Cefazolin Git: detailed information

Package leaflet: Information for the patient

Cefazolina GIT 1 g/4ml powder and solvent for injectable solution for intramuscular use

cefazolin sodium
Please read this leaflet carefully before you are given this medicine because 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, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

What Cefazolina GIT is and what it is used for
What you need to know before being given Cefazolina GIT
How Cefazolina GIT is administered
Possible side effects
How to store Cefazolina GIT
Contents of the pack and other information
What Cefazolina GIT is and what it is used for

Cefazolina GIT contains cefazolin sodium, a substance belonging to a group of medicines called cephalosporins, which acts against bacterial infections that can affect various parts of the body.
Cefazolina GIT is used to treat the following infections:

respiratory tract infections
urinary tract infections
genital organ infections
skin and soft tissue infections
biliary tract infections
bone and joint infections
blood infections (septicaemia)
infections of the inner surface of the heart (endocarditis)

Cefazolina GIT may be used before, during, and after surgical procedures to prevent infections.

2. What you need to know before being administered Cefazolina GIT

Do not administer Cefazolina GIT to you if:

you are allergic to cefazolin sodium, or to any of the other ingredients of this medicine (listed in section 6);
you are allergic to lidocaine or to other amide-type local anesthetics;
you are allergic to other antibiotics, particularly penicillins, cephalosporins, and other beta-lactam antibiotics;
in premature infants and newborns under 1 month of age.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before being administered Cefazolina GIT.
Pay special attention and inform your doctor:

If you have previously experienced an allergic reaction to medicines, particularly to cefazolin, cephalosporins, penicillins, other beta-lactam antibiotics, lidocaine, or other amide-type local anesthetics, because in this case you may also be allergic to Cefazolina GIT (risk of severe anaphylactic-type reactions).
If you experience any allergic-type reaction following administration of Cefazolina GIT, stop treatment immediately and contact your doctor; severe allergic reactions, and particularly anaphylaxis, may require emergency therapeutic interventions.
If you have a history of stomach and/or intestinal diseases, particularly inflammation of the colon (colitis).
If you develop diarrhea during treatment. Contact your doctor immediately, as this may lead to a serious condition called pseudomembranous colitis.
If you are being treated with blood-thinning medicines (anticoagulants), due to the risk of coagulation disorders. Your doctor may consider it necessary to adjust the dosage of oral anticoagulants.
If you have or are suspected of having kidney problems, as your doctor may reduce the dose of Cefazolina GIT depending on your condition. This medicine may cause kidney damage, and these effects are more likely if you are over 50 years old, if you already suffer from kidney problems, or if you are simultaneously taking other medicines that may cause kidney damage (see “Other medicines and Cefazolina GIT”).
If you have high blood pressure (hypertension) or heart problems (heart failure), because this medicine contains sodium (see “Cefazolina GIT contains sodium”).

Laboratory tests
Inform your doctor if you are being treated with Cefazolina GIT, as this medicine may alter the results of certain laboratory tests (false positive Coombs test, false positive urine glucose test with Benedict, Fehling, and Clinitest methods).
The concomitant use of medicines that promote fecal retention must be absolutely avoided.
Children
Cefazolina GIT must not be administered to premature infants and newborns under one month of age (see section “Do not administer Cefazolina GIT to you”).
In very early infancy, the medicine will be administered only when strictly necessary and under direct medical supervision.
Other medicines and Cefazolina GIT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

probenecid (used in the treatment of gout to reduce uric acid levels), as it increases the concentration of Cefazolina GIT in the blood;
antibiotic medicines that may cause kidney damage, such as aminoglycosides, colistin, polymyxin B, or vancomycin. Concomitant use with Cefazolina GIT should be avoided if possible;
other antibiotics such as penicillins or chloramphenicol;
medicines that thin the blood (oral anticoagulants or heparin), due to the risk of coagulation disorders. In these cases, your doctor must carefully monitor you and possibly adjust the dosage of anticoagulant medicines;
oral contraceptives, as Cefazolina GIT may reduce their effectiveness. For this reason, alternative contraceptive methods are recommended in addition to hormonal contraceptives during treatment with cefazolin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
During pregnancy, Cefazolina GIT should be administered only when clearly needed and under direct medical supervision.
Breastfeeding
This medicine is present in very low concentrations in breast milk; however, caution should still be exercised during breastfeeding.
Driving and using machines
Cefazolina GIT does not affect the ability to drive or operate machinery.
Cefazolina GIT contains sodium
This medicine contains 50.5 mg of sodium (a main component of table salt) per vial.
This is equivalent to 2.5% of the maximum daily dietary intake recommended for an adult.

