ceftazidime 500 mg POWDER FOR SOLUTION FOR INJECTION ceftazidime 1 g POWDER FOR SOLUTION FOR INJECTION OR INFUSION

CEFTAZIDIME 2 g POWDER FOR SOLUTION FOR INJECTION OR INFUSION

(ceftazidime)

The following information is intended for healthcare professionals only:

Chemical and physical in-use stability after reconstitution/dilution in the following reconstitution /dilution solutions:

•    water for injections

•    0.9% sodium chloride solution

•    10% glucose solution

•    10% dextrans solution

•    sodium lactate solution

has been demonstrated for 4 hours at a temperature not exceeding 25°C or for 24 hours between 2°C and 8°C.

However, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution has been taken place in controlled and validated aseptic conditions.

All sizes of vials of Ceftazidime Injection are supplied under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. Small bubbles of carbon dioxide in the constituted solution may be ignored.

Instructions for reconstitution

See table for addition volumes and solution concentrations, which may be useful when fractional doses are required.

*Note: Addition should be in two stages.

Solutions range in colour from light yellow to amber depending on concentration, diluent and storage conditions used. Within the stated recommendations, product potency is not adversely affected by such colour variations.

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PACKAGE LEAFLET: INFORMATION FOR THE USER CEFTAZIDIME 500 mg, POWDER FOR SOLUTION FOR INJECTION CEFTAZIDIME 1 g , 2 g POWDER FOR SOLUTION FOR INJECTION OR INFUSION

(ceftazidime)

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 further questions, ask your doctor or pharmacist or nurse.

•    If you get any of the side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

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

2.    What you need to know before you use Ceftazidime Injection.

3.    How to use Ceftazidime Injection.

4.    Possible side effects.

5.    How to store Ceftazidime Injection.

6.    Contents of the pack and other information.

1.    WHAT CEFTAZIDIME INJECTION IS AND WHAT IT IS USED FOR

Ceftazidime is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins.

Ceftazidime is used to treat severe bacterial infections of:

•    the lungs or chest

•    the lungs and bronchi in patients suffering from cystic fibrosis

•    the brain (meningitis)

•    the ear

•    the urinary tract

•    the skin and soft tissues

•    the abdomen and abdominal wall (peritonitis)

•    the bones and joints.

Ceftazidime can also be used:

•    to prevent infections during prostate surgery in men

•    to treat patients with low white blood cell counts (neutropenia) who have a fever due to a bacterial infection.

2.    WHAT DO YOU NEED TO KNOW BEFORE YOU USE CEFTAZIDIME INJECTION

Do not use Ceftazidime Injection:

•    If you are allergic (hypersensitive) to ceftazidime or any of the other ingredients of this medicine (listed in Section 6).

•    If you have had a severe allergic reaction to any other antibiotic (penicillins, monobactams and carbapenems) as you may also be allergic to Ceftazidime Injection.

Tell your doctor before you start on Ceftazidime Injection if you think that this applies to you. You must not be given Ceftazidime Injection.

Warnings and precautions

You must look out for certain symptoms such as allergic reactions, nervous system disorders and gastrointestinal disorders such as diarrhoea while you are being given Ceftazidime Injection. This will reduce the risk of possible problems. See ('Conditions you need to look out for') in Section 4. If you have had an allergic reaction to other antibiotics you may also be allergic to Ceftazidime Injection.

If you need a blood or urine test

Ceftazidime can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:

Tell the person taking the sample that you have been given Ceftazidime Injection.

Other medicines and Ceftazidime

Tell your doctor if you are taking any other medicines, if you've started taking any recently or you start taking new ones. This includes medicines you can obtain without a prescription.

You shouldn't be given Ceftazidime without talking to your doctor if you are also taking:

•    an antibiotic called chloramphenicol

•    a type of antibiotic called aminoglycosides e.g. gentamicin, tobramycin

•    water tablets called furosemide.

Tell your doctor if this applies to you.

Pregnancy and breast-feeding

Tell your doctor before you are given Ceftazidime:

•    if you are pregnant, think you might be pregnant or are planning to become pregnant

•    if you are breast-feeding.

Your doctor will consider the benefit of treating you with Ceftazidime against the risk to your baby.

Driving and using machines

Ceftazidime can cause side effects that affect your ability to drive, such as dizziness.

Don't drive or use machines unless you are sure you're not affected.

Ceftazidime contains sodium

You need to take this into account if you are on a controlled sodium diet.

3. HOW TO USE CEFTAZIDIME INJECTION

Ceftazidime Injection is usually given by a doctor or nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.

