Label: Information for the Patient

Ceftazidima Qilu 2 g Powder for Injection and for Infusion EFG

ceftazidima

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to refer to it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this label. See section 4.

1. Contents of the Package and Additional Information

Ceftazidima is an antibiotic used in adults and children (including newborns) that acts by killing bacteria that cause infections. It belongs to a group of medications calledcephalosporins.

Ceftazidima is used to treat severe bacterial infections of:

Ceftazidima may also be used:

Do not use Ceftazidima:

• If you are allergic to ceftazidima or any of the other components of this medication (listed in section6).
• If you have had a severe allergic reaction to another antibiotic (penicillins, monobactam, and carbapenem), you may also be allergic to ceftazidima.

→If you think you fall into any of these cases,inform your doctorbefore they administer CeftazidimaQilu.If so, you should not receive this medication.

Warnings and precautions

Consult your doctor or nurse before they administer Ceftazidima Qilu.

While receiving this medication, 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. Consult the sectionSpecial attention required diseasesof section4. If you have had an allergic reaction to other antibiotics, you may also be allergic to ceftazidima.

Severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug-induced eosinophilia and systemic symptoms (DRESS), and acute generalized pustular psoriasis (AGPP) have been reported in relation to ceftazidima 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

Ceftazidima may affect the results of glucose (sugar) tests in urine and a blood test calledCoombs test. If you are to have tests:

→Inform the person who takes the samplethat you have been administered CeftazidimaQilu.

Use of Ceftazidima Qilu with other medications

Inform your doctor if you are taking, have recently taken, or may need to take any other medication,including over-the-counter medications.

Do not administer ceftazidima without consulting your doctor if you are also taking:

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor before using thismedication.

Your doctor will evaluate the benefit of treating you with ceftazidima against the risk to your child.

Driving and operating machinery

This medication may cause side effects that affect your ability to drive, such as dizziness. Do not drive or operate machinery unless you are sure this will not affect you.

Ceftazidima Qilu contains sodium.

You should be aware of this if you follow a low-sodium diet.

CeftazidimeQilu is usually administered by a doctor or nurse.

Ceftazidime Qilu 2g can be administered via intravenous injection or infusion.

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

The recommended dose is:

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

Neonates (0-2months)

For every 1kg of the baby's weight, they will administer 25-60mg of ceftazidime per day, divided into two doses.

Infants (over 2months) and childrenwho weigh less than 40kg

For every 1kg of the baby's or child's weight, they will administer 100-150mg of ceftazidime per day, divided into threedoses. The maximum dose is 6g per day.

Adults and adolescentswith a weight of 40kg or more

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

Patients over 65years of age

The daily dose should not exceed, in general, 3g per day, especially if you are over 80years of age.

Patients with kidney problems

You may be administered a different dose than usual. Your doctor or nurse will decide how much Ceftazidime Qilu you need, based on the severity of your kidney disease. Your doctor will closely monitor you, and it is possible that they will perform kidney function tests more frequently.

If you use more Ceftazidime Qilu than you should

If you think you have been accidentally given more medication than the dose 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 Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Ceftazidime Qilu

If you miss an injection of this medication, you should receive it as soon as possible. Do not administer a double dose (two injections at once) to compensate for the missed dose.

If you interrupt the treatment with Ceftazidime Qilu

Do not stop receiving Ceftazidime Qilu unless your doctor tells you to.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

Special attention required diseases

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

• Severe allergic reaction. The signs includeswollen and itchy rash,swelling, sometimes on the face or in the mouth that causesdifficulty breathing.

• Skin rashthat can formblistersand appears assmall dots(dark central point, surrounded by a lighter area, with a dark ring around the edge).

• Generalizedskin rashaccompanied byblistersandskin peeling,ulcers in the mouth, throat, nose, genitals, or eyes. These severe skin rashes may be preceded by fever and pseudogripal symptoms (These signs may correspond to theStevens-Johnson syndromeor thetoxic epidermal necrolysis).

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

• There have been reports of rare severe hypersensitivity reactions, accompanied by severe rash, which could be accompanied by fever, fatigue, facial or lymph node swelling, increased eosinophils (a type of white blood cell), liver, kidney, or lung effects (a reaction known as DRESS).

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

Other side effects:

Frequent: may affect up to 1 in 10people

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

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

The frequent 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

Rare: may affect up to 1 in 100people

• inflammation of the intestine, which may cause pain, or diarrhea that 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, inform your doctor.

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

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

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

• inflammation or kidney insufficiency

Unknown frequency: cannot be estimated from available data.

• inflammation or kidney insufficiency
• tingling
• bad taste in the mouth
• yellowish discoloration of the whites of the eyes or skin

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

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

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Usewww.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

• Do not use this medication after the expiration date that appears on the vial and the box after CAD. The expiration date is the last day of the month indicated.
• Store below 25°C.
• Store the vials in the outer packaging to protect them from light.
• Reconstituted and diluted solution: the doctor, pharmacist, or nurse will prepare your medication with water for injectable or liquid preparations that are compatible.
• The physical and chemical stability during use is 24 hours at an entrance temperature of 2 ºC and 8 ºC and 2 hours at 25°C.
• From a microbiological point of view, the drug should be used immediately, unless the opening, reconstitution, and dilution method avoids the risk of microbiological contamination. If not used immediately, the time and storage conditions during use are the responsibility of the user.
• Medications should not be thrown down the drains or in the trash. Dispose of the containers and medications you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medications you no longer need. In this way, you will help protect the environment.

