Ceftazidime Sala 1,000 mg powder for injection solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ceftazidime Sala 1.000 mg powder for injectable solution EFG

Read all of this 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.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

1. What Ceftazidime is and what it is used for

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

Ceftazidime Sala is used to treat serious bacterial infections of the:

• 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 Sala may also be used:

• to prevent infections during prostate surgery in men
• to treat patients with low white blood cell count (neutropenia) and fever due to bacterial infection

2. What you need to know before you are given Ceftazidime Sandoz

Do not use Ceftazidime Sandoz

• if you are allergic to ceftazidime or 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 Ceftazidime Sandoz.

• Tell your doctor before starting treatment with Ceftazidime Sandoz if you think this applies to you. Ceftazidime Sandoz should not be administered to you.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Ceftazidime Sandoz.

While receiving Ceftazidime Sandoz, you should be alert for certain symptoms, such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhoea. This will reduce the risk of possible 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 Ceftazidime Sandoz.

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 symptoms related to these severe skin reactions described in section 4.

If you need blood or urine tests
Ceftazidime 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 Sandoz.

Other medicines and Ceftazidime Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.

You should not be given Ceftazidime Sandoz without first talking 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).

• Tell your doctor if this applies to you.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Your doctor will assess the benefit of treating you with Ceftazidime Sandoz against the potential risk to the baby.

Driving and using machines

Ceftazidime may cause side 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 Sandoz contains sodium

Patients on low-sodium diets should be aware that this medicine contains 55 mg (2.3 mmol) of sodium per vial.

3. How to administer Ceftazidime Sala

Ceftazidime is normally administered by a doctor or nurse. It may be given as an intravenous infusion (drip) or as a direct injection into a vein or muscle.

Ceftazidime Sala is reconstituted by a doctor, pharmacist, or nurse using water for injections or an appropriate infusion fluid.

Usual dose

Your doctor will determine the correct dose of Ceftazidime Sala based 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)

25 to 60 mg of ceftazidime per kg of body weight per day, divided into two doses.

Infants (over 2 months) 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 dose: 6 g per day.

Adults and adolescents weighing 40 kg or more

1 g to 2 g of ceftazidime three times daily. Maximum dose: 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. Your doctor will decide how much ceftazidime you need, depending on the severity of your kidney disease. Your doctor will monitor you closely and perform kidney function tests more frequently.

If you are given more Ceftazidime Sala than you should

If you accidentally receive more than the prescribed dose, contact your doctor or the nearest hospital immediately. You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the name of the medicine and the amount administered.

If you forget to use Ceftazidime Sala

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.

If you stop treatment with Ceftazidime Sala

Do not stop receiving Ceftazidime Sala unless instructed by your doctor.

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

4. Possible adverse effects

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

Symptoms to watch for

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

• Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes in the face or mouth, causing difficulty breathing.

• Skin rash that may form blisters, appearing as small target-like spots (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 a very high dose, 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).

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

• Red, target-shaped or circular patches on the trunk, often with blisters in the center, skin peeling, mouth ulcers, or sores in the throat, nose, genitals, or 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 enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

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

Frequent adverse effects

May affect up to 1 in 10 patients:

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

Uncommon adverse effects

May affect up to 1 in 100 patients:

• Inflammation of the intestine that may cause pain or diarrhea, which may contain blood

• 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.

Other adverse effects

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

• Tingling sensations
• 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 cells
• Severe decrease in the number of white blood cells.

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through 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 Sala

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

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

Do not store above 25°C. Keep in the original container to protect from light.

The shelf life after reconstitution is 8 hours at 25°C or 24 hours in the refrigerator (2-8°C).

Medicines should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused containers and medicines. This will help protect the environment.

6. Contents of the pack and other information

Composition of Ceftazidima Sala

• The active substance is Ceftazidime.

Each vial contains 1000 mg of ceftazidime (as pentahydrate).

• The other components are: anhydrous sodium carbonate (sodium).

Appearance of the medicinal product and contents of the pack

Ceftazidima Sala 1000 mg powder for injectable solution (hospital-use medicine) is presented as a powder for injectable solution. Each pack contains 1 vial of ceftazidime powder. Pack presentation: 50 vials (clinical pack).

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

LABORATORIO REIG JOFRE, S.A
Gran Capitan 10. 08970 Sant Joan Despi
Barcelona (Spain)

Manufacturer

LABORATORIO REIG JOFRE, S.A
Jarama 111
Toledo -45007- Spain

Date of the most recent revision of this leaflet: October 2024

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