Ceftazidime Biopharma

PACKAGE LEAFLET: INFORMATION FOR THE USER

Ceftazidime Biopharma 250 mg/1 ml powder and solvent for injectable solution for

intramuscular use
Ceftazidime Biopharma 500 mg/1.5 ml powder and solvent for injectable solution for
intramuscular use
Ceftazidime Biopharma 1 g/3 ml powder and solvent for injectable solution for
intramuscular use
Ceftazidime Biopharma 1 g/10 ml powder and solvent for injectable solution for
intravenous use
Ceftazidime Biopharma 2 g powder for solution for infusion
Ceftazidime
Equivalent medicine

Please 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 questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT CEFTAZIDIME BIOPHARMA IS AND WHAT IT IS USED FOR

Ceftazidime Biopharma 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.
Ceftazidime Biopharma 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.

Ceftazidime Biopharma may also be used:

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

2. WHAT YOU NEED TO KNOW BEFORE CEFTAZIDIME BIOPHARMA IS ADMINISTERED TO YOU

Do not be given Ceftazidime Biopharma if:

• you are allergic ( hypersensitive ) to ceftazidime, to other cephalosporins, or to any of the other ingredients of this medicine (listed in section 6)
• you have previously experienced a severe allergic reaction to any other antibiotic (such as penicillins, monobactams, or carbapenems), as you may also be allergic to Ceftazidime Biopharma.
• Inform your doctor before starting treatment with Ceftazidime Biopharma if you think this applies to you. Ceftazidime Biopharma must not be administered to you.

Warnings and precautions
Exercise special caution with Ceftazidime Biopharma
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).
Contact your doctor immediately if you notice any of the symptoms related to these serious skin
reactions described in section 4.
Be vigilant for certain symptoms such as allergic reactions, nervous system disorders, and
gastrointestinal disturbances such as diarrhoea while being treated with Ceftazidime Biopharma.
This will help reduce the risk of potential complications. 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 Biopharma.

If you require blood or urine tests
Ceftazidime Biopharma may interfere with test results for glucose in urine and with 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 Biopharma.

Other medicines and Ceftazidime Biopharma
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those not requiring a prescription.
Do not be given Ceftazidime Biopharma without first consulting your doctor if you are taking:

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

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Your doctor will weigh the benefits of treatment with Ceftazidime Biopharma against any potential risks to the unborn or nursing child.

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

Important information about the excipients of Ceftazidime Biopharma
Ceftazidime Biopharma contains sodium
Ceftazidime Biopharma 250 mg contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially ‘sodium-free’.
Ceftazidime Biopharma 500 mg contains 26 mg of sodium (the main component of table salt) per vial. This corresponds to 1.3% of the maximum daily intake recommended in an adult diet.
Ceftazidime Biopharma 1 g contains 52 mg of sodium (the main component of table salt) per vial. This corresponds to 2.6% of the maximum daily intake recommended in an adult diet.
Ceftazidime Biopharma 2 g contains 104 mg of sodium (the main component of table salt) per vial. This corresponds to 5.2% of the maximum daily intake recommended in an adult diet.

3. HOW CEFTAZIDIME BIOPHARMA IS ADMINISTERED

Ceftazidime Biopharma is generally administered by a doctor or nurse. It may be given as an intravenous infusion or as an injection directly into a vein or into a muscle.
Ceftazidime Biopharma is prepared by the doctor, pharmacist, or nurse using water for injections or appropriate infusion fluids.
Usual dose
The appropriate dose of Ceftazidime Biopharma 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 the condition of your kidneys.
Newborns (0–2 months)
For each kg of the infant’s body weight, 25 to 60 mg of Ceftazidime Biopharma per day will be administered in two divided doses.
Infants (over 2 months) and children weighing less than 40 kg
For each kg of body weight, 100 to 150 mg of Ceftazidime Biopharma 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 Biopharma 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 usual. The doctor or nurse will decide how much Ceftazidime Biopharma you need based on the severity of your kidney disease. Your doctor will monitor you closely and may perform kidney function tests at more regular intervals.
If you are given more Ceftazidime Biopharma than you should
If you accidentally use more than the prescribed dose, contact your doctor or the nearest hospital immediately.
If you forget to use Ceftazidime Biopharma
If you miss an injection, take it as soon as possible. However, if it is almost 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 a forgotten dose.
If you stop treatment with Ceftazidime Biopharma
Do not stop treatment with Ceftazidime Biopharma unless your doctor tells you to. If you have any doubts, consult your doctor or nurse.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Contact your doctor immediately if you notice any of the following symptoms:

