CEFTAZIDIME 2000 mg Powder

Contents of the leaflet

1. Package Leaflet: Information for the User
2. Ceftazidime Kabi, 2000 mg, Powder for Solution for Injection/Infusion
   1. Read All of This Leaflet Carefully Before Using This Medicine.
   2. Contents of the Pack
3. What Ceftazidime Kabi Is and What It Is Used For
   1. Ceftazidime Kabi Is Used to Treat Severe Bacterial Infections:
4. Before You Use Ceftazidime Kabi
   1. Do Not Use Ceftazidime Kabi
   2. Warnings and Precautions
   3. Blood and Urine Tests
   4. Ceftazidime Kabi and Other Medicines
   5. Pregnancy, Breastfeeding, and Fertility
   6. Driving and Using Machines
   7. Ceftazidime Kabi Contains Sodium
5. How to Use Ceftazidime Kabi
   1. Recommended Dose
   2. Newborns and Infants (Aged 0 to 2 Months)
   3. Patient Over 65 Years
   4. Patient with Kidney Disease
   5. Overdose of Ceftazidime Kabi
   6. Missed Dose of Ceftazidime Kabi
   7. Stopping Use of Ceftazidime Kabi
   8. If You Have Any Further Questions About Using This Medicine, Ask Your Doctor or Nurse.
6. Possible Side Effects
   1. Symptoms to Watch Out For
   2. Contact Your Doctor or Nurse Immediately If You Experience Any of the Above Symptoms.
   3. Frequent Side Effects (Less Than 1 in 10 Patients):
   4. Uncommon Side Effects (Less Than 1 in 100 Patients):
   5. Other Side Effects
   6. Reporting Side Effects
7. How to Store Ceftazidime Kabi
8. Contents of the Pack and Other Information
   1. What Ceftazidime Kabi Contains
   2. What Ceftazidime Kabi Looks Like and Contents of the Pack
   3. Marketing Authorization Holder
   4. Manufacturer
   5. This Medicine Is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:
   6. Austria
   7. Belgium
   8. Czech Republic
   9. Denmark
   10. Estonia
   11. Finland
   12. Greece
   13. Spain
   14. Netherlands
   15. Iceland
   16. Lithuania
   17. Luxembourg
   18. Latvia
   19. Malta
   20. Germany
   21. Norway
   22. Poland
   23. Portugal
   24. Slovakia
   25. Slovenia
   26. Hungary
   27. Italy
   28. United Kingdom
   29. Information Intended for Healthcare Professionals Only:
   30. Preparation of Ceftazidime Kabi Solution for Administration to Children
   31. Newborns and Infants Aged ≤2 Months
   32. Intermittent Intravenous Injections Dosing: 25 - 60 Mg/Kg/Day in Two Divided Doses
   33. Infants Aged >2 Months and Children Intermittent Intravenous Injections Dosing: 100 - 150 Mg/Kg/Day in 3 Divided Doses, Not More Than 6 G/Day
   34. Infants Aged >2 Months and Children Continuous Infusion
   35. Loading Dose: 60-100 Mg/Kg and Then Continuous Infusion at 100-200 Mg/Kg/Day, Not More Than 6 G/Day
   36. Instructions for Preparing the Solution

Package Leaflet: Information for the User

Ceftazidime Kabi, 2000 mg, Powder for Solution for Injection/Infusion

Ceftazidime

Read All of This Leaflet Carefully Before Using This Medicine.

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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

• 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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Soft Tissue and Skin Infections;
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Abdominal and Abdominal Wall 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 a Low White Blood Cell Count (Neutropenia) and Fever Caused by a 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 Have 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 Sugar Tests and Blood Tests Known as Coombs Test. If You Are Going to Have These Tests:
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Tell the Medical Staff Taking the SamplesThat You Are Using Ceftazidime Kabi.

Ceftazidime Kabi and Other Medicines

Tell Your Doctor About All Medicines You Are Currently Taking or Have Recently Taken, as Well as 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 the Group Called Aminoglycosides, Such as Gentamicin, Tobramycin;
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Diuretic Tablets Containing Furosemide;
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Tell Your DoctorIf You Are Affected by Any of the Above Situations.

Pregnancy, Breastfeeding, and Fertility

If You Are Pregnant or Breastfeeding, Think You May Be Pregnant, or Plan to Have a Child, 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 Have Not Experienced These Side Effects.

