CEFTAZIDIME LDP TORLAN 1.000 mg powder and solvent for injectable solution

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, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the pack

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 you use 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. Storage of 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 solution for injection 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 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.

Ceftazidime can also be used:

• to prevent infections during prostate surgery in men
• to treat patients with a low white blood cell count (neutropenia) and fever due to a bacterial infection.

2. What you need to know before you use CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG

Do not use CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG

• If you are allergic(hypersensitive) to ceftazidimeor to other cephalosporins, or to any of the other components of CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection (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.

Tell your doctor beforestarting treatment with ceftazidime if you think this applies to you. You should not be given ceftazidime.

Warnings and precautions

Consult your doctor or pharmacist before startingto use CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG

• If you are undergoing prolonged treatment with ceftazidime, 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, 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.

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 1,000 mg powder and solvent for solution for injection EFG with other medications

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

Do not use ceftazidime 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 urine glucose tests 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 medication.

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 that it does not affect you.

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

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

3. How to use CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG

Follow your doctor's instructions for administering ceftazidime exactly. If you are unsure, consult your doctor or pharmacist again. Ceftazidime will be administered to you by intravenous direct or intramuscular injection.

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 prematurely or prolong it.

A dose reduction may be necessary if you have kidney problems. In such cases, inform your doctor so that they can adjust the dose accordingly.

The normal dose is:

Use in children

Newborn babies (0-2 months)

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

Babies (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 ceftazidime will be administered per day, divided into three doses. Maximum 6 g per day.

Adults and adolescents weighing 40 kg or more

1,000 mg to 2,000 mg of ceftazidime three times a day. Maximum 9,000 mg per day.

Patients over 65 years of age

The daily dose should not normally 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. 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 1,000 mg powder and solvent for solution for injection EFG than you should

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

If you forget to use CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG

If you miss an injection, you should 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 the same time) to make up for missed doses.

If you stop treatment with CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection EFG

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

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

4. Possible side effects

Like all medicines, CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection 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 trunk, 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 enlarged lymph nodes (DRESS or drug hypersensitivity syndrome).

• Widespread and reddened rash with peeling, bumps under the skin, and blisters accompanied by fever. The 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 medication unless your doctor tells you to.

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. The signs include itchy and swollen rash, swelling, sometimes on the face or mouth, causing difficulty breathing.
• Skin rash, which can form blisters, and appears as small targets (a dark central spot surrounded by a paler area, with a dark ring around the edge).
• Generalized 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 given very high doses, especially in patients with kidney disease.

Frequent side effects

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

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 urea, ureic nitrogen, or serum creatinine levels in blood.

Frequency not known

• kidney inflammation or 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 1,000 mg powder and solvent for solution for injection EFG

Keep this medication out of sight and reach of children.

No special temperature storage conditions are required.

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

The validity period, 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 medication after the expiration date stated on the packaging after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and unused medication in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medication you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection:

• The active ingredient 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:

CEFTAZIDIME LDP Torlan 1,000 mg powder and solvent for solution for injection is presented as a powder and solvent for solution for injection. Each pack contains 1 vial of ceftazidime powder and an 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 last revision of this leaflet:October 2024

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Warning: For use by healthcare professionals only

This information is intended only 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 can be ignored.

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

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 can be reconstituted for intramuscular use with 0.5% or 1% lidocaine hydrochloride injection 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 help the entry of the diluent. Remove the needle with the syringe.

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

1. Invert the vial. With the syringe plunger fully compressed, insert the needle through the vial stopper and withdraw the total volume of the solution (the pressure created in the vial helps to withdraw the volume). Make sure the needle remains in the solution, not in the air chamber. The withdrawn solution may contain small carbon dioxide bubbles that can be ignored.

These solutions can 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 common parenteral fluids.

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/