Ceftazidime kabi

Patient Information Leaflet

Ceftazidime Kabi, 1000 mg, powder for solution for injection
Ceftazidimum
Please read all of this leaflet carefully before 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 nurse.
­ 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 the 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 Kabi is an antibiotic used in adults and children (including newborns). It kills 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 the 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 abdominal 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).
­ If the patient has ever had a severe allergic reaction to any other antibiotic (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 symptoms such as allergic reactions, nervous system disorders, or gastrointestinal disturbances including diarrhoea during treatment with Ceftazidime Kabi. This will reduce the risk of potential problems. See “Symptoms to watch for” in section 4. If the patient has ever had an allergic reaction to other antibiotics, they may also be allergic to Ceftazidime Kabi.
Serious skin reactions have been reported during treatment with ceftazidime, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If the patient develops any symptoms related to these serious skin reactions described in section 4, medical advice must 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 medical staff 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, i.e. 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 or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.

Driving and operating machinery
Ceftazidime Kabi may cause undesirable effects such as dizziness, which may affect the ability to drive. Patients should not drive or operate machinery unless they are certain that these adverse effects have not occurred.

Ceftazidime Kabi contains sodium
This medicine contains 52 mg of sodium (the main component of table salt) per vial. This is equivalent to 2.6% of the maximum recommended daily dietary intake of sodium 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 (aged 0 to 2 months)
For every 1 kg of the infant’s body weight, 25 to 60 mg of Ceftazidime Kabi is given per day, divided into two doses.

Infants (over 2 months of age) and children weighing less than 40 kg
For every 1 kg of the infant’s or child’s body weight, 100 to 150 mg of Ceftazidime Kabi is given per day, divided into three doses. Maximum 6 g per day.

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

Patients aged over 65 years
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 one. The doctor or nurse will decide which dose of Ceftazidime Kabi should be given, 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 more Ceftazidime Kabi has been administered than prescribed, contact a doctor immediately or go to the nearest hospital.

Missed dose of Ceftazidime Kabi
If a dose has been 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 treatment with 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 all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If any of the following symptoms occur in the patient, medical advice should be sought immediately:
­ Reddish spots on the trunk, rash resembling targets or circular lesions, often with central blisters, skin peeling, ulcers in 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 swollen 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 in breathing.
­ Skin rash , which may involve blisters and resemble target lesions (dark spot in the center surrounded by a lighter ring with a dark rim around the edge).
­ Nervous system 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 fewer 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.
→ Inform the doctor if any of the above symptoms are troubling the patient.
Common adverse reactions that may be revealed in blood tests:
­ Increase in number of one type of white blood cells (eosinophilia);
­ Increase in number of platelets, which are involved in blood clotting;
­ Increase in liver enzyme activity.
Uncommon adverse reactions (occurring in fewer than 1 in 100 patients):
­ Inflammation of the intestine, which may cause pain or diarrhoea, possibly containing blood;
­ Thrush – fungal infections of the mouth or vagina;
­ Headache;
­ Dizziness;
­ Abdominal pain;
­ Nausea or vomiting;
­ Fever and chills.
→ Inform the doctor if the patient experiences any of the above symptoms.
Uncommon adverse reactions that may be revealed in blood tests:
­ Decrease in number of white blood cells;
­ Decrease in number of platelets (cells involved in blood clotting);
­ Increase in blood 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:
­ Inflammation or failure of kidneys;
­ 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 tests:
­ Red blood cells breaking down too quickly;
­ Increase in number of one type of white blood cells in blood;
­ Marked decrease in number of white blood cells.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +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 to 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 it from light.
The solution obtained after reconstitution of 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.
Any unused solution should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Ceftazidime Kabi contains
- The active substance is ceftazidime (1000 mg) in the form of ceftazidime pentahydrate.
- Other ingredient: sodium carbonate.
The sodium content of the medicine is 52 mg of sodium per vial. This should be taken into account in patients
on a controlled sodium 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 combined by a physician with another suitable infusion fluid. Solutions may vary in colour from pale yellow to amber.
One pack of Ceftazidime Kabi contains 1 or 10 glass vials with powder, 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, 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 1 g Pulver zur Herstellung einer Injektionslösung
Belgium Ceftazidim Fresenius Kabi 1000 mg, poeder voor oplossing voor injectie
Czech Republic Ceftazidime Kabi
Denmark Ceftazidim Fresenius Kabi
Estonia Ceftazidime Fresenius Kabi 1000 mg
Finland Ceftazidim Fresenius Kabi 1 g injektiokuiva-aine, liuosta varten
Greece Ceftazidime Fresenius Kabi 1000 mg, κόνις για ενέσιμο διάλυμα
Netherlands Ceftazidim Kabi 1000 mg, poeder voor oplossing voor injectie
Iceland Ceftazidim Fresenius Kabi
Lithuania Ceftazidime Kabi 1000 mg
Luxembourg Ceftazidim Kabi 1 g Pulver zur Herstellung einer Injektionslösung
Latvia Ceftazidime Fresenius Kabi 1000 mg
Malta Ceftazidime Fresenius 1000 mg powder for solution for injection
Germany Ceftazidim Kabi 1 g Pulver zur Herstellung einer Injektionslösung
Norway Ceftazidim Fresenius Kabi 1 g pulver til injeksjonsvæske, oppløsning
Poland Ceftazidime Kabi
Portugal Ceftazidime Kabi
Slovakia Ceftazidim Kabi 1 g
Slovenia Ceftazidim Kabi 1000 mg prašek za raztopino za injiciranje
Hungary Ceftazidim Kabi 1 g
Italy Ceftazidima Fresenius
United Kingdom Ceftazidime 1 g
(Northern Ireland)

