Cefazolin Qilu 2 g powder for injection and for infusion EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the patient

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

cefazolin (as cefazolin sodium)

Read the entire 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, consult your doctor, pharmacist or nurse.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

1. What Cefazolin Qilu is and what it is used for
2. What you need to know before using Cefazolin Qilu
3. How to use Cefazolin Qilu
4. Possible side effects
5. How to store Cefazolin Qilu
6. Contents of the pack and other information

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

Cefazolina Qilu contains the active substance cefazolin (in the form of cefazolin sodium).

Cefazolin belongs to a group of antibiotics called cephalosporins that work by killing bacteria.

Antibiotics are used to treat bacterial infections and are not effective against viral infections such as flu 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 after completing your treatment, return it to the pharmacy for proper disposal. Do not dispose of medicines via the wastewater system or in household waste.

Cefazolin is used when it is known or likely that an infection is caused by bacteria sensitive to cefazolin. It is used to treat the following infections:

• Skin infections.
• Bone and joint infections.

Cefazolina Qilu may be used before and after surgical procedures to prevent infections.

2. What you need to know before using Cefazolin Qilu

Do not use Cefazolin Qilu:

• if you are allergic to sodium cefazolin.
• 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 using Cefazolin Qilu:

• If you have previously experienced a mild allergic reaction to penicillin or other similar antibiotics, for example, skin rashes that may cause itching.
• If you are allergic to any substance not listed 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 lead to vitamin K deficiency or risk factors affecting other mechanisms of blood coagulation.

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

This medicine must not be injected near the spinal cord (intrathecal route), as cases of central nervous system toxicity (including seizures) have been reported.

Prolonged use of cefazolin may lead to superinfections. Your doctor will closely monitor you for such infections and treat them if necessary.

Children

Cefazolin Qilu must not be used in premature infants or newborns during the first month of life.

Using Cefazolin Qilu with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This also applies to over-the-counter medicines and herbal medicines, as Cefazolin Qilu may affect how other medicines work. Likewise, other medicines may affect how Cefazolin Qilu works.

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

• Aminoglycosides or other antibiotics (used to treat infections).
• Probenecid (used to treat gout).
• Vitamin K.
• Anticoagulants (blood-thinning medicines).
• Furosemide (a diuretic medicine).

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, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

Cefazolin Qilu has no effect on the ability to drive or operate machinery. However, adverse reactions (see also section “Possible side effects”) may occur that could affect the ability to drive or operate machinery.

Cefazolin Qilu contains sodium

Cefazolin Qilu 2 g powder for injectable solution and for infusion contains 101.2 mg of sodium (the main component of table and cooking salt) per vial. This corresponds to 5.06% of the maximum recommended daily dietary sodium intake for adults and should be taken into consideration when treating patients on a low-sodium diet.

3. How to use Cefazolina Qilu

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

Cefazolina Qilu 2g powder for injectable solution and for infusion

• By slow injection into a vein (over 30–60 minutes).
• Through a small tube into a vein (this method is called "intravenous infusion").

Your doctor will determine the dose of Cefazolina Qilu based on your age, weight, severity of infection, and kidney function. Your doctor will explain this to you.

Adults and elderly patients

• In case of infections, the dose may range from 1 to 6 g, depending on the severity of the infection.
• If you are undergoing surgery, you may receive a dose of 1 g, 30–60 minutes before the start of the operation.
• For longer operations, an additional dose of 500 mg to 1 g may be administered during the procedure. Treatment with Cefazolina Qilu may continue for 24 hours after surgery to prevent the risk of infections.

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 up 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 you have received an adequate dose.

If you use more Cefazolina Qilu than you should

Inform your doctor or nurse if you think you have received too much Cefazolina Qilu.

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

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.

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

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

Possible symptoms include:

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

Other possible adverse effects

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

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

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

• Fungal mouth infection.
• Fever.
• Convulsions (seizures).
• Inflammation of the veins.
• 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 and itching or vaginal discharge.
• Prolonged use may lead to overgrowth of non-sensitive bacteria.
• Increased or decreased number of blood cells.
• Hyperglycaemia (high blood sugar level), hypoglycaemia (low blood sugar level).
• Dizziness.
• Respiratory disorders (breathing).
• Disorders of the kidneys and urinary tract.
• Cough.
• Rhinorrhoea.
• Loss of appetite.
• Liver failure (detectable in blood tests), jaundice.
• Severe rapidly progressing skin rash (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):

• Disorders of blood clotting.
• Inflammation of the colon. Symptoms include diarrhoea, usually with blood and mucus, abdominal pain and fever.
• Genital itching.

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Cefazolin Qilu

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

Do not use this medicine after the expiry date which is stated on the label of the vial and the outer packaging following "EXP". The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

After reconstitution and dilution:

The physical and chemical stability in use has been demonstrated for 12 hours at 25°C and for 14 hours at 2–8°C.

From a microbiological standpoint, unless the method of opening/reconstitution/dilution ensures the absence 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 must not exceed the physical and chemical stability times in use indicated above.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at the pharmacy or any other medicine waste collection system. If in doubt, ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Cefazolin Qilu

The active substance is cefazolin.

Each vial of Cefazolin Qilu 2 g contains 2 g of cefazolin (as cefazolin sodium).

Appearance of the product and contents of the pack

Powder for injectable solution and for infusion

Cefazolin Qilu 2 g is a white or almost white powder in 20 ml Type II soda-lime glass vials, with a 20 mm butyl rubber stopper coated with a plastic and aluminum seal.

Pack sizes: 1, 10 and 100 vials per carton.

Only some pack sizes may be marketed.

Marketing Authorization Holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, 28046-Madrid,

Spain

Manufacturer responsible

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parc Tecnològic 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 under the following names:

Date of the last review of this summary: 03/2021.

Up-to-date detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended exclusively for healthcare professionals.

Shelf life after reconstitution/dilution:

Chemical and physical in-use stability has been demonstrated for 12 hours at 25°C and for 14 hours at 2–8°C.

From a microbiological standpoint, unless the reconstitution/dilution method ensures the absence of microbial contamination risk, the product should be used immediately. If not used immediately, the storage conditions and duration are the responsibility of the user and must not exceed the in-use chemical and physical stability periods stated above.

Administration:

Cefazolina Qilu is a sterile powder and must be reconstituted before use in the patient. The volume of solvent used for reconstitution depends on the route of administration.

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

Cefazolina Qilu solution should be prepared immediately prior to injection.

Intravenous route

Intravenous injection

Cefazolina Qilu 2 g must be administered by slow intravenous injection over a period of 30–60 minutes.

Reconstitution table for intravenous injection

Intravenous infusion:

Cefazolin Qilu 2 g may be administered as a continuous or intermittent infusion.

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

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