Ceftazidime Qilu

PACKAGE LEAFLET

Package leaflet: Information for the patient

Ceftazidime Qilu 500 mg powder for injectable solution, 1 g powder for injectable/infusion solution, 2 g powder for injectable/infusion solution

ceftazidime
The name of your medicine is Ceftazidime Qilu 500 mg powder for injectable solution and Ceftazidime Qilu 1 g and 2 g powder for injectable/infusion solution, which will be referred to as "ceftazidime" throughout the rest of this document.
Please read this leaflet carefully before receiving this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet

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

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

Ceftazidime is an antibiotic used in adults and children (including newborns).
It works by killing the bacteria that cause infections. It belongs to a group of medicines called
cephalosporins.
Ceftazidime is used to treat serious bacterial infections of:

• lungs or chest
• lungs and bronchi in patients with cystic fibrosis
• brain (meningitis)
• ear
• urinary tract
• skin and soft tissues
• abdomen and abdominal wall (peritonitis)
• bones and joints.

Ceftazidime may also be used:

• to prevent infections during prostate surgery in men
• to treat patients with a low number of white blood cells (neutropenia) who have fever due to a bacterial infection.

2. What you should know before being given Ceftazidime Qilu

Ceftazidime must not be administered to you if:

• you are allergic to ceftazidime or to any of the other ingredients of this medicine (listed in section 6).
• you have previously experienced a severe allergic reaction to any other antibiotic (penicillins, monobactams, or carbapenems), as you may also be allergic to ceftazidime.

→ Inform your doctor before being given Ceftazidime Qilu if you think this applies to you. In such a case, this medicine must not be administered to you.

Warnings and precautions

Talk to your doctor or nurse before being given Ceftazidime Qilu:

Be alert for certain symptoms such as allergic reactions, nervous system disorders, and gastrointestinal disturbances such as diarrhoea while being treated with this medicine. This will reduce the risk of potential problems. See "Conditions to which you should pay attention" in section 4. If you have had an allergic reaction to other antibiotics, you may also be allergic to ceftazidime.

If you need blood or urine tests

Ceftazidime may affect the results of urine sugar tests and of a blood test known as the Coombs test. If you are undergoing these tests:

→ Inform the person taking the sample that you have been treated with Ceftazidime Qilu.

Other medicines and Ceftazidime Qilu

Inform your doctor if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription.

Ceftazidime must not be administered to you without first consulting your doctor if you are also taking:

• an antibiotic called chloramphenicol
• a type of antibiotics known as aminoglycosides, for example gentamicin, tobramycin
• diuretic tablets called furosemide → Inform your doctor if this applies to you.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, ask your doctor for advice before taking this medicine.

Your doctor will weigh the benefits of treatment with ceftazidime against the potential risks to the baby.

Driving and using machines

This medicine may cause side effects that could affect your ability to drive, such as dizziness. Do not drive or operate machinery unless you are certain you are not affected.

Ceftazidime Qilu contains sodium

This should be taken into consideration if you are on a low-sodium diet.

Dosage of Ceftazidime Qilu Amount per vial

Ceftazidime Qilu 500 mg: This medicine contains 28 mg of sodium (the main component of table/cooking salt) in each vial.
This amount corresponds to 1.4% of the maximum daily sodium intake recommended for an adult.

Ceftazidime Qilu 1 g: This medicine contains 56 mg of sodium (the main component of table/cooking salt) in each vial.
This amount corresponds to 2.8% of the maximum daily sodium intake recommended for an adult.

Ceftazidime Qilu 2 g: This medicine contains 111 mg of sodium (the main component of table/cooking salt) in each vial.
This amount corresponds to 5.55% of the maximum daily sodium intake recommended for an adult.

3. How Ceftazidime Qilu is administered

Ceftazidime Qilu is generally administered by a doctor or a nurse.
Ceftazidime Qilu 500 mg can be given by intravenous injection or by deep intramuscular injection.
Ceftazidime Qilu 1 g can be given by intravenous injection or by deep intramuscular injection.
Ceftazidime Qilu 2 g can be given by intravenous injection or by infusion.
Ceftazidime Qilu is prepared by the doctor, pharmacist, or nurse using water for injections or an appropriate infusion fluid.

