Ceftazidime LDP Torlan 2 g powder for solution for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CEFTAZIDIME LDP TORLAN 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, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only and must not be given to other people, 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.

Leaflet contents:

1. What CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG is and what it is used for
2. What you need to know before using CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG
3. How to use CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG
4. Possible side effects
5. How to store CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG
6. Contents of the pack and other information

1. What Ceftazidime LDP Torlan 2 g powder for solution for infusion EFG is and what it is used for

Ceftazidime belongs to a group of antibiotics known as cephalosporins.

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

Ceftazidime 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 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 using Ceftazidima LDP Torlan 2 g powder for solution for infusion EFG

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

• If you are allergic (hypersensitive) to ceftazidime or 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 a severe allergic reaction to any other antibiotic (penicillins, monobactams, and carbapenems), as you may also be allergic to ceftazidime.

Warnings and precautions

Talk to your doctor or pharmacist before starting treatment with CEFTAZIDIMA LDP TORLAN 2 g powder for solution for infusion EFG.

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

While receiving ceftazidime, 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 potential problems. See (‘Symptoms to watch for’) in section 4. If you have ever had an allergic reaction to other antibiotics, you may also be allergic to ceftazidime.

Serious skin reactions have been reported, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), associated with ceftazidime treatment. Seek immediate medical attention if you notice any symptoms related to these serious 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 taking, have recently taken, or might need to take any other medicines.

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

• an antibiotic called chloramphenicol
• a class of antibiotics known as aminoglycosides, for example: gentamicin, tobramycin
• a "water pill" (a diuretic called furosemide)

Interference with diagnostic 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 collecting the sample that you have been given ceftazidime

Pregnancy, breast-feeding 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.

Driving and using machines

Ceftazidime 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.

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

Patients on a low-sodium diet should be aware 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 for Ceftazidime as given by your doctor. If in doubt, consult your doctor or pharmacist again. Ceftazidime will be administered to you intravenously.

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

Your doctor will determine the appropriate dose and duration of your treatment; do not stop or extend it without medical advice.

A dose reduction may be necessary if you have any kidney impairment. In such case, inform your doctor so that your dose can be properly adjusted.

The recommended dose is:

Use in children

Newborn infants (0–2 months)

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

Infants (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, followed by continuous infusion of 100–200 mg per kilogram per day, up to 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 treatment of lung infections in patients with cystic fibrosis, the usual daily dose is 100 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 administered throughout the day.

Continuous infusion: loading dose of 2 g, followed by continuous infusion of 4 g to 6 g once daily.

Patients over 65 years of age

The daily dose should normally 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 use more CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG than you should:

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating 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 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 once) to make up for a forgotten dose.

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

Do not stop receiving ceftazidime 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, CEFTAZIDIME LDP TORLAN 2 g powder for solution for infusion EFG may produce adverse effects, although not everyone experiences 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, skin peeling, and 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, high body temperature, and enlarged lymph nodes (DRESS syndrome or drug hypersensitivity syndrome).

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

If you experience any of the adverse effects listed below, inform your doctor immediately. Do not use any more of the medicine unless your doctor tells you to. Your doctor may decide to stop treatment.

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

Common: may affect up to 1 in 10 people

Uncommon: may affect up to 1 in 100 people

Frequency not known: cannot be estimated from available data

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 raised, itchy rash, swelling, sometimes in the face or mouth, causing difficulty breathing.
• Skin rash, which may blister and appear as small targets (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, particularly in those with kidney disease.

Common adverse effects

• Diarrhea
• Swelling and redness around a vein
• Red, raised skin rash, which may be itchy

Common adverse effects that may appear in blood tests:

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

Uncommon adverse effects

• 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

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 urea, blood urea nitrogen, or serum creatinine levels

Frequency not known

• Inflammation or failure of the kidneys
• Tingling sensations
• Bad taste in the mouth
• Yellowing of the skin or whites of the eyes

Other adverse effects with frequency not known that may appear in blood tests:

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

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

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

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

No special storage conditions are required.

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

The shelf life of the solution after reconstitution 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Dispose of unused medicines and their containers at the SIGRE collection point at your pharmacy. If you are unsure, please ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of CEFTAZIDIMA 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 contents of the container:

CEFTAZIDIMA 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 Manufacturing Responsible

LDP-Laboratorios TORLAN S.A.

Ctra de Barcelona, 135 B

08290 Cerdanyola del Vallès, Barcelona

Spain

Local Representative

LAPHYSAN, SAU

C/ Anabel Segura nº11. Building A. 4th Floor. Door D

28108 Alcobendas, Madrid

Spain

Date of latest review of this leaflet: OCTOBER 2024

Warning: For use by healthcare professionals only

This information is intended solely for physicians or healthcare professionals:

How to prepare this medicine

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 carbon dioxide bubbles in the reconstituted solution should be disregarded.

Refer to the table for addition volumes and solution concentrations that may be useful when fractional doses are required.

• Note: Addition must be carried out in 2 steps.

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

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

• Sodium chloride 9 mg/ml (0.9%) injection solution
• Sodium lactate M/6 injection solution
• Compound sodium lactate injection solution (Hartmann's solution)
• 5% glucose injection solution
• 0.225% sodium chloride and 5% glucose injection solution
• 0.45% sodium chloride and 5% glucose injection solution
• 0.9% sodium chloride and 5% glucose injection solution
• 0.18% sodium chloride and 4% glucose injection solution
• 10% glucose injection solution
• 10% dextran 40 in 0.9% sodium chloride injection solution
• 10% dextran 40 in 5% glucose injection solution
• 6% dextran 70 in 0.9% sodium chloride injection solution
• 6% dextran 70 in 5% glucose injection solution

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

Preparation of solutions

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

1. Insert the syringe needle through the vial stopper and inject 10 ml of diluent. The vacuum may assist the entry of the diluent. Remove the syringe needle.
2. Shake until dissolved. Carbon dioxide is released, yielding a clear solution in approximately 1–2 minutes.
3. Insert the venting needle through the vial stopper to relieve internal pressure, and while keeping the needle in place, add diluent to achieve the total volume. Remove the venting needle and syringe needle, shake the vial, and proceed with normal infusion setup.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions of use are the responsibility of the user, unless reconstitution, dilution, etc., have been performed under controlled, validated aseptic conditions.

Note: To maintain product sterility, it is important that the venting needle is not inserted before the product is fully dissolved.

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