Label: information for the user

CEFTAZIDIMA LDP Torlan 1.000 mg powder and solvent for injection EFG

Ceftazidima

Read this label carefully before starting to use this medicine because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed only for you and should not be given to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label.

Ceftazidima belongs to a group of antibiotics known as cephalosporins.

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

Ceftazidima 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.

Ceftazidima 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 a bacterial infection.

No use CEFTAZIDIMA LDP Torlan 1.000 mg powder and diluent for injectable solution EFG

• If you are allergic(hypersensitive) toceftazidimeor to other cephalosporins, or to any of the other components of CEFTAZIDIMA LDP Torlan 1.000 mg powder and diluent for injectable solution (listed in section 6).
• If you have ever had asevere allergic reactionto anyother antibiotic(penicillins, monobactams, and carbapenems) as you may also be allergic to ceftazidime.

Inform your doctor beforestarting treatment with ceftazidime if you think this affects you. Do not be given ceftazidime.

Warnings and precautions

Consult your doctor or pharmacist before starting to useCEFTAZIDIMA LDP Torlan 1.000 mg powder and diluent for injectable solution EFG

• If you are on a prolonged treatment with ceftazidime, other infections may appear.
• If you have any kidney disease or are on prolonged treatment with ceftazidime or other drugs 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 you are being given 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 possible 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 generalized acute pustular psoriasis (GPP) have been reported in association with 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 CEFTAZIDIMA LDP Torlan 1.000 mg powder and diluent for injectable solution EFG with other medicines

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

Do not be given ceftazidime without talking to your doctor if you are also taking:

• An antibiotic calledchloramphenicol
• A type of antibiotic called aminoglycosides, for example: gentamicin, tobramycin.
• A “urine tablet” (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:

• Inform 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 intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machines

Ceftazidime may cause side effects, such as dizziness, that affect your ability to drive.

Do not drive or operate machines unless you are sure it does not affect you.

CEFTAZIDIMA LDP Torlan 1.000 mg powder and diluent for injectable solution EFG contains sodium

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

Follow exactly the administration instructions for ceftazidima indicated by your doctor. In case of doubt, consult your doctor or pharmacist again. Ceftazidima will be administered via direct intravenous or intramuscular route.

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 suspend or prolong it.

You may need a dose reduction if you have any kidney impairment. Inform your doctor about it 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 ceftazidima 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 ceftazidima 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 ceftazidima three times a day. Maximum 9,000 mg per day.

Patients over 65 years old

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

Patients with kidney problems

You may be administered a different dose than the usual one. Your doctor will decide how much ceftazidima you need, depending on the severity of the kidney disease. Your doctor will closely monitor you and perform more frequent kidney tests.

If you use more CEFTAZIDIMA LDP Torlan 1,000 mg powder and solvent for injectable solution EFG than you should

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

If you forgot to use CEFTAZIDIMA LDP Torlan 1,000 mg powder and solvent for injectable solution 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 injections at once) to compensate for the missed doses.

If you interrupt the treatment with CEFTAZIDIMA LDP Torlan 1,000 mg powder and solvent for injectable solution EFG

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

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

Like all medications, CEFTAZIDIMA LDP Torlan 1.000 mg powder and solvent for injectable solution may cause adverse effects, although not everyone will experience them.

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

• Reddish patches of skin in the shape of a bull's-eye or circles on the trunk, often with blisters in the center, skin peeling, ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin eruptions may be preceded by fever and flu-like symptoms (Stevens-Johnson syndrome, toxic epidermal necrolysis).

• Widespread rash, elevated body temperature, and enlarged lymph nodes (Rash-like FESS syndrome or drug hypersensitivity syndrome).

• Widespread and reddened rash with peeling, skin protuberances, 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, notify your doctor immediately. Do not use more medication unless your doctor instructs you to do so. Your doctor may decide to stop treatment.

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

Frequent:may affect up to 1 in 10 patients

Rare:may affect up to 1 in 100 patients

Unknown frequency: cannot be estimated from available data

Be aware of the following symptoms:

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

• Severe allergic reaction. Signs include hives, swelling, sometimes on the face or in the mouth that causes difficulty breathing.
• Skin rash, which may form blisters, and appears as small bull's-eyes (dark center surrounded by a lighter area, with a dark ring around the edge).
• Generalized 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 a very high dose, especially in patients with kidney disease.

Frequent adverse effects

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

Frequent adverse 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 to clot (platelets)
• an increase in liver enzymes

Rare adverse effects

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

Rare 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 serum urea, nitrogen ureic, or creatinine levels.

Unknown frequency

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

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

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

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

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

No special temperature conditions are required for conservation.

Store 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 a refrigerator (2°C - 8°C).

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Deposit the packaging and unused medications at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and unused medications. By doing so, you will help protect the environment.

Ceftazidime LDP Torlan 1.000 mg powder and diluent 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 diluent contains 10 ml of water for injection.

Appearance of the product and contents of the package:

Ceftazidime LDP Torlan 1.000 mg powder and diluent for injection is presented in the form of powder and diluent for injection. Each package contains 1 vial of ceftazidime powder and 1 ampoule with 10 ml of water for injection.

Holder of the marketing authorization and responsible for manufacturing:

LDP Laboratorios Torlan, S.A.

Ctra. de Barcelona, 135-B

08290 Cerdanyola del Vallès

(Barcelona) - Spain

Date of the last review of this leaflet: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 vials of CEFTAZIDIME LDP Torlan are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and positive pressure is developed. Small bubbles of carbon dioxide in the reconstituted solution should be ignored.

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

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 lidocaine hydrochloride injection 0.5% or 1%.

Preparation of solutions

Preparation of injection solutions by bolus

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

2. Agitate until dissolved: carbon dioxide is released and a transparent solution will be obtained in 1 or 2 minutes.

3. Invert the vial. With the plunger of the syringe fully compressed, insert the needle through the stopper of the vial and extract the total volume of the solution (the pressure developed in the vial helps to extract the volume). Ensure that the needle remains within the solution, not in the air chamber. The extracted solution may contain small bubbles of carbon dioxide 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 Medical Devices (AEMPS) http://www.aemps.gob.es/