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Ceftazidime (Ceftazidim Galenika) 1 g powder for solution for injection/infusion – a cephalosporin antibiotic
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- Stock: Zabrana online prodaje
- Brand: GALENIKA-EN
- Model: BR-60516256100
Ceftazidime is a cephalosporin antibiotic used in adults and children, including newborns. In Serbia it is manufactured and authorised by Galenika under the name Ceftazidim Galenika (previously authorised as “Ceftazidim”). It kills the bacteria that cause infection, and its spectrum is mainly directed against aerobic Gram-negative bacteria.
The medicine is a powder for solution for injection/infusion with 1 g ceftazidime per vial and is used only in a healthcare facility – it is prepared and given by a doctor, pharmacist or nurse, into a vein or a muscle.
Important warning
- The medicine is used only in a healthcare facility, under medical supervision.
- It must not be given if you are allergic to ceftazidime or other cephalosporins, or if you have had a severe allergic reaction to penicillins, monobactams or carbapenems.
- Excessive doses, especially in kidney disease, may cause tremor, convulsions and coma – this is why the doctor adjusts the dose to kidney function.
- Severe skin reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS) are possible – report them immediately.
- This page is for information only and is not an offer to buy the medicine online.
What is ceftazidime (Ceftazidim Galenika) used for and how is it given?
Key facts about the medicine
| Medicine name | Ceftazidim Galenika, 1 g, powder for solution for injection/infusion |
|---|---|
| Active substance | ceftazidime (as ceftazidime pentahydrate) |
| Strength | 1 g ceftazidime per vial |
| Pharmaceutical form | white or pale yellow powder for solution for injection/infusion |
| Therapeutic group | antibacterials for systemic use – third-generation cephalosporins (ATC J01DD02) |
| Pack | carton with 1 glass vial (1 x 1 g) |
| Marketing authorisation holder | GALENIKA A.D. BEOGRAD (manufacturers: Galenika AD Beograd; ACS Dobfar S.p.A., Italy) |
| ALIMS authorisation number | 515-01-00935-22-001 of 26 January 2023 (previously “Ceftazidim”, 515-01-00488-17-001 of 20 July 2017) |
| Dispensing category (Serbia) | for use in a healthcare facility |
What is Ceftazidim Galenika used for?
According to the package leaflet, ceftazidime is used to treat serious bacterial infections of the:
- lungs or chest, including hospital-acquired (nosocomial) pneumonia
- lungs and bronchi in patients with cystic fibrosis
- brain membranes (bacterial meningitis)
- ear (chronic suppurative otitis media, malignant otitis externa)
- urinary tract (complicated infections)
- skin and soft tissues (complicated infections)
- abdomen and abdominal wall (peritonitis), including peritonitis in patients on peritoneal dialysis
- bones and joints
It is also used to prevent infections during prostate surgery (transurethral resection), to treat patients with a low white blood cell count (neutropenia) and fever caused by a bacterial infection, and in bacteraemia associated with the above infections. When the pathogen may not be within the spectrum of ceftazidime, it is combined with other antibiotics.
How is it given and dosed?
The doctor determines the dose according to the severity and type of infection, other antibiotics the patient receives, body weight, age and kidney function.
| Patient group | Usual dose from the leaflet |
|---|---|
| Newborns (0–2 months) | 25–60 mg/kg body weight daily, divided into 2 doses |
| Infants from 2 months and children under 40 kg | 100–150 mg/kg daily, divided into 3 doses; maximum 6 g daily |
| Adults and children of 40 kg or more | 1–2 g three times daily; maximum 9 g daily |
| Over 65 years | the daily dose should not exceed 3 g, especially in patients over 80 years |
| Infection (adults and children ≥ 40 kg) | Dose according to the SmPC |
|---|---|
| Bronchopulmonary infections in cystic fibrosis | 100–150 mg/kg daily every 8 hours, maximum 9 g daily |
| Febrile neutropenia, hospital-acquired pneumonia, bacterial meningitis, bacteraemia | 2 g every 8 hours |
| Bone and joint infections, complicated skin, soft tissue and intra-abdominal infections, peritonitis in peritoneal dialysis | 1–2 g every 8 hours |
| Complicated urinary tract infections | 1–2 g every 8 or 12 hours |
| Prophylaxis in transurethral resection of the prostate | 1 g at induction of anaesthesia, a second dose at catheter removal |
The medicine is given as an intravenous infusion, an injection into a vein or an injection into a muscle; in some serious infections the doctor may also use a continuous infusion. This is general dosing from the package leaflet and SmPC – the doctor determines the dose for each patient.
Special patient groups
- Impaired kidney function: the doctor prescribes a dose different from the usual one and checks kidney function more often; excessive doses in kidney disease can cause neurological disorders.
- Over 65 years: daily dose usually up to 3 g, especially after the age of 80.
- Newborns and children: the dose is calculated according to body weight (see table).
- People on a low-sodium diet: one vial contains 50 mg (2.17 mmol) of sodium.
Contraindications – when the medicine must not be given
- allergy (hypersensitivity) to ceftazidime, any cephalosporin or sodium carbonate (excipient)
- previous severe allergic reaction to any antibiotic from the penicillin, monobactam or carbapenem groups
Warnings and precautions
- If you have had an allergic reaction to other antibiotics, you may also be allergic to ceftazidime – tell the doctor.
- During treatment, allergic reactions, nervous system disorders and digestive disorders such as diarrhoea are specially monitored.
