CEFTAZIDIME LDP TORLAN 1 g POWDER FOR INJECTION AND INFUSION SOLUTION

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

Do not use Ceftazidime:

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

• if you have had a severe allergic reaction to another antibiotic (penicillins, monobactams, and carbapenems), as you may also be allergic to ceftazidime.

If you think you are in one of these situations, tell your doctorbefore you are given Ceftazidime LDP TORLAN. If so, you should not receive this medicine.

Warnings and precautions

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

While you are receiving this medicine, you should be aware of certain symptoms, such as allergic reactions, nervous system disorders, and gastrointestinal disorders, such as diarrhea. This will reduce the risk of potential problems. See the section Diseases that require special attentionin section 4. If you have 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.

If you need a blood or urine test

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

→Inform the person taking the samplethat you have been given Ceftazidime.

Using Ceftazidime LDP TORLAN with other medicines

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including those that can be bought without a prescription. Ceftazidime should not be administered without consulting your doctor first if you are also taking:

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

→If you are in one of these situations, tell your doctor.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking 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 side effects that affect your ability to drive or use machines, such as dizziness. Do not drive or use machines unless you are sure that it will 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 administered by intravenous or intramuscular injection or infusion.

Your doctor, nurse, or pharmacist will prepare Ceftazidime with water for injections or a suitable infusion liquid.

The recommended dose is:

The correct dose of ceftazidime will be decided 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 working.

Newborns (0-2 months)

For every 1 kg of body weight,25-60 mg of ceftazidime will be administered per day, divided into two doses.

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

For every 1 kg of body weight,100-150 mg of ceftazidime will be administered per day, 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.

Patient over 65 years of age

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

Patient with kidney problems

You may be given a different dose than usual. Your 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 may perform more frequent tests of kidney function.

If you use more Ceftazidime LDP TORLAN than you should

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

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 medicine and the amount ingested.

If you forget to use Ceftazidime LDP TORLAN

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

If you stop using Ceftazidime LDP TORLAN

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

4. Possible side effects

Like all medicines, this medicine 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 torso, 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 swollen lymph nodes (DRESS or drug hypersensitivity syndrome).

• Widespread and red 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).

Diseases that require special attention

The following serious side effects have been reported in a small number of people (the 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 rashthat can form blistersand appears as small targets(dark central spot, surrounded by a lighter area, with a dark ring around the edge).

? A widespread rashaccompanied by blisters and skin peeling. (These signs may correspond to Stevens-Johnson syndrome or toxic epidermal necrolysis).

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

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

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

Other side effects:

Common:may affect up to 1 in 10 people

• diarrhea
• swelling and redness around a vein
• red and itchy skin rash
• pain, burning, swelling, or inflammation at the injection site

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

The common side effects that may appear in blood tests are:

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

Uncommon:may affect up to 1 in 100 people

• inflammation of the intestine, which can cause pain, or diarrhea, which may contain blood.
• candidiasis (fungal infections in the mouth or vagina).
• headache
• dizziness
• stomach pain
• feeling of discomfort or dizziness
• fever and chills

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

The uncommon side effects that may appear in blood tests are:

• a decrease in the count of white blood cells.
• a decrease in the count of platelets (the cells that help with blood clotting).
• an increase in the concentration of urea, ureic nitrogen, or serum creatinine in the blood.

Rare:may affect up to 1 in 10,000 people

• inflammation or failure of the kidneys

Frequency not known:cannot be estimated from the available data

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

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

• excessive destruction of red blood cells
• an increase in the count of a specific type of white blood cell
• a sudden decrease in the count of white blood cells

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use www.notificaram.es.

By reporting side 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 which is stated on the vial and carton after EXP. The expiry date is the last day of the month shown.

? No special storage conditions are required.

? Store the vials in the 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 point of view, the product should be used immediately, unless the opening, reconstitution, and dilution method precludes the risk of microbiological contamination. If not used immediately, the in-use storage times and conditions are the responsibility of the user.

? Medicines should not be disposed of via wastewater or household waste. Place the packaging and any unused medicine in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Container Contents and Additional Information

Composition of ceftazidime LDP TORLAN

? The active ingredient is 1 g of ceftazidime (in the form of ceftazidime pentahydrate)

? The other components are: sodium carbonate.

Refer to section 2 for important information about sodium, one of the components of Ceftazidime LDP TORLAN.

Appearance of the Product and Container Contents

Ceftazidime LDP TORLAN 1 g powder for solution for injection and infusion is presented in the form of powder for solution for injection and infusion. Each container contains 1, 10 or 100 vials.

Your doctor, pharmacist or nurse will prepare the injection or infusion with water for injectable preparations or a suitable infusion liquid. Ceftazidime LDP TORLAN varies in color when reconstituted, from yellow to 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 Last Revision of this Prospectus: October 2024

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

This information is intended only for healthcare professionals:

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

Please consult the detailed information of the Technical Sheet or summary of the product characteristics.

After reconstitution:

The physical and chemical stability during use is 24 hours at a temperature between 2 ºC and 8 ºC and 8 hours at 25 ºC in water for injectable preparations or compatible liquids listed below.

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

If not used immediately, the time and conditions of storage during use are the responsibility of the user and should 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 ºC and 8 ºC and 8 hours at 25 ºC in the compatible liquids listed below.

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

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 should be ignored.

See tables 1 and 2 for the volumes of addition and solution concentrations that may be useful when fractionated doses are needed.

Table 1. Powder for solution for injection

Note:

The resulting volume of the ceftazidime solution in the reconstituted medium increases as a consequence of the drug's displacement factor in the concentrations listed in mg/ml presented in the table above

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

Table 2. Powder for solution for infusion

*The addition should be performed in two stages

Note:

The resulting volume of the ceftazidime solution in the reconstituted medium increases as a consequence of the drug's displacement factor in the concentrations listed in mg/ml presented in the table above.

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

• Sodium chloride 9 mg/ml (0.9%) injectable solution

? Sodium lactate M/6 injectable solution

? Sodium lactate composite injectable solution (Hartmann solution)

? 5% glucose injectable solution

? 0.225% sodium chloride and 5% glucose injectable solution

? 0.45% sodium chloride and 5% glucose injectable solution

? 0.9% sodium chloride and 5% glucose injectable solution

? 0.18% sodium chloride and 4% glucose injectable solution

? 10% glucose injectable solution

? 10% dextran 40 in 0.9% sodium chloride injectable solution

? 10% dextran 40 in 5% glucose injectable solution

? 6% dextran 70 in 0.9% sodium chloride injectable solution

? 6% dextran 70 in 5% glucose injectable solution.

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