Ceftazidime Kabi 1 g powder for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ceftazidime Kabi 1 g powder for injectable solution EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you consider any of the side effects you experience to be serious, or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What Ceftazidime Kabi is and what it is used for
2. What you need to know before using Ceftazidime Kabi
3. How to use Ceftazidime Kabi
4. Possible side effects
5. How to store Ceftazidime Kabi
6. Contents of the pack and other information

1. What CeftazidimaKabi is and what it is used for

Ceftazidima is an antibiotic used in adults and children (including newborns). It works by eliminating the bacteria that cause infections. It belongs to a group of medicines known as cephalosporins.

Ceftazidime Kabi is used to treat serious bacterial infections of the:

• lungs or chest
• lungs and bronchi in patients with cystic fibrosis
• brain (meningitis)
• ear
• urinary tract
• skin and soft tissues
• abdomen and abdominal wall (peritonitis)
• bones and joints.

Ceftazidime Kabi may also be used:

• to prevent infections during prostate surgery in men
• to treat patients with low white blood cell count (neutropenia) and
  fever due to bacterial infection.

2. What you need to know before using Ceftazidime Kabi

Do not use Ceftazidime Kabi:

• if you are allergic (hypersensitive) to ceftazidime or to any of the other ingredients of this medicine (listed in section 6)

• if you have ever had a severe allergic reaction to any other antibiotic (penicillins, monobactams, and carbapenems), as you may also be allergic to Ceftazidime Kabi.

• Tell your doctor before starting treatment with Ceftazidime Kabi if any of the above applies to you. Do not be given Ceftazidime Kabi.

Warnings and precautions

While receiving Ceftazidime Kabi, you should be alert for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as

diarrhea. This will reduce the risk of potential problems. See (“Symptoms to be aware of”) in section 4. If you have ever had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidime Kabi.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with ceftazidime. Seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

If you need blood or urine tests

Ceftazidime may affect the results of urine glucose tests and a blood test known as the Coombs test. If you are having tests:

• Inform the person taking the sample that you have been administered Ceftazidime.

Using other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

Do not be given Ceftazidime without first talking to your doctor if you are also taking:

• an antibiotic called chloramphenicol

• a group of antibiotics called aminoglycosides, for example: gentamicin, tobramycin

• a "water tablet" (a diuretic called furosemide)

• Inform your doctor if any of the above applies to you.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Ceftazidime may cause adverse effects such as dizziness, which may affect your ability to

drive.

Do not drive or operate machinery unless you are certain that it does not affect you.

Ceftazidime Kabi contains sodium

Ceftazidime Kabi 1 g contains 52 mg of sodium (the main component of table/cooking salt) in each vial. This corresponds to 2.6% of the maximum daily recommended sodium intake for an adult.

3. How to administer Ceftazidime Kabi

Ceftazidime Kabi is normally administered by a doctor or nurse. It can be given as an intravenous infusion (slow drip) or directly as an injection into a vein or into a muscle.

Ceftazidime Kabi is reconstituted by a doctor, pharmacist, or nurse using water for injectable preparations.

Recommended dose

The correct dose of Ceftazidime for you will be decided by your doctor and depends on: the severity and type of infection, whether you are being treated with other antibiotics, your weight and age, and your kidney function.

Newborn babies (0–2 months)

For each 1 kg of the baby's weight, 25 to 60 mg of ceftazidime per day will be administered, divided into two doses.

Infants (over 2 months) and children weighing less than 40 kg

For each 1 kg of the infant's or child's weight, 100 to 150 mg of ceftazidime per day will be administered, divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more

1 g to 2 g of ceftazidime three times a day. Maximum 9 g per day.

Patients over 65 years of age:

The daily dose normally should not exceed 3 g per day, especially if you are over 80 years of age.

Patients with kidney problems

You may be given a different dose than usual. Your doctor will decide how much ceftazidime you need, depending on the severity of your kidney disease. Your doctor will monitor you closely and your kidney function tests will be performed more frequently.