- In kidney disease dose adjustment and more frequent monitoring are necessary.
- The medicine may affect urine sugar tests and the Coombs test – tell the person taking the sample that you are receiving ceftazidime.
Interactions with other medicines
- chloramphenicol (an antibiotic)
- aminoglycoside antibiotics, e.g. gentamicin, tobramycin
- furosemide (a diuretic)
Tell your doctor about all medicines you are taking, including those available without a prescription.
Pregnancy and breast-feeding
If you are pregnant or planning a pregnancy, ask your doctor – they will assess the benefit of treatment against the possible risks to the baby.
According to the leaflet, Ceftazidim Galenika can be used during breast-feeding.
Driving and using machines
The medicine may cause side effects such as dizziness. Do not drive or use machines if you are not sure how the medicine affects you.
Possible side effects
- Common (up to 1 in 10 patients): diarrhoea, swelling and redness along the vein, red itchy rash similar to hives, pain, burning, swelling or inflammation at the injection site; in blood tests eosinophilia, increased platelet count, raised liver enzymes and a positive Coombs test.
- Uncommon (up to 1 in 100): inflammation of the bowel with pain or bloody diarrhoea, fungal infections of the mouth or vagina, headache, dizziness, abdominal pain, nausea and vomiting, fever and chills, itching; in tests reduced white blood cell and platelet counts, raised urea and creatinine.
- Very rare (up to 1 in 10,000): inflammation or loss of kidney function.
- Frequency not known: severe allergic and skin reactions (SJS, TEN, DRESS), tremor, convulsions and coma with excessive doses, pins and needles, unpleasant taste in the mouth, jaundice, haemolytic anaemia, lymphocytosis, agranulocytosis.
Report any suspected side effects to your doctor, nurse or ALIMS.
Overdose, missed dose and stopping treatment
- The medicine is given by medical staff, so a wrong dose is unlikely; if you think you have received too much, tell the doctor or nurse.
- If you think you did not receive a dose on time, tell the staff; a double dose (two injections at once) is not given.
- Treatment is not stopped without consulting the doctor.
When to seek medical help immediately?
- rash and itching with swelling of the face, lips or tongue and difficulty breathing
- rash with blisters looking like small targets or widespread rash with peeling skin
- tremor, convulsions or impaired consciousness
- severe rash with fever, tiredness and swelling of the face or lymph glands (DRESS)
- abdominal pain and bloody diarrhoea
Pharmacist's advice
Ceftazidime is given in hospital; before treatment tell the doctor about any antibiotic allergies and kidney disease, because the dose depends on them. In elderly people the doctor usually gives a lower daily dose – this is part of the leaflet, not a mistake.
Diarrhoea is common during treatment. Ask your doctor or pharmacist about using probiotics, and report diarrhoea with blood or severe abdominal pain immediately. If a fungal infection of the mouth or vagina occurs (uncommon), see your doctor for treatment.
Availability and price
Ceftazidim Galenika is used only in a healthcare facility; it is not dispensed in pharmacies to the public and cannot be ordered online. This page is for information only.
Related information
For additional care and support with restoring the gut flora during and after antibiotic treatment, see also the Probiotics category – products in this category do not replace the medicine you have been prescribed.
In Serbia ceftazidime is also authorised under other names (e.g. Fortum®, Tizacef®, Salazidime, Ceftazidim Corapharm); each medicine has its own leaflet.
Composition, packaging and manufacturer
- Active substance: ceftazidime 1 g (as ceftazidime pentahydrate) per vial.
- Excipient: sodium carbonate; sodium content 50 mg (2.17 mmol) per vial.
- Appearance and pack: white or pale yellow powder in a 10 mL clear glass vial with a rubber stopper and flip-off cap; carton with 1 vial.
- Marketing authorisation holder: GALENIKA A.D. BEOGRAD, Batajnički drum b.b., Belgrade. Manufacturers: Galenika AD Beograd; ACS Dobfar S.p.A., Teramo and Verona, Italy.
Storage
- Store in the original package; the medicine does not require any special temperature storage conditions.
- Use immediately after reconstitution; physical and chemical stability has been shown for up to 24 hours, depending on the solvent and temperature.
- Keep out of the sight and reach of children. Return unused medicine to a pharmacy that collects unused medicines.
Frequently asked questions
Is Ceftazidim Galenika the same medicine as “Ceftazidim”?
Galenika previously authorised the medicine under the name “Ceftazidim”; since 2023 the authorisation is in the name Ceftazidim Galenika (1 g, 1 vial). The active substance is the same – ceftazidime.
Can ceftazidime be obtained from a pharmacy?
No. The medicine is used only in a healthcare facility and is given by a healthcare professional.
Why do elderly people receive a lower dose?
According to the leaflet, in patients over 65 years the daily dose should not exceed 3 g, especially after the age of 80.
Can I breast-feed during treatment?
According to the package leaflet, Ceftazidim Galenika can be used during breast-feeding. Nevertheless, tell your doctor about it.
What is cystic fibrosis and why is ceftazidime used in it?
In cystic fibrosis serious lung and bronchial infections with Gram-negative bacteria are common; ceftazidime is approved for treating bronchopulmonary infections in these patients, at higher weight-based doses.
Sources
- ALIMS – Summary of Product Characteristics, Ceftazidim Galenika 1 g powder for solution for injection/infusion (Serbian)
- ALIMS – Package leaflet, Ceftazidim Galenika 1 g (January 2023, Serbian)
Sources checked on: 24 October 2026.
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