CEFAZOLIN QILU

Package leaflet: Information for the patient

Cefazolin Qilu 1 g powder for injectable solution or for infusion, 2 g powder for injectable solution or for infusion

Cefazolin (as sodium cefazolin)
Please read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet

1. What Cefazolin Qilu is and what it is used for
2. What you need to know before you use 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 (as cefazolin sodium).
Cefazolin is an antibiotic that belongs to a group of antibiotics called cephalosporins, which work by killing bacteria.
Cefazolin is used to treat infections that are definitely or probably 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 surgery to prevent infections.

2. What you need to know before using Cefazolin Qilu

Do not use Cefazolin Qilu:

• if you are allergic to cefazolin sodium;
• if you have ever had a severe allergic reaction to penicillin or to a similar antibiotic;

Cefazolin Qilu 1 g powder for injectable solution or for infusion

• if you are allergic to lidocaine and Cefazolin Qilu is to be administered by intramuscular injection.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Cefazolin Qilu if:

• you have previously had a mild allergic reaction (e.g. itchy rash) to penicillin or to similar antibiotics;
• you are allergic to something not mentioned in this leaflet;
• you have suffered from intestinal disorders, especially colitis (inflammation of the intestine);
• you have kidney problems;
• you are on a low-sodium diet.

Risk factors that may lead to vitamin K deficiency or that affect other mechanisms of coagulation.
Rarely, coagulation disorders may occur during treatment with cefazolin. In addition,
alterations in coagulation may occur in patients with conditions that can cause or
worsen bleeding, such as haemophilia or stomach or intestinal ulcers. In such cases,
your blood coagulation will be monitored.
This medicine must not be injected into the area surrounding the spinal cord (intrathecal administration), as cases of central nervous system toxicity, including seizures, have been reported.
Prolonged use of cefazolin may lead to superinfection. Your doctor will monitor you closely for the development of such infections and treat them if necessary.
Children
Cefazolin Qilu must not be used in premature newborns and infants under 1 month of age.
Other medicines and Cefazolin Qilu
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes non-prescription medicines and herbal medicinal products, as Cefazolin Qilu may affect the action of other medicines. In addition, other medicines may affect the action of Cefazolin Qilu.
In particular, it is very important to inform your doctor or nurse 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 (medicines that thin the blood);
• furosemide (a remedy for urinary disorders).

Also inform your doctor or nurse if you are undergoing tests to measure glucose levels or other blood tests.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before using this medicine.
Driving and using machines
Cefazolin Qilu has no effect on the ability to drive or operate machinery.
Cefazolin Qilu contains sodium
Cefazolin Qilu 1 g powder for injectable solution or for infusion contains 50.6 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 2.53% of the maximum daily recommended sodium intake for an adult.
Cefazolin Qilu 2 g powder for injectable solution or for infusion contains 101.2 mg of sodium (main component of table/cooking salt) per vial. This corresponds to 5.06% of the maximum daily recommended sodium intake for an adult.
This should be taken into consideration for patients on a sodium-controlled diet.

3. How to use Cefazolina Qilu

Cefazolina Qilu will be administered to you by a doctor or nurse. The medicine will be given to you in one of the following ways:
Cefazolina Qilu 1 g powder for injectable solution or for infusion

• by injection into muscle tissue (e.g. into the muscle of the arm);
• by slow injection into a vein (over 3-5 minutes);
• by means of a tube inserted into a vein (this method is called "intravenous infusion").

Cefazolina Qilu 2 g powder for injectable solution or for infusion

• by slow injection into a vein (over a period of 30-60 minutes);
• by means of a tube inserted into a vein (this method is called "intravenous infusion").

Your doctor will determine the dose of Cefazolina Qilu based on your age, body weight, severity of infection, and kidney function. Your doctor will provide you with further information on this.
Adults and elderly

• For infections, the dose may range from 1 to 6 g, depending on the severity of the infection.
• If you are undergoing surgery, you may be given a dose of 1 g, 30-60 minutes before the start of the procedure.
• For prolonged surgical procedures, an additional dose of 500 mg to 1 g may be given during the operation. 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 body weight. The daily dose in children ranges from 25 to 50 mg per kg of body weight. Depending on the severity of the infection, this dose may be increased up to 100 mg per kg of body weight.
Adults and children with reduced kidney function
If you have kidney problems, you may be given a lower dose. A blood test may be necessary to ensure that an adequate dose has been administered.
If you are given more Cefazolina Qilu than you should
Inform your doctor or nurse if you think you have been given too high a dose of Cefazolina Qilu.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine 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, seek immediate medical advice.
Possible signs include:

• sudden swelling of the face, throat, mouth or lips, causing difficulty in breathing or swallowing;
• sudden swelling of the hands, feet and ankles.

Other possible side effects

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

• skin rashes;
• nausea and vomiting;
• diarrhoea;
• pain or hardening (hard skin) at the injection site.

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

• fungal infection of the mouth;
• fever;
• seizures (epileptic fits);
• inflammation of veins;
• skin redness and itching, joint pain, skin lesions, widespread rash and hives.

