Ceftazidime LDP Torlan 1 g powder for solution for injection and for infusion EFG

Package leaflet: Information for the patient

Introduction

Package leaflet: information for the patient

Ceftazidime LDP TORLAN 1 g powder for injectable and infusion solution EFG

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 or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, since it may harm them.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Ceftazidima LDP TORLAN is and what it is used for

Ceftazidime is an antibiotic used in adults and children (including newborns) that works by killing the bacteria causing infections. It belongs to a group of medicines called cephalosporins.

Ceftazidime is used to treat serious bacterial infections of the:

• lungs or chest
• lungs and bronchi in patients with cystic fibrosis
• brain (meningitis)
• ears
• urinary tract
• skin and soft tissues
• abdomen and abdominal wall
• bones and joints

Ceftazidime may also be used:

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

2. What you need to know before using Ceftazidime LDP TORLAN

Do not use Ceftazidime:

• if you are allergic to ceftazidime or to any of the other ingredients of this medicine (listed in section 6).

• if you have previously experienced a serious allergic reaction to another antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to ceftazidime.

If you think you fall into any of these categories, inform your doctor before being administered Ceftazidime LDP TORLAN. If so, you must not receive this medicine.

Warnings and precautions

Talk to your doctor or nurse before you are administered Ceftazidime.

While receiving this medicine, you should remain alert for certain symptoms, such as allergic reactions, disorders of the nervous system, and gastrointestinal disorders such as diarrhoea. This will help reduce the risk of potential problems. See the section Conditions requiring special attention in section 4. If you have previously 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 (DRSS), 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.

If you need blood or urine tests

Ceftazidime may affect the results of urine glucose (sugar) tests and a blood test known as the Coombs test. If you are due to have tests:

→Inform the person taking the sample that you have been administered Ceftazidime.

Use of Ceftazidime LDP TORLAN with other medicines

Inform your doctor if you are taking, have recently taken, or might need to take any other medicines, including medicines you can buy without a prescription. Ceftazidime must not be administered without first consulting your doctor if you are also taking:

• An antibiotic called chloramphenicol.
• A type of antibiotic called an aminoglycoside (e.g., gentamicin or tobramycin).
• Diuretics called furosemide.

→If you are in any of these situations, inform your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicine. Your doctor will assess the benefit of treating you with ceftazidime against the risk to your child.

Driving and using machines

This medicine may cause adverse effects that affect your ability to drive, such as dizziness. Do not drive or operate machinery unless you are certain that this does not affect you.

Ceftazidime LDP TORLAN contains sodium.

3. How to use Ceftazidime LDP TORLAN

Ceftazidime is usually administered by a doctor or nurse.

This medicine can be given by intravenous injection or infusion, or by deep intramuscular injection.

The doctor, nurse, or pharmacist will prepare Ceftazidime with water for injection or an appropriate infusion liquid.

Recommended dose:

The correct dose of ceftazidime to be administered will be determined by your doctor and depends on the severity and type of infection, whether you are taking other antibiotics, your weight and age, and how well your kidneys are functioning.

Neonates (0–2 months)

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

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

For each 1 kg of the infant's or child's body weight, 100–150 mg of ceftazidime per day will be administered, divided into three doses. The maximum dose is 6 g per day.

Adults and adolescents weighing 40 kg or more

1 g to 2 g of ceftazidime three times a day. The maximum dose is 9 g per day.

Patients over 65 years of age

Daily dose should generally 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. The doctor or nurse will decide the amount of Ceftazidime you need, based on the severity of your kidney disease. Your doctor will monitor you closely, and you may have kidney function tests performed more frequently.

If you use more Ceftazidime LDP TORLAN than you should

If you think you have accidentally been given more medicine than your prescribed dose, contact your doctor or the nearest hospital immediately.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at: 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Ceftazidime LDP TORLAN

If you miss an injection of this medicine, it should be given as soon as possible. You must not be given a double dose (two injections at the same time) to make up for a missed dose.

If you stop treatment with Ceftazidime LDP TORLAN

Do not stop receiving Ceftazidime unless your doctor tells you to. If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause 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, peeling skin, 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, elevated 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).

Conditions requiring special attention

The following serious side effects have been reported in a small number of people (their exact frequency is unknown):

? Severe allergic reaction. Signs include raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty breathing.

? Skin rash that may form blisters and appears as small target-like lesions (dark central spot, surrounded by a paler area, with a dark ring around the edge).

? A widespread rash accompanied by blisters and skin peeling. (These signs may indicate Stevens-Johnson syndrome or toxic epidermal necrolysis.)

? Nervous system disorders: tremors, seizures, and in some cases, coma. These adverse effects have occurred in patients who received too high a dose, especially in patients with kidney disease.

? Rare cases of severe hypersensitivity reactions have been reported, accompanied by severe rash, which may be associated with fever, fatigue, swelling of the face or lymph nodes, increased eosinophils (a type of white blood cell), and effects on the liver, kidneys, or lungs (a reaction known as DRESS).

If you experience any of these symptoms, contact your doctor or nurse immediately.

Other adverse effects:

Frequent: may affect up to 1 in 10 people

• diarrhea

• swelling and redness around a vein

• red, raised rash, which may be itchy

• pain, burning, swelling, or inflammation at the injection site

• If you are concerned about any of these symptoms, inform your doctor.

