Primaceph 1 g powder for solution for injection/infusion – cefazolin, an antibiotic for serious infections

Primaceph is a medicine in the form of a powder for solution for injection/infusion containing cefazolin (as cefazolin sodium) – an antibiotic from the group of cephalosporins. It works by preventing bacteria from building their cell wall, which kills them.

One vial contains 1 g cefazolin. Before use the powder is dissolved and given into a muscle, slowly into a vein or as an infusion. It is used in adults and children older than 1 month to treat serious infections caused by bacteria sensitive to cefazolin and to prevent infections during surgery. It is administered only by a healthcare professional in a healthcare facility.

What is Primaceph used for and how is it given?

Key information about the medicine

What is Primaceph used for?

According to the leaflet, Primaceph is used in adults and children older than 1 month to treat infections caused by bacteria sensitive to cefazolin:

• respiratory tract infections;
• infections of the kidneys, urinary tract and genital organs;
• infections of the gallbladder and bile ducts;
• skin and soft tissue infections; bone and joint infections;
• septicaemia (bacteria or their toxins in the blood);
• endocarditis (inflammation of the inner lining of the heart or heart valves);
• prevention (prophylaxis) of infections during surgery – before, and if needed during and after the operation.

How is Primaceph given?

You will never give this medicine yourself – it is given by a doctor or nurse. The dose depends on the severity of the infection, the sensitivity of the bacteria, body weight, age and kidney function. According to the leaflet:

• Adults and adolescents over 12: for infections with highly sensitive bacteria 1–2 g daily in 2–3 doses (every 8 or 12 hours); for less sensitive bacteria 3–4 g daily in 3–4 doses (every 6 or 8 hours); for severe and life-threatening infections 6–12 g daily in 3–4 doses.
• Prevention of infection during surgery: 1 g intravenously or intramuscularly 30–60 minutes before surgery; for operations lasting 2 hours or longer an additional 0.5–1 g during the procedure; after surgery 0.5–1 g every 6–8 hours for 24 hours, and for particularly high-risk procedures 3–5 days.
• Infants older than 1 month and children up to 12: 25–50 mg/kg body weight daily in 3–4 doses; for severe infections up to 100 mg/kg daily.
• Route: deep into a large muscle (no more than 500 mg per intramuscular injection), slowly into a vein over 3–5 minutes, or as an intravenous infusion.
• It is important to receive treatment for as long as the doctor has prescribed, even when you feel better.

Special patient groups

• Impaired kidney function: the dose is reduced according to creatinine clearance (e.g. with clearance 11–34 mL/min half the usual dose every 12 hours, with ≤ 10 mL/min half the dose every 18–24 hours); special schemes also exist for children.
• Premature babies and newborns (under 1 month): use is not recommended, as safety has not been established.
• Elderly people with normal kidney function: no dose adjustment is needed.

Contraindications – when the medicine must not be used

• allergy to cefazolin or any other cephalosporin;
• previous severe allergic reactions to penicillin or other beta-lactam antibiotics (cross-sensitivity is possible).

Precautions and warnings

Talk to your doctor or nurse if:

• you are allergic to penicillin or other beta-lactam antibiotics, even if the reaction was mild;
• you are prone to allergies, have bronchial asthma or hay fever;
• you have risk factors for vitamin K deficiency or a clotting disorder (liver or kidney disease, low platelet count, malnutrition, intravenous feeding, haemophilia, stomach ulcer) – the doctor monitors clotting parameters;
• you have had bowel problems, especially colitis – if diarrhoea occurs the medicine is stopped, and medicines that slow the bowel must not be used;
• you have impaired kidney function or are on a controlled-sodium diet (the medicine contains 50.6 mg sodium per vial).
• With prolonged use, superinfection with resistant bacteria or fungi is possible; with prolonged use or high doses the doctor monitors kidney, liver and bone marrow function.
• The medicine may affect the Coombs test and urine glucose tests – tell laboratory staff that you are receiving Primaceph.

Interactions with other medicines, food and drink

Tell your doctor if you take:

• other antibiotics (aminoglycosides, tetracyclines, sulphonamides, erythromycin, chloramphenicol, colistin, polymyxin B);
• probenecid (a medicine for gout);
• vitamin K; anticoagulants (warfarin, acenocoumarol, heparin);
• diuretics (e.g. furosemide).