Ceftazidime Injection is made up by the doctor, pharmacist or nurse using water for injections or a suitable infusion fluid.

The usual dose

The correct dose of Ceftazidime for you will be decided by your doctor and depends on: the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys are working.

Newborn babies (0-2 months)

For every 1 kg the baby weighs, they'll be given 25 to 60 mg Ceftazidime per day divided in two doses.

Babies (over 2 months) and children who weigh less than 40 kg

For every 1 kg the baby or child weighs, they'll be given 100 to 150 mg of Ceftazidime per day divided in three doses. Maximum 6 g per day.

Adults and adolescents who weigh 40 kg or more

1 to 2 g of Ceftazidime three times daily. Maximum of 9 g per day.

Patients over 65

The daily dose should not normally exceed 3 g per day, especially if you are over 80 years of age.

Patients with kidney problems

You may be given a different dose to the usual dose. The doctor or nurse will decide how much Ceftazidime you will need, depending on the severity of the kidney disease. Your doctor will check you closely and you may have more regular kidney function tests.

If you use more Ceftazidime Injection than you should

If you accidentally use more than your prescribed dose, contact your doctor or nearest hospital straight away.

Preparation for direct administration for 500 mg IM-IV, 1 g IM-IV and 2 g IV

The following reconstitution guidelines should be followed:

1.    Insert the syringe needle through the original vial closure and inject the recommended volume of diluent.

The vacuum may assist entry of the diluent.

2.    Remove the syringe needle.

3.    Shake the original vial to dissolve the content. CO2 is released and a clear solution will be obtained in about 1 to 2 minutes.

4.    Invert the original vial. With the syringe plunger fully depressed, insert the needle through the vial closure and withdraw the total volume of solution into the syringe (the pressure in the vial may aid withdrawal). Ensure that the needle remains within the solution and does not enter the head space.

5.    The withdrawn solution may contain small bubbles of carbon dioxide; they may be disregarded.

For intravenous injection, the solution must be administered directly into the vein or introduced into the tubing

of the giving set if the patient is receiving parenteral fluid.

For intramuscular injection, the solution should be administered deeply into a large muscle mass, such as the

upper outer quadrant of the gluteus maximus or lateral part of the thigh.

Preparation for administration of 2 g vials by infusion

This vial may be constituted for short intravenous infusion (e.g. up to 30 minutes).

Prepare using a total of 50 ml of compatible diluent, added in two stages as below:

1.    Insert the syringe needle through the vial closure and add 10 ml of diluent. The vacuum may assist entry of the diluent.

2.    Remove the syringe needle.

3.    Shake the original vial to dissolve the content. CO2 is released and a clear solution will be obtained in about 1 to 2 minutes.

4.    Do not insert a gas relief needle until the product has dissolved. Insert a gas relief needle through the vial closure to relieve the internal pressure.

5.    Transfer the reconstituted solution to the final delivery vehicle, making up to a total volume of at least 50 ml, and administer by intravenous infusion over 15-30 minutes.

Reconstitution for 1 g and 2 g vials with a transfer cap

For use with transfer cap, the 1 g presentation must be constituted in not less than 50 ml infusion bag and the 2 g

presentation must be constituted in not less than 100 ml infusion bag to allow release of the gas.

1.    Position and fit the transfer cap on ceftazidime original vial in aseptic conditions on a plane surface.

2.    Adapt the set (transfer cap + original vial) on the injection site of the infusion bag in oblique position (vial at the top with regard to the bag).

3.    Push the injection site of the bag up to the end of the needle of the transfer cap.

4.    Invert the set group (vial down). Press the bag 2-3 times to fill the solution in about 3/4 of the vial volume for the 1 g presentation and in about 1/5 of the vial volume for the 2 g presentation.

5.    Shake the system (vial + transfer cap + bag), to dissolve the vial content. To avoid leaks, maintain the system (vial + transfer cap + bag) tightly together

6.    Invert again the system (vial on the top). Transfer the reconstituted solution into the infusion bag by squeezing and releasing the bag. If needed, repeat the previous steps in order to have well dissolved content of the vial into the bag.

7.    Remove slowly and carefully, the transfer cap and the vial from the injection site of the bag, in oblique position (vial at the top).

Single use only.

Unused solution should be discarded.

Only clear solutions practically free from particles should be used.

Any unused product or waste material should be disposed of in accordance with local requirements.

