CEFTAZIDIME LDP TORLAN 2 g POWDER FOR SOLUTION FOR INFUSION

2. What you need to know before you use Ceftazidime LDP Torlan 2 g powder for solution for infusion EFG

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

• If you are allergic(hypersensitive) to ceftazidimeor to other cephalosporins, or to any of the other components of CEFTAZIDIME LDP TORLAN 2.000 mg powder for solution for infusion EFG (listed in section 6).
• if you have ever had a severe allergic reactionto any other 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 CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG.

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

While you are being administered 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 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 ceftazidime.

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 in relation to 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 CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG with other medicines

Tell your doctor or pharmacist if you are using or have recently used or may need to use any other medicines.

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

• a type of antibiotic called chloramphenicol
• a type of antibiotics called aminoglycosides, for example: gentamicin, tobramycin.
• a "water pill" (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:

• Tell the person taking the sample that you have been given ceftazidime

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

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.

CEFTAZIDIME 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.

3. How to use Ceftazidime LDP Torlan 2 g powder for solution for infusion EFG

Follow exactly the administration instructions of Ceftazidime indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Ceftazidime 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 stop it before or prolong it.

A dose reduction may be necessary if you have kidney problems. 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 ceftazidime 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 ceftazidime 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 and 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 4 g to 6 g once a day.

Patient over 65 years

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

Patient with kidney problems

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

If you use more CEFTAZIDIME 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 Toxicology Information Service, telephone: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG:

If you miss a dose, you should receive 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 doses at the same time) to make up for missed doses.

If you stop treatment with CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG

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

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

4. Possible side effects

Like all medicines, CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG can cause side effects, although not everybody gets them.

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

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

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

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

If you experience any of the following side effects, tell your doctor immediately. Do not use more medicine unless your doctor tells you to. The doctor may decide to stop treatment.

The following side effects have been reported according to the frequencies detailed below:

Frequent:may affect up to 1 in 10 patients

Uncommon:may affect up to 1 in 100 patients

Frequency not known:cannot be estimated from the available data

Symptoms to be aware of

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

• Severe allergic reaction. Signs include itchy, swollen rash, swelling, sometimes on the face or mouth, causing difficulty breathing.
• Skin rash, which can form blisters, and appears as small targets (central dark spot surrounded by a lighter area, with a dark ring around the edge).
• Widespread rashwith blisters and skin peeling. (These can 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 who receive a very high dose, especially in patients with kidney disease.

Frequent side effects

• diarrhea
• swelling and redness around a vein
• red, itchy skin rash

Frequent side 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 clot (platelets)
• an increase in liver enzymes.

Uncommon side effects

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

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 clot)
• an increase in the level of urea, nitrogen ureic, or creatinine in the blood.

Frequency not known

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

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

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

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

5. Storage of Ceftazidime LDP Torlan 2g powder for solution for infusion

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

No special storage conditions are required.

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

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

Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month that is indicated.

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

6. Contents of the pack and other information

Composition of CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion:

• The active substance is ceftazidime.

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

The other components (excipients) are: sodium carbonate.

Appearance of the product and pack contents:

CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG is presented as a powder for solution for infusion. Each pack contains 1, 10, or 50 vials of ceftazidime.

Marketing authorization holder and 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

Date of the last review of this prospectus: 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 sizes of ceftazidime LDP TORLAN vials are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and positive pressure develops. The small carbon dioxide bubbles in the reconstituted solution should be ignored.

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

• Note: Addition should be performed in 2 stages.

The solutions vary in color from pale yellow to amber, depending on the concentration, diluent, and storage conditions. Within the established recommendations, the potency of the product 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
• Composite sodium lactate injectable solution (Hartmann solution)
• 5% glucose injectable solution
• 0.225% sodium chloride and 5% glucose injectable solution
• 0.45% sodium chloride and 5% glucose injectable solution
• 0.9% sodium chloride and 5% glucose injectable solution
• 0.18% sodium chloride and 4% glucose injectable solution
• 10% glucose injectable solution
• 10% dextran 40 in 0.9% sodium chloride injectable solution
• 10% dextran 40 in 5% glucose injectable solution
• 6% dextran 70 in 0.9% sodium chloride injectable solution
• 6% dextran 70 in 5% glucose injectable solution.

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with intraperitoneal 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 vial stopper and inject 10 ml of diluent. The vacuum may aid the entry of the diluent. Remove the syringe needle.
2. Shake until dissolved. Carbon dioxide is released and a clear solution is obtained in almost 1-2 minutes.
3. Insert the gas relief needle through the vial stopper to relieve internal pressure, and with the needle in place, add diluent to complete the total volume. Remove the gas relief needle and the syringe needle, shake the vial, and place it for normal infusion.

From a microbiological point of view, the product should be

used immediately. If it is 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.

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

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/