Ceftazidim Aptapharma

Package Leaflet: Information for the User

Ceftazidim AptaPharma, 1 g, Powder for Solution for Injection/Infusion

Ceftazidim AptaPharma, 2 g, Powder for Solution for Injection/Infusion

Ceftazidime

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

• You should keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Pack and Other Information

• 1. What is Ceftazidim AptaPharma and What It Is Used For
• 2. Before You Use Ceftazidim AptaPharma
• 3. How to Use Ceftazidim AptaPharma
• 4. Possible Side Effects
• 5. How to Store Ceftazidim AptaPharma
• 6. Contents of the Pack and Other Information

1. What is Ceftazidim AptaPharma and What It Is Used For

Ceftazidim AptaPharma 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 called
cephalosporins .

Ceftazidim AptaPharma is Used to Treat Severe Bacterial Infections:

• of the lungs or lower respiratory tract;
• 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 abdominal cavity and abdominal lining (peritonitis);
• of bones and joints.

Ceftazidim AptaPharma can also be used:

• to prevent infections during transurethral resection of the prostate in men;
• to treat patients with a low number of white blood cells (neutropenia) who have a fever due to a bacterial infection.

2. Before You Use Ceftazidim AptaPharma

When Should You Not Be Given Ceftazidim AptaPharma

• If You Are Allergicto ceftazidimeor any of the other ingredients of this medicine (listed in section 6);
• if you have ever had a severe allergic reactionto any other antibiotic(penicillins, monobactams and carbapenems), as you may also be allergic to Ceftazidim AptaPharma.

→ If you think any of the above applies to you, tell your doctor beforeyou start using Ceftazidim AptaPharma.
You should not be given Ceftazidim AptaPharma.

When Should You Be Especially Careful Using Ceftazidim AptaPharma

You should be aware of any special symptoms that may occur while using Ceftazidim AptaPharma, such as allergic reactions, nervous system disorders, and stomach and intestinal 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 Ceftazidim AptaPharma.
Severe skin reactions have been reported with ceftazidime, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). If you experience any of the symptoms associated with these severe skin reactions, as described in section 4, you should contact your doctor immediately.

Blood and Urine Tests

Ceftazidim AptaPharma may affect the results of urine tests for sugar and blood tests known as the Coombs test. If you are going to have these tests:
→ Tell the person taking the samplethat you have been taking Ceftazidim AptaPharma.

Ceftazidim AptaPharma and Other Medicines

Tell your doctor about all the medicines you are taking now or have recently taken, and any medicines you plan to take. This includes medicines that you buy without a prescription.
You should not take Ceftazidim AptaPharma without consulting your doctor if you are also taking:

• an antibiotic called chloramphenicol;
• an antibiotic from a group called aminoglycosides, such as gentamicin, tobramycin;
• a diuretic called furosemide. → If any of the above applies to you, tell your doctor.

Pregnancy, Breast-feeding and Fertility

Ask your doctor for advice before taking Ceftazidim AptaPharma:

• if you are pregnant, think you may be pregnant or are planning to have a baby;
• if you are breast-feeding.

Your doctor will decide whether the benefits of taking Ceftazidim AptaPharma during pregnancy and breast-feeding outweigh the risks to your baby.

Driving and Using Machines

Ceftazidim AptaPharma may cause side effects that affect your ability to drive or use machines, such as dizziness. You should not drive or use machines unless you are sure that you are not affected.

Ceftazidim AptaPharma Contains Sodium

Ceftazidim AptaPharma, 1 g
The medicine contains about 2.28 mmol (about 52.44 mg) of sodium (the main ingredient of common salt) per gram. This is equivalent to 2.62% of the maximum recommended daily intake of sodium in the diet for adults.
This should be taken into account for patients on a controlled sodium diet.
Ceftazidim AptaPharma, 2 g
The medicine contains about 4.56 mmol (about 104.88 mg) of sodium (the main ingredient of common salt) per two grams. This is equivalent to 5.24% of the maximum recommended daily intake of sodium in the diet for adults. This should be taken into account for patients on a controlled sodium diet.

3. How to Use Ceftazidim AptaPharma

Ceftazidim AptaPharma is usually given to you by a doctor or nurse.It can be given as an infusion(intravenous infusion) or as an injectiondirectly into a vein or into a muscle.
Ceftazidim AptaPharma is prepared by a doctor, pharmacist or nurse using water for injections or another suitable infusion fluid.

