Ceftazidime Kabi

Package Leaflet: Information for the User

Ceftazidime Kabi, 1000 mg, Powder for Solution for Injection

Ceftazidime

Read All of This Leaflet Carefully Before You Start Using This Medicine Because It Contains Important Information for You.

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Keep This Leaflet. You May Need to Read It Again.
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If You Have Any Further Questions, Ask Your Doctor or Nurse.
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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 Pack and Other Information

• 1. What Ceftazidime Kabi Is and What It Is Used For
• 2. 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 Works by Killing Bacteria That Cause Infections. It Belongs to a Group of Medicines Called Cephalosporins.

Ceftazidime Kabi Is Used to Treat Severe Bacterial Infections:

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Lower Respiratory Tract Infections, Including Pneumonia;
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Lung and Bronchial Infections in Patients with Cystic Fibrosis;
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Brain Infections (Meningitis);
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Ear Infections;
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Urinary Tract Infections;
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Skin and Soft Tissue Infections;
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Abdominal and Pelvic Infections (Peritonitis);
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Bone and Joint Infections.
Ceftazidime Kabi Can Also Be Used:
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To Prevent Infections During Transurethral Resection of the Prostate in Men;
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To Treat Patients with Low White Blood Cell Counts (Neutropenia) and Fever Caused by Bacterial Infection.

2. Before You Use Ceftazidime Kabi

Do Not Use Ceftazidime Kabi

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If You Are Allergicto Ceftazidimeor Any of the Other Ingredients of This Medicine (Listed in Section 6).
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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.
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Tell Your Doctor BeforeStarting Treatment with Ceftazidime Kabi, If You Think You May Be Affected by These Situations. Do Not Use Ceftazidime Kabi.

Warnings and Precautions

Pay Attention to Whether You Experience Any of the Following Symptoms While Using Ceftazidime Kabi: Allergic Reactions, Nervous System Disorders, and Gastrointestinal Disorders, Including Diarrhea. This Will Reduce the Risk of Possible Problems. See "Symptoms to Watch Out for" 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 Rash with Eosinophilia and Systemic Symptoms (DRESS), and Acute Generalized Exanthematous Pustulosis (AGEP), Have Been Reported with Ceftazidime Treatment. If You Experience Any of the Symptoms Associated with These Severe Skin Reactions, Described in Section 4, Seek Medical Attention Immediately.

Blood and Urine Tests

Ceftazidime Kabi May Affect the Results of Urine Tests for Sugar and Blood Tests Known as Coombs Test. If You Are Going to Have These Tests:
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Tell the Medical StaffTaking the Samples That You Are Using Ceftazidime Kabi.

Ceftazidime Kabi and Other Medicines

Tell Your Doctor About All Medicines You Are Taking or Have Recently Taken, and Any Medicines You Plan to Take.
Do Not Use Ceftazidime Kabi Without Consulting Your Doctor, If You Are Also Taking:
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An Antibiotic Called Chloramphenicol;
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An Antibiotic from a Group Called Aminoglycosides, Such as Gentamicin or Tobramycin;
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Diuretic Tablets Containing Furosemide.
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Tell Your DoctorIf Any of the Above Situations Apply to You.

Pregnancy, Breast-Feeding, and Fertility

If You Are Pregnant or Breast-Feeding, Think You May Be Pregnant, or Are Planning to Have a Baby, Ask Your Doctor for Advice Before Using This Medicine.

Driving and Using Machines

Ceftazidime Kabi May Cause Side Effects That Affect Your Ability to Drive or Use Machines, Such as Dizziness. Do Not Drive or Use Machines Unless You Are Sure You Are Not Affected by These Side Effects.

Ceftazidime Kabi Contains Sodium

This Medicine Contains 52 Mg of Sodium (a Major Component of Common Salt) per Vial. This Is Equivalent to 2.6% of the Maximum Recommended Daily Intake of Sodium for Adults.

3. How to Use Ceftazidime Kabi

Ceftazidime Kabi Is Usually Given by a Doctor or Nurse.It Is Given as an Intravenous Infusion 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

Your Doctor Will Decide the Correct Dose of Ceftazidime Kabi for You, Taking Into Account the Severity and Type of Infection, Whether You Are Taking Other Antibiotics, Your Body Weight, Age, and Kidney Function.

