Label: Information for the User

CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG

Ceftazidima

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

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

Ceftazidima belongs to a group of antibiotics known as cephalosporins.

Ceftazidima is an antibiotic used in adults and children (including newborns). It works by eliminating the bacteria that cause infections.

Ceftazidima is used to treat severe 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.

Ceftazidima 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.

Do not use CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG

• If you are allergic(hypersensitive) toceftazidimeor to other cephalosporins, or to any of the other components of CEFTAZIDIMA LDP TORLAN 2.000 mg powder for solution for infusion EFG (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 ceftazidime.

Warnings and precautions

Consult your doctor or pharmacist before starting to use CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG.

• If you are on a prolonged treatment with ceftazidime, as other infections may appear.
• If you have any kidney disease or are on prolonged treatment with ceftazidime or other medications that may affect kidney function, your doctor may need to adjust the dose of ceftazidime you should receive.
• If you are allergic to other antibiotics.

While you are receiving ceftazidime, 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 ceftazidime.

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

Use of CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG with other medicines

Inform your doctor or pharmacist if you are using or have used recently or may have to use any other medicine.

Ceftazidime should not be administered without consulting your doctor if you are also taking:

• an antibiotic calledchloramphenicol
• a type of antibiotic called aminoglycosides, for example: gentamicin, tobramycin.
• a “urine tablet” (a diuretic called furosemide)

Interference with diagnostic tests

Ceftazidime may affect the results of glucose tests in urine 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

Pregnancy, breastfeeding, and fertility

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

Driving and operating machinery

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

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

CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG contains sodium.

Patients on low-sodium diets should note that this medicine contains 104 mg (5 mmol) of sodium per dose.

Follow exactly the administration instructions for Ceftazidima indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Ceftazidima will be administered intravenously.

This medication will always be administered by qualified personnel. You will never self-administer this medication.

Your doctor will indicate the appropriate dose and determine the duration of your treatment; do not suspend it before or prolong it.

You may need a dose reduction if you have any kidney impairment. In this case, inform your doctor so that they can adjust the dose accordingly.

The recommended dose is:

Use in children

Newborn babies (0-2 months)

Intermittent infusion: 25 to 60 mg of ceftazidima per kilogram of body weight per day, divided into two doses.

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

Intermittent infusion: 100 to 150 mg of ceftazidima per kilogram of body weight per day, divided into three doses. Maximum 6 g per day.

Continuous infusion: initial dose of 60-100 mg per kilogram of body weight followed by continuous infusion of 100-200 mg per kilogram of body weight per day, with a maximum of 6 g per day.

Adults and adolescents weighing 40 kg or more:

Intermittent infusion: 1 or 2 g two or three times a day. For the treatment of lung infections in patients with cystic fibrosis, the usual daily dose is 100 mg to 150 mg per kilogram of body weight, up to a maximum of 9 g per day. The total daily dose should be divided into three doses throughout the day.

Continuous infusion: loading dose of 2 g followed by a continuous infusion of 4g to 6g once a 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 given a different dose than usual. Your doctor will decide how much ceftazidima you need, depending on the severity of your kidney disease. Your doctor will closely monitor you and perform more frequent kidney tests.

If you use more CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG:

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

If you interrupt treatment with CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG

Do not stop receiving ceftazidima unless your doctor tells you to.

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

Like all medications, CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG may cause adverse effects, although not everyone will experience them.

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

• Reddish patches of skin in the shape of a bull's-eye or circles on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, elevated body temperature, and enlarged lymph nodes (Rash-like FESS syndrome or drug hypersensitivity syndrome).

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

If you experience any of the adverse effects described below, inform your doctor immediately. Do not use more medication unless your doctor instructs you to do so. The doctor may decide to stop treatment.

The following adverse effects have been reported with the frequencies detailed below:

Frequent:may affect up to 1 in 10 patients

Rare:may affect up to 1 in 100 patients

Unknown frequency:cannot be estimated from available data

Be aware of the following symptoms

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

• Severe allergic reaction. Signs include hives, swelling, sometimes on the face or in the mouth that causes difficulty breathing.
• Skin rash, which may form blisters, and appears as small bull's-eyes (central dark spot surrounded by a lighter area, with a dark ring around the edge).
• Generalized rashwith blisters and skin peeling. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Neurological disorders: tremors, seizures, and, in some cases, coma. These have occurred in patients receiving a very high dose, especially in patients with kidney disease.