• reddish patches on the trunk; the patches are target-like or circular macules, often with central blisters, skin peeling, mouth, throat, nose, genital or eye ulcers. These serious 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, fatigue, facial swelling, increased eosinophils (a type of white blood cells), effects on kidneys, liver or lungs (DRESS syndrome or drug hypersensitivity syndrome)
• widespread, red, scaly rash, with bumps under the skin and blisters, accompanied by fever. Symptoms usually occur at the beginning of treatment (acute generalized exanthematous pustulosis)

Conditions requiring attention
The following serious adverse reactions have occurred in a small number of people, but their exact frequency is unknown:

• severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing breathing difficulties
• skin rash with blistering formations resembling small targets (a dark spot in the center surrounded by a light area with a black ring around the edge)
• nervous system disorders: tremors, seizures and, in some cases, coma. These have occurred in patients receiving too high a dose, especially in patients with kidney disease

Contact your doctor or nurse urgently if you experience any of these symptoms.
Common adverse reactions
These may affect up to 1 in 10 patients:

• diarrhoea
• 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 adverse reactions 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 adverse reactions
These may affect up to 1 in 100 patients:

• inflammation of the intestine, which may cause pain or diarrhoea that may contain blood
• candidiasis – fungal infections 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 adverse reactions 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 or serum creatinine.

Very rare adverse reactions
These may affect up to 1 in 10,000 patients:

• kidney inflammation or kidney failure

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

• sensation of pins and needles
• unpleasant taste in the mouth
• yellowing of the whites of the eyes or skin

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

5. HOW TO STORE CEFTAZIDIME BIOPHARMA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month, provided the packaging remains intact and the product is stored correctly.
Before reconstitution, store the vials at a temperature not exceeding 25 °C and protected from light.
The reconstituted solution, prepared with water for injections or with compatible infusion fluids (e.g. sodium chloride solution, glucose solution, or Sodium lactate solution), should normally be used within 12 hours if stored at a temperature below 25 °C.

6. PACKAGING CONTENTS AND OTHER INFORMATION

What Ceftazidima Biopharma contains
CEFTAZIDIME BIOPHARMA 250 mg/1 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:
Active substance: ceftazidime pentahydrate 291 mg (equivalent to ceftazidime 250 mg)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections
CEFTAZIDIME BIOPHARMA 500 mg/1.5 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:
Active substance: ceftazidime pentahydrate 582 mg (equivalent to ceftazidime 500 mg)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections
CEFTAZIDIME BIOPHARMA 1 g/3 ml powder and solvent for injectable solution for
intramuscular use
One vial of powder contains:
Active substance: ceftazidime pentahydrate 1.164 g (equivalent to ceftazidime 1 g)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections
CEFTAZIDIME BIOPHARMA 1 g/10 ml powder and solvent for injectable solution for
intravenous use
One vial of powder contains:
Active substance: ceftazidime pentahydrate 1.164 g (equivalent to ceftazidime 1 g)
Excipients: powder vial: sodium carbonate; solvent vial: water for injections
CEFTAZIDIME BIOPHARMA 2 g powder for solution for infusion
One vial contains:
Active substance: ceftazidime pentahydrate 2.328 g (equivalent to ceftazidime 2 g)
Excipients: sodium carbonate

Description of the appearance of Ceftazidima Biopharma and packaging contents
Powder and solvent for injectable solution for intramuscular use
Box containing 1 vial of 250 mg powder + 1 vial of 1 ml solvent
Box containing 1 vial of 500 mg powder + 1 vial of 1.5 ml solvent
Box containing 1 vial of 1 g powder + 1 vial of 3 ml solvent

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

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

Marketing Authorization Holder and Manufacturer
Biopharma S.r.l. - Via Paolo Mercuri 8 – 00193 Rome, Italy

Responsible Person for Batch Release
Biopharma S.r.l. – Via delle Gerbere 22/30 – 00134 Santa Palomba, Rome, Italy