Ceftazidime Sandoz

Package leaflet: Information for the patient

Ceftazidime Sandoz 1 g/3 ml

powder and solvent for injectable solution for intramuscular use
Ceftazidime Sandoz 1 g/10 ml
powder and solvent for injectable solution for intravenous use
Ceftazidime Sandoz 2 g powder for solution for infusion
Generic medicine
Please read all of this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it could be harmful.
• If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What Ceftazidime Sandoz is and what it is used for
2. What you need to know before you are given Ceftazidime Sandoz
3. How Ceftazidime Sandoz is administered
4. Possible side effects
5. How to store Ceftazidime Sandoz
6. Contents of the pack and other information

1. What Ceftazidima Sandoz is and what it is used for

Ceftazidima Sandoz is an antibiotic used in adults and children (including newborns). It
works by killing the bacteria that cause infections and belongs to a group of medicines called
cephalosporins.
Ceftazidima Sandoz is used to treat serious bacterial infections of:

• lungs or chest
• lungs and bronchi in patients with cystic fibrosis
• brain ( meningitis )
• ear
• urinary tract
• skin and soft tissues
• abdomen and abdominal wall ( peritonitis )
• bones and joints.

Ceftazidima Sandoz may also be used:

• to prevent infections during surgical procedures of the prostate in men
• to treat patients with low white blood cell counts ( neutropenia ) who have fever due to a bacterial infection.

2. What you need to know before using Ceftazidime Sandoz

Do not use Ceftazidime Sandoz:

• if you are allergic ( hypersensitive ) to ceftazidime or to any of the other ingredients of this medicine ( listed in section 6 ).
• if you have previously experienced a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to Ceftazidime Sandoz.

Warnings and precautions
Talk to your doctor or pharmacist before using Ceftazidime Sandoz if you think this applies to you. Do not use Ceftazidime Sandoz.
Severe 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). Seek immediate medical advice if you notice any of the symptoms related to these serious skin reactions described in section 4.

Take special care with Ceftazidime Sandoz
Be alert for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhoea while being treated with Ceftazidime Sandoz. This will reduce the risk of potential problems. See ( Conditions requiring caution ) in section 4. If you have previously had an allergic reaction to other antibiotics, you may also be allergic to Ceftazidime Sandoz.

If you require blood or urine tests
Ceftazidime Sandoz may interfere with the results of urine sugar tests and the blood test known as the Coombs test. If you are undergoing these tests:

• Inform the person collecting the sample that you are being treated with Ceftazidime Sandoz.

Other medicines and Ceftazidime Sandoz
Inform your doctor or pharmacist if you are currently taking, have recently taken, or might take any other
medicines.
Do not use Ceftazidime Sandoz without first consulting your doctor if you are taking:

• an antibiotic called chloramphenicol
• a class of antibiotics called aminoglycosides, such as gentamicin, tobramycin
• diuretic tablets called furosemide
  Inform your doctor if this applies to you.

Pregnancy, breast-feeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or are breast-feeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will assess the benefits of treatment with Ceftazidime Sandoz against any potential risks to the unborn or breastfed child.

Driving and using machines
Ceftazidime Sandoz may cause side effects such as dizziness, which could affect your ability to drive or operate machinery.
Do not drive or use machines unless you are certain you will not be affected.

Ceftazidime Sandoz contains sodium
You should take the following into account if you are on a sodium-controlled diet.

Ceftazidime Sandoz 1 g
This medicine contains 50.5 mg of sodium (the main component of table salt). This corresponds to 2.5% of the maximum daily intake recommended by the WHO, which is 2 g of sodium for an adult.

Ceftazidime Sandoz 2 g
This medicine contains 101 mg of sodium (the main component of table salt). This corresponds to 5.05% of the maximum daily intake recommended by the WHO, which is 2 g of sodium for an adult.

3. How to use Ceftazidime Sandoz

Ceftazidime Sandoz is generally administered by a doctor or nurse. It can be given as an intravenous infusion or as an injection directly into a vein or into a muscle.
Ceftazidime Sandoz is prepared by the doctor, pharmacist, or nurse using water for injections or appropriate infusion fluids.

Usual dose
The appropriate dose of Ceftazidime Sandoz will be decided by your doctor and depends on: the severity and type of infection; whether you are being treated with other antibiotics; your body weight and age; and your kidney function.

Newborns (0–2 months)
For each kg of the baby's body weight, 25 to 60 mg of Ceftazidime Sandoz per day will be administered in two divided doses.

Children (over 2 months) and children weighing less than 40 kg
For each kg of the infant’s or child’s body weight, 100 to 150 mg of Ceftazidime Sandoz per day will be administered in three divided doses. The maximum dose is 6 g per day.

