Document: leaflet MAH GENERIC_PL 08828-0193 change

• leaflet MAH GENERIC_PL 04416-0561
• leaflet MAH GENERIC_PL 04569-0975
• leaflet MAH GENERIC_PL 08828-0193
• leaflet MAH GENERIC_PL 39655-0003

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797107/02

Size before folding: 320 x 170 mm Size after folding:    107x42,5 mm

Colour:    black

Pharmacode:

Package Leaflet: Information for the user

cefTAZIDime 500 mg

powder for solution for injection

cefTAZIDime 1 g

powder for solution for injection

cefTAZIDime 2 g

powder for solution for injection/infusion

2. What you need to know before you use Ceftazidime

Do not use Ceftazidime:

•    if you are allergic to ceftazidime or any of the

other ingredients of this medicine (listedin 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.

—^{1 2} Talk to your doctor before you start on Ceftazidime if you think that this applies to you. You must not be given Ceftazidime.

Take special care with Ceftazidime

•    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. This will reduce the risk of possible problems. See ('Conditionsyou 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.

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.

Other medicines and Ceftazidime

Tell your doctor if you are using, have recently used or might use any other medicines.

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 and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

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

Ceftazidime 500 mg contains 1.1 mmol (26 mg) of sodium per vial of Ceftazidime.

Ceftazidime 1 g contains 2.3 mmol (52 mg) of sodium per vial of Ceftazidime.

Ceftazidime 2 g contains 4.6 mmol (104 mg) of sodium per vial of Ceftazidime.

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

3. How to use Ceftazidime

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

The recommended 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.

Text size: 6,7 pt

If you use more Ceftazidime than you should

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

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. Do not 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 further questions on the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine 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 (ieosinophilia)

•    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.

Reporting of side effects

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

You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Ceftazidime

■ 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 after EXP. The expiry date refers to the last day of that month.

•    Do not store above 25°C. Protect from light.

•    Once Ceftazidime powder is reconstituted into a solution, it should be used for 6h at 25°C and 12h at 5°C.

•    The solution should not be given if it is cloudy: it should be completely clear. Any unused solution should be thrown away.

•    Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Ceftazidime contains:

■    Ceftazidime 500 mg powder for solution

for    injection    contains    the    active    substance

ceftazidime (500 mg) as ceftazidime pentahydrate.

■    Ceftazidime    1 g powder for    solution

for    injection    contains    the    active    substance

ceftazidime (1 g) as ceftazidime pentahydrate.

■    Ceftazidime 2 g powder for solution for injection/infusion contains the active substance ceftazidime (2 g) as ceftazidime pentahydrate.

■    The    sodium content is    26    mg sodium per

Ceftazidime 500 mg, 52 mg sodium per Ceftazidime 1.0 g and 104 mg sodium per Ceftazidime 2.0 g. This should be considered if you are restricting or measuring your sodium (salt) intake. All powders contain sodium carbonate anhydrous.

What Ceftazidime looks like and contents of

the pack:

■    Ceftazidime powder is normally mixed with water for injection to make up a clear solution for injection or infusion. Once made up, your doctor may mix the Ceftazidime solution with other suitable fluids for infusion. Solutions can range from amber to light yellow in colour.

■    Ceftazidime 500 mg, 1 g and 2 g powder for solution for injection/infusion comes in packs containing 1 and 10 glass vials of powder, closed with a rubber stopper, aluminium cap and plastic flip-off cap.

■    Not all the pack sizes may be marketed.

Marketing Authorisation holder and manufacturer:

Marketing Authorisation Holder:

Fresenius Kabi Limited,

Cestrian Court, Eastgate Way,

Manor Park, Runcorn,

Cheshire, WA7 1NT

Manufacturer:

Labesfal - Laboratories Almiro S.A Lagedo, 3465 -157 Santiago de Besteiros, Portugal This medicinal product is authorised in the member states of the EEA under the following names:

Austria Ceftazidim Kabi 0,5g Pulver zur Hersteliung einer Injektionslosung

Ceftazidim Kabi 1g Pulver zur Hersteliung einer Injektionslosung

Ceftazidim Kabi 2g Pulver zur Hersteliung einer Injektionslosung Oder Infusionslosung Germany Ceftazidim Kabi 0,5 g Pulver zur Hersteliung einer Injektionslosung

Ceftazidim Kabi 1 g Pulver zur Hersteliung einer Injektionslosung

Ceftazidim Kabi 2 g Pulver zur Hersteliung einer Injektionslosung Oder Infusionslosung Belgium Ceftazidim Fresenius Kabi 500mg, poeder voor opiossing voor injectie

Ceftazidim fresenius Kabi 1000mg, poeder voor opiossing voor injectie.

