, as only the doctor can assess whether continued use of this medicine is necessary.
Breastfeeding
Breastfeeding is possible while taking this medicine.
If the newborn develops problems such as diarrhoea, allergy or skin rash, inform the doctor, who will advise on appropriate action, as these symptoms in the infant may be caused by the medicine.
Driving and operating machinery
Cefazolin Phagecon has a significant effect on the ability to drive and operate machinery, 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 dietary sodium intake for adults. This should be taken into account in patients who are monitoring their dietary sodium intake.

3. How to use Cefazolin Phagecon

This medicine should always be used according to the doctor's instructions. If in doubt, consult
your 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 muscle of the upper arm)
• by slow injection into a vein. The injection will take from 3 to 5 minutes
• through a small tube inserted into a vein. This is known as "intravenous infusion".

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

• In case of infection, the dose may range from 1 g to 6 g or 12 g per day, depending on the severity of the infection.
• Prior to planned surgery, the patient will receive a 1 g dose, given 30–60 minutes before the start of the procedure.
• In case of prolonged surgical procedures, the patient may additionally receive 500 mg to 1 g of the medicine during surgery. Administration of Cefazolin Phagecon may continue for 24 hours after surgery to prevent the risk of infection.

Use in children and infants (aged 1 month and older)
The doctor will determine the appropriate dose based on the child's body weight. In children, the daily dose may
range from 25 mg to 50 mg per kg of body weight. This dose may be increased to 100 mg per kg of body
weight, depending on the severity of the infection.
Data are insufficient to recommend dosing in children under 1 month of age.
Adults and children with impaired kidney function
The doctor should adjust the dosage in patients with kidney impairment (see table).

• Severe or very severe infection:

• Mild or moderate infection:

How to use Cefazolin Phagecon
Cefazolin may be administered deep intramuscularly or intravenously.
Intramuscular administration: Dissolve 1 g of powder by diluting 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 reconstituted solution should be clear and free from visible particles. The reconstituted solution may have a yellow tint, which is normal. Administer as a deep intramuscular injection.
Intravenous administration: Cefazolin may be given as a direct injection or by continuous or intermittent infusion.
Instructions for reconstitution and dilution of the medicinal product prior to administration are provided in the section Information for healthcare professionals.
Use of a higher than recommended dose of Cefazolin Phagecon
Consult a physician.
As with all antibiotics belonging to this therapeutic group, administration of this medicinal product, especially in cases of overdose, may carry the risk of encephalopathy (which may lead to confusion, disturbances of consciousness, seizures, or abnormal movements). If such symptoms occur, seek immediate advice from a physician or pharmacist (see sections 2 and 4).
Missed dose of Cefazolin Phagecon
Do not administer a double dose to make up for a missed dose.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Severe allergic reactions (very rare, may occur in less than 1 in 10,000 people): If the
patient experiences a severe allergic reaction, you must tell the doctor immediately.
Symptoms may include:

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

Other possible adverse reactions
Common (may occur in less than 1 in 10 people)

• Skin rash
• Nausea and vomiting
• Diarrhoea
• Loss of appetite
• Abdominal bloating
• Abdominal pain
• Pain and hardening at the injection site

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

• Increased number of a specific type of blood cells
• Low number of white blood cells
• Low number of blood cells involved in blood clotting
• Inflammation of veins
• Severe hypersensitivity reactions, drug fever
• Skin redness, skin itching, joint pain, skin lesions, generalized rash, urticaria
• 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 may be observed with nosebleeds or minor 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 available data)

• Fungal infections (yeast infection of the vagina, mouth or skin folds); the doctor may recommend treatment for fungal infections.
• Headache
• Dizziness
• Unpleasant, sometimes painful sensations with tingling, numbness, limb numbness, disturbances in perception of cold and heat
• Central nervous system excitation
• Involuntary muscle contractions
• Seizures
• Inflammation of the large intestine (colitis). Symptoms include: diarrhoea, usually with blood and mucus, abdominal pain and fever.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed
in this leaflet, tell your doctor, pharmacist or nurse. Adverse reactions
can be reported directly to the Department of Monitoring of Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Cefazolin Phagecon