Ceftazidime Kabi Contains Sodium

This Medicine Contains 104 Mg of Sodium (Main Component of Common Salt) per Vial. This Is Equivalent to 5.2% of the Maximum Recommended Daily Intake of Sodium in the Diet for Adults.

3. How to Use Ceftazidime Kabi

Ceftazidime Kabi Is Usually Administered by a Doctor or Nurse.It Is Given as an Infusion(Intravenous Infusion) or as an InjectionDirectly 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 Appropriate Dose of Ceftazidime Kabi for You, Taking Into Account the Severity and Type of Infection, Your Use of Other Antibiotics, Your Body Weight, Age, and Kidney Function.

Newborns and Infants (Aged 0 to 2 Months)

For Every 1 Kg of Infant Body Weight, 25 to 60 Mg of Ceftazidime Kabi Is Administered Over 24 Hours in Two Divided Doses.
Infants (Aged Over 2 Months) and ChildrenWeighing Less Than 40 Kg
For Every 1 Kg of Infant or Child Body Weight, 100 to 150 Mg of Ceftazidime Kabi Is Administered Over 24 Hours in Three Divided Doses. Maximum 6 G per Day.
Adult Patients and AdolescentsWeighing 40 Kg or More
1 to 2 G of Ceftazidime Kabi Three Times a Day. Maximum 9 G per Day.

Patient Over 65 Years

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

Patient with Kidney Disease

The Patient May Receive a Different Dose Than Usually Used. The Doctor or Nurse Will Decide What Dose of Ceftazidime Kabi to Administer to the Patient, Depending on the Severity of Kidney Disease.
The Doctor Will Closely Monitor the Patient and May Order More Frequent Kidney Function Tests.

Overdose of Ceftazidime Kabi

If You Have Accidentally Used a Higher Dose of Ceftazidime Kabi Than Prescribed, Contact Your Doctor or Go to the Nearest Hospital Immediately.

Missed Dose of Ceftazidime Kabi

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

Stopping Use of Ceftazidime Kabi

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

If You Have Any Further Questions About Using 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 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 Drug 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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Rash on the Skin,Which Can Be Accompanied by Blistersand Resemble Small Targets(Dark Spot in the Center Surrounded by a Lighter Border with a Dark Ring Around the Edge).
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Nervous System Disorders:Tremors, Seizures, and Sometimes Coma. These Disorders 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 Revealed by Blood Tests:
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Increased Number of a Type of White Blood Cell (Eosinophilia);
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Increased Number of Platelets Involved in Blood Clotting;
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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 Revealed by 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 That Have Occurred in a Small Number of Patients, but the 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 Revealed by 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. Side Effects Can Be Reported Directly to the Department of Drug Safety, Ministry of Health
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side Effects Can Also Be Reported to the Marketing Authorization Holder.
Reporting Side Effects Will Help to Gather More Information on the Safety of This Medicine.

5. How to Store Ceftazidime Kabi

Keep the 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.
Do Not Store Above 25°C. Store the Vial in the Outer Carton to Protect from Light.
The Solution Obtained After Reconstituting 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 You Notice Turbidity; the Solution Should Be Completely Clear.
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

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The Active Substance Is Ceftazidime (2000 Mg) in the Form of Ceftazidime Pentahydrate.
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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 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 Obtain a Clear Solution for Injection or Infusion. The Prepared Solution of Ceftazidime Kabi Can Be Mixed by the Doctor with Another Suitable Infusion Fluid. The Solutions May Have a Color Ranging from Light Yellow to Amber.
The Pack Contains 1 or 10 Glass Vials with Powder, with a Rubber Stopper and an Aluminum Cap with a Plastic Flip-Off Seal. 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
To Obtain More Detailed 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 2 g Powder for Solution for Injection/Infusion

