Prospecto: information for the patient

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

cefazolina (in the form of cefazolina sodium)

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

-Conserve this prospectus, as you mayneed to read it again.

-If you have any questions, consult your doctor, pharmacist or nurse.

-If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospectus. See section 4.

1.What is Cefazolina Qilu andfor what it is used

2.What you need to know before starting to use Cefazolina Qilu

3.How to use Cefazolina Qilu

4.Possible adverse effects

5.Storage of Cefazolina Qilu

6.Contents of the package and additional information

Cefazolina Qilu contains the active ingredientcefazolina (in the form of cefazolina sodium).

Cefazolina belongs to a group of antibiotics calledcephalosporinsthat act byeliminating bacteria..

Cefazolina is used when it is known that an infection has been caused or is likely to be caused by a bacterium that is sensitive to cefazolina. It is used in the treatment ofthe followinginfections:

• Skin infections.
• Bone and joint infections.

Cefazolina Qilu may be usedbeforeandafter asurgical proceduretoprevent infections..

No use CefazolinaQilu:

• If you are allergic to cefazolin sodium.
• If you have ever had a severe allergic reaction to penicillin or another similar antibiotic.

Advertencias y precauciones

Consult your doctor, pharmacist, or nurse before starting to use CefazolinaQilu:

• If you have had a mild allergic reaction to penicillin or other similar antibiotics, for example, skin eruptions that may cause itching.
• If you are allergic to something not mentioned in this prospectus.
• If you have intestinal disorders, especially colitis (inflammation of the intestine).
• If you have kidney problems.
• If you are on a low-sodium diet.

Factores de riesgo que pueden provocar deficiencia de vitamina K o factores de riesgo que influyen en otros mecanismos de la coagulación sanguínea.

Bleeding disorders may occur during treatment with cefazolin in rare cases. Additionally, bleeding disorders may occur in patients with diseases that may cause or worsen bleeding, such ashemophilia or stomach or intestinal ulcers. In these cases, your coagulation will be monitored.

This medication should not be injected near the spinal cord (intratecal), as cases of central nervous system toxicity (including seizuresconvulsivas) have been reported.

Prolonged use of cefazolin may cause overinfections. Your doctor will closely monitor you for any signs of overinfections and treat you if necessary.

Niños

CefazolinaQilushould not be usedin premature babies or infants in the first month of life.

Uso de CefazolinaQilucon otros medicamentos

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This also applies to over-the-counter medications and herbal medications, as CefazolinaQilumay affect how other medications work. Additionally, other medications may affect how CefazolinaQiluworks.

It is very important that you consult your doctor or nurse, especially if you are taking any of the following medications:

• Aminoglycosides or other antibiotics (used to treat infections).
• Probenecid (used to treat gout).
• Vitamin K.
• Anticoagulants (blood thinners).
• Furosemide (diuretic).

You should also inform your doctor or nurse if you need to have blood tests to measure glucose levels or other blood tests.

Embarazo y lactancia

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

Conducción y uso de máquinas

The influence of CefazolinaQiluon the ability to drive and use machines is negligible. However, adverse reactions may occur (see also the section “Possible side effects”) that may affect the ability to drive and use machines.

CefazolinaQilucontains sodium

Cefazolina Qilu 2g powder for injectable solution and for infusion contains101.2mg of sodium (the main component of table salt and cooking salt) in each vial. This is equivalent to5.06% of the maximum recommended daily sodium intake in the adult diet, which should be taken into account in the treatment of patients with low-sodium diets.

Cefazolina Qilu will be administered by a doctor or a nurse. It will be administered in one of the following ways:

Cefazolina Qilu 2g powder for injectable solution and for infusion

• By slow injection into a vein (30-60minutes).
• Through a small tube in a vein (this method is called «intravenous infusion»).

Your doctor will determine the dose of Cefazolina Qilu based on your age, weight, the severity of the infection, and the state of your kidneys. The doctor will explain it to you.

Adults and elderly people

• In case ofinfections, the dose may rangebetween 1 and 6g, depending on the severity of the infection.
• If you are going to undergo a surgical procedure, you may receive a dose of 1g, 30-60minutes before the start of the operation.
• For longer operations, you may be administered an additional dose of 500mg to 1g during the operation. Treatment with Cefazolina Qilu may be continued for 24hours after the operation to prevent the risk of infections.

Use in children and infants (from 1month of age)

The doctor will determine the dose based on the child's weight. The daily dose in children may be 25-50mg per kilogram of body weight. Depending on the severity of the infection, this dose may be increased up to 100mg per kilogram of body weight.

Adults and children with reduced renal function

If you have kidney problems, you may receive a lower dose. It may be necessary to have a blood test to ensure that you have received a sufficient dose.

If you use more CefazolinaQiluthan you should

Inform your doctor or nurse if you think you have received an excessive amount of Cefazolina Qilu.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 915 620 420, indicating the medication and the amount ingested.

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

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

Severe allergic reactions(very rare, may affect up to 1 in 10,000 people).