Recommended Dose

Your doctor will decide on the right dose of Ceftazidim AptaPharma for you, taking into account the severity and type of infection, whether you are taking any other antibiotics, your body weight, age and kidney function.

Newborns and Infants (0-2 Months)

For every 1 kg of body weight of the newborn or infant, 25 to 60 mg of Ceftazidim AptaPharma is given over 24 hours in two divided doses.
Infants (over 2 months) and childrenweighing less than 40 kg
For every 1 kg of body weight of the infant or child, 100 to 150 mg of Ceftazidim AptaPharma 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 Ceftazidim AptaPharma three times a day. Maximum 9 g per day.

Patients Over 65 Years

The daily dose should not be more than 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 Ceftazidim AptaPharma you should be given, depending on the severity of your kidney disease. Your doctor will closely monitor you and may order more frequent kidney function tests.

Using More Ceftazidim AptaPharma Than Recommended

If you accidentally use more Ceftazidim AptaPharma than prescribed: contact your doctor immediately or go to the nearest hospital.

Missing a Dose of Ceftazidim AptaPharma

If you miss an injection, it should be given as soon as possible. Do not take a double dose (two injections at the same time) to make up for a missed dose, but take the next dose at the usual time.

Do Not Stop Using Ceftazidim AptaPharma

Do not stop using Ceftazidim AptaPharma without your doctor's advice. If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Symptoms to Watch Out For

The following serious side effects have been reported in a small number of people, but their exact frequency is unknown.

If You Experience Any of the Following Symptoms, Contact Your Doctor Immediately:

• Red spots on the torso, spots resembling a target or circle, often with central blisters, peeling of the skin, ulcers in the mouth, throat, nose, genitals and eyes. These severe skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS or drug hypersensitivity syndrome).
• Red, peeling, widespread rash with bumps under the skin and blisters and fever at the same time. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).
• Severe allergic reaction. Symptoms are: swollen, itchy rash, sometimes swelling of the face or lips, which can cause difficulty breathing.
• Nervous system disorders: tremors, seizures and sometimes coma. These disorders occurred in patients who were given too high doses, especially in patients with kidney disease.
• Reports of severe hypersensitivity reactions have been received, including severe skin rash, which may be accompanied by fever, fatigue, swelling of the face and lymph nodes, increased number of eosinophils (a type of white blood cell), liver and kidney involvement, and lung involvement (drug reaction with eosinophilia and systemic symptoms, DRESS).

Common Side Effects

May affect up to 1 in 10 people:

• diarrhea
• swelling and redness along the vein
• red, itchy rash on the skin
• pain, burning, swelling or inflammation at the injection site. → If any of the above symptoms worry you, tell your doctor.

Common side effects that may be seen in blood tests:

• increased number of one type of white blood cell (eosinophilia)
• increased number of platelets, which are involved in blood clotting
• increased activity of liver enzymes.

Uncommon Side Effects

May affect up to 1 in 100 people:

• inflammation of the intestines, which can cause abdominal pain or diarrhea that may contain blood
• fungal infections of the mouth or vagina
• headache
• dizziness
• abdominal pain
• nausea or vomiting
• fever and chills. → Tell your doctorif you experience any of the above symptoms.

Uncommon side effects that may be seen in blood tests:

• decreased number of white blood cells
• decreased number of platelets (cells involved in blood clotting)
• increased levels of urea, urea nitrogen or creatinine in the blood.

Rare Side Effects

May affect up to 1 in 10,000 people:

• inflammation or failure of the kidneys.

Other Side Effects

Other side effects that have occurred in a small number of people, but the exact frequency is unknown:

• tingling and numbness
• unpleasant taste in the mouth
• yellowing of the whites of the eyes and skin.

Other side effects that may be seen in blood tests:

• red blood cells breaking down too quickly
• increased number of one type of white blood cell in the blood
• significantly decreased 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 pharmacist.
Side effects can also be reported to the Department of Drug Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Jerozolimskie Avenue 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.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Ceftazidim AptaPharma

Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.
• This medicine does not require any special storage conditions.
• Store the vial in the outer carton in order to protect from light.
• Ceftazidim AptaPharma is prepared by a doctor, pharmacist or nurse using water for injections or compatible infusion fluids. The prepared solution should be used within 24 hours if stored in the refrigerator (at a temperature of 2°C to 8°C) or immediately after preparation, depending on the route of administration.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the Pack and Other Information

What Ceftazidim AptaPharma Contains

• The active substance is 1 g or 2 g of ceftazidime (as ceftazidime pentahydrate).
• The only other ingredient is: sodium carbonate.
• Other important information about sodium, one of the ingredients of Ceftazidim AptaPharma, see section 2.

