Ceftazidime Qilu 2 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

Ceftazidima Qilu 2 g powder for injectable solution and for infusion 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 or nurse.
• 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.

Contents of this leaflet

1. What Ceftazidima Qilu is and what it is used for

2. What you need to know before using Ceftazidima Qilu

3. How to use Ceftazidima Qilu

4. Possible adverse reactions

5. How to store Ceftazidima Qilu

6. Contents of the pack and other information

1. What Ceftazidime Qilu 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.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as influenza or the common cold.

It is important that you follow the instructions regarding dose, dosing interval, and duration of treatment as directed by your doctor.

Do not store or reuse this medicine. If you have any antibiotic left over after completing treatment, return it to the pharmacy for proper disposal. Medicines must not be disposed of via wastewater or household waste.

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 ears
• 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 counts (neutropenia) and fever due to bacterial infection.

2. What you need to know before using Ceftazidime Qilu

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 receiving Ceftazidime Qilu. If so, you must not be given this medicine.

Warnings and precautions

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

While receiving this medicine, you should be alert for certain symptoms, such as allergic reactions, nervous system disorders, and gastrointestinal disorders such as diarrhoea. This will help reduce the risk of potential problems. See the Conditions requiring special attention section in section 4. If you have previously 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 during treatment with ceftazidime. Seek immediate medical attention if you notice any 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 urine glucose (sugar) tests and a blood test known as the Coombs test. If you are due to have tests:

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

Use of Ceftazidime Qilu 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 should not be administered without first consulting your doctor if you are also taking:

• An antibiotic called chloramphenicol.
• A type of antibiotic called 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, 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 potential risk to your baby.

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 it does not affect you.

Ceftazidime Qilu contains sodium.

You should take this into account if you are on a low-sodium diet.

Ceftazidime Qilu (concentration)	Amount per vial
Ceftazidime Qilu 2 g	This medicine contains 104 mg of sodium (main component of table and cooking salt) in each vial, equivalent to 5.2% of the maximum recommended daily dietary sodium intake for an adult.

3. How to use Ceftazidime Qilu

Ceftazidime Qilu is usually administered by a doctor or nurse.

Ceftazidime Qilu 2 g can be given by intravenous injection or infusion.

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

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 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 daily. The maximum dose is 9 g per day.

Patients over 65 years of age

The 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 determine the amount of Ceftazidime Qilu you need based on the severity of your kidney disease. Your doctor will monitor you closely and you may have kidney function tests more frequently.

If you use more Ceftazidime Qilu than you should

If you think you have accidentally been given more medication than prescribed, 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 medication and the amount ingested.

If you forget to use Ceftazidime Qilu

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 Qilu

Do not stop receiving Ceftazidime Qilu unless instructed by your doctor.

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 will experience them.

Diseases 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 which may form blisters and appears as small targets (a dark central spot, surrounded by a paler area, with a dark ring around the edge).

• A widespread rash accompanied by blisters and peeling of the skin, with ulcers in the mouth, throat, nose, genitals, or eyes. These serious skin rashes may be preceded by fever and flu-like symptoms (These signs may correspond to 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, particularly 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, facial swelling or swollen lymph nodes, increased eosinophils (a type of white blood cell), and effects on the liver, kidneys, or lungs (a reaction known as DRESS).

• Widespread red rash with peeling, skin nodules, and blisters accompanied by fever. Symptoms usually appear at the beginning of treatment (acute generalized exanthematous pustulosis).

-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 be observed 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 of the mouth or vagina)

• headache

• dizziness

• stomach pain

• feeling unwell or nausea

• fever and chills

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

Uncommon adverse effects that may appear in blood tests are:

• a decrease in white blood cell count
• a decrease in platelet count (cells that help blood clotting)
• an increase in 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
• altered taste
• yellowing of the whites of the eyes or of the skin

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

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

Reporting of adverse effects

If you experience any adverse reaction, consult your doctor, pharmacist, or nurse, even if it is a reaction not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines at www.notificaram.es.