This leaflet was last revised in: November 2011    EVQ 10003599 I.107114-A

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If you forget to use Ceftazidime

If you miss an injection, you should have it as soon as possible. However, if it is almost time for your next injection, skip the missed injection. Don't take a double dose (two injections at the same time) to make up for a missed dose.

If you stop using Ceftazidime

Don't stop taking Ceftazidime unless your doctor tells you to. If you have any questions ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Ceftazidime Injection can cause side effects, although not everybody gets them.

Conditions you need to look out for

The following serious side effects have occurred in a small number of people but their exact frequency is unknown:

•    Severe allergic reaction. Signs include raised and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing.

•    Skin rash, which may blister, and looks like small targets (central dark spot surrounded by a paler area, with a dark ring around the edge).

•    A widespread rash with blisters and peeling skin. (These may be signs of Stevens-Johnson syndrome or toxic epidermal necrolysis).

•    Nervous system disorders: tremors, fits and, in some cases coma. These have occurred in people when the dose they are given is too high, particularly in people with kidney disease.

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

Common side effects

These may affect up to 1 in 10 people:

•    diarrhoea

•    swelling and redness along a vein

•    red raised skin rash which may be itchiness

•    pain, burning, swelling or inflammation at the injection site.

Tell your doctor if any of these are troubling you.

Common side effects that may show up in blood tests:

•    an increase in a type of white blood cell (eosinophilia)

•    an increase in the number of cells that help the blood to clot

•    an increase in liver enzymes.

Uncommon side effects

These may affect up to 1 in 100 people:

•    inflammation of the gut which can cause pain or diarrhoea which may contain blood

•    thrush (fungal) infections in the mouth or vagina

•    headache

•    dizziness

•    stomach ache

•    feeling sick or being sick

•    fever and chills.

Tell your doctor if you get any of these.

Uncommon side effects that may show up in blood tests:

•    a decrease in the number of white blood cells

•    a decrease in the number of blood platelets (cells that help the blood to clot)

•    an increase in the level of urea, urea nitrogen or serum creatinine in the blood.

Other side effects

Other side effects have occurred in a small number of people but their exact frequency is unknown:

•    inflammation or failure of the kidneys

•    pins and needles

•    unpleasant taste in the mouth

•    yellowing of the whites of the eyes or skin.

Other side effects that may show up in blood tests:

•    red blood cells destroyed too quickly

•    an increase in a certain type of white blood cells

•    severe decrease in the number of white blood cells.

If you get side effects

Tell your doctor or pharmacist if any of the side effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

5.    HOW TO STORE CEFTAZIDIME INJECTION

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

No special storage conditions. Keep the container in the outer packaging in order to protect from light.

Do not use Ceftazidime Injection after the expiry date which is stated on the carton or vial.

After reconstitution

The medicinal product is for single use only.

Any unused solution should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Ceftazidime Injection contains

Ceftazidime 500 mg: each vial contains the active ingredient, ceftazidime pentahydrate, equivalent to 500 mg of ceftazidime, as a powder for solution for injection (quick administration).

Ceftazidime 1 g: each vial contains the active ingredient, ceftazidime pentahydrate, equivalent to

1    g of ceftazidime, as a powder for solution for injection (quick administration) or infusion (slow administration).

Ceftazidime 2 g: each vial contains the active ingredient, ceftazidime pentahydrate, equivalent to

2    g of ceftazidime, as a powder for solution for injection (quick administration) or infusion (slow administration).

The other ingredient is: sodium carbonate.

Please refer to the the last paragraph of section 2 'What you need to know before you use Ceftazidime Injection' for important information about the ingredient.

What Ceftazidime Injection 500 mg looks like and contents of the pack

This medicine is a powder for solution for injection.

Vial of 500 mg of powder. Pack of 1,5, 10, 25 or 50 vials. Not all pack sizes may be marketed.

What Ceftazidime Injection 1 g looks like and contents of the pack:

This medicine is a powder for solution for injection or infusion.

Vial of 1 g of powder. Pack of 1,5, 10, 25 or 50 vials.

Not all pack sizes may be marketed.

What Ceftazidime Injection 2 g looks like and contents of the pack

This medicine is a powder for solution for injection or infusion.

Vial of 2 g of powder. Pack of 1,5, 10, 25 or 50 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturer

Laboratorio Farmaceutico C.T. S.r.l., Via Dante Alighieri, 71 - 18038 SANREMO - IM , ITALY. or

MYLAN S.A.S., 117 allee des Parcs, 69800 SAINT-PRIEST, FRANCE.

This leaflet was last revised in: November 2011 EVQ 10003599 I.107114-A