Ceftazidime Normon 2 g powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ceftazidime Normon 2 g powder for solution for infusion EFG

ceftazidime

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as 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, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist, or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Ceftazidime Normon is and what it is used for

Ceftazidime Normon is an antibiotic used in adults and children (including newborns). It works by eliminating the bacteria that cause infections. It belongs to a group of medicines known as cephalosporins.

Ceftazidime Normon is used to treat serious bacterial infections of:

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

Ceftazidime Normon may also be used:

• To prevent infections during prostate surgery in men

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

2. What you need to know before Ceftazidime Normon is administered to you

Do not use this medicine:

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

♦ Inform your doctor before starting treatment with Ceftazidime Normon if any of the above applies to you. This medicine must not be administered to you.

Warnings and precautions

While receiving this medicine, be alert for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disorders, such as diarrhea. This will reduce the risk of potential problems. See (Symptoms to be aware of) in section 4. If you have ever had an allergic reaction to other antibiotics, you may also be allergic to this medicine.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), have been reported during treatment with ceftazidime. Seek immediate medical attention if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need blood or urine tests

Ceftazidime Normon may affect the results of urine glucose tests and a blood test known as the Coombs test. If you are having tests:

♦ Inform the person taking the sample that you have been administered ceftazidime.

Use of Ceftazidime Normon with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Do not use this medicine without speaking to your doctor if you are also taking:

• an antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, for example: gentamicin, tobramycin
• a "water tablet" (a diuretic called furosemide)

♦ Inform your doctor if any of the above applies to you.

Pregnancy and breastfeeding

Inform your doctor before this medicine is administered to you:

• If you are pregnant, think you may be pregnant, or plan to become pregnant
• If you are breastfeeding

Your doctor will assess the benefit of treating you with this medicine against the risk to the baby.

Driving and use of machines

Ceftazidime Normon may cause adverse effects such as dizziness, which may affect your ability to drive.

Do not drive or operate machinery unless you are certain that it does not affect you.

Ceftazidime Normon contains sodium.

This medicine contains 104.15 mg (4.53 mmol) of sodium (the main component of table/cooking salt) per vial. This corresponds to 5.2% of the maximum daily intake for an adult.

3. How to administer Ceftazidime Normon

This medicine is normally administered by a doctor or nurse. It is given as an infusion (intravenous infusion).

This medicine is reconstituted by the doctor, pharmacist, or nurse using an appropriate infusion fluid.

Recommended dose

The correct dose of this medicine for you will be decided by your doctor and depends on: the severity and type of infection, whether you are being treated with other antibiotics, your weight and age, and your kidney function.

Newborn babies (0–2 months)

From 25 to 60 mg of this medicine per day per 1 kg of the baby's body weight, divided into two doses.

Infants (over 2 months) and children weighing less than 40 kg

From 100 to 150 mg of this medicine per day per 1 kg of the infant or child's body weight, divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more

1 g to 2 g of this medicine, three times a day. Maximum 9 g per day.

Patients over 65 years of age

The daily dose should normally not exceed 3 g per day, especially if you are over 80 years old.

Patients with kidney problems

You may be given a different dose than usual. Your doctor will decide how much of this medicine you need, depending on the severity of your kidney disease. Your doctor will monitor you closely and your kidney function tests will be performed more frequently.

If you are given more Ceftazidime Normon than you should

If you accidentally receive more than the prescribed dose, contact your doctor or the nearest hospital.

You may also call the Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount administered.

If you forget to use Ceftazidime Normon

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 use a double dose (two injections at the same time) to make up for the forgotten dose. Take the next dose at the usual time.

If you stop treatment with Ceftazidime Normon

Do not stop receiving this medicine unless instructed by your doctor.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

Seek immediate medical attention if you notice any of the following symptoms:

• Red, target-shaped or circular skin patches on the trunk, often with blisters in the center, peeling skin, or ulcers in the mouth, throat, nose, genitals, or eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, elevated body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

• Widespread red rash with peeling, lumps under the skin, and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

Symptoms to watch for

The following serious adverse effects have occurred in a small number of patients, but their exact frequency is unknown:

• Severe allergic reaction. Signs include itchy, raised rash, swelling, sometimes of the face or mouth, causing difficulty breathing.
• Skin rash, which may blister and appear as small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge).
• Widespread rash with blisters and skin peeling. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis.)
• Nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in patients receiving very high doses, especially in patients with kidney disease.

Rare cases of severe hypersensitivity reaction with severe skin rash have been reported, which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophils (a type of white blood cell), and involvement of the liver, kidneys, or lungs (a reaction known as DRESS syndrome).

♦ Contact your doctor or nurse immediately if you experience any of these symptoms.

Frequent adverse effects

May affect 1 in 10 people:

• Diarrhea
• Swelling and redness around a vein
• Red, raised rash, which may be itchy
• Pain, burning, swelling, or inflammation at the injection site.

♦ Inform your doctor if any of these adverse effects concern you.

Frequent adverse effects that may appear in blood tests:

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

Uncommon adverse effects

May affect 1 in 100 people:

• Inflammation of the intestine, which may cause pain or bloody diarrhea
• 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.

Uncommon adverse effects that may appear in blood tests:

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

Very rare adverse effects

May affect 1 in 10,000 people:

• Inflammation or failure of the kidneys

Other adverse effects

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

• Tingling
• Bad taste in the mouth
• Yellowing of the skin or whites of the eyes.

Other adverse effects that may appear in blood tests:

• Rapid destruction of red blood cells
• Increase in a certain type of white blood cell
• Severe decrease in the number of white blood cells.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftazidime Normon

Keep this medicine out of the sight and reach of children.

Store below 25 °C.

Keep in the original container to protect from light.

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the maximum shelf life after reconstitution of the injectable with the indicated volume of diluent is 8 hours at 25 °C and 24 hours at a temperature between 2 °C and 8 °C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Ceftazidime Normon

The active substance is ceftazidime. Each vial contains 2 g of ceftazidime (as pentahydrate).

The excipient contained is anhydrous sodium carbonate.

Presentation of the product and package contents

The package of Ceftazidime Normon 2 g powder for solution for infusion contains a 20 ml vial with 2 g of ceftazidime in powder form. It is available in packages containing 1 vial or 50 vials (hospital pack).

Marketing Authorization Holder and Manufacturer

LABORATORIOS NORMON, S.A.

Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (Spain)

Date of latest revision of this package leaflet: October 2024

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.