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

5. Storage of Ceftazidime Qilu

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 carton after EXP. The expiry date refers to the last day of the month indicated.
• Store below 25 °C.
• Keep 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 chemical and physical in-use stability is 24 hours at a temperature between 2 °C and 8 °C, and 2 hours at 25 °C.
• From a microbiological standpoint, the medicine should be used immediately, unless the method of opening, reconstitution, and dilution ensures against the risk of microbiological contamination. If not used immediately, the duration and conditions of in-use storage are the user's responsibility.
• Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to your pharmacy’s SIGRE collection point. If you are unsure, ask your pharmacist how to dispose of medicines and containers you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Ceftazidime Qilu

Ceftazidime Qilu is available in the following presentations: 2 g, 1 g and 500 mg.

• The active substance is 2 g, 1 g or 500 mg 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 Qilu.

Appearance of the product and contents of the container

Ceftazidime Qilu 2 g powder for solution for injection and for infusion is a sterile, crystalline white or almost white powder contained in a 50 ml glass vial, with a butyl rubber stopper and an aluminium seal.

Available in pack sizes of 1, 10 or 50 vials.

Only certain pack sizes may be marketed.

Your doctor, pharmacist or nurse will prepare the injection or infusion using water for injections or an appropriate infusion fluid. Ceftazidime Qilu may vary in colour upon reconstitution, from pale yellow to amber. This is completely normal.

Marketing Authorisation Holder and Manufacturer

QILU PHARMA SPAIN S.L.,

Paseo de la Castellana 40

8th floor, 28046 - Madrid

Spain

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona, Spain

Manufacturing responsible

KYMOS, S.L

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès, 08290,

Barcelona, Spain

MIAS Pharma Limited

Suite 2, Stafford House, Strand Road, Portmarnock, Co. Dublin,

Ireland

Tillomed Malta Ltd.

Malta Life Sciences Park, LS2.01.06 Industrial Estate, San Gwann, SGN 3000,

Malta

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

UK	Ceftazidime 2 g powder for solution for injection/infusion
DE	Ceftazidim Qilu 2 g powder for solution for injection/infusion
ES	Ceftazidima Qilu 2 g powder for injectable solution and for perfusion EFG
FR	CEFTAZIDIME QILU 2 g, powder for injectable solution/perfusion (IV)
IT	Ceftazidima Qilu
SE	Ceftazidim Qilu 2 g powder for injection/infusion liquid, solution

Date of the last review of this package leaflet: 70/2025.

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

---

This information is intended for healthcare professionals only:

Ceftazidime Qilu 2 g powder for injectable solution and for infusion EFG

Ceftazidime

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 2 hours at 25 °C in water for injections or the compatible liquids listed below.

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

If not used immediately, the storage time and conditions during use are the responsibility of the user.

After dilution:

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

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

If not used immediately, the storage time and conditions during use are the responsibility of the user.

Special storage precautions

Store below 25 °C.

Keep vials in the outer packaging to protect from light.

Special precautions for disposal and other handling

As the product dissolves, carbon dioxide is released and positive pressure develops. Small bubbles of carbon dioxide in the reconstituted solution may be disregarded.

Instructions for reconstitution

Refer to the volumes to be added and concentrations of the solution in Tables 1 and 2, which may be useful when fractional doses are required.

Table 1. Powder for injectable solution

Presentation	Amount of diluent to be added (ml)	Approximate concentration (mg/ml)
2 g
Intravenous bolus	10 ml	170

Note:

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

Table 2. Powder for solution for infusion

Presentation	Amount of diluent to be added (ml)	Approximate concentration (mg/ml)
2 g
	Intravenous infusion	50 ml*	40

• The addition must be carried out in two steps.

Note:

• The final 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.