3. How Cefazolina GIT is administered

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
Adults
The recommended dose of cefazolin for intramuscular administration is 1–3 g per day,
divided into 2–3 equal doses, depending on the type and severity of the infection.
Use in children
The daily dose for intramuscular administration in children ranges from 25 to 50 mg per kg of body
weight, divided into 3–4 equal doses. Depending on the severity of the infection, the doctor
may increase the dose up to 100 mg per kg of body weight.
Cefazolina GIT must not be administered in premature infants and newborns under 1 month of age (see
section “When Cefazolina GIT must not be used”).
In very early infancy, Cefazolina GIT will be administered only when strictly necessary and under
direct medical supervision.
The solvent vial included in the package containing lidocaine, a local anesthetic, must be
used only for intramuscular use.
Use in perioperative prophylaxis
If you are undergoing a surgical procedure, you may be given a dose of 1 g intramuscularly or
directly into a vein, 30–60 minutes before the start of surgery.
For prolonged procedures, an additional dose of 500 mg to 1 g may be administered during
the operation. Treatment with Cefazolina GIT may continue every 6–8 hours for 24 hours after
surgery to prevent the risk of infections.
The solvent vial included in the package containing lidocaine, a local anesthetic, must be
used only for intramuscular use.
Use in patients with kidney problems
If you have renal impairment, you must receive a lower dose of Cefazolina GIT than the
usual recommended dose. Your doctor will adjust the dose of the medicine according to your condition.
If you take more Cefazolina GIT than you should
If you are accidentally given more Cefazolina GIT than prescribed, contact your doctor or the nearest
hospital immediately.
If you forget to take Cefazolina GIT
If a dose has been missed, inform your doctor immediately.
If you stop treatment with Cefazolina GIT
Do not stop taking Cefazolina GIT unless instructed by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

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

Severe allergic reaction (anaphylactic reaction) with breathing difficulties, circulatory problems (cardiovascular collapse) or shock, itching and hives, with or without skin and mucosal swelling, nausea, vomiting, abdominal pain with cramps and diarrhoea;
Increased platelet count (thrombocytosis), reduced number of white blood cells (neutropenia, leucopenia, agranulocytosis) or platelets (thrombocytopenia), reduced number of red blood cells (anaemia, haemolytic anaemia), reduced counts of all blood cells (aplastic anaemia, pancytopenia), and bleeding;
Kidney problems (acute renal failure associated with interstitial nephritis);
Severe colon infection associated with antibiotic use (pseudomembranous colitis), which may be fatal. Colitis may also occur after treatment has been stopped;
Hives, itching, various types of skin rash (maculopapular, erythematous or morbilliform);
Fever and chills;
Serum sickness-like reactions (fever, hives, joint pain, swelling and enlarged lymph nodes);
Increased number of white blood cells (eosinophilia);
Joint pain;
Swelling;
Skin redness;
Anal and genital itching;
Swelling of the skin and mucous membranes (angioedema);
Severe skin allergic reactions, possibly fatal (Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis);
Skin peeling (exfoliative dermatitis);
Hypersensitivity reactions may occur especially in patients who have previously shown allergic reactions, particularly to penicillin.
Increased levels of certain enzymes indicating liver function impairment, for example transaminases (AST/SGOT, ALT/SGPT), alkaline phosphatase, lactate dehydrogenase (LDH), gamma-glutamyl transpeptidase (GGTP), or increased bilirubin levels, or liver dysfunction including impaired bile excretion (cholestasis). These effects are generally mild and resolve upon discontinuation of therapy;
Transient increase in blood urea nitrogen and creatinine levels;
Nausea, vomiting, diarrhoea;
Oral thrush (oral candidiasis);
Abdominal pain;
Persistent urge to defecate;
Indigestion;
Inflammation of the tongue;
Stomach burning;
Reactions at the injection site, such as pain, tissue hardening, swelling;
Vein inflammation (phlebitis) following intravenous administration;
Chest tightness;
Dizziness, headache;
Malaise, fatigue;
Positive Coombs test (a laboratory test used to detect the presence of autoimmune diseases);
Fungal infection and vaginal inflammation, with genital and anal itching.

