Ceftazidime kabi

Package leaflet: Information for the user

Ceftazidime Kabi, 2000 mg, powder for solution for injection/infusion
Ceftazidimum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any further questions, please ask your doctor or nurse.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse.
See section 4.

Contents of the leaflet

1. What Ceftazidime Kabi is and what it is used for
2. What you need to know before using 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 Kabi is an antibiotic used in adults and children (including newborns). It acts by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftazidime Kabi is used to treat serious bacterial infections:
- of the lower respiratory tract, including lungs;
- of the lungs and bronchi in patients with cystic fibrosis;
- of the brain (meningitis);
- of the ear;
- of the urinary tract;
- of the skin and soft tissues;
- of the abdomen and peritoneal lining (peritonitis);
- of bones and joints.

Ceftazidime Kabi may also be used:
- to prevent infections during transurethral resection of the prostate in men;
- to treat patients with low white blood cell count (neutropenia) and fever caused by bacterial infection.

2. Important information before using Ceftazidime Kabi

When not to use Ceftazidime Kabi
­ Do not use this medicine if the patient is allergic to ceftazidime or to any of the other
ingredients of this medicine (listed in section 6).
­ Do not use this medicine if the patient has ever had a severe allergic reaction to any other
antibiotic (such as penicillins, monobactams or carbapenems), because the patient may also
be allergic to Ceftazidime Kabi.
→ Inform the doctor before starting treatment with Ceftazidime Kabi if the patient suspects
that any of the situations described above apply. Do not administer Ceftazidime Kabi to the
patient.

Warnings and precautions
Care should be taken to monitor whether the patient experiences any symptoms such as allergic
reactions, nervous system disorders, or gastrointestinal disturbances including diarrhoea during
treatment with Ceftazidime Kabi. This may reduce the risk of potential complications. See
"Symptoms which require attention" in section 4. If the patient has ever experienced an allergic
reaction to other antibiotics, they may also be allergic to Ceftazidime Kabi.

Serious 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 during treatment with ceftazidime. If the patient develops
any of the symptoms associated with these serious skin reactions described in section 4, medical
advice should be sought immediately.

Blood and urine tests
Ceftazidime Kabi may alter the results of urine glucose tests and blood tests known as the Coombs' test.
If the patient is due to have such tests performed:
→ Inform the healthcare personnel collecting the samples that the patient is receiving
Ceftazidime Kabi.

Ceftazidime Kabi and other medicines
Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any
medicines the patient plans to take.

Do not use Ceftazidime Kabi without consulting a doctor if the patient is also taking:
­ an antibiotic called chloramphenicol;
­ an antibiotic from a group called aminoglycosides, such as gentamicin, tobramycin;
­ diuretic tablets containing furosemide;
→ Inform the doctor if any of the above situations apply to the patient.

Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a
child, she should consult her doctor before using this medicine.

Driving and operating machinery
Ceftazidime Kabi may cause adverse effects such as dizziness, which may affect the ability to drive.
Do not drive or operate machinery unless the patient is certain that these adverse effects have not
occurred.

Ceftazidime Kabi contains sodium
This medicine contains 104 mg of sodium (the main component of table salt) per vial. This is
equivalent to 5.2% of the maximum daily recommended sodium intake for adults.

3. How to use Ceftazidime Kabi

Ceftazidime Kabi is usually administered by a doctor or nurse. It is given as an intravenous infusion (drip) or as an injection directly into a vein or as an intramuscular injection.
Ceftazidime Kabi is prepared by a doctor, pharmacist, or nurse using water for injections or another suitable infusion fluid.

Recommended dose
The doctor will decide the appropriate dose of Ceftazidime Kabi for the patient, taking into account the severity and type of infection, whether the patient is taking other antibiotics, body weight, age, and kidney function.

Newborns and infants (from 0 to 2 months of age)
For each 1 kg of body weight, a daily dose of 25 to 60 mg of Ceftazidime Kabi is given in two divided doses.