Newborns and Infants (0 to 2 Months)

For Every 1 Kg of the Infant's Body Weight, 25 to 60 Mg of Ceftazidime Kabi Is Given Over 24 Hours in Two Divided Doses.
Infants (Over 2 Months) and ChildrenWeighing 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 Over 24 Hours in Three Divided Doses. Maximum 6 G per Day.
Adults and AdolescentsWeighing 40 Kg or More
1 to 2 G of Ceftazidime Kabi Three Times a Day. Maximum 9 G per Day.

Patients Over 65 Years

The Daily Dose Should Not Exceed 3 G per Day, Especially in Patients Over 80 Years.

Patients with Kidney Disease

You May Be Given a Different Dose Than Usual. Your Doctor or Nurse Will Decide What Dose of Ceftazidime Kabi to Give You, Depending on the Severity of Your Kidney Disease. Your Doctor Will Closely Monitor You and May Order More Frequent Kidney Function Tests.

Overdose of Ceftazidime Kabi

If You Have Been Given More Ceftazidime Kabi Than Prescribed, Contact Your Doctor or Go to the Nearest Hospital Immediately.

Missing a Dose of Ceftazidime Kabi

If You Miss a Dose, It Should Be Given as Soon as Possible. However, If It Is Almost Time for the Next Dose, Skip the Missed Dose. Do Not Take a Double Dose (Two Injections at the Same Time) to Make Up for the Missed Dose.

Stopping Ceftazidime Kabi Treatment

Do Not Stop Using Ceftazidime Kabi Without Consulting Your Doctor First.

If You Have Any Further Questions on the Use of This Medicine, Ask Your Doctor or Nurse.

4. Possible Side Effects

Like All Medicines, Ceftazidime Kabi Can Cause Side Effects, Although Not Everybody Gets Them.
If You Experience Any of the Following Symptoms, Contact Your Doctor Immediately:
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Red Spots on the Trunk, Spots Resembling a Target or a Circle, Often with Central Blisters, Peeling of the Skin, Ulcers in the Mouth, Throat, Nose, Genital Area, and Eyes. These Severe Skin Rashes May Be Preceded by Fever and Flu-Like Symptoms (Stevens-Johnson Syndrome, Toxic Epidermal Necrolysis).
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Widespread Rash, High Fever, and Enlarged Lymph Nodes (Dress or Hypersensitivity Syndrome).
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Red, Peeling, Widespread Rash with Bumps Under the Skin and Blisters and Accompanying Fever. Symptoms Usually Occur at the Beginning of Treatment (Acute Generalized Exanthematous Pustulosis).

Symptoms to Watch Out for

The Following Severe Side Effects Have Occurred in a Small Number of People, but Their Exact Frequency Is Unknown:
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Severe Allergic Reaction. Symptoms Are: Swollen, Itchy Rash, Swelling, Sometimes of the Face or Mouth, Which Can Cause Difficulty Breathing.
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Skin Rash, Which Can Be Accompanied by Blistersand Resemble Small Targets(Dark Spot in the Center Surrounded by a Lighter Ring with a Dark Ring Around the Edge).
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Nervous System Disorders:Tremors, Seizures, and Sometimes Coma. These Disorders Have Occurred in Patients Who Received Too High Doses, Especially in Patients with Kidney Disease.
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Contact Your Doctor or Nurse Immediately If You Experience Any of the Above Symptoms.

Frequent Side Effects (Less Than 1 in 10 Patients):

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Diarrhea;
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Swelling and Redness Along the Vein;
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Red, Itchy Rash on the Skin;
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Pain, Burning, Swelling, or Inflammation at the Injection Site.
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Tell Your DoctorIf Any of the Above Symptoms Concern You.
Frequent Side Effects That May Be Detected in Blood Tests:
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Increased Number of a Type of White Blood Cell (Eosinophilia);
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Increased Number of Platelets in the Blood;
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Increased Liver Enzyme Activity.