These side effects require appropriate therapeutic measures and careful evaluation by the physician, who will decide, if necessary, whether treatment should be discontinued.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at 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 GIT

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp". The expiry date refers to the last day of that month.
The expiry date applies to the product in its original, undamaged packaging, stored correctly.
The solution should be used immediately after reconstitution.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cefazolina GIT contains
Vial of powder:

the active substance is cefazolin sodium. Each vial contains 1.048 g of cefazolin sodium (equivalent to 1 g of cefazolin).
Solvent vial:
the solvent vial for intramuscular use contains: lidocaine hydrochloride monohydrate, water for injections.

Description of the appearance of Cefazolina GIT and contents of the package
Cefazolina GIT is presented as a powder and solvent for injectable solution for intramuscular use.
Packaging: 1 vial of 1 g powder + 1 vial of 4 ml solvent.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
SF GROUP S.r.l. – Via Tiburtina 1143, 00156 Rome
Manufacturer
Esseti Farmaceutici S.r.l. - Via Campobello, 15 – 00040 Pomezia (Rome)
La.Fa.Re. S.r.l. - Via Sac. Benedetto Cozzolino, 77 – 80056 Ercolano (NA)

The following information is intended exclusively for healthcare professionals:

Read carefully the information contained in sections 1–6 as well.

Warnings and precautions
Any allergic reaction requires immediate discontinuation of treatment. Severe hypersensitivity reactions, and particularly anaphylaxis, may require administration of adrenaline and other emergency therapeutic interventions.

It is important to consider the possibility of pseudomembranous colitis in the differential diagnosis of patients presenting with diarrhea following antibiotic use. Mild cases of pseudomembranous colitis may resolve upon discontinuation of therapy. Moderate to severe cases should be treated with oral vancomycin, supplemented by administration of fluids, electrolytes, and proteins.

In patients with suspected renal disease, particularly, careful clinical and laboratory evaluation of renal function must be performed before and during therapy with cephalosporins. Nephrotoxic effects are more likely in patients over 50 years of age, in those with pre-existing renal disease, and when other nephrotoxic drugs are administered concomitantly.

In cases of infection, the causative microorganism should always be isolated, and antibacterial therapy should be based on sensitivity testing performed on specimens collected before initiation of treatment.

Sensitivity to cefazolin should be confirmed using standardized methods (antibiotic discs containing 30 mg active substance – Kirby-Bauer test).

However, cefazolin therapy may be initiated while awaiting results of these tests. Before using Cefazolin GIT in combination with other antibiotics, potential interactions, contraindications, warnings, precautions, and adverse effects should be carefully evaluated.

Pregnancy
Administration of cefazolin before cesarean section results in umbilical cord blood levels ranging from ¼ to ⅓ of maternal plasma concentrations. Cefazolin does not appear to cause adverse effects on the fetus. Nevertheless, cefazolin should only be administered after clamping of the umbilical cord.

Cefazolin GIT contains sodium
This medicinal product contains 50.5 mg of sodium (as cefazolin sodium) per vial, equivalent to 2.5% of the maximum daily intake recommended by the WHO, which corresponds to 2 g of sodium for an adult.

How to administer Cefazolin GIT

Use in adults
The usual dosage of cefazolin is 1–3 g/day, divided into 2–3 equal doses depending on the type and severity of infection, as shown in the following table:

DOSING IN ADULTS
| Type of infection | Dose | Frequency |
|------------------------|----------|---------------|
| Pneumococcal pneumonia | 500 mg | every 12 hours |
| Mild infections caused by susceptible strains of gram-positive cocci | 500 mg | every 8 hours |
| Acute, uncomplicated urinary tract infections | 1 g | every 12 hours |
| Moderate to severe infections | 0.5–1 g | every 6–8 hours |
| Severe, life-threatening infections (e.g. endocarditis, septicemia)* | 1–1.5 g | every 6 hours |
* In exceptional cases, cefazolin doses up to 12 g/day have been used.

Use in children
The total daily dosage is 25–50 mg/kg body weight, divided into 3–4 equal doses; this is effective in treating most mild or moderately severe infections. The total daily dosage may be increased up to 100 mg/kg body weight in severe infections.

The medicinal product is contraindicated in preterm infants and neonates under one month of age.

In early infancy, the product should be administered only when clearly needed and under direct medical supervision.