Infants (over 2 months of age) and children weighing less than 40 kg
For each 1 kg of body weight, a daily dose of 100 to 150 mg of Ceftazidime Kabi is given in three divided doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more
1 g to 2 g of Ceftazidime Kabi three times daily. Maximum 9 g per day.

Patients over 65 years of age
The daily dose should usually not exceed 3 g per day, especially in patients over 80 years of age.

Patients with kidney disease
The patient may receive a dose different from the usual. The doctor or nurse will decide the appropriate dose of Ceftazidime Kabi depending on the severity of kidney disease.
The doctor will closely monitor the patient and may order more frequent kidney function tests.

Accidental overdose of Ceftazidime Kabi
If a larger than recommended dose of Ceftazidime Kabi is accidentally administered, contact a doctor immediately or go to the nearest hospital.

Missed dose of Ceftazidime Kabi
If a dose is missed, it should be administered as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped.
Do not administer a double dose (two injections at the same time) to make up for a missed dose.

Stopping treatment with Ceftazidime Kabi
Do not stop using Ceftazidime Kabi without first consulting your doctor.

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

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone will experience them.
If the patient experiences any of the following symptoms, medical advice should be sought immediately:
­ red spots on the trunk, target-like spots or circular rashes, often with central blisters, skin peeling,
ulceration of the mouth, throat, nose, genital organs and eyes. These severe 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).
­ red, peeling, widespread rash with subcutaneous nodules and blisters accompanied by fever.
Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).
Symptoms to be aware of
The serious adverse reactions described below have occurred in a small number of people, but their
exact frequency is unknown:
­ Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or
lips, which may cause difficulty breathing.
­ Skin rash, which may include blisters and appear as target lesions (a dark spot in the centre
surrounded by a lighter ring with a dark rim around the edge).
­ Neurological disorders: tremors, seizures and sometimes coma. These disorders occurred in
patients who received excessive doses, particularly in patients with kidney disease.
→ Contact a doctor or nurse immediately if the patient experiences any of the above symptoms.
Common adverse reactions (occurring in less than 1 in 10 patients):
­ diarrhoea;
­ swelling and redness along the vein;
­ red, raised skin rash, which may be itchy;
­ pain, burning, swelling or inflammation at the injection site.
→ Tell the doctor if any of the above symptoms are troubling the patient.
Common adverse reactions that may be revealed in blood test results:
­ increased number of one type of white blood cells (eosinophilia);
­ increased number of platelets, which are involved in blood clotting;
­ increased activity of liver enzymes.
Uncommon adverse reactions (occurring in less than 1 in 100 patients):
­ inflammation of the intestine, which may cause abdominal pain or diarrhoea, possibly containing blood;
­ fungal infections (e.g. oral or vaginal candidiasis);
­ headache;
­ dizziness;
­ abdominal pain;
­ nausea or vomiting;
­ fever and chills.
→ Tell the doctor if the patient has experienced any of the above symptoms.
Uncommon adverse reactions that may be revealed in blood test results:
­ decreased number of white blood cells;
­ decreased number of platelets (cells involved in blood clotting);
­ increased serum levels of urea, blood urea nitrogen or creatinine.
Other adverse reactions
Other adverse reactions that occurred in a small number of patients, but their exact frequency is unknown:
­ kidney inflammation or kidney failure;
­ tingling sensations;
­ unpleasant taste in the mouth;
­ yellowing of the whites of the eyes and skin.
Other adverse reactions that may be revealed in blood test results:
­ red blood cells breaking down too quickly;
­ increased number of one type of white blood cells in the blood;
­ marked decrease in the number of white blood cells.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, tell your doctor or nurse. Adverse
reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the
Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
tel.: + 48 22 49 21 301
fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store 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 label after EXP. The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store the vial in the outer packaging to protect from light.
The solution prepared after dissolving Ceftazidime Kabi should be used within 6 hours if stored at 25°C, or within 12 hours if stored at 5°C.
Do not use this medicine if cloudiness is observed; the solution should be completely clear and transparent.
Any 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. Contents of the pack and other information

What Ceftazidime Kabi contains
­ The active substance is ceftazidime (2000 mg) in the form of ceftazidime pentahydrate.
­ The other ingredient is: sodium carbonate.
The sodium content of the medicine is 104 mg of sodium per vial. This should be taken into account for patients on a sodium-restricted diet.