Ceftazidime Qilu Composition

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

• The active ingredient is 2g, 1g or 500mg of ceftazidime (in the form of ceftazidime pentahydrate).

• The other components are: sodium carbonate.

See section2 regarding important information about sodium, one of the components of Ceftazidime Qilu.

Appearance of the product and contents of the pack

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

Available in packs of 1, 10 or 50vials.

Only some pack sizes may be marketed.

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

Marketing Authorisation Holder and Responsible Person

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

Responsible Person

KYMOS, S.L

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès, 08290,

Barcelona,Spain

NETPHARMALAB CONSULTING SERVICES

Carretera de Fuencarral 22

Alcobendas, 28108 - Madrid,

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 authorised in the member states of the European Economic Area with the following names:

Last update of the summary of product characteristics: 10/2024.

Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

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This information is intended solely for healthcare professionals:

Ceftazidime Qilu 2g polvo para solución inyectable y para perfusión EFG

Ceftazidime

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

After reconstitution:

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

From a microbiological point of view, the product 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.

After dilution:

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

From a microbiological point of view, the product 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.

Special precautions for storage

Store below 25ºC.

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

Special precautions for disposal and other manipulations

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

Instructions for reconstitution

See the volumes of addition and the concentrations of the solution in Tables1 and 2, which may be useful when fractional doses are required.

Table1. Powder for solution for injection

Nota:

• The resulting volume of the ceftazidime solution in the reconstituted medium increases as a result of the displacement factor of the resulting drug at the concentrations listed in mg/ml in the table above.

Table2. Powder for solution for infusion

• The addition should be made in two stages.

Nota:

• The resulting volume of the ceftazidime solution in the reconstituted medium increases as a result of the displacement factor of the resulting drug at the concentrations listed in mg/ml in the table above.

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

Ceftazidime in concentrations ranging from 1mg/ml to 40mg/ml is compatible with:

• Sodium chloride 0.9% (9mg/ml) solution for injection
• Sodium lactate M/6 solution for injection
• Sodium lactate solution for injection (Hartmann's solution)
• Glucose 5% (50mg/ml) solution for injection
• Sodium chloride 0.225% (2.25mg/ml) and glucose 5% (50mg/ml) solution for injection
• Sodium chloride 0.45% (4.5mg/ml) and glucose 5% (50mg/ml) solution for injection
• Sodium chloride 0.9% (9mg/ml) and glucose 5% (50mg/ml) solution for injection
• Sodium chloride 0.18% (1.8mg/ml) and glucose 4% (40mg/ml) solution for injection
• Glucose 10% (100mg/ml) solution for injection
• Dextran 40 10% (100mg/ml) in sodium chloride 0.9% (9mg/ml) solution for injection
• Dextran 40 10% (100mg/ml) in glucose 5% (50mg/ml) solution for injection
• Dextran 70 6% (60mg/ml) in sodium chloride 0.9% (9mg/ml) solution for injection
• Dextran 70 6% (60mg/ml) in glucose 5% (50mg/ml) solution for injection

Ceftazidime in concentrations ranging from 0.05mg/ml (0.005%) to 0.25mg/ml (0.025%) is compatible with peritoneal dialysis fluid (lactate).

Ceftazidime can be reconstituted for intramuscular use with lidocaine hydrochloride solution for injection 0.5% (5mg/ml) or 1% (10mg/ml) with the concentrations listed in Table1.

The contents of a 500mg vial of Ceftazidime Qilu, reconstituted with 1.5ml of water for injection, can be added to a metronidazole injection (500mg in 100ml), in which both will retain their activity.

500mg powder for solution for injection, 1g, 2g powder for solution for injection and infusion:

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

Preparation of solutions for intravenous bolus injection:

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

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

3.Invert the vial. With the plunger of the syringe fully compressed, insert the needle through the closure of the vial and extract the total volume of the solution (the pressure developed in the vial may help with extraction). Ensure that the needle remains in the solution and does not enter the upper free space. The extracted solution may contain small bubbles of carbon dioxide, which can be ignored.

These ceftazidime solutions can be administered directly into the vein or introduced into the tube of an enteral nutrition equipment in the case of the patient receiving parenteral fluids. Ceftazidime is compatible with the intravenous fluids listed above.

1g, 2g powder for solution for injection and infusion:

Preparation of solutions for i.v. infusion of Ceftazidime Qilu in standard vial presentation (mini-bag or burette infusion system):

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

1. Insert the needle of the syringe through the closure of the vial and inject 10ml of diluent for 1g and 2g vials.
2. Extract the needle and shake the vial until a transparent solution is obtained.
3. Do not insert a needle to release gas until the product has dissolved. Insert a needle to release gas through the closure of the vial to release the internal pressure.
4. Transfer the reconstituted solution to the final distribution vehicle (e.g. mini-bag or burette infusion system) until a total volume of at least 50ml is reached and administer by intravenous infusion over 15-30minutes.

Nota: To maintain the sterility of the product, it is essential that the needle for releasing gas is not inserted through the closure of the vial until the product has dissolved.

Any unused antibiotic solution should be discarded.

For single use only.

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