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 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 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 is it used for
• 2. Before you are given Ceftazidim AptaPharma
• 3. How Ceftazidim AptaPharma is given
• 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 is it used for

Ceftazidim AptaPharma 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.

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 white blood cell count (neutropenia) who have a fever due to a bacterial infection.

2. Before you are given Ceftazidim AptaPharma

When must 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 are given Ceftazidim AptaPharma.
You must not be given Ceftazidim AptaPharma.

When should you be especially careful when given Ceftazidim AptaPharma

You should be aware that while you are being given Ceftazidim AptaPharma, you may get certain side effects, such as allergic reactions, nervous system problems and stomach and gut problems, including diarrhea. This will reduce the risk of possible problems (see "Symptoms to watch 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 get any of the symptoms of 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 given Ceftazidim AptaPharma.

Ceftazidim AptaPharma and other medicines

Tell your doctor about all the medicines you are taking, or have recently taken, including those you have bought without a prescription.
You must not be given Ceftazidim AptaPharma if you are also taking:

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

Pregnancy, breastfeeding 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;
• you are breast-feeding.

Your doctor will decide whether the benefits of taking Ceftazidim AptaPharma during pregnancy and breastfeeding 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 about 2.62% of the maximum recommended daily intake of sodium for adults.
This should be taken into account if you are 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 2 grams. This is about 5.24% of the maximum recommended daily intake of sodium for adults. This should be taken into account if you are on a controlled sodium diet.

3. How Ceftazidim AptaPharma is given

Ceftazidim AptaPharma is usually given by a doctor or nurse.It can be given as a drip(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 the correct dose of Ceftazidim AptaPharma for you, depending on the severity and type of infection, whether you are taking other antibiotics, your weight, age and how well your kidneys are working.

Newborns and infants (0-2 months)

For every 1 kg of body weight, 25 to 60 mg of Ceftazidim AptaPharma is given in 2 divided doses over 24 hours.
Infants (over 2 months) and childrenweighing less than 40 kg
For every 1 kg of body weight, 100 to 150 mg of Ceftazidim AptaPharma is given in 3 divided doses over 24 hours. Maximum 6 g per day.
Adults and adolescentsweighing 40 kg or more
1 to 2 g of Ceftazidim AptaPharma is given 3 times a day. Maximum 9 g per day.

Patients over 65 years

The daily dose should not usually 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 how severe your kidney disease is. Your doctor will monitor you closely and may ask you to have more frequent kidney function tests.

Overdose of Ceftazidim AptaPharma

If you are given more Ceftazidim AptaPharma than you should, contact your doctor or go to the nearest hospital immediately.

Missing a dose of Ceftazidim AptaPharma

If you miss a dose, 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.

Stopping Ceftazidim AptaPharma

Do not stop taking Ceftazidim AptaPharma without talking to your doctor. 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 for

The following serious side effects have been reported in a small number of people but the frequency is not known.

If you get any of the following symptoms, contact your doctor immediately:

• Red patches on the trunk, patches that look like targets or circles, often with central blisters, peeling of the skin, ulcers of the mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high fever 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 start of treatment (acute generalized exanthematous pustulosis).
• Severe allergic reaction. Symptoms include: hives, itching, swelling, sometimes of the face or mouth, which can cause difficulty breathing.
• Nervous system problems: tremors, convulsions and sometimes coma. These problems have occurred in patients who have been given too high doses, especially in patients with kidney disease.
• Reports have been received of severe hypersensitivity reactions with severe skin reactions, which can be accompanied by fever, fatigue, swelling of the face and lymph nodes, increased eosinophils (a type of white blood cell), liver and kidney 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 a vein
• red, raised rash on the skin that may itch
• 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:

• increase in the number of a type of white blood cell (eosinophilia)
• increase in the number of platelets in the blood, which are involved in blood clotting
• increase in liver enzyme activity.

Uncommon side effects

May affect up to 1 in 100 people:

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

Uncommon side effects that may be seen in blood tests:

• decrease in the number of white blood cells
• decrease in the number of platelets in the blood (cells involved in blood clotting)
• increase in urea, urea nitrogen or creatinine levels 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 frequency is not known:

• tingling or 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
• increase in the number of a type of white blood cell in the blood
• severe decrease in the number of white blood cells.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in the https://smz.ezdrowie.gov.plwebsite.
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 a refrigerator (at 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 glass vials of 10 mL capacity, with a 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 glass vials of 50 mL capacity, with a 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 a suitable infusion fluid. After preparation, the solution has a color from light yellow to amber. This is normal.

Marketing Authorisation Holder

Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Tel.: 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

To obtain further information, 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 infusion fluids: 0.9% sodium chloride injection, 5% glucose injection, 10% glucose injection, 5% glucose and 0.9% sodium chloride injection, 5% glucose and 0.45% sodium chloride injection, 5% glucose and 0.18% sodium chloride injection, 4% glucose and 0.18% sodium chloride injection, 10% dextran 40 in 5% glucose injection, 10% dextran 40 in 0.9% sodium chloride injection, 6% dextran 70 in 0.9% sodium chloride injection, 6% dextran 70 in 5% glucose injection.

Ceftazidim AptaPharma at concentrations between 1 mg/mL and 40 mg/mL is compatible with peritoneal dialysis fluid (lactate).

The color of the solution ranges from light yellow to amber, depending 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 product.

Ceftazidim AptaPharma solutions have the following pH: pH 5.0 to 7.5.

Solutions of Ceftazidim AptaPharma for intramuscular injection may be prepared with 0.5% or 1% lidocaine hydrochloride injection.

Preparation of solution for intravenous injection (bolus)

• 1. Insert the needle through the rubber stopper and inject the recommended volume of diluent into the vial. Negative pressure in the vial may facilitate entry of the diluent. Withdraw the needle from the syringe.
• 2. Shake until dissolved: carbon dioxide is released and a clear solution is obtained within 1 to 2 minutes.
• 3. Invert the vial. With the syringe plunger fully depressed, insert the needle through the rubber stopper and withdraw the total volume of solution into the syringe (increased pressure in the vial facilitates this). Keep the needle within the solution to avoid drawing in air. The solution drawn into the syringe may contain small carbon dioxide bubbles; these can be ignored. These solutions can be administered directly into a vein or into an intravenous infusion line, if the patient is receiving intravenous fluids. Ceftazidim AptaPharma is compatible with the above-mentioned intravenous fluids.

Preparation of solution for intravenous infusion using standard vials (mini-bag or burette system)

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