Ceftazidime Kabi 2 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Ceftazidime Kabi 2 g powder for solution for injection and for 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 questions, ask your doctor.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

1. What Ceftazidime Kabi is and what it is used for
2. What you need to know before you use 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 Ceftazidime Kabi is and what it is 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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold. It is important that you follow your doctor's instructions regarding dosage, dosing intervals, and duration of treatment. Do not store or reuse this medicine. If you have any antibiotic left after completing the treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

Ceftazidime 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 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, or 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. Ceftazidime Kabi must not be administered to you.

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.

Severe skin reactions have been reported with ceftazidime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Seek immediate medical attention if you notice any symptoms related to these severe 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 Ceftazidime Kabi with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.

Do not take Ceftazidime Kabi without speaking to your doctor if you are also taking:

??an antibiotic called chloramphenicol

??a type 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 it does not affect you.

Ceftazidime Kabi contains sodium.

Ceftazidime Kabi 2000 mg contains 104 mg of sodium (the main component of table/cooking salt) per vial. This corresponds to 5.2% of the maximum recommended daily sodium intake for an adult.

3. How to use Ceftazidime Kabi

Ceftazidime Kabi is normally administered by a doctor or nurse. It may be given as an intravenous infusion (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 injections or an appropriate infusion fluid.

Recommended dose

Your doctor will decide the correct dose of Ceftazidime for you, based 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 body weight, 25 to 60 mg of ceftazidime per day will be given, 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 body weight, 100 to 150 mg of ceftazidime per day will be given, 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 should normally 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 determine how much ceftazidime you need, depending on the severity of your kidney disease. Your doctor will monitor you closely and kidney function tests will be performed 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, contact the Toxicology Information Service. Telephone 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 dose. Do not use a double dose (two injections at once) to make up for the missed dose.

If you stop using 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 adverse effects

Like all medicines, Ceftazidime Kabi may cause adverse effects, although not everyone gets 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 patients, but their exact frequency is unknown:

• Severe allergic reaction. Signs include itchy, raised rash,

swelling, sometimes of the face or mouth, causing difficulty breathing.

• Skin rash, which may blister, appearing as small target-like lesions

(dark center 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 patients with kidney disease.

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

Frequent adverse effects

May affect up to 1 in 10 patients:

• Diarrhea
• Swelling and redness around a vein
• Red, raised skin rash, which may be itchy
• Pain, burning, swelling, or inflammation at the injection site.

Tell your doctor if any of these adverse effects concern you.

Frequent adverse effects that may show up 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 patients:

• 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.

Tell your doctor if you experience any of these.

Uncommon adverse effects that may show up 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:

• Kidney inflammation or kidney failure
• Tingling sensations
• Bad taste in the mouth
• Yellowing of the skin or whites of the eyes.

Other adverse effects that may show up 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 effects, consult your doctor or nurse, even if they are adverse effects 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 this medicine out of the sight and reach of children.

??Do not use this medicine after the expiry date stated on the container,
after EXP. The expiry date refers to the last day of the month indicated.

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

??Once Ceftazidime Kabi powder has been reconstituted into a solution, it should be administered immediately.

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

??Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftazidime Kabi

Ceftazidime Kabi 2 g powder for injectable and infusion solution contains the active substance ceftazidime (2 g) in the form of ceftazidime pentahydrate.

The sodium content is 104 mg of sodium. You should 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 container

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

??Ceftazidime Kabi 2 g is available in boxes containing 1 and 10 glass vials of powder, closed with rubber stoppers, aluminium caps and flip-off caps.