If you are given more Ceftazidime Kabi than you should

If you accidentally receive more than the prescribed dose, contact your doctor or the nearest hospital. In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone 91 562 04 20.

If you forget to use Ceftazidime Kabi

If you miss an injection, you should receive it as soon as possible. However, if it is almost time for the next injection, skip the missed dose. Do not use a double dose (two injections at once) to make up for the forgotten dose; take the next dose at the usual time.

If you stop treatment with Ceftazidime Kabi

Do not stop receiving Ceftazidime Kabi unless your doctor tells you to do so.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, Ceftazidime Kabi can cause adverse effects, although not everyone experiences them.

Seek immediate medical attention if you notice any of the following symptoms:

• Red, target-shaped or circular skin patches on the trunk, often with blisters in the center, peeling skin, or ulcers in the mouth, throat, nose, genitals, or eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Widespread red, peeling rash with bumps under the skin and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Symptoms to watch for

The following serious adverse effects have occurred in a small number of people, but their exact frequency is unknown:

• Severe allergic reaction. Signs include itchy, raised rash, swelling, sometimes in the face or mouth, causing difficulty breathing.
• Skin rash, which may blister and appear as small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge).
• Nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in patients receiving very high doses, especially in those with kidney disease.

Contact your doctor or nurse immediately if you experience any of these symptoms.

Common adverse effects

May affect up to 1 in 10 patients:

• Diarrhea,

• Swelling and redness around a vein,

• Red, raised, possibly itchy skin rash,

• Pain, burning, swelling, or inflammation at the injection site.

• Inform your doctor if any of these adverse effects concern you.

Common adverse effects that may appear in blood tests:

• Increase in a type of white blood cells (eosinophilia)
• Increase in the number of cells that help blood to clot
• Increase in liver enzymes.

Uncommon adverse effects

May affect up to 1 in 100 people:

• Inflammation of the intestine, which may cause pain or bloody diarrhea
• Fungal infections in the mouth or vagina
• Headache
• Dizziness
• Stomach pain
• Nausea or vomiting
• Fever and chills.

Inform your doctor if you experience any of these.

Uncommon adverse effects that may appear in blood tests:

• Decrease in the number of white blood cells
• Decrease in the number of platelets (cells that help blood to clot)
• Increase in blood levels of urea, blood urea nitrogen, or serum creatinine.

Other adverse effects

Other adverse effects that have occurred in a small number of patients, but whose exact frequency is unknown:

• Inflammation or failure of the kidneys
• Tingling sensations
• Bad taste in the mouth
• Yellowing of the skin or whites of the eyes.

Other adverse effects that may appear in blood tests:

• Rapid destruction of red blood cells
• Increase in a certain type of white blood cells
• Severe decrease in the number of white blood cells.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftazidime Kabi

Keep out of the reach and sight of children.

Do not use Ceftazidime Kabi after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 25°C. Keep the vial in its outer packaging to protect it from light.

Once Ceftazidime Kabi powder has been reconstituted into a solution, it must be administered within 6 hours if stored at 25°C or within 12 hours if stored at 5°C.

Do not use the solution if it is cloudy; it should be completely clear. Any unused solution must be discarded.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of Ceftazidime Kabi

Ceftazidime Kabi 1 g powder for injectable solution EFG contains the active substance
ceftazidime (1 g) in the form of ceftazidime pentahydrate.

The sodium content is 52 mg of sodium. You should take this into account if you are on a low-sodium diet. All concentrate powders contain anhydrous sodium carbonate.

Appearance of the product and contents of the pack

• Ceftazidime Kabi powder is normally mixed with water for injection to produce an injectable solution or a solution for infusion. Once reconstituted, your doctor must mix the Ceftazidime Kabi solution with other suitable infusion fluids. The colour of the solutions may vary from pale yellow to amber.