What Ceftazidim AptaPharma Looks Like and Contents of the Pack

Ceftazidim AptaPharma, 1 g, powder for solution for injection/infusion is a white to cream-colored sterile powder. It is packed in 10 mL glass vials with a bromobutyl rubber stopper and an aluminum cap.
The pack contains 10 vials.
Ceftazidim AptaPharma, 2 g, powder for solution for injection/infusion is a white to cream-colored sterile powder. It is packed in 50 mL glass vials with a bromobutyl rubber stopper and an aluminum cap.
The pack contains 10 vials in a carton.
Ceftazidim AptaPharma is prepared by a doctor, pharmacist or nurse using water for injections or suitable infusion fluid. After preparation, the solution has a color from light yellow to amber. This is normal.

Marketing Authorization Holder

Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Phone: 00386 51 615 015
e-mail: [email protected]

Manufacturer

ACS Dobfar S.p.A.
Nucleo Industriale S. Atto, S. Nicolò a Tordino
64100 Teramo (TE)
Italy
ACS DOBFAR S.p.A.
Via Alessandro Fleming 2
37135 Verona
Italy

This Medicinal Product is Authorized in the Member States of the European Economic Area Under the Following Names:

Date of Last Revision of the Leaflet: October 2024

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Information Intended for Healthcare Professionals Only:

Ceftazidim AptaPharma, 1 g, Powder for Solution for Injection/Infusion

Ceftazidim AptaPharma, 2 g, Powder for Solution for Injection/Infusion

For Further Information, Please Read the Summary of Product Characteristics

Shelf Life

Unopened vials: 3 years.
Solution after reconstitution/dilution:
Physical and chemical stability of the solution after reconstitution/dilution for intravenous administration has been demonstrated for 24 hours at 2°C to 8°C.
From a microbiological point of view, the solution should be used immediately after preparation. If not used immediately, the user is responsible for the storage conditions and storage time, which should not normally exceed 24 hours at 2°C to 8°C.
Instructions for Preparation of the Medicinal Product

• Ceftazidim AptaPharma is compatible with the following intravenous fluids: water for injections, 0.9% sodium chloride injection, 0.45% sodium chloride injection, 0.225% sodium chloride injection, 5% glucose injection, 10% glucose injection, 0.9% sodium chloride injection with 5% glucose, 0.18% sodium chloride injection with 4% glucose, 10% dextran 40 in 0.9% sodium chloride injection, 10% dextran 40 in 5% glucose injection, 6% dextran 70 in 0.9% sodium chloride injection, 6% dextran 70 in 5% glucose injection.

Ceftazidim AptaPharma is also compatible with peritoneal dialysis fluid (lactate).

The color of the solution from light yellow to amber depends on the concentration, type of solvent and storage conditions. If the recommended conditions are met, the variability of the solution color does not adversely affect the effectiveness of the product.

Preparation of Solution for Injection

Note:

• The resulting volume of the ceftazidime solution in the solvent increases due to the phase shift coefficient of the active substance, resulting in the concentrations [mg/mL] shown in the table above. Ceftazidime at a concentration of 90 mg/mL is compatible with:
• water for injections
• 0.9% sodium chloride injection

Preparation of Solution for Intravenous Infusion with Ceftazidime in a Standard Vial (Mini-Bag or Burette System)

Prepare using a total of 50 mL of compatible solvent (listed above), added in TWO stages, as described below:

• 1. Insert the needle through the stopper and inject 10 mL of solvent into the 1 g vial.
• 2. Remove the needle and shake the vial until a clear solution is obtained.
• 3. Do not insert the venting needle until the drug is completely dissolved. Insert the venting needle through the stopper to reduce the pressure inside the vial.
• 4. Transfer the solution to the final container (mini-bag or burette system), making up to a total volume of not less than 50 mL, and administer by intravenous infusion over 15 to 30 minutes. Note: To maintain the sterility of the product, it is important not to insert the venting needle through the vial stopper before the drug is completely dissolved.

Unused solution of the antibiotic should be discarded.
Solutions of Ceftazidim AptaPharma have a color from light yellow to amber.
For single use only.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.