Keep the medicine in a place inaccessible and out of sight 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 stated month.
Before opening: this medicinal product does not require special storage conditions.
To protect from light, the vial should be stored in the outer carton.
After reconstitution:
Chemical and physical stability has been demonstrated in water for injections for 8 hours at 25°C and for 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 responsibility for storage conditions and duration prior to use lies with the user, and this period should usually not exceed 8 hours at 25°C and 24 hours at 2–8°C.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer in use. Such measures 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 2.096 g of cefazolin sodium, equivalent 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 vials containing 2 g of cefazolin in the form of the sodium salt, with a chlorobutyl rubber stopper and sealed with an aluminium-polypropylene cap, packed in a cardboard box.
Cefazolin Phagecon is packed in cardboard boxes containing 10 or 100 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 medicinal product is authorised in the European Economic Area Member States under the following names:
Portugal Cefazolina Phagecon
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 Cefazolin 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.
Your doctor has prescribed this antibiotic because it is appropriate for you and your condition.
Bacteria can survive or multiply despite the action of an antibiotic. This phenomenon is known as resistance and causes certain antibiotics to become ineffective.
Resistance increases due to excessive or inappropriate use of antibiotics.
You risk contributing to the emergence of resistant bacteria and thereby delay recovery or even render this medicine ineffective if you do not follow the instructions 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 - Use the antibiotic only when prescribed by a doctor.
2 - Strictly follow the instructions provided on the prescription.
3 - Do not reuse antibiotics without a doctor's advice, even if you believe you have a similar illness.
4 - Never give your antibiotics to another person; they may not be suitable for their condition.
5 - After completing treatment, return all opened packaging to a pharmacist for proper and safe disposal of this medicine.

Information intended exclusively for healthcare professionals:

Cefazolin Phagecon can be administered intramuscularly or intravenously. In both cases, the total daily doses are the same. The dosage and route of administration depend on the site and severity of infection, as well as on clinical and bacteriological progression.

Adults and adolescents (aged over 12 years 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 microorganisms with moderate susceptibility: 3 g to 4 g of cefazolin per day divided into 3–4 equal doses.

In severe infections, doses up to 6 g of cefazolin per day may be administered, divided into three or four equal doses (one dose every 6 or every 8 hours).

Prophylactic use in preventing perioperative infections:
The recommended dose for preventing postoperative infections in contaminated or potentially contaminated surgical procedures is: 1 g of cefazolin 30–60 minutes before surgery.

Children and adolescents
Children and infants older than 30 months (im):
25 to 50 mg/kg body weight 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 is not recommended in preterm infants and infants under 1 month of age, as safety has not been established in these patients.

Patients with renal impairment
In patients with renal impairment, dosage should be adjusted by the physician according to 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 longer than 48 hours.
2 g iv at induction of anesthesia,
followed by repeated injection of 1 g every 4 hours throughout the duration of surgery.
In cases of administration outside the intraoperative period, a repeated injection of 1 g should be given every
8 hours.
In cardiac surgery involving extracorporeal circulation (ECC), an additional 1 g injection should be administered after ECC is initiated.
For cesarean sections, the injection should be given after clamping of the umbilical cord.
Method of administration
Cefazolin Phagecon may be administered intravenously, by direct injection or
by continuous or intermittent infusion.
For direct intravenous injection, this medicinal product can be slowly injected
into the vein over 3 to 5 minutes.
The solution of this medicinal product may also be administered as a slow intravenous infusion.
Cefazolin can be administered deep intramuscularly.
Intramuscular administration: this formulation should not be used in children under 30 months of age
(solvent is lidocaine hydrochloride).
Special precautions for disposal and preparation of the medicinal product for
use

• Direct intravenous injection: Reconstitute the vial of cefazolin powder with 5 ml of water for injections and inject slowly over three to five 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 5 ml of water for injections and inject deeply intramuscularly.

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

Do not use intrathecally.

• Reconstitution Cefazolin Phagecon should be reconstituted with water for injections: 1 g is stable in 2 ml. Although Cefazolin Phagecon is very well soluble, it is preferable to add 5 ml of water for injections to 1 g vials for intravenous use. Shake to dissolve, withdraw 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 entire contents of the vial into a syringe. Intramuscular administration: this formulation should not be used in children under 30 months of age (solvent is lidocaine hydrochloride). The reconstituted solution may have a yellow coloration, which is normal.
• Dilution The reconstituted solution should be diluted with one of 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 medicinal product or waste material should be disposed of in accordance with local regulations.

Shelf life
3 years.
Physicochemical stability of the reconstituted solution has been demonstrated for 8 hours at 25°C
and for 24 hours at temperatures from 2°C to 8°C.
From a microbiological standpoint, the product should be used immediately. If not used immediately, the user is responsible for storage conditions and duration prior to use, which generally should not exceed 8 hours at 25°C and 24 hours at 2–8°C.