Frequent adverse effects that may appear in blood tests are:

• increased count of a type of white blood cell (eosinophilia)
• increased count of cells involved in blood clotting
• increased liver enzymes

Uncommon: may affect up to 1 in 100 people

• inflammation of the intestine, which may cause pain or diarrhea, possibly containing blood

• candidiasis (fungal infections in the mouth or vagina)

• headache

• dizziness

• stomach pain

• feeling unwell or nauseous

• fever and chills

• If you experience any of these symptoms, inform your doctor.

Uncommon adverse effects that may appear in blood tests are:

• decreased white blood cell count
• decreased platelet count (cells that help in blood clotting)
• increased blood levels of urea, blood urea nitrogen, or serum creatinine

Very rare: may affect up to 1 in 10,000 people

• inflammation or kidney failure

Frequency not known: cannot be estimated from available data

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

Adverse effects of unknown frequency that may appear in blood tests are:

• too rapid destruction of red blood cells
• increased count of a specific type of white blood cell
• acute decrease in white blood cell count

Reporting of adverse effects

If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a side effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es.

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Ceftazidime LDP TORLAN

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

? Do not use this medicine after the expiry date stated on the vial and the outer carton following EXP. The expiry date refers to the last day of the month indicated.

? No special temperature storage conditions are required.

? Store the vials in their outer packaging to protect them from light.

? Reconstituted and diluted solution: your doctor, pharmacist, or nurse will prepare your medicine with water for injections or compatible liquids.

? The physical and chemical stability during use is 24 hours at a temperature between 2 °C and 8 °C, and 8 hours at 25 °C.

? From a microbiological standpoint, the medicine should be used immediately unless the method of opening, reconstitution, and dilution prevents the risk of microbiological contamination. If not used immediately, the duration and conditions of storage during use are the responsibility of the user.

? Medicines must not be disposed of via wastewater or household waste. Dispose of unused medicines and their packaging at a SIGRE collection point in your pharmacy. If you are unsure, ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Package contents and other information

Composition of ceftazidime LDP TORLAN

• The active substance is 1 g of ceftazidime (as ceftazidime pentahydrate)

• The other component is: sodium carbonate.

See section 2 for important information regarding sodium, one of the components of Ceftazidime LDP TORLAN.

Appearance of the product and contents of the pack

Ceftazidime LDP TORLAN 1 g powder for injectable solution and for infusion is presented as a powder for injectable solution and for infusion. Each pack contains 1, 10, or 100 vials.

Your doctor, pharmacist, or nurse will prepare the injection or infusion using water for injection or an appropriate infusion fluid. Ceftazidime LDP TORLAN may vary in color upon reconstitution, appearing yellow or slightly yellowish. This is completely normal.

Marketing Authorization Holder and Manufacturer

LDP LABORATORIOS TORLAN, S.A.

Ctra. Barcelona 135

08290 Cerdanyola del Vallés (Barcelona)

Spain

Local Representative

Laphysan, SAU

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

28108 Alcobendas (Madrid)

Spain

Date of the most recent review of this leaflet: October 2024

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

This information is intended exclusively for healthcare professionals:

Ceftazidime LDP TORLAN 1 g powder for injectable solution and for infusion EFG

Please refer to the detailed information in the Summary of Product Characteristics.

After reconstitution:

The physical and chemical stability during use is 24 hours at a temperature between 2 °C and 8 °C, and 8 hours at 25 °C in water for injection or the compatible diluents listed below.

From a microbiological standpoint, the reconstituted solution should be used immediately, unless the method of opening, reconstitution, and dilution prevents the risk of microbiological contamination.

If not used immediately, the duration and storage conditions during use are the responsibility of the user and must not exceed the periods indicated above for physical and chemical stability during use, whichever is shorter.

After dilution:

The physical and chemical stability during use is 24 hours at a temperature between 2 °C and 8 °C, and 8 hours at 25 °C in the compatible diluents listed below.

From a microbiological standpoint, the reconstituted and diluted solution should be used immediately, unless the method of opening, reconstitution, and dilution prevents the risk of microbiological contamination. If not used immediately, the duration and storage conditions during use are the responsibility of the user.

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 bubbles of carbon dioxide in the reconstituted solution should be disregarded.

See tables 1 and 2 for volumes of diluent and resulting solution concentrations that may be useful when fractional doses are required.

Table 1. Powder for injectable solution

Note:

The resulting volume of the ceftazidime solution in the reconstituted medium increases due to the drug displacement factor, resulting in the concentrations listed in mg/ml shown in the table above.

Ceftazidime can be reconstituted for intramuscular use with injectable lidocaine hydrochloride 1% solution (10 mg/ml).

Table 2. Powder for solution for infusion

*Addition must be carried out in two steps.

Note:

The resulting volume of the ceftazidime solution in the reconstituted medium increases due to the drug displacement factor, resulting in the concentrations listed in mg/mL shown in the table above.

Solutions 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:

• 9 mg/mL (0.9%) sodium chloride injection solution
  ? M/6 sodium lactate 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 intraperitoneal dialysis fluid (lactate).