Recommended dose
The appropriate dose of ceftazidime will be decided by your doctor and depends on: the severity and type of infection; whether you are being treated with other antibiotics; your body weight and age; and the condition of your kidneys.

Newborns (0–2 months)
For each kg of the child's body weight, 25 to 60 mg of ceftazidime per day will be administered, divided into two doses.

Infants (over 2 months) and children weighing less than 40 kg
For each kg of the child's body weight, 100 to 150 mg of ceftazidime per day will be administered, divided into three doses. The maximum dose is 6 g per day.

Adults and adolescents weighing 40 kg or more
1 to 2 g of ceftazidime three times daily. The maximum dose is 9 g per day.

Patients over 65 years of age
The daily dose should generally not exceed 3 g per day, especially if over 80 years of age.

Patients with kidney problems
You may be given a different dose than usual. The doctor or nurse will determine how much Ceftazidime Qilu you need based on the severity of your kidney disease. Your doctor will monitor you closely and may perform regular kidney function tests at regular intervals.

If you are given more Ceftazidime Qilu than you should
If you think you have accidentally been given more than the prescribed dose, contact your doctor or the nearest hospital immediately.

If you forget to use Ceftazidime Qilu
If you miss an injection of this medicine, it should be given as soon as possible. Do not take a double dose (two injections at the same time) to make up for a missed dose.

If you stop treatment with Ceftazidime Qilu
Do not stop treatment with Ceftazidime Qilu unless instructed to do so by your doctor.
If you have any doubts about how to use this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

Conditions to be aware of
The following serious side effects have occurred in a small number of people (their exact frequency is unknown):

• Severe allergic reaction. Signs include: raised, itchy rash, swelling, sometimes of the face or mouth, causing difficulty in breathing.
• Skin rash that may present with blisters appearing as small target-like spots (dark spots in the center surrounded by a lighter area, with a dark ring around the edge).
• Widespread rash with blisters and peeling of the skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).
• Nervous system disorders: tremors, seizures, and in some cases coma. These have occurred in people who were given too high a dose, especially in those with kidney disease.
• There have been rare reports of severe hypersensitivity reactions with severe rash, which may be accompanied by fever, fatigue, facial swelling or swollen lymph nodes, increased eosinophils (a type of white blood cells), and effects on the liver, kidneys, or lungs (a reaction known as DRESS).

→ Contact a doctor or nurse immediately if you experience any of these symptoms.

Other side effects:
Common: may affect up to 1 in 10 people

• diarrhoea
• swelling and redness along a vein
• raised red rash which may be itchy
• pain, burning, swelling or inflammation at the injection site.

→ Inform your doctor if any of these affect you.

Common side effects that may be detected by blood tests are:

• increase in a type of white blood cells (eosinophilia)
• increase in the number of cells involved in blood clotting
• increase in liver enzymes.

Uncommon: may affect up to 1 in 100 people

• inflammation of the intestine which may cause pain or diarrhoea that may contain blood
• candidiasis (fungal infections in the mouth or vagina)
• headache
• dizziness
• stomach pain
• nausea or vomiting
• fever and chills.

→ Inform your doctor if you experience any of these conditions.

Uncommon side effects that may be detected by blood tests are:

• decrease in the number of white blood cells
• decrease in the number of platelets (cells involved in blood clotting)
• increase in blood levels of urea, blood nitrogen, or serum creatinine.

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

• inflammation or kidney failure

Not known: frequency cannot be estimated from the available data

• inflammation or kidney failure
• sensation of pins and needles
• unpleasant taste in the mouth
• yellowing of the whites of the eyes or skin.

Side effects with unknown frequency that may be detected by blood tests are:

• too rapid destruction of red blood cells
• increase in a certain type of white blood cells
• severe decrease in the number of white blood cells.

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

5. How to store Ceftazidime 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 and carton after "Exp.". The expiry date refers to the last day of that month.
• Store below 25 °C.
• Keep the vials in the outer packaging to protect them from light.
• Reconstituted and diluted solution: Your doctor, pharmacist, or nurse will prepare your medicine using water for injections or compatible infusion liquids.
• Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C - 8 °C and for 2 hours at 25 °C.
• From a microbiological point of view, 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.
• Do not dispose of any medicine via wastewater or household waste. Your doctor or nurse will dispose of any unused medicine. This will help protect the environment.

