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)
Please read this leaflet carefully before using this medicine, because it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm other people, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

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

Ceftazidim MIP Pharma is an antibiotic used in adults and children (including newborns).
It acts bactericidally against bacteria causing infections. It belongs to a group of medicines called
cephalosporins.
Ceftazidim MIP Pharma is used to treat severe bacterial infections:

• of the lower respiratory tract, including lungs
• 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 peritoneum (peritonitis)
• of bones and joints.

Ceftazidim MIP Pharma may also be used:

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

2. Important information before using Ceftazidim MIP Pharma

When not to give the patient Ceftazidim MIP Pharma

• If the patient is allergic (hypersensitive) to ceftazidime or any of the other ingredients of this medicine (listed in section 6).
• If the patient has ever experienced a severe allergic reaction to any other antibiotic (penicillins, monobactams or carbapenems), because the patient may also be allergic to Ceftazidim MIP Pharma.
• If the patient suspects that any of the above circumstances apply, they should inform their doctor before starting treatment with Ceftazidim MIP Pharma. Do not administer Ceftazidim MIP Pharma to the patient.

When to exercise special caution when using Ceftazidim MIP Pharma
Care should be taken to monitor whether the patient experiences any specific symptoms during treatment with Ceftazidim MIP Pharma, such as allergic reactions, nervous system disorders, or gastrointestinal disturbances including diarrhoea. This will reduce the risk of potential complications. See ('Symptoms to be aware of') in section 4. If the patient has ever had an allergic reaction to other antibiotics, they may also be allergic to Ceftazidim MIP Pharma.
Serious skin reactions have been reported during treatment 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 develops any of the symptoms associated with these serious skin reactions described in section 4, medical advice should be sought immediately.

Blood and urine tests
Ceftazidim MIP Pharma may alter the results of urine glucose tests and blood tests known as the Coombs test. If the patient is due to have such tests:

• The person collecting the sample should be informed that the patient has been receiving Ceftazidim MIP Pharma.

Ceftazidim MIP Pharma and other medicines
Tell the doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, including those available 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 any of the above circumstances apply to the patient, the patient's doctor should be informed.

Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a baby, she should consult her doctor before using this medicine.
The patient's doctor will assess whether the benefits of taking Ceftazidim MIP Pharma during pregnancy or breastfeeding outweigh any potential risks to the baby.

Driving and using machines
Ceftazidim MIP Pharma may cause side effects affecting the ability to drive, such as dizziness.
The patient should not drive or operate machinery unless they are certain that these side effects have not occurred.

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

How to use Ceftazidim MIP Pharma
Ceftazidim MIP Pharma is usually administered by a doctor or nurse. It may be given by infusion (intravenous infusion) or as an injection directly into a vein or as an intramuscular injection.
Ceftazidim MIP Pharma is prepared by a doctor, pharmacist, or nurse using water for injections or another suitable infusion fluid.

Usual dose
The patient's doctor will decide the appropriate dose of Ceftazidim MIP Pharma based on the severity and type of infection, whether the patient is taking other antibiotics, the patient's body weight, age, and kidney function.

Newborns and infants (aged 0–2 months)
25 to 60 mg of ceftazidime per kg of body weight per day, divided into two doses.

Infants (over 2 months of age) and children weighing less than 40 kg
100 to 150 mg of ceftazidime per kg of body weight per day, divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more
1 to 2 g of ceftazidime three times daily. Maximum 9 g per day.

Patients over 65 years of age
The daily dose should usually not exceed 3 g, especially in patients over 80 years of age.

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

Use of a higher than recommended dose of Ceftazidim MIP Pharma
If a higher dose of Ceftazidim MIP Pharma than prescribed is accidentally administered: contact the patient's doctor immediately or go to the nearest hospital.

Missed dose of Ceftazidim MIP Pharma
If an injection is missed, it should be given as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped. Do not administer a double dose (two injections at the same time) to make up for a missed dose.

Stopping treatment with Ceftazidim MIP Pharma
Do not stop taking Ceftazidim MIP Pharma without the doctor's advice. If there are any further doubts about using this medicine, consult the doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If the patient experiences any of the following symptoms, they should seek immediate medical advice:

• Red spots on the trunk, rash resembling a target or circular lesions, often with central blisters, peeling of the skin, ulceration of the mouth, throat, nose, genital organs and eyes. These severe skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).
• Widespread rash, high body temperature and swollen lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).
• Red, peeling, extensive rash with subcutaneous nodules and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis).
• Severe allergic reaction. Symptoms include: raised, itchy rash, swelling, sometimes of the face or lips, which may cause difficulty breathing.
• Nervous system disorders: tremors, seizures and sometimes coma. These disorders occurred in patients who received excessive doses, particularly in patients with kidney disease.