• Ceftazidime Kabi 1 g is available in packs containing 1 and 10 glass vials of powder,
  sealed with a rubber stopper, aluminium cap and flip-off cap.

• Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.
C/ Marina, 16-18
08005 Barcelona (Spain)

Manufacturer:

LABESFAL – Laboratórios Almiro S.A. (Fresenius Kabi Group)
Lagedo, P-3465 157
Santiago de Besteiros (Portugal)

This summary of product characteristics was approved in June 2025.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

This medicine is for single use only. Any unused portion should be discarded.

Intravenous route – injection:

For direct intermittent intravenous administration, ceftazidime must be reconstituted with water for injection (see table below). The solution should be injected slowly into a vein over a period of up to 5 minutes or via an administration set.

Intramuscular route:

Ceftazidime should be reconstituted with water for injection or with hydrochloride lidocaine 10 mg/ml (1%) injectable solution as indicated in the table below. The lidocaine product information should be consulted before reconstituting ceftazidime with lidocaine.

Reconstitution instructions

See the table for the volumes to be added and solution concentrations that may be useful when fractional doses are required.

Preparation of Ceftazidime solutions for use in neonates and infants ≤ 2 months

Intermittent intravenous administration

Dosage: 25 to 60 mg/kg body weight/day given in two divided doses.

Infants > 2 months and children < 40 kg

Intermittent administration

Dosage: 100 to 150 mg of Ceftazidime Kabi per day in three divided doses, maximum 6 g/day.

Consideration should be given to not administering more than 6 g per day (equivalent to 150 ml). Compatible intravenous fluids:

At ceftazidime concentrations between 90 mg/ml and 260 mg/ml, Ceftazidima Kabi may be mixed with commonly used infusion solutions:

• Sodium chloride solution 9 mg/ml (0.9%) (physiological saline),
• Ringer Lactate
• Glucose solution 100 mg/ml (10%)

When reconstituted for intramuscular use, Ceftazidima Kabi may be diluted with lidocaine solution 10 mg/ml (1%).

When ceftazidime is dissolved, carbon dioxide is released and positive pressure is created. For ease of use, the recommended reconstitution techniques described below should be followed.

Instructions for reconstitution:

Preparation of solutions for bolus injection:

1. Insert the syringe needle through the vial stopper and inject the recommended volume of diluent. The vacuum may assist in drawing in the diluent. Remove the needle from the syringe.
2. Shake to dissolve: carbon dioxide is released and a clear solution is obtained within 1–2 minutes.
3. Invert the vial. With the syringe plunger fully depressed, insert the syringe through the vial stopper and withdraw the total volume of solution into the syringe (the pressure in the vial aids withdrawal of the solution). Ensure that the needle remains within the solution and does not enter the headspace. Small carbon dioxide bubbles in the reconstituted solution may be disregarded.

This solution should be administered directly into the vein or via a tubing connected to an infusion system, in case the patient is receiving parenteral fluids. Ceftazidime is compatible with the intravenous fluids mentioned above.

NOTE: To preserve the sterility of the product, it is important not to insert the venting needle through the stopper of the vial before the product has been completely dissolved.

For single use only.

Reconstituted solution: Physical and chemical stability has been demonstrated for up to 6 hours at 25°C and 12 hours at 5°C after reconstitution of the product with water for injections, 1% lidocaine solution, 0.9% sodium chloride solution, Ringer lactate, and 10% glucose solution. From a microbiological standpoint, the product should be used immediately.

Any unused solution should be discarded according to local regulations.

Reconstitution must be performed under aseptic conditions.

The solution should be inspected visually for particulate matter or discoloration prior to administration.

The solution should be used only if it is clear and free of particles.

Solutions may vary from pale yellow to amber in color depending on concentration, solvent, and storage conditions used. Within the recommended guidelines, the potency of the product is not adversely affected by these color variations.