6. Package contents and other information

What Ceftazidima Qilu contains

• Ceftazidima Qilu is available in the following strengths: 2 g, 1 g and 500 mg. The active substance is ceftazidime 2 g, 1 g or 500 mg (present as ceftazidime pentahydrate).
• The only other ingredient is sodium carbonate. See section 2 for further important information about sodium, one of the components of Ceftazidima Qilu.

Description of the appearance of Ceftazidima Qilu and package contents
Ceftazidima Qilu 500 mg powder for solution for injection is a sterile crystalline powder, white or almost white, contained in a 15 ml glass vial with a butyl rubber stopper and an aluminium seal.
Available in packs of 1, 10 or 50 vials.
Ceftazidima Qilu 1 g powder for solution for injection is a sterile crystalline powder, white or almost white, contained in a 15 ml glass vial with a butyl rubber stopper and an aluminium seal.
Available in packs of 1, 10 or 50 vials.
Ceftazidima Qilu 2 g powder for solution for injection is a sterile crystalline powder, white or almost white, contained in a 50 ml glass vial with a butyl rubber stopper and an aluminium seal.
Available in packs of 1, 10 or 50 vials.
Not all pack sizes may be marketed.
Your doctor, pharmacist or nurse will prepare the injection solution or infusion solution using water for injection or an appropriate infusion fluid. Once prepared, the colour of Ceftazidima Qilu may range from pale yellow to amber. This is perfectly normal.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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 Fatjó,
7B (Parque Tecnológico del Vallès),
Cerdanyola del Valles, 08290,
Barcelona, Spain

This medicinal product is authorised in EEA Member States under the following names:
Ceftazidime 500 mg powder for solution for injection
UK Ceftazidime 1 g powder for solution for injection/infusion
Ceftazidime 2 g powder for solution for injection/infusion
Ceftazidim Qilu 500 mg Pulver zur Herstellung einer Injektionslösung
DE Ceftazidim Qilu 1 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Ceftazidim Qilu 2 g Pulver zur Herstellung einer Injektions-/Infusionslösung
Ceftazidima Qilu 500 mg polvo para solucion inyectable
ES Ceftazidima Qilu 1 g polvo para solución inyectable y para perfusión
Ceftazidima Qilu 2 g polvo para solución inyectable y para perfusión
CEFTAZIDIME QILU 500 mg, poudre pour solution injectable (IM, IV)
FR CEFTAZIDIME QILU 1 g, poudre pour solution injectable (IM, IV)
CEFTAZIDIME QILU 2 g, poudre pour solution injectable (IM, IV)
IT Ceftazidima Qilu
Ceftazidim Qilu 500 mg pulver till injektionsvätska, lösning
SE Ceftazidim Qilu 1 g pulver till injektions-/infusionsvätska, lösning
Ceftazidim Qilu 2 g pulver till injektions-/infusionsvätska, lösning
<------------------------------------------------------------------------------------------------------------------------>
The following information is intended exclusively for healthcare professionals:
Ceftazidima Qilu 500 mg powder for solution for injection
Ceftazidima Qilu 1 g powder for solution for injection/infusion
Ceftazidima Qilu 2 g powder for solution for injection/infusion
ceftazidime
For further information, refer to the Summary of Product Characteristics

After reconstitution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C - 8 °C and for 2 hours at 25 °C in water for injection or in the compatible diluents listed below.
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.

After dilution:
Chemical and physical in-use stability has been demonstrated for 24 hours at 2 °C - 8 °C and for 2 hours at 25 °C in water for injection or in the compatible diluents listed below.
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.

Special precautions for storage
Store below 25 °C.
Keep vials in the outer packaging to protect from light.

Special precautions for disposal and handling
When the product dissolves, carbon dioxide is released and positive pressure develops.
Small bubbles of carbon dioxide in the reconstituted solution can be disregarded.

Instructions for reconstitution
See Table 1 and Table 2 for volumes to be added and resulting concentrations, which may be useful if fractional doses are required.
Table 1: Powder for solution for injection

Note:

• The resulting volume of the ceftazidime solution in the reconstitution medium increases due to the displacement factor of the medicinal product, resulting in the concentrations listed in mg/ml shown in the table above.

