Label: Information for the Patient

Ceftazidima 1.000 mg Powder for Injection EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse even if they are not listed in this label. See section 4.

Ceftazidima is an antibiotic used in adults and children (including newborns). It acts by eliminating the bacteria that cause infections. It belongs to the group of medications known as cephalosporins.

Ceftazidima Salm is used to treat severe bacterial infections in :

• 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.

Ceftazidima Salm 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 a bacterial infection

No use Ceftazidima Sala

• if you are allergictoceftazidimaor to other cephalosporins or any of the other ingredients of this medicine (listed in section 6).
• if you have ever had asevere allergic reactionto anyother antibiotic(penicillins, monobactams, and carbapenems) as you may also be allergic to Ceftazidima Sala

• Inform your doctor beforestarting treatment with Ceftazidima Sala if you think this affects you. Do not be given Ceftazidima Sala.

Warnings and precautions

Consult your doctor, pharmacist, or nurse beforestarting to use Ceftazidima Sala.

While you are being given Ceftazidima Sala, you should be aware of certain symptoms, such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhea. 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 Ceftazidima Sala.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced eosinophilia with systemic symptoms (DRESS), and acute generalized pustular psoriasis (AGPP) have been reported in association with ceftazidima treatment. Seek medical attention immediately if you notice any of the symptoms related to these severe skin reactions described in section 4.

If you need blood or urine testsCeftazidima may affect the results of blood glucose tests and a blood test known asCoomb's test. If you are having tests:

• Inform the person taking thesamplethat you have been given Ceftazidima Sala.

Other medicines and Ceftazidima Sala

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine, including those obtained without a prescription.

Do not be given Ceftazidima Sala without talking to your doctor if you are also taking:

• a type of antibiotic calledchloramphenicol
• a type of antibiotic calledaminoglycosides, for example :gentamicin, tobramycin
• a “urine tablet” (a diuretic calledfurosemide).

• Inform your doctorif this affects you

Pregnancy, breastfeeding, and fertility

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

Your doctor will assess the benefit of treating you with Ceftazidima Sala against the risk to the baby.

Driving and operating machines

Ceftazidima may cause side effects, such as dizziness, that affect your ability to drive.

Do not drive or operate machines unless you are sure it does not affect you.

Ceftazidima Sala contains sodium

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

Ceftazidima is usually administered by a doctor or nurse. It can be administered as an infusion (intravenous perfusion) or directly as an injection into a vein or muscle.

Ceftazidima Sala is reconstituted by a doctor, pharmacist, or nurse using water for injectable preparations or an appropriate perfusion fluid.

Usual Dose

The correct dose of Ceftazidima Sala for you will be decided by your doctor and depends on: the severity and type of infection, if you are being treated with other antibiotics, your weight and age, and your renal function.

Newborns (0-2 months)

For every 1 kg of the baby's weight, 25 to 60 mg of ceftazidima will be administered per day, divided into two doses.

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

For every 1 kg of the baby's or child's weight, 100 to 150 mg of ceftazidima will be administered per day, divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more

1 g to 2 g of ceftazidima three times a day. Maximum 9 g per day.

Patients over 65 years old

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

Patients with kidney problems

You may be administered a different usual dose. Your doctor will decide how much ceftazidima you need depending on the severity of the renal disease. Your doctor will closely monitor you and more frequent renal tests will be performed.

If you are administered more Ceftazidima Sala than you should

If you accidentally receive more than the prescribed dose, contact your doctor or the nearest hospital. You can also call the Toxicological Information Service at phone 91 562 04 20, indicating the medication and the amount administered.

If you forget to use Ceftazidima Sala

If you miss an injection, receive it as soon as possible. However, if it is almost time for the next injection, skip the missed injection. Do not use a double dose (two injections at once) to compensate for the missed dose.

If you interrupt the treatment with Ceftazidima Sala

Do not stop receiving Ceftazidima Sala unless your doctor tells you to.

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

Symptoms to be aware of

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

• Severe allergic reaction. The signs includeswollen, itchy hives,swelling, sometimes on the face or in the mouth that causesdifficulty breathing.

• Skin rash, which may formblisters, and appears assmall dots(dark central point surrounded by a lighter area, with a dark ring around the edge).

• Generalized rashwithblisters 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, which may be accompanied by fever, fatigue, facial or lymph node swelling, increased eosinophils (a type of white blood cell), liver, kidney, or lung damage (a reaction known as DRESS) have been reported.

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

• Red patches on the skin in the shape of a ring or circle on the trunk, often with blisters in the center, skin peeling, mouth ulcers, throat, nose, genital, or eye ulcers. These severe skin reactions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Generalized rash, high body temperature, and swollen lymph nodes (RFESS syndrome or drug hypersensitivity syndrome).

• Generalized rash and redness with peeling, skin nodules, and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized pustular psoriasis).

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

Common side effects

May affect up to1 in 10patients:

• diarrhea
• swelling and redness around a vein
• red, swollen skin rash, which may cause itching
• pain, burning, swelling, or inflammation at the injection site.

• Inform your doctorif any of these side effects concern you

Common side effects that may appear in blood tests:

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

Uncommon side effects

May affect up to1 in 100patients:

• inflammation of the intestine that may cause abdominal pain or diarrhea that may have blood
• yeast infections in the mouth or vagina
• headache
• dizziness
• stomach pain
• nausea or vomiting
• fever and chills.

• Inform your doctorif you experience any of them

Uncommon side effects that may appear in blood tests:

• a decrease in the number of white blood cells
• a decrease in the number of platelets (cells that help blood to clot)
• an increase in urea, ureic nitrogen, or serum creatinine levels in the blood.

Other side effects

Other side effects that have occurred in a small number of patients but whose

exact frequency is unknown:

• tingling
• bad taste in the mouth
• skin or eye whites turn yellow.

Other side effects that may appear in blood tests:

• rapid destruction of red blood cells
• increase in a certain type of white blood cell
• significant decrease in the number of white blood cells.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist or nurse, even if it is a possible side effect that does not appear in this leaflet.You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 25°C. Store in the original packaging to protect it from light.

The shelf life once reconstituted is 8 hours at 25°C or 24 hours in a refrigerator (2-8°C).

Medications should not be disposed of through drains or trash. Deposit the packaging and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused packaging and medications. By doing so, you will help protect the environment.

Composition of Ceftazidima Sala

• The active ingredient is Ceftazidima

Each vial contains 1000 mg of ceftazidima (as pentahydrate)

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

Appearance of the product and contents of the packaging

Ceftazidima Sala 1.000 mg powder for injectable solution (hospital use medication), is presented in the form of powder for injectable solution. Each package contains 1 vial of ceftazidima powder. It is presented in clinical packaging of 50 vials.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorio Reig Jofre, S.A

Gran Capitan 10. 08970 Sant Joan Despi (Barcelona) Spain

Responsible for manufacturing

Laboratorio Reig Jofre, S.A

Jarama 111

Toledo -45007- Spain

LDP Laboratorios Torlan, S.A.

Ctra. de Barcelona, 135-B.

Cerdanyola del Valles (Barcelona)

08290 Spain

Last review date of this leaflet: October 2024

The detailed and updated information of this medication is available on the webpage of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/