Ceftazidim Mip Pharma

Package Leaflet: Information for the Patient

Ceftazidim MIP Pharma, 1 g, Powder for Solution for Injection/Infusion

Ceftazidim MIP Pharma, 2 g, Powder for Solution for Injection/Infusion

Ceftazidime (Ceftazidimum)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

• 1. What is Ceftazidim MIP Pharma and what is it used for
• 2. Important information before using Ceftazidim MIP Pharma
• 3. How to use Ceftazidim MIP Pharma
• 4. Possible side effects
• 5. How to store Ceftazidim MIP Pharma
• 6. Contents of the pack and other information

1. What is Ceftazidim MIP Pharma and what is it used for

Ceftazidim MIP Pharma 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 MIP Pharma is used to treat severe bacterial infections:

• lower respiratory tract, including lungs
• lungs and bronchi in patients with cystic fibrosis
• brain (meningitis)
• ear
• urinary tract
• skin and soft tissues
• abdominal cavity and abdominal wall (peritonitis)
• bones and joints.

Ceftazidim MIP Pharma 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. Important information before using Ceftazidim MIP Pharma

When not to give Ceftazidim MIP Pharma to the patient

• -If the patient is allergic(hypersensitive) to ceftazidimeor any of the other ingredients of this medicine (listed in section 6).
• -If the patient has ever had a severe allergic reactionto any other antibiotic(penicillins, monobactams, and carbapenems) ,as the patient may also be allergic to Ceftazidim MIP Pharma.
• If the patient suspects that they are affected by the above conditions, they should tell their doctor beforestarting treatment with Ceftazidim MIP Pharma. Do not give Ceftazidim MIP Pharma to the patient.

When to be careful when using Ceftazidim MIP Pharma

Pay attention to whether the patient has any special symptoms while using Ceftazidim MIP Pharma, such as allergic reactions, nervous system disorders, and stomach and intestine disorders, including diarrhea. This will reduce the risk of possible problems. See ('Side effects to look out for') in section 4. If the patient has ever had an allergic reaction to other antibiotics, they may also be allergic to Ceftazidim MIP Pharma.
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 the patient experiences any of the symptoms associated with these severe skin reactions, described in section 4, they should see a doctor immediately.

Blood and urine tests

Ceftazidim MIP Pharma may affect the results of urine tests for sugar and blood tests known as the Coombs test. If the patient is to have these tests:

• Tell the person taking the samplethat the patient has been taking Ceftazidim MIP Pharma.

Ceftazidim MIP Pharma and other medicines

Tell the doctor or pharmacist about all medicines the patient is taking, or has recently taken, including those obtained without a prescription.
The patient should not take Ceftazidim MIP Pharma without consulting their doctor if they are also taking:

• an antibiotic called chloramphenicol .
• an antibiotic from a group called aminoglycosides, such as gentamicin, tobramycin
• diuretic tablets containing furosemide
• If the above conditions apply to the patient, tell their doctor.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should ask their doctor for advice before taking this medicine.
The doctor will assess whether the benefits of taking Ceftazidim MIP Pharma during pregnancy and breastfeeding outweigh the risks to the baby.

Driving and using machines

Ceftazidim MIP Pharma may cause side effects that affect the ability to drive or use machines, such as dizziness.
The patient should not drive or use machines unless they are sure that they have not had these side effects.

Ceftazidim MIP Pharma contains sodium

Ceftazidim MIP Pharma, 1 g, contains approximately 52 mg of sodium (the main component of common salt) per vial. This corresponds to 2.6% of the maximum recommended daily intake of sodium in the diet for adults.
Ceftazidim MIP Pharma, 2 g, contains approximately 104 mg of sodium (the main component of common salt) per vial. This corresponds to 5.2% of the maximum recommended daily intake of sodium in the diet for adults.
This should be taken into account in patients controlling their sodium intake.

How to use Ceftazidim MIP Pharma

Ceftazidim MIP Pharma is usually given by a doctor or nurse.It can be given as an intravenous infusionor as an injection directly into a vein or into a muscle.
Ceftazidim MIP Pharma is prepared by a doctor, pharmacist, or nurse using water for injections or another suitable infusion fluid.

Usual dose

The doctor will decide on the appropriate dose of Ceftazidim MIP Pharma for the patient, taking into account the severity and type of infection, whether the patient is taking any other antibiotics, their body weight, age, and kidney function.

Newborns and infants (0-2 months)

For every 1 kg of the infant's body weight, 25 to 60 mg of ceftazidime is given in two divided doses per day.
Infants (over 2 months) and childrenwith a body weight of less than 40 kg For every 1 kg of the infant's or child's body weight, 100 to 150 mg of ceftazidime is given in three divided doses per day. Maximum 6 g per day.
Adults and adolescentswith a body weight of 40 kg or more
1 to 2 g of ceftazidime three times a day. Maximum 9 g per day.

Patients over 65 years of age

The daily dose should not be higher than 3 g per day, especially in patients over 80 years of age.