Table 2: Powder for solution for infusion

* Addition must be performed in two steps.
Note:

• The resulting volume of the ceftazidime solution in the reconstitution medium increases due to the displacement factor of the medicinal product, resulting in the concentrations listed in mg/ml shown in the table above.

The color of solutions may vary from pale yellow to amber, depending on the concentration, type of diluent, and storage conditions used. Within the recommendations provided, such color variations do not impair the product's activity.
Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:

• Sodium chloride 9 mg/ml (0.9%) injection solution
• Sodium lactate M/6 for injectable preparations
• Compound sodium lactate for injectable preparations (Hartmann's solution)
• Glucose 50 mg/ml (5%) for injectable preparations
• Sodium chloride 2.25 mg/ml (0.225%) and glucose 50 mg/ml (5%) for injectable preparations
• Sodium chloride 4.5 mg/ml (0.45%) and glucose 50 mg/ml (5%) for injectable preparations
• Sodium chloride 9 mg/ml (0.9%) and glucose 50 mg/ml (5%) for injectable preparations
• Sodium chloride 1.8 mg/ml (0.18%) and glucose 40 mg/ml (4%) for injectable preparations
• Glucose 100 mg/ml (10%) for injectable preparations
• Dextran 40 100 mg/ml (10%) for injectable preparations in sodium chloride 9 mg/ml (0.9%) for injectable preparations
• Dextran 40 100 mg/ml (10%) for injectable preparations in glucose 50 mg/ml (5%) for injectable preparations
• Dextran 70 60 mg/ml (6%) for injectable preparations in sodium chloride 9 mg/ml (0.9%) for injectable preparations
• Dextran 70 60 mg/ml (6%) for injectable preparations in glucose 50 mg/ml (5%) for injectable preparations

Ceftazidime at concentrations between 0.05 mg/ml (0.005%) and 0.25 mg/ml (0.025%) is compatible with lactate solution for intraperitoneal dialysis.
Ceftazidime at the concentrations listed in Table 1 may be reconstituted for intramuscular use with lidocaine hydrochloride 5 mg/ml (0.5%) or 10 mg/ml (1%) for injectable preparations.
The contents of a 500 mg vial of Ceftazidima Qilu, reconstituted with 1.5 ml of water for injections, may be added to solutions of metronidazole for injectable preparations (500 mg in 100 ml), and both retain their activity.
500 mg powder for injectable solution, 1 g, 2 g powder for injectable solution or infusion:
THIS SECTION WILL BE ILLUSTRATED BY PICTOGRAMS, AS PER PREVIOUS GRAPHIC
Preparation of solution for bolus injection

1. Insert the needle of the syringe through the closure of the vial and inject the recommended amount of diluent. Remove the syringe needle.

2. Shake to dissolve: carbon dioxide is released and a clear solution will be obtained within 1–2 minutes.

3. Turn the vial. With the syringe plunger fully depressed, insert the needle through the closure of the vial and withdraw the total volume of solution into the syringe (the pressure in the vial may assist withdrawal). Ensure that the needle remains within the solution and does not enter the headspace. The withdrawn solution may contain small bubbles of carbon dioxide; these may be disregarded.

These solutions may be administered directly intravenously or introduced into the tubing of an infusion set if the patient is receiving parenteral fluids. Ceftazidime is compatible with the intravenous infusion fluids listed above.
1 g, 2 g powder for injectable solution / for infusion:
Preparation of intravenous infusion solutions from Ceftazidima Qilu in standard vial presentation (mini bags or burette-type infusion sets):
Prepare the solution using a total volume of compatible diluent (from those listed above) of 50 ml (for 1 g and 2 g vials), added in TWO steps, as follows.

1. Insert the needle of the syringe through the closure of the vial and inject 10 ml of diluent for both 1 g and 2 g vials.
2. Withdraw the needle and shake the vial to obtain a clear solution.
3. Do not insert a needle to vent gas before the product has dissolved. Insert a venting needle through the closure of the vial to release internal pressure.
4. Transfer the reconstituted solution into the final administration device (e.g., mini bag or burette-type infusion set), preparing a total volume of at least 50 ml, and administer by intravenous infusion over 15 to 30 minutes.

Note: To maintain product sterility, it is important that the venting needle is not inserted through the closure of the vial before the product has fully dissolved.
Any remaining antibiotic solution must be discarded.
For single use only.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.