Pregnancy and breast-feeding

• Pregnancy: the medicine should not be used during pregnancy (especially in the first trimester) unless the expected benefit outweighs the possible risk, as decided by the doctor.
• Breast-feeding: cefazolin passes into breast milk in small amounts; the doctor decides whether to stop breast-feeding or postpone treatment.

Driving and using machines

• The medicine may cause allergic reactions and dizziness; if they occur, do not drive or use machines.

Possible side effects

• Severe allergic reactions (very rare), including anaphylactic shock: sudden swelling of the face, throat, lips or mouth with difficulty breathing or swallowing, swelling of the hands, feet or ankles – tell the doctor immediately.
• Common: allergic skin reactions (redness, hives, itching); nausea, vomiting, diarrhoea, loss of appetite, bloating, abdominal pain.
• Uncommon: changes in blood cell counts (thrombocytopenia, neutropenia, leukopenia, eosinophilia, agranulocytosis, haemolytic anaemia); angioneurotic oedema and drug fever; mild, transient increase in liver enzymes; inflammation of veins (phlebitis, thrombophlebitis).
• Rare and very rare: clotting disorders and bleeding; interstitial nephritis; reversible hepatitis and cholestatic jaundice.
• Frequency not known: superinfection (e.g. fungal infection of the mouth or vagina); headache, vertigo, paraesthesia, myoclonus, convulsions; pseudomembranous colitis (diarrhoea with blood and mucus, abdominal pain, fever).

Overdose, missed dose and stopping treatment

• Overdose: the medicine is given by a healthcare professional, so this is unlikely; if you think it has happened, tell your doctor.
• Missed dose: staff make sure you receive the medicine regularly; if you think a dose has been missed, tell the doctor. A double dose is not given.
• Stopping treatment: stopping too early may cause the infection to return – the medicine is given for as long as prescribed.

Related information

The medicine is given intramuscularly or intravenously, only in a healthcare facility. For questions about treatment, please contact your treating doctor.

Composition, pack and manufacturer

• Active substance: cefazolin, 1 g per vial (as cefazolin sodium). The medicine contains no excipients.
• The medicine contains 2.2 mmol (50.6 mg) sodium per vial.
• Appearance: white to almost white powder.
• Pack: colourless glass vial (10 mL) with a bromobutyl stopper and a green flip-off cap; 50 vials of 1 g per box.
• Marketing authorisation holder and manufacturer: PharmaSwiss d.o.o. Beograd, Batajnički drum 5A, Belgrade, Serbia.
• Marketing authorisation number: 515-01-01891-22-001 of 08.05.2023.

Storage

• The medicine does not require any special storage conditions.
• Shelf life of the unopened medicine: 3 years. The prepared solution should be used immediately; it is chemically stable for 24 hours at room temperature (25 °C) or 96 hours in a refrigerator (2–8 °C), but from a microbiological point of view it is used immediately.
• Do not use the medicine if there are signs of damage (particles, discolouration). Keep out of the sight and reach of children.

Frequently asked questions

Can I receive Primaceph if I am allergic to penicillin?

The medicine must not be given if you have ever had a severe allergic reaction to penicillin or other beta-lactam antibiotics. Always report even a mild allergy to your doctor, who assesses the risk of cross-sensitivity.

How is Primaceph given?

The powder is dissolved and given deep into a muscle, slowly into a vein over 3–5 minutes, or as an infusion. The medicine is always administered by a doctor or nurse in a healthcare facility.

Why is Primaceph given before surgery?

Giving it 30–60 minutes before surgery ensures sufficient antibiotic levels in the blood and tissues at the time of incision and so reduces the risk of infection after the operation.

Does Primaceph affect laboratory tests?

It may affect the Coombs test and urine glucose tests. Tell the staff taking samples that you are receiving this medicine.

Sources

• ALIMS – Primaceph 1 g package leaflet (PIL, in Serbian)
• ALIMS – Primaceph 1 g summary of product characteristics (SmPC, in Serbian)

Sources checked on: 25.10.2026.