CEFTAZIDIME KABI 2 g POWDER FOR INJECTION AND INFUSION SOLUTION

Introduction

Package Leaflet: Information for the User

Ceftazidime Kabi 2g powder for solution for injection and infusion EFG

Ceftazidime

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 or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist, even if they are 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

1. Contents of the pack and other 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 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 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

• if you are allergic to ceftazidime or any of the other components 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 beforestarting treatment with Ceftazidime Kabi if you think this applies to you. Ceftazidime should not be administered.

Warnings and precautions

While you are being administered 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 which you should pay attention') 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 administered Ceftazidime.

Using Ceftazidime Kabi with other medicines

Tell your doctor that you are using, have recently used, or might use any other medicines.

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

a antibiotic called chloramphenicol

a type of antibiotic called aminoglycosides, such as gentamicin, tobramycin

a "water pill" (a diuretic called furosemide)

Tell your doctorif this 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 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 2000 mg contains 104 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 5.2% of the maximum recommended daily sodium intake 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 or a suitable infusion fluid.

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.

Patient over 65 years:

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

Patient with kidney problems

You may be administered 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 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 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.

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 on the use of this product, ask your doctor or pharmacist.

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 trunk, 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 which you should pay attention

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

• Severe allergic reaction. The signs include itchy and lumpy rash, swelling, sometimes in the face or mouth that causes difficulty breathing.

Skin rashthat can form blistersand appears as small targets(dark center 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 who receive 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 to 1 in 10patients:

• diarrhea
• swelling and redness around a vein
• red and lumpy skin rash, which can be itchy
• 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 100patients:

• inflammation of the intestine that can 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.

Tell your doctorif you experience any of them.

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 urea, ureic nitrogen, or serum creatinine levels in 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
• increase in a certain type of white blood cell
• significant decrease in the number of white blood cells.

Reporting of side effects

If you experience side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them 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 this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the pack, after EXP. The expiry date is the last day of the month indicated.

Do not store above 25°C. Protect from light.

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

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

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Container Contents and Additional Information

Composition of Ceftazidime Kabi

Ceftazidime Kabi 2g powder for solution 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 Container Contents

The Ceftazidime Kabi powder is normally mixed with water for injection to give an injectable solution or for infusion. Once reconstituted, your doctor must mix the Ceftazidime Kabi solution with other suitable infusion fluids. The color of the solutions may vary between amber and light yellow.

Ceftazidime Kabi 2g comes in boxes containing 1 and 10 glass vials with powder, closed with a rubber stopper, aluminum cap, and flip-off cap.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

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 medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Date of the last revision of this leaflet:June 2024

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

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This information is intended only for healthcare professionals:

This medicinal product is for single use. Discard any unused content.

Intravenous route – injection:

For intermittent intravenous administration, ceftazidime should 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 through an administration set.

Intravenous route – infusion (see section 3):

For intravenous infusion, the contents of the 2 g vial should be reconstituted with 10 ml of water for injection (for bolus) and 50 ml of water for injection (intravenous infusion) or with one of the compatible intravenous fluids and administered by intravenous infusion over 15-30 minutes. Intermittent intravenous infusion can be performed with a Y-administration set with compatible solutions. However, during the infusion of a solution containing ceftazidime, it is advisable to interrupt the other solution.

All sizes of Ceftazidime Kabi vials are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and positive pressure develops. Small carbon dioxide bubbles in the reconstituted solution should be ignored.

Reconstitution instructions

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

• Note: Addition should be performed in 2 stages.

Preparation of Ceftazidime Solutions for Use in Children

Neonates and Infants ≤ 2 months

Intermittent Administration

Dosage: 25 to 60 mg/kg body weight/day administered in 2 divided doses.

Infants > 2 months and children <40 kg< strong>

Intermittent Administration

Dosage: 100 to 150 mg of Ceftazidime Kabi per day in 3 divided doses, maximum 6 g/day.

Infants > 2 months and children <40 kg< strong>

Continuous Infusion

Loading dose of 60 - 100 mg/kg followed by a continuous infusion of 100 - 200 mg/kg/day, maximum 6 g/day

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

Compatible intravenous fluids:

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

• sodium chloride 9 mg/ml (0.9%) solution (physiological saline solution),
• Ringer's lactate solution
• glucose 100 mg/ml (10%) solution

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

When ceftazidime is dissolved, carbon dioxide is released and positive pressure is created.

For simple use, the recommended reconstitution techniques described below should be followed.

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

1. Insert the needle of the syringe through the vial stopper and inject 10 ml of diluent.
2. Remove the needle and shake the vial until a clear 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 vial stopper to release the internal pressure.
4. Transfer the reconstituted solution to the final distribution vehicle (e.g., mini-bag or burette-type infusion system) to a total volume of at least 50 ml and administer by intravenous infusion over 15-30 minutes.

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

For single use.

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 injectable preparations, 1% lidocaine solution, 0.9% sodium chloride solution, Ringer's lactate, and 10% glucose solution. From a microbiological point of view, the product should be used immediately.

Discard any remaining solution in accordance with local regulations.

The dissolution should be performed 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.

The solutions 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.