What Ceftazidime Kabi looks like and contents of the pack
Ceftazidime Kabi is a powder which is usually mixed with water for injections to obtain a clear solution for injection or infusion. The prepared solution of Ceftazidime Kabi may be mixed by the physician with another suitable infusion fluid. Solutions may vary in colour from pale yellow to amber.
Each pack of Ceftazidime Kabi contains 1 or 10 glass vials with powder, each with a rubber stopper and an aluminium cap with a plastic flip-off cap.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland

Manufacturer
Labesfal - Laboratorios Almiro, S.A.
Lagedo, 3463-157 Santiago de Besteiros
Portugal

For further information, please contact the Marketing Authorisation Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Poland
Tel.: +48 22 345 67 89

This medicinal product is authorised in the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria Ceftazidim Kabi 2 g Pulver zur Herstellung einer Injektions/Infusionslösung
Belgium Ceftazidim Fresenius Kabi 2000 mg, poeder voor oplossing voor injectie/infusie
Czech Republic Ceftazidim Kabi
Denmark Ceftazidim Fresenius Kabi
Estonia Ceftazidime Fresenius Kabi 2000 mg
Finland Ceftazidim Fresenius Kabi 2 g injektio-/infuusiokuiva-aine, liuosta varten
Greece Ceftazidime Kabi, 2000 mg, κόνις για διάλυμα προς ένεση/έγχυση
Spain Ceftazidima Kabi 2g
Netherlands Ceftazidim Fresenius Kabi 2000 mg, poeder voor oplossing voor injectie/infusie
Iceland Ceftazidim Fresenius Kabi
Lithuania Ceftazidime Kabi 2000 mg
Luxembourg Ceftazidim Kabi 2 g Pulver zur Herstellung einer Injektions/Infusionslösung
Latvia Ceftazidime Fresenius Kabi 2000 mg
Malta Ceftazidime Fresenius 2000 mg powder for solution for injection/infusion
Germany Ceftazidim Kabi 2 g Pulver zur Herstellung einer Injektions/Infusionslösung
Norway Ceftazidim Fresenius Kabi 2 g, pulver til injeksjons-/infusjonsvæske, oppløsning
Poland Ceftazidime Kabi
Portugal Ceftazidime Kabi
Slovakia Ceftazidim Kabi 2 g
Slovenia Ceftazidim Kabi 2000 mg prašek za raztopino za injiciranje ali infundiranje
Hungary Ceftazidim Kabi 2 g por oldatos injekcióhoz / infúzióhoz
Italy Ceftazidima Fresenius
United Kingdom Ceftazidime 2 g
(Northern Ireland)

Information intended exclusively for medical professionals:

Single-use medicinal product. Any unused solution must be discarded.
Intravenous administration – injection
To prepare for intravenous injection, ceftazidime should be dissolved in water for injections (as indicated in the table below). The solution should be administered slowly over 5 minutes, directly into the vein or via an intravenous infusion set.
Intramuscular administration (applies to 500 mg and 1000 mg)
Ceftazidime should be dissolved in water for injections or in 10 mg/ml (1%) lidocaine hydrochloride injection solution, as indicated in the table below. Prior to administering ceftazidime with lidocaine, refer to the information regarding lidocaine use.
Intravenous administration – infusion (see section 3)
For intravenous infusion, 2000 mg of powder should be dissolved in 10 ml of water for injections (for injection preparation) or in 50 ml of water for injections (for intravenous infusion preparation), or in another compatible intravenous solution. The intravenous infusion should be administered over 15 to 30 minutes. Intravenous infusion via a Y-type set may be administered simultaneously with one of the compatible solutions. However, during administration of the solution containing ceftazidime, infusion of other solutions should be interrupted.
The pressure inside the Ceftazidime Kabi vials of all sizes is lower than atmospheric pressure. During reconstitution, pressure increases due to carbon dioxide release. Small carbon dioxide bubbles in the prepared solution may be disregarded.
Instructions for preparation of the medicinal product for administration
Refer to the table of added volumes and resulting concentrations, which may be helpful when partial doses are required.