Frequent adverse effects

• diarrhea
• swelling and redness around a vein
• red and swollen skin rash, which may cause itching

Frequent adverse effects that may appear in blood tests:

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

Rare adverse effects

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

Rare adverse 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.

Unknown frequency

• inflammation or failure of the kidneys
• tingling
• bad taste in the mouth
• yellowing of the skin or the whites of the eyes.

Other adverse effects with unknown frequency that may appear in blood tests:

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

If you experience adverse effects, consult your doctor or pharmacist.

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

No special conditions for conservation are required.

Store the vial in the outer packaging to protect it from light.

The period of validity, once the solution has been reconstituted, is 8 hours at 25°C, or 24 hours in a refrigerator (2°C - 8°C).

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.

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

Ceftazidime LDP Torlan 2 g powder for solution for infusion composition:

• The active ingredient is ceftazidime.

Each vial contains 2 g of ceftazidime (as ceftazidime pentahydrate).

The other components (excipients) are: sodium carbonate.

Product appearance and packaging contents:

Ceftazidime LDP Torlan 2 gpowder for solution for infusionEFG is presented in the form of powder for solution for infusion. Each package contains 1, 10 or 50 vials of ceftazidime.

Marketing authorization holder and responsible manufacturer:

LDP-Laboratorios TORLAN S.A

Ctra de Barcelona, 135 B

08290 Cerdanyola del Vallès,Barcelona

Spain

Local Representative

LAPHYSAN, SAU

C/ Anabel Segura nº11. Edificio A. Planta 4. Puerta D

28108 Alcobendas, Madrid

Spain

Last review date of this leaflet: OCTOBER 2024

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Warning: To be used exclusively by a healthcare professional

This information is intended solely for doctors or healthcare professionals:

How to prepare this medication

All vial sizes of ceftazidime LDP Torlan are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and positive pressure develops. Small bubbles of carbon dioxide in the reconstituted solution should be ignored.

See the table for volumes of addition and concentrations of solution that may be useful when fractional doses are needed.

* Note: The addition should be made in 2 stages.

Solutions vary in color from pale yellow to amber, depending on the concentration, diluent, and storage conditions. Within the established recommendations, the product's potency is not affected by these color variations.

Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:

•Sodium chloride 9 mg/ml (0.9%) injectable solution

•Sodium lactate M/6 injectable solution

•Sodium lactate compound injectable solution (Hartmann's solution)

•Glucose 5% injectable solution

•Sodium chloride 0.225% and glucose 5% injectable solution

•Sodium chloride 0.45% and glucose 5% injectable solution

•Sodium chloride 0.9% and glucose 5% injectable solution

•Sodium chloride 0.18% and glucose 4% injectable solution

•Glucose 10% injectable solution

•Dextran 40 10% injectable solution in sodium chloride 0.9% injectable solution

•Dextran 40 10% injectable solution in glucose 5% injectable solution

•Dextran 70 6% injectable solution in sodium chloride 0.9% injectable solution

•Dextran 70 6% injectable solution in glucose 5% injectable solution.

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with peritoneal dialysis fluid (lactate).

Preparation of solutions

Vials of 2g for administration by infusion (e.g., up to 30 minutes)::

1. Insert the needle of the syringe through the stopper of the vial and inject 10 ml of diluent. The vacuum may help the diluent enter. Remove the needle from the syringe.

2. Shake until dissolved. Carbon dioxide is released and a clear solution is obtained in almost 1-2 minutes.

3. Insert the gas release needle through the stopper of the vial to relieve the internal pressure, and with the needle in place, add diluent to the desired volume. Remove the gas release needle and the syringe needle, shake the vial, and place for infusion as normal.

From a microbiological point of view, the product should be

used immediately. If not used immediately, the storage times

and usage conditions are the responsibility of the user, unless

the reconstitution, dilution, etc. have taken place in

controlled and validated aseptic conditions.

Nota: To preserve the sterility of the product, it is essential that the gas release needle is not inserted before the product has dissolved.

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

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