Adults and adolescents weighing 40 kg or more
1 to 2 g of Ceftazidime Sandoz three times a day. The maximum dose is 9 g per day.

Patients over 65 years of age
The daily dose should generally not exceed 3 g per day, especially if over 80 years of age.

Patients with kidney problems
You may be given a different dose than the usual one. The doctor or nurse will decide how much Ceftazidime Sandoz you need based on the severity of your kidney disease. Your doctor will monitor you closely and may carry out kidney function tests at regular intervals.

If you are given more Ceftazidime Sandoz than you should
If you accidentally receive a higher dose than prescribed, contact your doctor or the nearest hospital immediately.

If you forget to use Ceftazidime Sandoz
If you miss an injection, it should be given as soon as possible. However, if it is almost time for the next injection, skip the missed dose. Do not take a double dose (two injections at the same time) to make up for a forgotten dose.

If you stop treatment with Ceftazidime Sandoz
Do not stop treatment with Ceftazidime Sandoz unless your doctor tells you to do so. If you have any doubts, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Conditions requiring attention
The following serious side effects have occurred in a small number of people, but their exact frequency is unknown:
Contact your doctor immediately if you notice any of the following symptoms

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash with blistering resembling small targets (a dark spot in the center surrounded by a lighter area with a black ring around the edge). Reddish patches on the trunk; the patches are target-like or circular macules, often with central blisters, skin peeling, ulcers in the mouth, throat, nose, genitals, and eyes. These severe skin reactions 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).
• Widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).
• Nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in patients receiving too high a dose, especially in those with kidney disease.
• Contact your doctor or nurse immediately if you experience any of these symptoms.

Common side effects
May affect up to 1 in 10 patients:

• Diarrhea
• Swelling and redness along the vein
• Raised red rash which may be itchy
• Pain, burning, swelling, or inflammation at the injection site.
• Inform your doctor if any of these conditions concern you.

Common side effects that may be detected by blood tests include:

• Increase in a type of white blood cells (eosinophilia)
• Increase in the number of cells that help blood clotting
• Increase in liver enzymes.

Uncommon side effects
May affect up to 1 in 100 patients:

• Inflammation of the intestine, which may cause pain or diarrhea that may contain blood
• Fungal infections (candidiasis) in the mouth or vagina
• Headache
• Dizziness
• Stomach pain
• Nausea or vomiting
• Fever and chills.
• Inform your doctor if you experience any of these conditions.

Uncommon side effects that may be detected by blood tests include:

• Decrease in the number of white blood cells
• Decrease in the number of platelets (cells that help blood clotting)
• Increase in blood levels of urea, blood urea nitrogen (BUN), or serum creatinine.

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

• Inflammation or kidney failure
• Sensation of pins and needles
• Unpleasant taste in the mouth
• Yellowing of the whites of the eyes or skin.

Other side effects that may be detected by blood tests include:

• Too rapid destruction of red blood cells
• Increase in certain types of white blood cells
• Severe decrease in the number of white blood cells.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ceftazidime Sandoz

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after "exp".
The expiry date refers to the last day of that month.
Before reconstitution, store the vials in their original packaging to protect the medicine from light.
The reconstituted solution, prepared with water for injections or with compatible infusion fluids (e.g. physiological saline, glucose, or Sodium lactate solution), should normally be used within 18 hours when stored at room temperature, and within 7 days when stored at 4°C.

6. Package contents and other information

What Ceftazidima Sandoz contains
The active substance is ceftazidime pentahydrate.
One 1 g vial of powder contains: ceftazidime pentahydrate 1.164 g (equivalent to 1 g of ceftazidime)
Excipients: Vial of powder: anhydrous sodium carbonate; solvent vial: water for injections
One 2 g vial of powder contains: ceftazidime pentahydrate 2.328 g (equivalent to 2 g of ceftazidime)
Excipients: anhydrous sodium carbonate

Description of the appearance of Ceftazidima Sandoz and contents of the pack
Powder and solvent for injectable solution for intramuscular use
Box containing 1 vial of 1 g powder + 1 solvent vial of 3 ml

Powder and solvent for injectable solution for intravenous use
Box containing 1 vial of 1 g powder + 1 solvent vial of 10 ml

Powder for solution for infusion
Box containing 1 vial of 2 g powder

Marketing Authorization Holder
Sandoz S.p.A. – Largo U. Boccioni, 1 - 21040 Origgio (VA)

Manufacturer
Laboratorio Farmaceutico C.T. S.r.l. – Via D. Alighieri, 71 – Sanremo (IM)