| Package size | Volume of solvent to add (ml) | Approximate concentration of ceftazidime (mg/ml) | |--------------|-------------------------------|--------------------------------------------------| | 500 mg powder for solution for injection | Intramuscular injection 1.5 ml | 260 | | | Intravenous injection 5 ml | 90 | | 1 g powder for solution for injection | Intramuscular injection 3 ml | 260 | | | Intravenous injection 10 ml | 90 | | 2 g powder for solution for injection/infusion | Intravenous injection 10 ml | 170 | | | Intravenous infusion 50 ml* | 40 | * Note: add in two steps

Preparation of Ceftazidime Kabi solution for administration in children
Neonates and infants aged ≤2 months
Intermittent intravenous injections
Dosage: 25–60 mg/kg body weight/day in two divided doses

Infants over 2 months of age and children under 40 kg
Intermittent administration as intravenous injections
Dosage: 100–150 mg/kg body weight/day in 3 divided doses, not exceeding 6 g/day

Infants over 2 months of age and children under 40 kg
Administration by continuous infusion
Loading dose 60-100 mg/kg body weight, followed by continuous infusion at a dose of 100-200 mg/kg
body weight/day, not exceeding 6 g/day

Do not administer a dose greater than 6 g (corresponding to 150 ml) per day.
Compatible solutions for intravenous administration
To obtain a ceftazidime solution with a concentration between 40 mg/ml and 170 mg/ml, Ceftazidime
Kabi may be mixed with commonly used infusion solutions:
­ 9 mg/ml (0.9%) sodium chloride solution (normal saline);
­ Ringer's lactate solution;
­ 100 mg/ml (10%) glucose solution.
For preparation of a solution for intramuscular injection, Ceftazidime Kabi, powder for
preparation of injection solution, may also be dissolved in 10 mg/ml (1%) lidocaine solution.
During dissolution of ceftazidime, carbon dioxide is released, causing internal pressure.
To facilitate preparation of the medicinal product for use, the following techniques are recommended.
Instructions for solution preparation
Preparation of infusion solution containing ceftazidime in a standard vial (mini-bag or burette-type set)

1. Pierce the stopper with a needle and inject 10 ml of solvent.
2. Remove the needle and shake the vial until a clear solution is obtained.
3. Do not insert the venting needle before the medicinal product is completely dissolved. Insert the venting needle through the stopper to reduce internal pressure in the vial.
4. Transfer the solution into the final container (mini-bag or burette), obtaining a total volume of not less than 50 ml, and administer as an intravenous infusion over 15 to 30 minutes.

NOTE: To ensure sterility of the medicinal product, do not insert the venting needle through
the closure until the medicinal product is completely dissolved.
For single use only.
The prepared solution is chemically and physically stable for 6 hours at 25°C and for 12 hours at 5°C
after reconstitution with water for injections, 1% lidocaine solution, 0.9% sodium chloride solution,
Ringer's lactate solution, and 10% glucose solution.
From a microbiological standpoint, the medicinal product should be used immediately.
Any unused portions or waste material should be disposed of in accordance with local
regulations.
The solution must be prepared under aseptic conditions.
The solution should be inspected visually prior to administration for presence of particulate matter or discoloration.
Only clear solutions, free from particulate matter, should be used.
The color of the solution, ranging from pale yellow to amber, depends on the concentration, type of solvent,
and storage conditions. Provided recommended conditions are met, variation in solution color does not adversely affect the efficacy of the medicinal product.