CEFAZOLINE QILU 2 g POWDER FOR INJECTION AND INFUSION SOLUTION

2. What you need to know before you use Cefazoline Qilu

Do not use CefazolineQilu:

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

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before you start using Cefazoline Qilu:

• If you have had a mild allergic reaction to penicillin or other similar antibiotics, such as skin rashes that may cause itching.
• If you are allergic to something 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 blood coagulation mechanisms.

On rare occasions, blood coagulation disorders may occur during treatment with cefazoline. Additionally, changes in blood coagulation may occur in patients with diseases that can cause or worsen bleeding, such as hemophilia or stomach or intestinal ulcers. In these cases, your blood coagulation will be monitored.

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

Prolonged use of cefazoline may cause superinfections. Your doctor will closely monitor you for these and treat them if necessary.

Children

Cefazoline Qilu should notbe used in premature babies or infants in the first month of life.

Use of CefazolineQilu with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medications. This also applies to over-the-counter medications and herbal medicines, as Cefazoline Qilu may affect how other medications work. Additionally, other medications may affect how Cefazoline 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-thinning medications).
• Furosemide (a medication to increase urine production).

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

Pregnancy and breastfeeding

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

Driving and using machines

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

CefazolineQilu contains sodium

Cefazoline Qilu 2 g powder for solution for injection and infusion contains 101.2 mg of sodium (the main component of table salt and cooking salt) in each vial. This is equivalent to 5.06% of the maximum recommended daily intake of sodium in the adult diet, which should be taken into account in the treatment of patients with low-sodium diets.

3. How to use Cefazoline Qilu

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

Cefazoline Qilu 2g powder for solution for injection and infusion

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

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

Adults and elderly

• In the case of infections, the dose may range from 1 to 6 g, depending on the severity of the infection.
• If you are going 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 Cefazoline Qilu may continue for 24 hours 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 25-50 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 kidney function

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

If you use more CefazolineQilu than you should

Inform your doctor or nurse if you think you have received too much Cefazoline 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 further questions about the use of this medication, ask your doctor or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everybody gets them.

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

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

Possible symptoms include:

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

Other possible side effects

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

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

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

• Oral thrush.
• Fever.
• Seizures (fits).
• Vein inflammation.
• Itching and redness of the skin, joint pain, skin lesions, generalized rash, and hives.

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 blood cell count.
• Hyperglycemia (high blood sugar), hypoglycemia (low blood sugar)
• Dizziness.
• Respiratory disorders (breathing).
• Kidney and urinary tract disorders.
• Cough.
• Runny nose.
• Lack of appetite.
• Liver failure (detectable in blood tests), jaundice.
• Severe rash with rapid progression (with blisters on the skin and skin peeling, and possible blisters in the mouth).
• Severe fatigue and weakness.
• Chest pain.

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

• Blood coagulation disorders.
• Colon inflammation. Symptoms include diarrhea, usually with blood and mucus, abdominal pain, and fever.
• Genital itching.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Cefazoline Qilu

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

Do not use this medication after the expiry date stated on the label and carton after “EXP”. The expiry 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 12 hours at 25°C and for 14 hours at 2-8°C.

From a microbiological point of view, 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 storage conditions are the responsibility of the user and should not exceed the times of physical and chemical stability in use indicated above.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medication at the pharmacy's SIGRE point or any other medication waste collection system. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Contents of the pack and other information

Composition of CefazolineQilu

The active substance is cefazoline.

Each vial of Cefazoline Qilu 2 g contains 2 g of cefazoline (as cefazoline sodium).

Appearance and packaging

Powder for solution for injection and infusion

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

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

Not all package sizes may be marketed.

Marketing authorization holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, 28046-Madrid,

Spain

Manufacturer

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 medication is authorized in the Member States of the European Economic Area under the following names:

Date of last revision of this leaflet:03/2021.

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

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This information is intended only for healthcare professionals.

Validity period after reconstitution/dilution:

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

From a microbiological point of view, 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 storage conditions are the responsibility of the user and should not exceed the times of physical and chemical stability in use indicated above.

Administration:

Cefazoline 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 method of administration.

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

The Cefazoline Qilu solution is prepared just before injection.

Intravenous route

Intravenous injection

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

Reconstitution table for intravenous injection

Intravenous infusion:

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

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

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