Uncommon Side Effects (Less Than 1 in 100 Patients):

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Colitis, Which Can Cause Abdominal Pain or Diarrhea, Which May Contain Blood;
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Fungal Infections of the Mouth or Vagina;
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Headache;
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Dizziness;
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Abdominal Pain;
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Nausea or Vomiting;
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Fever and Chills.
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Tell Your DoctorIf You Experience Any of the Above Symptoms.
Uncommon Side Effects That May Be Detected in Blood Tests:
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Decreased Number of White Blood Cells;
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Decreased Number of Platelets (Cells Involved in Blood Clotting);
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Increased Urea, Uric Acid, or Creatinine Levels in the Blood.

Other Side Effects

Other Side Effects Have Occurred in a Small Number of Patients, but Their Exact Frequency Is Unknown:
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Kidney Inflammation or Failure;
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Numbness;
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Unpleasant Taste in the Mouth;
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Yellowing of the Whites of the Eyes and Skin.
Other Side Effects That May Be Detected in Blood Tests:
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Red Blood Cells Break Down Too Quickly;
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Increased Number of a Type of White Blood Cell in the Blood;
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Significant Decrease in the Number of White Blood Cells.

Reporting Side Effects

If You Experience Any Side Effects, Including Any Not Listed in This Leaflet, Tell Your Doctor or Nurse. You Can Also Report Side Effects Directly to the Department of Drug Safety Monitoring of 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
You Can Also Report Side Effects to the Marketing Authorization Holder.
By Reporting Side Effects, You Can Help Provide More Information on the Safety of This 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 Expiration Date Stated on the Label After EXP. The Expiration Date Refers to the Last Day of the Month Stated.
Do Not Store Above 25°C. Store the Vial in the Outer Carton to Protect from Light.
The Reconstituted Solution 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 You Notice Turbidity; the Solution Should Be Completely Clear.
Dispose of Any Unused Solution.
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

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The Active Substance Is Ceftazidime (1000 Mg) as Ceftazidime Pentahydrate.
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The Other Ingredient Is Sodium Carbonate.
The Sodium Content of the Medicine Is 52 Mg per Vial. This Should Be Taken Into Account for Patients on a Controlled Sodium Diet.

What Ceftazidime Kabi Looks Like and Contents of the Pack

Ceftazidime Kabi Is a Powder That Is Usually Mixed with Water for Injections to Produce a Clear Solution for Injection or Infusion. The Prepared Solution of Ceftazidime Kabi Can Be Mixed with Other Suitable Infusion Solutions by Your Doctor. The Solutions May Have a Color Ranging from Light Yellow to Amber.
One Pack of Ceftazidime Kabi Contains 1 or 10 Glass Vials with Powder, with a Rubber Stopper and an Aluminum Cap with a Plastic Flip-Off Cover. Not All Pack Sizes May Be Marketed.

Marketing Authorization Holder

Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw

Manufacturer

Labesfal - Laboratorios Almiro, S.A.
Lagedo, 3463-157 Santiago de Besteiros
Portugal
For More Information, Contact the Marketing Authorization Holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
Phone: +48 22 345 67 89

This Medicine 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 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)
Date of Last Revision of the Leaflet:08.10.2024
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Information Intended for Healthcare Professionals Only:

For Single Use Only. Unused Solution Should Be Discarded.
Intravenous Administration - Injection
To Administer an Intravenous Injection, Ceftazidime Should Be Dissolved in Water for Injections (According to the Following Table). The Solution Should Be Injected Slowly Over 5 Minutes, Directly into a Vein or Through an Intravenous Infusion Set.
Intramuscular Administration (Applicable to 500 Mg and 1000 Mg)
Ceftazidime Should Be Dissolved in Water for Injections or 1% Lidocaine Hydrochloride Injection, as Shown in the Table Below. Before Administering Ceftazidime with Lidocaine, Refer to the Information on the Use of Lidocaine.
Intravenous Administration - Infusion (See Section 3)
The Intravenous Infusion Should Be Administered Over 15 to 30 Minutes. The Intravenous Infusion Can Be Administered Through a Y-Set with One of the Compatible Solutions. However, During the Administration of the Solution Containing Ceftazidime, the Administration of Other Solutions Should Be Interrupted.
The Pressure in Ceftazidime Kabi Containers of Any Size Is Lower Than Atmospheric Pressure. During the Dissolution of the Powder, the Pressure Increases Due to the Release of Carbon Dioxide. Small Carbon Dioxide Bubbles in the Prepared Solution Can Be Ignored.
Instructions for Preparing the Medicine for Use
Refer to the Table of Added Volumes and Resulting Concentrations, Which May Be Useful When Partial Doses Are Needed.
Volume of Diluent to Be Added (Ml)
Approximate Ceftazidime Concentration (Mg/Ml)
Container Size
500 Mg Powder for Solution for Injection
500 Mg
Intramuscular Injection
1.5 Ml
260
90
1 G Powder for Solution for Injection
Intravenous Injection
5 Ml
1 G
Intramuscular Injection
3 Ml
10 Ml
260
90
2 G Powder for Solution for Injection/Infusion
Intravenous Injection
2 G
Intravenous Injection
10 Ml
50 Ml*
170
40
* Note: Add in Two Stages
Intravenous Infusion