Common adverse reactions
May occur in not more than 1 in 10 patients:

• diarrhoea
• swelling and redness along the vein
• red, raised rash on the skin, which may be itchy
• pain, burning, swelling or inflammation at the injection site.
• If any of the above symptoms concern the patient, they should inform their doctor.

Common adverse reactions that may be revealed in blood test results:

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

Uncommon adverse reactions
May occur in not more than 1 in 100 patients:

• intestinal inflammation, which may cause abdominal pain or diarrhoea, possibly containing blood
• candidiasis – fungal infections of the mouth or vagina
• headache
• dizziness
• abdominal pain
• nausea or vomiting
• fever and chills.
• The patient should inform their doctor if any of the above symptoms occur.

Uncommon adverse reactions that may be revealed in blood test results:

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

Very rare adverse reactions
May occur in not more than 1 in 10,000 patients:

• kidney inflammation or kidney failure

Other adverse reactions
Other adverse reactions observed in a small number of patients, but their exact frequency is unknown:

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

Other adverse reactions that may be revealed in blood test results:

• red blood cells breaking down too quickly
• increased number of one type of white blood cells in blood
• marked decrease in the number of white blood cells.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, the patient should inform their doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, 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 adverse reactions helps provide more information on the safety of this medicine.

5. How to store Ceftazidim MIP Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton following:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Keep the vial in the outer packaging to protect from light.
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 Ceftazidim MIP Pharma contains

• The active substance is ceftazidime. Each vial contains either 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 pale 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 Authorisation Holder Manufacturer/Importer
MIP Pharma GmbH MIP Pharma GmbH
Kirkeler Str. 41 Mühlstraße 50
66440 Blieskastel, Germany 66386 St. Ingbert, Germany
Tel.: 0049 (0) 6842 9609 0
Fax: 0049 (0) 6842 9609 355

Information intended exclusively for medical professionals:

During dissolution of the powder, pressure increases due to the release of carbon dioxide. Small bubbles of carbon dioxide in the prepared solution may be disregarded.
Instructions for preparation of the medicinal product for administration
Refer to the table of added volumes and resulting concentrations, which may be helpful when partial doses are required.

The colour of the solution ranges from light yellow to amber, depending on concentration, type of solvent,
and storage conditions. Provided that recommended conditions are met, variation in the colour of the solution does
not adversely affect the product's efficacy.

Compatibility with intravenous fluids
The following solvents may 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 injection may be dissolved in a solution containing 1% lidocaine hydrochloride for injection.

Preparation of solution for rapid injection

1. Pierce the stopper with a needle and inject the recommended volume of solvent into the vial. Withdraw the syringe with the needle.
2. Shake until dissolved: carbon dioxide is released and a clear solution is obtained within 1 to 2 minutes.
3. Invert the vial. While keeping the syringe plunger fully depressed, pierce the stopper with the needle and withdraw the entire solution volume into the syringe (increased pressure inside the vial facilitates this procedure). Keep the needle immersed in the solution to avoid drawing in air. The solution in the syringe may contain small bubbles of carbon dioxide.

These solutions may be administered directly into a vein or into an intravenous infusion set if the patient is receiving intravenous fluids. Ceftazidime is compatible with commonly used intravenous fluids.

Preparation of solution for infusion
Prepare using a total of 50 ml of a compatible solvent, added in TWO stages, as described below.

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 before the drug is completely dissolved. Insert the venting needle through the stopper to reduce internal pressure in the vial.
4. Transfer the solution to the final container (mini bag or burette set), to achieve a total volume of 50 ml, and administer by intravenous infusion over 15 to 30 minutes. Note: To ensure sterility of the medicinal product, the venting needle must not be inserted through the vial stopper before the drug is completely dissolved.

Important pharmaceutical incompatibilities
Ceftazidime shows lower stability in sodium bicarbonate solutions compared to other intravenous fluids. The use of sodium bicarbonate as a solvent is not recommended.
Ceftazidime must not be mixed with aminoglycosides in the same infusion set or in the same syringe.
Precipitation has been reported when vancomycin was added to a ceftazidime solution. It is recommended to flush intravenous infusion sets and cannulae between administration of the two antibiotics.

Storage after reconstitution
Shelf life of the prepared solution
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. When mixed with lidocaine: use immediately (within 2 hours). From a microbiological standpoint, the prepared solution should be used immediately.