Belgium

Ceftazidim Fresenius Kabi 2000 mg, Powder for Solution for Injection/Infusion

Czech Republic

Ceftazidim Kabi

Denmark

Ceftazidim Fresenius Kabi

Estonia

Ceftazidime Fresenius Kabi 2000 mg

Finland

Ceftazidim Fresenius Kabi 2 g Injection/Infusion Solution, Powder for Solution

Greece

Ceftazidime Kabi, 2000 mg, Powder for Solution for Injection/Infusion

Spain

Ceftazidima Kabi 2g

Netherlands

Ceftazidim Fresenius Kabi 2000 mg, Powder for Solution for Injection/Infusion

Iceland

Ceftazidim Fresenius Kabi

Lithuania

Ceftazidime Kabi 2000 mg

Luxembourg

Ceftazidim Kabi 2 g Powder for Solution for Injection/Infusion

Latvia

Ceftazidime Fresenius Kabi 2000 mg

Malta

Ceftazidime Fresenius 2000 mg Powder for Solution for Injection/Infusion

Germany

Ceftazidim Kabi 2 g Powder for Solution for Injection/Infusion

Norway

Ceftazidim Fresenius Kabi 2 g, Powder for Injection/Infusion Solution

Poland

Ceftazidime Kabi

Portugal

Ceftazidime Kabi

Slovakia

Ceftazidim Kabi 2 g

Slovenia

Ceftazidim Kabi 2000 mg Powder for Solution for Injection/Infusion

Hungary

Ceftazidim Kabi 2 g Powder for Solution for Injection/Infusion

Italy

Ceftazidima Fresenius

United Kingdom

Ceftazidime 2 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 of Ceftazidime, It 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 10 Mg/Ml (1%) Lidocaine Hydrochloride Injection Solution, as Indicated in the Table Below. Before Administering Ceftazidime with Lidocaine, Consult the Information on the Use of Lidocaine.
Intravenous Administration - Infusion (See Section 3)
For Intravenous Infusion, 2000 Mg of Powder Should Be Dissolved in 10 Ml of Water for Injections (Preparation of Injection) or 50 Ml of Water for Injections (Preparation of Infusion) or in Another Compatible Intravenous Solution. The Intravenous Infusion Should Be Administered Over 15 to 30 Minutes. The Intravenous Infusion Through a Y-Set Can Be Administered with One of the Compatible Solutions. However, During the Administration of the Ceftazidime Solution, the Administration of Other Solutions Should Be Interrupted.

Preparation of Ceftazidime Kabi Solution for Administration to Children

Newborns and Infants Aged ≤2 Months

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

Infants Aged >2 Months and Children <40 kg< h4>

Intermittent Intravenous Injections Dosing: 100 - 150 Mg/Kg/Day in 3 Divided Doses, Not More Than 6 G/Day

Infants Aged >2 Months and Children <40 kg< h4>

Continuous Infusion

Loading Dose: 60-100 Mg/Kg and Then Continuous Infusion at 100-200 Mg/Kg/Day, Not More Than 6 G/Day

Do Not Administer a Dose Greater Than 6 G (Equivalent 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 Can Be Mixed with Commonly Used Intravenous Solutions:
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9 Mg/Ml (0.9%) Sodium Chloride Solution (Physiological Saline Solution);
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Ringer's Solution with Lactate;
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100 Mg/Ml (10%) Glucose Solution.
To Prepare a Solution for Intramuscular Injection, Ceftazidime Kabi Powder for Solution for Injection Can Also Be Dissolved in 10 Mg/Ml (1%) Lidocaine Hydrochloride Injection Solution.
During the Dissolution of Ceftazidime, Carbon Dioxide Is Released, Causing Overpressure.
To Facilitate the Preparation of the Medicine for Use, the Following Techniques Are Recommended.

Instructions for Preparing the Solution

Preparing the Ceftazidime Solution for Intravenous Infusions in a Standard Vial (Mini-Bag or Burette 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 Until the Medicine Is Completely Dissolved. Insert the Venting Needle Through the Stopper to Reduce the Overpressure Inside the Vial.
• 4. Transfer the Solution to the Final Container (Mini-Bag or Burette Set), Achieving a Total Volume of Not Less Than 50 Ml, and Administer as an Intravenous Infusion Over 15 to 30 Minutes.

NOTE: To Ensure the Sterility of the Medicine, It Is Important Not to Pierce the Vial Stopper with the Venting Needle Before the Medicine Is Completely Dissolved.
For Single Use Only.
The Prepared Solution Shows Chemical and Physical Stability for 6 Hours at 25°C and for 12 Hours at 5°C After Reconstitution in Water for Injections, 1% Lidocaine Hydrochloride Injection 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 Should Be Disposed of in Accordance with Local Regulations.
The Solution Should Be Prepared Under Aseptic Conditions.
Check the Solution for Particulate Matter and Discoloration Before Administration.
Only Use a Clear Solution Free from Particulate Matter.
The Color of the Solution Ranging from Light Yellow to Amber Depends on the Concentration, Type of Solvent, and Storage Conditions. If the Recommended Storage Conditions Are Met, the Variability in the Color of the Solution Does Not Adversely Affect the Efficacy of the Medicine.