Use in perioperative prophylaxis
To prevent post-surgical infections in procedures with risk of potential bacterial contamination, the recommended dosage is:

1 g IV or IM administered 30 to 60 minutes before surgery.
For prolonged procedures (e.g. 2 hours or longer), 0.5–1 g IV or IM during surgery (adjusted according to duration of surgery).
0.5–1 g IV or IM every 6–8 hours for 24 hours after surgery.

It is important that:

The initial dose is administered 30 to 60 minutes before the start of surgery to ensure adequate antibiotic blood and tissue levels at the time of incision;
If significant exposure to pathogens is likely, cefazolin should be administered at regular intervals during surgery to maintain constant blood levels;
Prophylactic use of cefazolin should not extend beyond 24 hours after surgery;
In surgical procedures where infection could be particularly devastating (e.g. open-heart surgery, joint prosthesis implantation), prophylaxis with cefazolin may continue for 3–5 days after surgery.

Use in patients with renal impairment
In patients with renal impairment, doses should be appropriately reduced according to the degree of renal dysfunction, as shown in the following table:

DOSING IN RENAL IMPAIRMENT
| Renal impairment | Creatinine clearance (ml/min) | Serum creatinine (mg%) | Dose | Interval |
|----------------------|-------------------------------------|----------------------------|----------|-------------|
| ADULTS | | | | |
| Mild | > 55 | < 1.5 | Full dose | 6–8 h |
| Moderate | 35–54 | 1.6–3.0 | Full dose | > 8 h |
| Marked | 11–34 | 3.1–4.5 | 50% dose | 12 h |
| Severe | < 10 | > 4.6 | 50% dose | 18–24 h |
| CHILDREN | | | | |
| Mild-moderate | 40–70 | | 60% dose | 12 h |
| Moderate | 20–39 | | 25% dose | 12 h |
| Severe | 5–19 | | 10% dose | 24 h |

Note: In infections of particular severity, an appropriate loading dose is recommended before proceeding with dose reductions as described above.

Administration method
After reconstitution, cefazolin may be administered by intramuscular or intravenous route.

Total daily dosages are the same for both routes of administration.

Intramuscular administration
Reconstitute cefazolin by dissolving the vial contents with the attached diluent vial (4 ml), or with 0.9% sodium chloride for injections, or water for injectable preparations, as shown in the table below. Shake well until complete dissolution. The solution must be used immediately after reconstitution.

DILUTION CHART
| Vial | Diluent to be added | Approximate volume of solution | Average concentration |
|------|----------------------|-------------------------------|------------------------|
| 1 g* | 2.5 ml | 3 ml | 350 mg/ml |
*If the 4 ml diluent vial provided in the package is not used, the 1 g vial must be reconstituted only with water for injectable preparations.

Warning: The 4 ml diluent vial containing 0.5% lidocaine hydrochloride as anesthetic, provided in the package, must be used exclusively for intramuscular administration.

Intravenous administration
Solutions of cefazolin reconstituted without using the diluent vial provided in the package may be administered by continuous or intermittent intravenous infusion.

Continuous intravenous infusion: Reconstituted solutions must be further diluted in at least 10 ml of water for injectable preparations and infused slowly over a period of 3–5 minutes directly into the vein or via a cannula. Never complete the infusion in less than 3 minutes.
Intermittent intravenous infusion: Cefazolin may be administered together with other fluids used in hemodynamic support regimens, or using a separate container. Reconstituted solutions of 500 mg or 1 g cefazolin must be further diluted in 50–100 ml of one of the following solutions:
- 0.9% Sodium chloride for injections;
- 5% or 10% Dextrose for injections;
- 5% Dextrose in Ringer’s lactate for injections;
- 5% Dextrose and 0.9% Sodium chloride for injections (5% Dextrose with 0.45% or 0.2% Sodium chloride may also be used);
- Ringer’s lactate for injections;
- 5% or 10% Invert sugar in sterile water for injections;
- Ringer’s solution for injections;
- Normosol-M in D5-W;
- Ionosol B with 5% Dextrose;
- Plasma-Lyte with 5% Dextrose.

Extemporaneously prepared intravenous solutions may be stored protected from light and at low temperature; under these conditions, they may be used no later than 48 hours after preparation. For intravenous use or slow infusion, the product should be administered every 6 hours.

Cefazolin Git