If you have a severe allergic reaction,inform your doctor immediately.

The possible symptoms include:

• Sudden swelling of the face, throat, mouth, or lips, which may cause difficulty breathing or swallowing.
• Sudden swelling of the hands, feet, and ankles.

Other possible side effects

Frequent(may affect up to 1 in 10 people):

• Skin rash.
• Nausea and vomiting.
• Diarrhea.
• Pain or induration (skin hardening) at the injection site.

Occasional(may affect up to 1 in 100 people):

• Oral fungal infection.
• Fever.
• Convulsions (seizures).
• Phlebitis (inflammation of the veins).
• Pruritus and erythema of the skin, joint pain, skin lesions, generalized rash, and urticaria.

Rare(may affect up to 1 in 1,000 people):

• Genital infection, vaginal candidiasis —vaginal pain or itching, or vaginal discharge.
• Prolonged use may cause the proliferation of non-susceptible bacteria.
• Increased or decreased number of blood cells.
• Hyperglycemia (high blood sugar), hypoglycemia (low blood sugar)
• Dizziness.
• Respiratory disorders (respiration).
• Renal and urinary tract disorders.
• Cough.
• Rhinorrhea.
• Loss of appetite.
• Hepatic insufficiency (detectable in blood tests), jaundice.
• Severe skin eruption (with blisters on the skin and skin peeling, and possible blisters in the mouth).
• Intense fatigue and weakness.
• Chest pain.

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

• Blood coagulation disorders.
• Colitis (inflammation of the colon). Symptoms include diarrhea, often with blood and mucus, abdominal pain, and fever.
• Genital pruritus.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report themdirectly to the Spanish System for Pharmacovigilance of Medicines for Human Use: www.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 label and the outer packaging after «CAD». The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After reconstitution and dilution:

Physical and chemical stability has been demonstrated for use during 12 hours at 25°C and during 14 hours at 2-8°C.

From a microbiological standpoint, and unless the opening/reconstitution/dilution method allows for the exclusion of microbial contamination risk, the product should be used immediately. If not used immediately, the storage period and conditions are the responsibility of the userand should not exceed the physical and chemical stability in use times indicated above.

Medications should not be disposed of through drains or in the trash. Dispose of containers and medications that you no longer need at the SIGRE point of the pharmacy or in any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of containers and medications that you no longer need. This will help protect the environment.

Cefazolina CompositionQilu

The active ingredient is cefazolin.

Cefazolina Qilu 2g contains 2g of cefazolin (in the form of cefazolin sodium).

Appearance of the product and contents of the package

Powder for injectable solution and for infusion

Cefazolina Qilu 2g is a white or almost white powder in 20ml type II glass vials with a 20mm butyl rubber stopper and sealed with a combined aluminum and plastic cap.

Package sizes: 1, 10, and 100vials per box.

Only some package sizes may be commercially available.

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, 28046-Madrid,

Spain

Responsible for manufacturing

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

Local Representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya 53-55

08007 – Barcelona

Spain

This medicine is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:03/2021.

For detailed and updated information on this medicine, please visit 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.

Shelf life after reconstitution/dilution:

Physical and chemical stability has been demonstrated for 12hours at 25°C and for 14hours at 2-8°C.

From a microbiological point of view, and unless the opening/reconstitution/dilution method allows the risk of microbial contamination to be ruled out, the product should be used immediately. If not used immediately, the storage period and conditions are the responsibility of the userand should not exceed the physical and chemical stability in use times indicated above.

Administration:

Cefazolina Qilu is a sterile powder and must be reconstituted before use in the patient. The volume of solvent used to dissolve it depends on the administration method.

Add the recommended volume of solution for reconstitution and shake well until the contents of the vial are completely dissolved. The solution should be visually inspected before use. Only transparent and practically particle-free solutions should be used.

The Cefazolina Qilu solution is prepared just before injection.

Intravenous route

Intravenous injection

Cefazolina Qilu 2g should be injected slowly over a period of 30-60 minutes.

Reconstitution table for intravenous injection

Intravenous infusion:

Cefazolina Qilu 2g can be administered as a continuous or intermittent infusion.

Cefazolina Qilu 2g is dissolved in at least 5ml of water for injectable preparations. After reconstitution, dilute the cefazolin solution with 50-100ml of the following compatible solutions:

• Sodium chloride solution for injection 0.9% (9mg/ml).
• Lactate Ringer's solution with glucose 5% (50mg/ml).
• Glucose solution 5% (50mg/ml) or 10% (100mg/ml).
• Ringer's solution.
• Glucose solution 5% (50mg/ml) and sodium chloride solution 0.9% (9mg/ml) (or sodium chloride solution 0.45% [4.5mg/ml] with glucose solution 5% [50mg/ml] or sodium chloride solution 0.2% [2mg/ml] with glucose solution 5% [50mg/ml]).
• Lactate Ringer's solution.
• Water for injectable preparations with invert sugar solution 5% (50mg/ml) or 10% (100mg/ml).
• Water for injectable preparations.