Information intended exclusively for healthcare professionals:

Single-use medicinal product. Any unused solution must be discarded.
Intravenous administration – injection
For intravenous bolus injection, ceftazidime should be dissolved in Water for Injections
(according to the table below). The solution should be administered slowly over 5 minutes, directly into a 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 on the use of lidocaine.
Intravenous administration – infusion (see section 3)
Intravenous infusions should be administered over 15 to 30 minutes. Intravenous infusions via a Y-type set may be given
concomitantly with one compatible solution. 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 dissolution of the powder, pressure increases due to release of carbon dioxide. Small bubbles of carbon dioxide
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 | Route of administration | Volume to be added (ml) | Approximate concentration of ceftazidime (mg/ml) | |------------|------------------------|-------------------------|--------------------------------------------------| | 500 mg powder for solution for injection | Intramuscular injection | 1.5 ml | 260 | | 500 mg | Intravenous injection | 5 ml | 90 | | 1 g powder for solution for injection | Intramuscular injection | 3 ml | 260 | | 1 g | Intravenous injection | 10 ml | 90 | | 2 g powder for solution for injection/infusion | Intravenous injection | 10 ml | 170 | | 2 g | 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 bolus administration
Dosage: 25–60 mg/kg body weight/day in two divided doses

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

Compatible solutions for intravenous administration
To obtain a ceftazidime solution with a concentration between 90 mg/ml and 260 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.

To prepare a solution for intramuscular injection, Ceftazidime Kabi, powder for solution for injection, may also be dissolved in 10 mg/ml (1%) lidocaine solution.

During dissolution of ceftazidime, carbon dioxide is released, causing increased pressure.
To facilitate preparation of the medication for use, the following techniques are recommended.

Instructions for preparing the solution
Preparation of solution for rapid intravenous injection (bolus)

1. Pierce the stopper with a needle and inject the recommended volume of solvent into the vial. The negative pressure inside the vial may assist in adding the solvent. Remove the needle and syringe.
2. Shake the vial until complete dissolution is achieved: carbon dioxide is released and a clear solution is obtained within 1 to 2 minutes.
3. Invert the vial. While keeping the syringe plunger fully depressed, pierce the vial stopper with the needle and withdraw the entire volume of solution into the syringe (increased pressure in the vial will facilitate this process). Keep the needle tip submerged in the solution to avoid drawing in air. Small bubbles of carbon dioxide may be present in the solution withdrawn into the syringe.

These solutions may be administered directly into the vein or via an intravenous infusion set if the patient is receiving intravenous fluids. Ceftazidime is compatible with the most commonly used intravenous fluids.

WARNING: To ensure sterility of the medication, do not pierce the closure with a venting needle before the drug 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 product should be used immediately.
Any unused portions or waste material should be disposed of in accordance with local regulations.

The solution should be prepared under aseptic conditions.
The solution should be inspected visually for particulate matter and discoloration prior to administration.
Only clear, particle-free solutions 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 followed, variation in solution color does not adversely affect the therapeutic efficacy of the medication.