The color of the solutions varies from pale yellow to amber, depending on concentration, diluents, and storage conditions used. The potency of the product is not negatively affected by such color variations, provided they remain within the recommended guidelines.

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

• 0.9% (9 mg/ml) Sodium Chloride Injection
• M/6 Sodium Lactate Injection
• Compound Sodium Lactate Injection (Hartmann's solution)
• 5% (50 mg/ml) Glucose Injection
• 0.225% (2.25 mg/ml) Sodium Chloride and 5% (50 mg/ml) Glucose Injection
• 0.45% (4.5 mg/ml) Sodium Chloride and 5% (50 mg/ml) Glucose Injection
• 0.9% (9 mg/ml) Sodium Chloride and 5% (50 mg/ml) Glucose Injection
• 0.18% (1.8 mg/ml) Sodium Chloride and 4% (40 mg/ml) Glucose Injection
• 10% (100 mg/ml) Glucose Injection
• 10% (100 mg/ml) Dextran 40 in 0.9% (9 mg/ml) Sodium Chloride Injection
• 10% (100 mg/ml) Dextran 40 in 5% (50 mg/ml) Glucose Injection
• 6% (60 mg/ml) Dextran 70 in 0.9% (9 mg/ml) Sodium Chloride Injection
• 6% (60 mg/ml) Dextran 70 in 5% (50 mg/ml) Glucose Injection

Ceftazidime at concentrations between 0.05 mg/ml (0.005%) and 0.25 mg/ml (0.025%) is compatible with peritoneal dialysis fluid (lactate).

Ceftazidime may be reconstituted for intramuscular use with 0.5% (5 mg/ml) or 1% (10 mg/ml) Lidocaine Hydrochloride Injection, using the concentrations detailed in Table 1.

The contents of a 500 mg vial of Ceftazidima Qilu, reconstituted with 1.5 ml of Water for Injections, may be added to an infusion of metronidazole (500 mg in 100 ml), with both agents retaining their activity.

500 mg powder for injection, 1 g, 2 g powder for injection or infusion:

THIS SECTION MUST BE PRESENTED WITH PICTOGRAMS, AS IN THE PREVIOUS MATERIAL.

Preparation of solutions for bolus injection:

1. Insert the syringe needle through the vial closure and inject the recommended volume of diluent. Remove the syringe needle.

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

1. Invert the vial. With the syringe plunger fully depressed, insert the needle through the vial closure and withdraw the total volume of solution into the syringe (the pressure built up in the vial may assist withdrawal). Ensure that the needle remains immersed in the solution and not in the headspace. The withdrawn solution may contain small bubbles of carbon dioxide, which can be disregarded.

These ceftazidime solutions may be administered directly into the vein or introduced into the feeding port of an enteral nutrition set if the patient is receiving parenteral fluids. Ceftazidime is compatible with the intravenous fluids listed above.

1 g, 2 g powder for injection and infusion:

Preparation of intravenous infusion solutions of Ceftazidima Qilu in standard vial presentations (mini-bag or burette-type infusion system):

Prepare with a total of 50 ml (for 1 g and 2 g vials) of compatible diluent (as listed above), added in TWO steps as described below.

1. Insert the syringe needle through the vial closure and inject 10 ml of diluent for both 1 g and 2 g vials.
2. Remove the needle and shake the vial until a clear solution is obtained.
3. Do not insert a vent needle until the product is fully dissolved. Insert a vent needle through the vial closure to release internal pressure.
4. Transfer the reconstituted solution to the final delivery vehicle (e.g., mini-bag or burette-type infusion system) to achieve a total volume of at least 50 ml, and administer by intravenous infusion over 15–30 minutes.

Note: To maintain product sterility, the vent needle must not be inserted through the vial closure until the product is completely dissolved.

Any unused antibiotic solution must be discarded.

For single use only.

Disposal of unused medication and all materials that have come into contact with it must be carried out in accordance with local regulations.