Patients with kidney problems

The patient may receive a different dose than usual. The doctor or nurse will decide what dose of Ceftazidim MIP Pharma to give, depending on the severity of the kidney disease. The doctor will closely monitor the patient and may order more frequent kidney function tests.

Using more Ceftazidim MIP Pharma than recommended

If more Ceftazidim MIP Pharma is used than prescribed: contact the doctor immediately or go to the nearest hospital.

Missing a dose of Ceftazidim MIP Pharma

If the patient misses an injection, it should be given as soon as possible. However, if it is close to the 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 Ceftazidim MIP Pharma

Do not stop taking Ceftazidim MIP Pharma without the doctor's advice. In case of any further questions about using this medicine, ask the doctor, pharmacist, or nurse.

4. Possible side effects

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

If the patient experiences any of the following symptoms, they should see a 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 facial or lip swelling, which can cause difficulty breathing.
• -Nervous system disorders: tremors, seizures, and sometimes coma. These disorders occurred in patients who received too high doses, especially those with kidney problems.

Common side effects

May affect up to 1 in 10patients:

• 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 the patient , they should tell their doctor.

Common side effects that may appear in blood tests:

• increase in the number of one 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 100patients:

• inflammation of the intestines, 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 the doctorif the patient experiences any of the above symptoms.

Uncommon side effects that may appear 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, nitrogen, or creatinine levels in the blood.

Rare side effects

May affect up to 1 in 10,000patients:

• inflammation or kidney failure

Other side effects

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

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

Other side effects that may appear in blood tests:

• red blood cells break down too quickly
• increase in the number of one type of white blood cell in the blood
• significant decrease in the number of white blood cells.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor or pharmacist. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocides of the Office for Registration of Medicinal Products, Medical Devices, and Biocides, Al.
Jerozolimskie 181C, PL-02 222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store Ceftazidim MIP Pharma

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after:
“EXP”. The expiry date refers to the last day of the month.
Do not store above 30°C. Store the vial in the outer packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. Ask the pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Ceftazidim MIP Pharma contains

• The active substance is ceftazidime. Each vial contains 1 g or 2 g of ceftazidime (as ceftazidime pentahydrate).
• The other ingredient is sodium carbonate, anhydrous.

What Ceftazidim MIP Pharma looks like and contents of the pack

White or light yellow powder
Ceftazidim MIP Pharma, 1 g, is available in 15 ml glass vials, sealed with a rubber stopper and a flip-off cap.
Ceftazidim MIP Pharma, 2 g, is available in 50 ml glass vials, sealed with a rubber stopper and a flip-off cap.
Pack sizes: cardboard boxes containing 1, 5, or 10 vials.
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

MIP Pharma GmbH
Kirkeler Str. 41
66440 Blieskastel, Germany
tel.: 0049 (0) 6842 9609 0
fax: 0049 (0) 6842 9609 355

Date of last revision of the package leaflet: 12.12.2024

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Information intended for healthcare professionals only:
During 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 achieved concentrations, which may be useful when partial doses are needed.

The color of the solution ranges from light yellow to amber, depending on the concentration, type of solvent, and storage conditions. If the recommended conditions are met, the variability in the color of the solution does not adversely affect the effectiveness of the product.
Compatibility with intravenous fluids
The following solvents can be used to prepare the solution:

• water for injections,
• glucose solution 50 mg/ml (5%),
• sodium chloride solution 9 mg/ml (0.9%).

Ceftazidime for intramuscular injections can be dissolved in a solution containing 1% lidocaine hydrochloride for injection.
Preparing the solution for rapid injection

• 1. Pierce the stopper with a needle and inject the recommended volume of solvent into the vial. Withdraw the needle with 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. Holding the syringe plunger in a 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 will facilitate 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 into an intravenous infusion set, if the patient is receiving intravenous fluids. Ceftazidime is compatible with most commonly used intravenous fluids.
Preparing the solution for infusion

• 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 a vent needle until the drug is completely dissolved. Insert a vent needle through the stopper to reduce the pressure in the vial.
• 4. Transfer the solution to a final container (mini bag or burette), achieving a total volume of 50 ml, and administer as an intravenous infusion over 15 to 30 minutes. Note: To ensure the sterility of the product, it is essential not to insert the vent needle through the vial stopper before the drug is completely dissolved.

Important incompatibilities
Ceftazidime is less stable in sodium bicarbonate solutions than in other intravenous fluids. Sodium bicarbonate should not be used as a solvent.
Ceftazidime should not be mixed with aminoglycosides in the same infusion set or syringe.
Precipitation has been reported when ceftazidime is mixed with vancomycin. It is recommended to flush intravenous infusion sets and cannulae between administration of the two antibiotics.

Storage after dissolution

Shelf life of the prepared solution
The chemical and physical stability of the prepared solution has been demonstrated for 6 hours at 25°C and for 12 hours at 2-8°C. After mixing with lidocaine: use immediately (within 2 hours). From a microbiological point of view, the prepared solution should be used immediately.