CEFTAZIDIME KABI 1 g POWDER FOR INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Ceftazidime Kabi 1 g powder for solution for injection EFG

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

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

1. What is Ceftazidime Kabi and what is it used for

Ceftazidime is an antibiotic used in adults and children (including newborns). It works

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

Ceftazidime Kabi can also be used:

• to prevent infections during prostate surgery in men
• to treat patients with a low white blood cell count (neutropenia) and

fever due to a bacterial infection.

2. What you need to know before you use Ceftazidime Kabi

Ceftazidime Kabi should not be administered to you:

• (hypersensitive) to ceftazidimeor to any of the other components of this medicine (listed in section 6)
• to any other antibiotic(penicillins, monobactams, and carbapenems) as you may also be allergic to Ceftazidime Kabi.

• Tell your doctor beforestarting treatment with Ceftazidime Kabi if you think this applies to you. You should not be given Ceftazidime Kabi.

Warnings and precautionsWhile you are being given Ceftazidime Kabi, you should be aware of certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as

diarrhea. This will reduce the risk of possible 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.

Severe 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 in relation to ceftazidime treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need a blood or urine test

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

• Tell the person taking the samplethat you have been given Ceftazidime.

Use of other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use other medicines, including those obtained without a prescription.

You should not be given Ceftazidime without talking to your doctor if you are also taking:

• a type of antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, such as gentamicin, tobramycin
• a “water pill” (a diuretic called furosemide)

• Tell your doctorif this applies to you.

Pregnancy and breastfeeding

Tell your doctor before you are given Ceftazidime:

• If you are pregnant, think you may be pregnant, or plan to become pregnant
• If you are breastfeeding

Your doctor will weigh the benefits of treating you with Ceftazidime against the risks to the baby.

Driving and using machines

Ceftazidime may cause side effects such as dizziness that affect your ability to

drive.

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

Ceftazidime Kabi contains sodium

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

3. How to use Ceftazidime Kabi

Ceftazidime Kabi is usually administered by a doctor or nurse. It can

be administered as a drip(intravenous infusion) or directly as an injectioninto a

vein or muscle.

Ceftazidime Kabi is reconstituted by the 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 every 1 kg of the baby's weight, 25 to 60 mg of ceftazidime will be administered per day, divided into two doses.

Babies (over 2 months) and childrenwho weigh less than 40 kg

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

Adults and adolescentswho weigh 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 should not normally exceed 3 g per day, especially if you are over 80 years old.

Patients with kidney problems

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

If you are given too much Ceftazidime Kabi

If you accidentally receive more than the prescribed dose, contact your doctor or the nearest hospital

immediately. In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone 91 562 04 20.

If you miss a dose of 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 injection. Do not use a double dose (two injections at the same time) to make up for the missed dose; receive 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.

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

4. Possible side effects

Like all medicines, Ceftazidime Kabi can cause side effects, although not everybody gets them.

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

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

Symptoms to be aware of

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

• Severe allergic reaction. The signs include itchy, lumpy rash, swelling, sometimes in the face or mouth that causes difficulty breathing.
• Skin rash, which can form blistering, and appears as small targets(a dark central spot surrounded by a lighter area, with a dark ring around the edge).
• Nervous system disorders: tremors, seizures, and, in some cases, coma. These have occurred in patients given very high doses, especially in patients with kidney disease.

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

Common side effects

May affect up to 1 in 10patients:

• Diarrhea,
• swelling and redness around a vein,
• red, itchy, lumpy rash,
• pain, burning, swelling, or inflammation at the injection site.

• Tell your doctorif any of these side effects worry you

Common side effects that may appear in blood tests:

• an increase in a type of white blood cell (eosinophilia)
• an increase in the number of cells that help blood clot
• an increase in liver enzymes.

Uncommon side effects

May affect up to 1 in 100people:

• inflammation of the intestine that can cause pain or diarrhea that may contain blood
• fungal infections in the mouth or vagina
• headache
• dizziness
• stomach pain
• nausea or vomiting
• fever and chills.

Tell your doctorif you experience any of these.

Uncommon side effects that may appear in blood tests:

• a decrease in the number of white blood cells
• a decrease in the number of platelets (cells that help blood clot)
• an increase in the level of urea, ureic nitrogen, or serum creatinine in the blood.

Other side effects

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

• inflammation or kidney failure
• tingling
• bad taste in the mouth
• yellowing of the skin or the whites of the eyes.

Other side effects that may appear in blood tests:

• rapid destruction of red blood cells
• an increase in a certain type of white blood cell
• a significant decrease in the number of white blood cells.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side 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 expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

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

Once Ceftazidime Kabi powder is reconstituted into a solution, it should be administered immediately.

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

Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicines in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the pack and further information

Composition of Ceftazidime Kabi

Ceftazidime Kabi 1 g powder for solution for injection EFGcontains the active

ingredient ceftazidime (1 g) in the form of ceftazidime pentahydrate.

The other ingredients are: sodium carbonate for injectable preparations.

Appearance and packaging of the product

• Ceftazidime Kabi 1 g comes in boxes containing 1 and 10 glass vials with powder,

closed with a rubber stopper, aluminum cap, and flip-off cap.

• Not all 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 leaflet was approved in February 2022.

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