Prospecto: information for the user

Ceftazidima Kabi 2g powder for injectable solution and for infusion EFG

Ceftazidima

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.

-If you experience adverse effects, consult your doctor or nurse, even if they do not appear in this prospect. See section 4.

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

2.What you need to know before starting to use Ceftazidima Kabi

3.How to use Ceftazidima Kabi

4.Possible adverse effects

5Storage of Ceftazidima Kabi

6.Contents of the package and additional information

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 medications known ascephalosporins.

Ceftazidima 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 allergictoceftazidimaor to any of the other components of this medicine (including those listed in section6).

- if you have ever had asevere allergic reactionto any otherantibiotic(penicillins, monobactams, and carbapenems) as you may also be allergic to Ceftazidima Kabi.

Inform your doctor before starting treatment with Ceftazidima Kabi if you think this affects you. Do not be given Ceftazidima

Warnings and precautions

While you are being given Ceftazidima 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 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 as theCoombs test. If you are having tests:

• Inform the person taking the samplethat you have been given

Ceftazidima.

Use of Ceftazidima Kabi with other medicines

Inform your doctor that you are using, have recently used, or may need to use any other medicine.

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 lactation

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

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 2000 mg contains 104 mg of sodium (main component of table salt/for cooking) in each vial. This is equivalent to 5.2% 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 aintravenous infusionor directly as aninjectioninto a vein or muscle.

Ceftazidime Kabi is reconstituted by the doctor, pharmacist, or nurse using sterile water for injection or an appropriate infusion fluid.

Recommended dose

The correct dose of Ceftazidime for you will be determined 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:

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 dose than usual. Your doctor will decide how much

ceftazidime you need, depending on the severity of the kidney disease. Your doctor will closely monitor you and perform more frequent renal function tests.

If you use 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 0420.

If you forget to use Ceftazidime Kabi

If you miss a dose, you should receive it as soon as possible. However, if it is almost time for the next dose, skip the missed dose. Do not use a double dose (two injections at once) to compensate for the missed dose.

If you interrupt the 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 flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, elevated body temperature, and enlarged lymph nodes (Rash-like Flu-like Exanthem Syndrome or drug hypersensitivity syndrome).
• Widespread and reddened rash 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 patients, but their exact frequency is unknown:

• Severe allergic reaction. Signs includeswollen and itchy rash,

swelling, sometimes in the face or mouth that causesdifficulty breathing.

• Skin rash,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

Common side effects

May affect up to1 in 10patients:

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

Inform your doctorif any of these side effects concern 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 to clot
• an increase in liver enzymes.

Rare side effects

May affect up to1 in 100patients:

• inflammation of the intestine that may cause pain or diarrhea that may have blood
• yeast 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:

• decrease in the number of white blood cells
• decrease in the number of platelets (cells that help blood to clot)
• 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:

• inflammation or failure of the kidneys
• 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
• increase in a certain type of white blood cell
• significant decrease in the number of white blood cells.

Reporting side effects

If you experience side effects, consult your doctor or nurse, even if they are side effects that do not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine. .

??Keep this medication out of the sight and reach of children.

??Do not use this medication 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. Protect from light.

??Once Ceftazidima Kabi powder is reconstituted into a solution, it must be administeredimmediately.

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

??Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Ceftazidima Kabi Composition

Ceftazidima Kabi 2g powder for injection and infusioncontains the active ingredient ceftazidime (2 g) in the form of ceftazidime pentahydrate.

The sodium content is 104 mg of sodium. You need to take this into account if you are on a low-sodium diet. All powder concentrates contain anhydrous sodium carbonate.

Appearance of the product and contents of the pack

??The Ceftazidima Kabi powder is normally mixed with injection water to give a

injectable or infusion solution. Once reconstituted, your doctor must mix the

Ceftazidima Kabi solution with other suitable infusion fluids. The colorof the

solutions may vary between amber and light yellow.

??Ceftazidima Kabi 2g comes in boxes containing 1 and 10 glass vials with powder,

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

??You may only be marketed some sizes of packaging.

Marketing Authorization Holder and Responsible Person for Manufacturing

Marketing Authorization Holder:

Fresenius Kabi España, S.A.U.

C/ Marina, 16-18

08005 Barcelona (Spain)

Responsible Person for Manufacturing:

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

Lagedo, P-3465-157 Santiago de Besteiros (Portugal)

This medicinal product is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Last review date of this leaflet:June 2024

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

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This information is intended solely for medical professionals or healthcare professionals:

This medicinal product is for single use only. Dispose of any unused content.

Intravenous – injection:

For intravenous intermittent direct administration, ceftazidima must be reconstituted with injection water (see table below). The solution must be injected slowly into a vein over a period of up to 5 minutes or through a system of an administration device.

Intravenous – infusion (see section 3):

For intravenous infusion, the 2 g vial content must be reconstituted with 10 ml of injection water (for bolus) and 50 ml of injection water (intravenous infusion) or with one of the compatible intravenous liquids and administer by intravenous infusion over 15 – 30 minutes. It may be performed the intravenous intermittent infusion with an administration device in Y with compatible solutions. However, during the infusion of a solution containing ceftazidima, it is advisable to interrupt the other solution.

All sizes of vials/Ceftazidima Kabi containers are supplied at reduced pressure. As the product dissolves, carbon dioxide is released and positive pressure develops. Small carbon dioxide bubbles in the reconstituted solution must be ignored.

Instructions for reconstitution

See the table for the volumes of addition and concentrations of solution that may be useful when fractional doses are needed.

* Note: the addition must be made in 2 stages.

Preparation of Ceftazidima solutions for use in children

Newborns and infants ≤ 2 months

Intermittent administration

Dose: 25 to 60 mg/kg of body weight/day administered in two divided doses.

Infants > 2 months and children <40>

Intermittent administration

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

Infants > 2 months and children <40>

Continuous infusion

Dose: 60 to 100 mg/kg followed by a continuous infusion of 100 to 200 mg/kg/day, maximum 6 g/day

It must be considered that no more than 150 ml per day (equivalent to 6 g) should be administered.

Compatible intravenous liquids:

At ceftazidima concentrations between 40 mg/ml and 170 mg/ml, Ceftazidima Kabi can be mixed with commonly used infusion solutions:

- 0.9% sodium chloride solution (physiological saline solution),

- Ringer Lactate solution

- 10% glucose solution

Ceftazidima Kabi can be diluted with 1% lidocaine solution when reconstituted for intramuscular use.

When ceftazidima dissolves, carbon dioxide is released and positive pressure develops.

To simplify use, the recommended reconstitution techniques described below should be followed.

Preparation of IV infusion solutions of ceftazidima injectable in standard presentation in vial (mini-bag or burette infusion system):

1. Insert the needle of the syringe through the stopper of the vial and inject 10 ml of diluent.

2. Remove the needle and agitate the vial until a transparent solution is obtained.

3. Do not insert a needle to release gas until the product has dissolved. Insert a needle to release gas through the stopper of the vial to release the internal pressure.

4. Transfer the reconstituted solution to the final distribution vehicle (e.g. mini-bag or burette infusion system) until a total volume of at least 50 ml is reached and administer by intravenous infusion over 15 to 30 minutes.

NOTE: To preserve the sterility of the product, it is essential not to insert the gas-releasing needle through the stopper of the vial before the product has dissolved.

For single use only.

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

Dispose of any remaining solution in accordance with local regulations.

The solution should be prepared under aseptic conditions.

The solution should be visually inspected for particles or discoloration before administration.

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

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