Preparation of Ceftazidime Kabi Solution for Administration to Children

Newborns and Infants (0 to 2 Months)

Intermittent Intravenous Injections Dosing: 25 - 60 Mg/Kg/Day in Two Divided Doses

Infants (Over 2 Months) and Children Under 40 Kg

Intermittent Intravenous Injections Dosing: 100 - 150 Mg/Kg/Day in Three 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 Can Be Mixed with Commonly Used Intravenous Solutions:
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0.9% Sodium Chloride Solution (Physiological Saline Solution);
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Ringer's Solution with Lactate;
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10% Glucose Solution.
To Prepare a Solution for Intramuscular Injection, Ceftazidime Kabi Powder for Solution for Injection Can Also Be Dissolved in 1% Lidocaine Solution.
During the Dissolution of Ceftazidime, Carbon Dioxide Is Released, Causing Overpressure. To Facilitate the Preparation of the Medicine, the Following Techniques Are Recommended.

Instructions for Preparing the Solution

Preparation of Solution for Rapid Injection (Bolus)

• 1. Pierce the Stopper with a Needle and Inject the Recommended Volume of Diluent into the Vial. The Negative Pressure Inside the Vial May Facilitate the Addition of the Diluent. Remove the Needle from the Syringe.
• 2. Shake the Vial Until the Powder Is Dissolved: Carbon Dioxide Is Released and a Clear Solution Is Obtained Within 1 to 2 Minutes.
• 3. Invert the Vial. With the Plunger in the Fully Depressed Position, Pierce the Vial Stopper with the Needle and Withdraw the Entire Volume of Solution into the Syringe (the Increased Pressure in the Vial Facilitates This). Keep the Needle in the Solution to Avoid Drawing in Air. The Solution Withdrawn into the Syringe May Contain Small Carbon Dioxide Bubbles.

These Solutions Can Be Administered Directly into a Vein or Through an Intravenous Infusion Set, If the Patient Is Receiving Intravenous Fluids. Ceftazidime Shows Compatibility with Most Commonly Used Intravenous Solutions.
Important: to Ensure the Sterility of the Medicine, It Is Essential Not to Insert the Venting Needle Through the Vial Stopper Before the Powder Is Completely Dissolved.
For Single Use Only.
The Reconstituted Solution Has Chemical and Physical Stability for 6 Hours at 25°C and 12 Hours at 5°C After Dissolution in Water for Injections, 1% Lidocaine Solution, 0.9% Sodium Chloride Solution, Ringer's Solution with Lactate, and 10% Glucose Solution.
From a Microbiological Point of View, the Medicine Should Be Used Immediately.
Any Unused Solution or Waste Material Should Be Disposed of in Accordance with Local Requirements.
The Solution Should Be Prepared in Aseptic Conditions.
Inspect the Solution Before Administration to Ensure It Does Not Contain Particulate Matter or Discoloration.
Only Use a Clear Solution Free from Particulate Matter.
The Color of the Solution Ranges from Light Yellow to Amber, Depending on the Concentration, Type of Diluent, and Storage Conditions. If the Recommended Storage Conditions Are Met, the Variability in the Color of the Solution Does Not Affect the Efficacy of the Medicine.