Ceftazidime LDP Torlan 1,000 mg powder and solvent for injectable solution EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG

Ceftazidime

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.
• 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, since it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if these adverse effects are not listed in this leaflet.

Contents of the leaflet

1. What CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG is and what it is used for
2. What you need to know before using CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG
3. How to use CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG
4. Possible side effects
5. How to store CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG
6. Contents of the pack and other information

1. What CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for injectable solution 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
• 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.

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 Ceftazidime LDP Torlan 1000 mg powder and solvent for injectable solution EFG

Do not use CEFTAZIDIME LDP Torlan 1000 mg powder and solvent for injectable solution EFG

• If you are allergic (hypersensitive) to ceftazidime or to other cephalosporins, or to any of the other components of CEFTAZIDIME LDP Torlan 1000 mg powder and solvent for injectable solution (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.

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use CEFTAZIDIME LDP Torlan 1000 mg powder and solvent for injectable solution EFG

• If you are undergoing prolonged treatment with ceftazidime, 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 the dose of ceftazidime you should receive.
• If you are allergic to other antibiotics.

While receiving ceftazidime, you should be alert to 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.

Serious skin reactions have been reported with ceftazidime treatment, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). Seek immediate medical attention if you notice any symptoms related to these serious skin reactions described in section 4.

Use of CEFTAZIDIME LDP Torlan 1000 mg powder and solvent for injectable solution EFG with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

You should not be given ceftazidime without first talking to your doctor if you are also taking:

• An antibiotic called chloramphenicol
• A class 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 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

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.

Driving and use of machines

Ceftazidime may cause adverse effects such as dizziness, which may impair your ability to drive.

Do not drive or operate machinery unless you are certain that you are not affected.

CEFTAZIDIME LDP Torlan 1000 mg powder and solvent for injectable solution EFG contains sodium

Patients on low-sodium diets should be aware that this medicine contains 52 mg (2 mmol) of sodium per dose.

3. How to use Ceftazidima LDP Torlan 1000 mg powder and solvent for injectable solution EFG

Follow exactly the administration instructions for ceftazidima as indicated by your doctor. If in doubt, consult your doctor or pharmacist again. Ceftazidima will be administered to you either by intravenous or intramuscular route.

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 the treatment prematurely.

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 usual dose is:

Use in children

Newborn infants (0–2 months)

25 to 60 mg of ceftazidima 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 ceftazidima per kg of body weight per day, divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more

1000 mg to 2000 mg of ceftazidima three times daily. Maximum 9000 mg per day.

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 ceftazidima you need, depending on the severity of your kidney disease. Your doctor will monitor you closely and perform renal function tests more frequently.

If you use more CEFTAZIDIMA LDP Torlan 1000 mg powder and solvent for injectable solution 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, indicating the medicine and the amount ingested.

If you forget to use CEFTAZIDIMA LDP Torlan 1000 mg powder and solvent for injectable solution EFG

If you miss an injection, it should be given 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 make up for a missed dose.

If you interrupt treatment with CEFTAZIDIMA LDP Torlan 1000 mg powder and solvent for injectable solution EFG

Do not stop receiving ceftazidima 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 1000 mg powder and solvent for injectable solution may produce adverse effects, although not everyone experiences them.

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

• Red, circular skin patches resembling targets or rings on the trunk, often with blisters in the center, skin peeling, or ulcers in the mouth, 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 rash with 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 described below, inform your doctor immediately. Do not use more of the medicine unless instructed by your doctor. 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 patients

Uncommon: may affect up to 1 in 100 patients

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, appearing as small targets (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 very high doses, especially in those with kidney disease.

Common adverse effects

• Diarrhea
• Swelling and redness around a vein
• Red, raised skin rash, which may be itchy
• Pain, burning, swelling, or inflammation at the injection site

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 levels of urea, blood urea nitrogen, or serum creatinine

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
• Marked 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 1,000 mg powder and solvent for injectable solution EFG

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

No special temperature storage conditions are required.

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

The shelf life of the reconstituted solution is 8 hours at 25°C, or 24 hours under refrigeration (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 must not be disposed of via wastewater or household waste. Dispose of containers and unused medicines at the SIGRE point in your pharmacy. If you have any doubts, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of CEFTAZIDIMA LDP Torlan 1,000 mg powder and solvent for injectable solution:

• The active substance is ceftazidime.

Each vial contains 1,000 mg of ceftazidime (as ceftazidime pentahydrate).

The other components (excipients) are: sodium carbonate.

• Each ampoule of solvent contains 10 ml of water for injections.

Appearance of the product and contents of the pack:

CEFTAZIDIMA LDP Torlan 1,000 mg powder and solvent for injectable solution is presented as powder and solvent for injectable solution. Each pack contains one vial of ceftazidime powder and one ampoule with 10 ml of water for injections.

Marketing Authorization Holder and Manufacturer:

LDP Laboratorios Torlan, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

(Barcelona) - Spain

Date of the most recent revision 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 CEFTAZIDIMA 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 disregarded.

See the table for volumes to add and resulting solution concentrations, which may be useful when fractional doses are required.

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 can be reconstituted for intramuscular use with 0.5% or 1% lidocaine hydrochloride injectable solution.

Preparation of solutions

Preparation of solutions for bolus injection

1. Insert the needle of the syringe through the vial stopper and inject the recommended volume of diluent. The vacuum may assist in drawing in the diluent. Remove the syringe with the needle.

2. Shake until dissolved: carbon dioxide is released and a clear solution is obtained within 1 or 2 minutes.

3. Invert the vial. With the syringe plunger fully compressed, insert the needle through the vial stopper and withdraw the total volume of solution (the pressure created in the vial aids in extracting the volume). Ensure that the needle tip remains within the solution, not in the air chamber. The withdrawn solution may contain small carbon dioxide bubbles, which can be disregarded.

These solutions may be administered directly into a vein or introduced into parenteral administration systems if the patient is receiving parenteral fluids. Ceftazidime is compatible with the most commonly used parenteral fluids.

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