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

• genital infection, vaginal candidiasis: vaginal burning and itching or vaginal discharge;
• prolonged use may lead to overgrowth of bacteria not sensitive to the medicine;
• increase or decrease in blood cell counts;
• hyperglycaemia (high blood sugar levels), hypoglycaemia (low blood sugar levels);
• dizziness;
• respiratory disorders (breathing problems);
• kidney and urinary disorders;
• cough;
• nasal discharge;
• loss of appetite;
• liver failure (detectable by blood tests), jaundice;
• rapidly progressing skin rash (with blisters on the skin and skin peeling, possible blisters inside the mouth);
• severe fatigue and weakness;
• chest pain.

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

• blood clotting disorders;
• inflammation of the colon. Symptoms include diarrhoea (often with blood and mucus), abdominal pain and fever;
• genital itching.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system
Website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Cefazolin Qilu

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the vial label and on the carton after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
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 method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the conditions and duration of in-use storage are the responsibility of the user and must not exceed the previously indicated time limits for chemical and physical stability during use.
Do not dispose of any medicine via wastewater. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Cefazolina Qilu contains
The active substance is cefazolin.
Each vial of Cefazolina Qilu 1 g contains 1 g of cefazolin (as cefazolin sodium).
Each vial of Cefazolina Qilu 2 g contains 2 g of cefazolin (as cefazolin sodium).

Description of the appearance of Cefazolina Qilu and package contents
Powder for injectable solution or for infusion.
Cefazolina Qilu 1 g is a white or almost white powder in a 10 ml type II soda-lime glass vial, fitted with a laminated butyl rubber stopper with a 20 mm overseal and sealed with a combined aluminium and plastic cap.
Cefazolina Qilu 2 g is a white or almost white powder in a 20 ml type II soda-lime glass vial, fitted with a laminated butyl rubber stopper with a 20 mm overseal and sealed with a combined aluminium and plastic cap.
Pack sizes: 1, 10 and 100 vials per carton.
Not all pack sizes may be marketed.

Marketing Authorization Holder
QILU PHARMA SPAIN S.L.
Paseo de la Castellana 40,
8th floor, 28046-Madrid
Spain

Manufacturer
KYMOS PHARMA SERVICES, S.L.
Ronda de Can Fatjò,
7B (Parc Tecnològic del Vallès),
Cerdanyola del Vallès, 08290
Barcelona, Spain

This medicinal product is authorized in the EEA Member States under the following trade names:
Germany: Cefazolin Qilu 1 g Powder for the preparation of an injection/infusion solution
Cefazolin Qilu 2 g Powder for the preparation of an injection/infusion solution
France: Cefazoline 1 g Powder for injectable/infusion solution
Cefazoline 2 g Powder for injectable/infusion solution
Spain: Cefazolin Qilu 1 g Powder for injectable solution and for infusion
Cefazolin Qilu 2 g Powder for injectable solution and for infusion
Italy: Cefazolina Qilu

The following information is intended for healthcare professionals only.

In-use stability 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 method of opening/reconstitution/dilution precludes the risk of microbial contamination, the product should be used immediately. If not used immediately, the conditions and duration of in-use storage are the responsibility of the user and must not exceed the previously indicated time limits for chemical and physical stability during use.

Administration:
Cefazolin Qilu is a sterile powder to be reconstituted prior to administration to the patient. The volume of solvent used to dissolve the powder depends on the route of administration.
Add the recommended volume of reconstitution solution and shake well until the powder is completely dissolved. The solution should be visually inspected before use. The solution should only be used if it is clear and practically free of particulate matter.
The Cefazolin Qilu solution must be prepared immediately before injection.

Intramuscular injection
Cefazolin Qilu 1 g is generally dissolved in 2.5 ml of water for injections (approximately 330 mg/ml) or in 4 ml of a solution containing 0.5% lidocaine (approximately 250 mg/ml). Shake the vial well until the contents are completely dissolved and administer via deep intramuscular injection.

Intravenous use
Intravenous injection
Cefazolin Qilu 1 g should be injected slowly over a period of 3–5 minutes (never less than 3 minutes), directly into a vein or into an open intravenous infusion line.

Reconstitution table for intravenous injection

Cefazolina Qilu 2 g must be injected slowly over a period of 30–60 minutes.
Reconstitution table for intravenous injection
Content per vial Minimum volume of diluent to add Approximate concentration
2 g 5 ml 330 mg/ml

Intravenous infusion:
Cefazolina Qilu 1 g may be administered by continuous or intermittent infusion.
Cefazolina Qilu 1 g is dissolved in 2.5 ml of water for injections. After reconstitution, dilute the cefazolin solution with a volume of 50 ml to 100 ml of the following compatible solutions:

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

Cefazolina Qilu 2 g may be administered by continuous or intermittent infusion.
Cefazolina Qilu 2 g is dissolved in at least 5 ml of water for injections. After reconstitution, dilute the cefazolin solution with a volume of 50 ml to 100 ml of the following compatible solutions:

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