Prospecto: information for the patient

Cefazolina Qilu 1g 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 mayhave to read it again.

-If you have any doubts, 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 interventiontoprevent infections..

Do not use CefazolinaQilu:

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

Cefazolina Qilu 1g powder for injectable solution and for infusion

• If you are allergic to lidocaine and will receive Cefazolina Qilu by intramuscular injection.

Warnings and precautions

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

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

Risk factors that may cause vitamin K deficiency or risk factors that affect other mechanisms of blood coagulation

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

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

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

Children

Cefazolina Qilushould notbe used in premature babies or infants in the first month of life.

Use of CefazolinaQiluwith other medications

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 Cefazolina Qilu may affect the way other medications work. Additionally, other medications may affect the way Cefazolina Qilu works.

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.

Pregnancy and breastfeeding

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

Driving and operating machinery

The influence of Cefazolina Qilu on the ability to drive and operate machinery is negligible. However, adverse reactions may occur (see also the section “Possible side effects”) that may affect the ability to drive and operate machinery.

CefazolinaQilucontains sodium

Cefazolina Qilu 1g powder for injectable solution and for infusion contains 50.6mg of sodium (the main component of table salt and cooking salt) in each vial. This is equivalent to 2.53% 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 1 g powder for injectable solution and for infusion

• By intramuscular injection (for example, in a muscle of the arm).
• By slow injection into a vein (this may take 3-5 minutes).
• 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

• The dose may range from 1 to 6 g, depending on the severity of the infection.
• If you are about to undergo surgery, you may receive a dose of 1 g, 30-60 minutes before the start of the operation.
• For longer operations, you may be given an additional dose of 500 mg to 1 g during the operation. Treatment with Cefazolina Qilu may be continued for 24 hours after the operation to prevent the risk of infection.

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

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

Adults and children with reduced renal function

If you have kidney problems, you may receive a lower dose. You may need a blood test to ensure that you have received a sufficient dose.

If you use more Cefazolina Qilu than 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 Toxicological 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 thrush.
• Fever.
• Convulsions (seizures).
• Phlebitis.
• 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. 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 that does not appear 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 user and should not exceed the physical and chemical stability times in use 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 Qilu Composition

The active ingredient is cefazoline.

Each vial of Cefazolina Qilu 1g contains 1g of cefazoline (in the form of cefazoline sodium).

Appearance of the product and contents of the package

Powder for injectable solution and for infusion

Cefazolina Qilu 1g is a white or almost white powder in a 10ml type II glass vial 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 medicinal product is authorized in the member states of the European Economic Area with the following names:

Last review date of this leaflet:03/2021.

Detailed and updated 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.

Shelf life after reconstitution/dilution:

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

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

Administration:

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

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 solutions that are transparent and practically particle-free should be used.

The Cefazolina Qilu solution is prepared just before injection.

Intramuscular injection

Cefazolina Qilu 1g is generally dissolved in 2.5ml of water for injection (approximately 330mg/ml)or in 4ml of lidocaine hydrochloride solution 0.5%(approximately 250mg/ml). Shake the vial until the contents are completely dissolved and administer by deep intramuscular injection.

Intravenous injection

Intravenous injection

Cefazolina Qilu 1g should be injected slowly over a period of 3-5minutes (never in less than 3minutes), directly into a vein or through an intravenous infusion tube.

Table of reconstitution for intravenous injection

Intravenous infusion:

Cefazolina Qilu 1g may be administered as a continuous or intermittent infusion.

Cefazolina Qilu 1g is dissolved in 2.5ml of water for injection. After reconstitution, dilute the cefazolina 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 injection with invert sugar solution 5%(50mg/ml) or 10%(100mg/ml).
• Water for injection.