??Only certain pack 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:

Austria	Ceftazidim Kabi 2g - Powder for solution for injection or infusion
Germany	Ceftazidim Kabi 2 g powder for solution for injection or infusion
Belgium	Ceftazidim Fresenius Kabi 2000mg, powder for solution for injection/infusion
Czech Republic	Ceftazidim Kabi 2g
Denmark	Ceftazidim Fresenius Kabi
Estonia	Ceftazidime Fresenius Kabi 2000 mg
Greece	Ceftazidime Kabi 2000mg, κόνις για διάλυμα προς ένεση/έγχυση
Finland	Ceftazidim Fresenius Kabi 2 g for injection/infusion concentrate, for solution
Hungary	Ceftazidim Kabi 2 g powder for solution for injection / infusion
Italy	Ceftazidima Fresenius
Iceland	Ceftazidim Fresenius Kabi
Latvia	Ceftazidime Fresenius Kabi 2000 mg
Lithuania	Ceftazidime Kabi 2000 mg
Luxembourg	Ceftazidim Kabi 2 g powder for solution for injection or infusion
Malta	Ceftazidime Fresenius 2000 mg powder for solution for injection/infusion
Netherlands	Ceftazidim Fresenius Kabi 2000mg, powder for solution for injection/infusion
Norway	Ceftazidim Fresenius Kabi 2g, powder for solution for injection/infusion
Poland	Ceftazidime Kabi
Portugal	Ceftazidime Kabi
Slovenia	Ceftazidim Kabi 2000mg powder for solution for injection or infusion
Slovakia Spain	Ceftazidim Kabi 2g Ceftazidima Kabi 2g
United Kingdom (Northern Ireland)	Ceftazidime 2 g

Date of the most recent review of this summary: June 2024

The detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

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This information is intended only for healthcare professionals:

This medicine is for single use. Any unused content must 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 administered through an infusion system.

Intravenous route – infusion (see section 3):

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

All vial/bottle sizes of Ceftazidima Kabi 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 disregarded.

Reconstitution instructions

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

Size of vial	Amount of diluent to add (ml)	Approximate concentration (mg/ml)
2 g powder for injectable solution and for infusion
2 g	Intravenous bolus	10 ml	170
	Intravenous infusion	50 ml*	40

• Note: Addition must be performed in 2 steps.

Preparation of Ceftazidime solutions for use in children

Neonates and infants ≤ 2 months

Intermittent administration

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

Ceftazidime Kabi 2g powder for injectable solution and for infusion (reconstitution for IV injection in 10 ml of diluent)
Body Weight [kg]	2 doses per day volume per partial dose
	25 mg/kg/day	60 mg/kg/day
3	0.25 ml	0.55 ml
4	0.30 ml	0.70 ml
5	0.40 ml	0.85 ml
6	0.50 ml	1.00 ml

Infants > 2 months and children < 40 kg

Intermittent administration

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

Ceftazidime Kabi 2g powder for injectable solution and for infusion (reconstitution for IV injection in 10 ml of diluent)
Body Weight [kg]		3 doses per day volume per partial dose
			100 mg/kg/day	150 mg/kg/day
10			2.00 ml	3.00 ml
20			4.00 ml	6.00 ml
30			6.00 ml	9.00 ml
40			8.00 ml	12.00 ml
50			10.00 ml	-
60			12.00 ml	-

Infants > 2 months and children < 40 kg

Continuous infusion

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

Ceftazidime Kabi 2g powder for injectable solution and for infusion
Body weight [kg]	volume of loading dose per dose (reconstitution for IV injection in 10 ml of diluent)	volume of continuous infusion per day (reconstitution for IV infusion in 50 ml of diluent)
	60 mg/kg/day	100 mg/kg/day	100 mg/kg/day	150 mg/kg/day	200 mg/kg/day
10	3.5 ml	5.9 ml	25.00 ml	37.50 ml	50.00 ml
20	7.0 ml	11.8 ml	50.00 ml	75.00 ml	100.00 ml
30	10.6 ml	17.6 ml	75.00 ml	112.50 ml	150.00 ml
40	14.1 ml	23.5 ml	100.00 ml	150.00 ml	-

The following should be considered: 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, Ceftazidima Kabi can be mixed with commonly used infusion solutions:

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

When reconstituted for intramuscular use, Ceftazidima Kabi can 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.

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

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

NOTE: To preserve product sterility, it is important not to insert the venting needle through the vial stopper before the product has 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 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 particles or discoloration prior to administration.

The solution should only be used 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, product potency is not adversely affected by these color variations.