Prospect: information for the user

Ceftazidima Kabi 1 g powder for injectable solution EFG

Read this prospect carefully before starting to use this medicine because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• If you consider that any of the adverse effects you are experiencing is severe or if you appreciate any adverse effect not mentioned in this prospect, inform your doctor or pharmacist. See section 4.

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

2.What you need to know before using Ceftazidima Kabi

3.How to use Ceftazidima Kabi

4.Possible adverse effects

5.Storage of Ceftazidima Kabi

6.Contents of the package and additional information

Ceftazidima is an antibiotic used in adults and children (including newborns). It acts

by eliminating the bacteria that cause infections. It belongs to a group of medications

known ascephalosporins.

Ceftazidima Kabi is used to treat severe bacterial infections in:

• 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

Ceftazidima 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 a bacterial infection.

You should not be given Ceftazidima Kabi:

• if you are allergic(hypersensitive) toceftazidimaor to any of the other components of this medication (listed in section 6)
• if you have ever had asevere allergic reactionto anyother antibiotic(penicillins, monobactams, and carbapenems) as you may also be allergic to Ceftazidima Kabi.

• Inform your doctor beforestarting treatment with Ceftazidima Kabi if you think this affects you. You should not be given Ceftazidima Kabi.

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

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 Ceftazidima Kabi.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced eosinophilia and systemic symptoms (DRESS) and generalized acute pustular psoriasis (GAPP), have been reported in association with ceftazidima 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 blood or urine tests

Ceftazidima may affect the results of blood glucose tests and a blood test known asCoomb's test. If you are having tests:

• Inform the person taking the samplethat you have been given Ceftazidima.

Use of other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use other medications, including those purchased without a prescription.

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

• a type of antibiotic calledchloramphenicol
• a type of antibiotic calledaminoglycosides, for example:gentamicin, tobramycin
• a “urine tablet” (a diuretic calledfurosemide)

• Inform your doctorif this affects you.

Pregnancy and breastfeeding

Inform your doctor before Ceftazidima is administered:

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

Your doctor will assess the benefit of treating you with Ceftazidima against the risk to the baby.

Driving and operating machines

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

drive.

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

Ceftazidima Kabi contains sodium

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

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

be administered as aninfusion(intravenous perfusion) or directly as aninjectioninto 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, if you are being treated with other antibiotics, your weight and age, and your renal

function.

Newborns (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 old:

The usual daily dose should not exceed 3 g per day, especially if you are over 80 years old.

Patients with kidney problems

You may be administered a different usual dose. Your doctor will decide how much ceftazidime you need, depending on the severity of the kidney disease. Your doctor will closely monitor you and more frequent renal tests will be performed.

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, consult the Toxicology Information Service. Phone 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 injection. Do not use a double dose (two injections at once) to compensate for the missed dose, receive the next dose at the usual time.

If you interrupt treatment with Ceftazidime Kabi

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

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

Like all medicines, Ceftazidima Kabi may cause side effects, although not everyone will experience them.

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

• Reddish patches of skin in the shape of a bull's-eye or circles on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin eruptions may be preceded by fever and pseudogripal symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread eruption, elevated body temperature, and enlarged lymph nodes (Rash-like FESS syndrome or drug hypersensitivity syndrome).
• Widespread and reddened eruption with peeling, skin protuberances, and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular exanthema).

Symptoms to be aware of

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

• Severe allergic reaction. Signs includehives and itching,swelling, sometimes on the face or in the mouth that causesdifficulty breathing.
• Skin eruption,which may formblisters, and appears assmall bull's-eyes(dark center surrounded by a lighter area, with a dark ring around the edge).
• Neurological disorders: tremors, seizures, and, in some cases, coma. These have occurred in patients receiving a very high dose, especially in patients with kidney disease.

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

Frequent side effects

May affect up to1 in 10patients:

• Diarrhea,
• swelling and redness around a vein,
• red and swollen skin rash that may cause itching,
• pain, burning, swelling, or inflammation at the injection site.

• Inform your doctorif any of these side effects concern you

Frequent 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 to clot
• An increase in liver enzymes.

Rare side effects

May affect up to1 in 100people:

• Intestinal inflammation that may cause pain or diarrhea that may have blood
• Fungal infections in the mouth or vagina
• Headache
• Dizziness
• Stomach pain
• Nausea or vomiting
• Fever and chills.

• Inform your doctorif you experience any of them.

Rare 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 to clot)
• An increase in urea, ureic nitrogen, or serum creatinine levels in the blood.

Other side effects

Other side effects that have occurred in a small number of patients, but whose

exact frequency is unknown:

• Renal inflammation or failure
• Tickling sensations
• Bad taste in the mouth
• The skin or whites of the eyes may turn yellow.

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
• Significant decrease in the number of white blood cells.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use Ceftazidima Kabi after the expiration date that appears on the packaging after CAD.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store the vial in the outer packaging to protect it from light.

Once Ceftazidima Kabi powder is reconstituted into a solution, it must be administered immediately.

Do not use the solution if it is cloudy, it must be completely transparent. Unused solution must be discarded.

Medicines should not be thrown away through drains or in the trash. Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. By doing so, you will help toprotectthe environment.

Ceftazidima Kabi Composition

Ceftazidima Kabi 1 g powder for injection EFGcontains the active principle

active ceftazidima (1 g) in the form of ceftazidima pentahidrate.

The other components are: sodium carbonate for injectable preparations.

Product appearance and container content

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

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

• Only some container sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

C/ Marina, 16-18

08005 Barcelona (Spain)

Manufacturer responsible:

LABESFAL – Laboratórios Almiro S.A. (Fresenius Kabi Group)

Lagedo, P-3465 157

Santiago de Besteiros (Portugal)

This leaflet was approved in February 2022.

The detailed and updated information of this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/