Ceftazidim Fresenius Kabi 2000mg, poeder voor opiossing voor injectie/infusie Czech    Ceftazidime ig

Republic    Ceftazidim Kabi 2g

Denmark    Ceftazidim Fresenius Kabi

Estonia Ceftazidime Fresenius Kabi 500 mg Ceftazidime Fresenius Kabi 1000 mg Ceftazidime Fresenius Kabi 2000 mg Greece Ceftazidime Fresenius Kabi 1000mg, xdvig yia evioipo SidAupa

Ceftazidime 2000mg, xdvig yia SidAupa rrpog fveoq/tyxuaq

Finland    Ceftazidim Fresenius    Kabi    1    g    injektiokuiva-

aine, liuosta varten

Ceftazidim Fresenius Kabi 2 g injektio-/ infuusiokuiva-aine, liuosta varten Hungary    Ceftazidim Kabi 1 g

Ceftazidim Kabi 2 g por oldatos injekeioboz / infuziohoz

Latvia    Ceftazidime Fresenius    Kabi 500    mg

Ceftazidime Fresenius Kabi 1000 mg Ceftazidime Fresenius Kabi 2000 mg Luxemburg Ceftazidim Kabi 0,5 g Pulver zur Hersellung einer Injektionslosung

Ceftazidim Kabi 1 g Pulver zur Hersellung einer Injektionslosung

Ceftazidim Kabi 2 g Pulver zur Hersteliung einer Injektionslosung Oder Infusionslosung

Lithuania Ceftazidime 500 mg Ceftazidime 1000 mg Ceftazidime 2000 mg

Netherlands Ceftazidim Kabi 500mg, poeder voor opiossing voor injectie.

Ceftazidim Kabi lOOOmg, poeder voor opiossing voor injectie.

Ceftazidim Fresenius Kabi2000mg, poeder voor opiossing voor injectie/infusie

Norway    Ceftazidim Fresenius Kabi 500 mg pulver til

infusjonsvaeske, oppl0sning Ceftazidim Fresenius Kabi Ig Pulver til injeksjonsvaeske, opplosning Ceftazidim Fresenius    Kabi    2g,    pulver    til

injeksjons-/infusjonsvasske,oppl0sning Poland    Ceftazidime Kabi

Portugal    Ceftazidime Kabi

Slovenia    Ceftazidim Fresenius    1000    mg    prasek    za

pripravo injekeij ali infuzij;

Ceftazidim Fresenius 2000mg Prasek za raztopino za injiciranje ali infundiranje Slovakia    Ceftazidime Ig

Ceftazidim Kabi 2g Spain    Ceftazidima Kabi 2g

UK    Ceftazidime 0,5 g

Ceftazidime 1 g Ceftazidime 2 g

This leaflet was revised in 07/2014

The following information is intended for medical or healthcare professionals only:

This medicinal product is for single use only. Discard any unused contents.

Intravenous use - injection:

For direct intermittent intravenous administration, ceftazidime should be reconstituted with water for injections (see table below). The solution has to be injected slowly directly into the vein over a period of up to 5 minutes or given through the tubing of a giving set.

intramuscular use (for 500 mg and 1000mg): Ceftazidime should be reconstituted with water for injections or Lidocaine Hydrochloride 10 mg/mi (1%) solution for injection as indicated in the table below. Information for Lidocaine should be consulted before reconstitution of ceftazidime with lidocaine.

Intravenous use - infusion (see section 3):

For intravenous infusion, the content of the 2 g infusion vial should be reconstituted with 10 ml of water for injections (for bolus) and 50 mi of water for injections (intravenous infusion) or one of the compatible intravenous fluids. Administer by intravenous infusion over 15-30 minutes. Intermittent intravenous infusion with a Y-type giving set can be accomplished with compatible solutions. However, during infusion of a solution containing ceftazidime, it is desirable to discontinue the other solution.

Ail sizes of vials of Ceftazidime 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 constitution

Preparation of solutions of Ceftazidime for use in children

Neonates and infants < 2 months Intermittent intravenous injection Posology: 25 to 60 mg/kg/day in two divided doses

Please consider that no more than 6 g (equivalent to 150 ml) should be given per day

Compatible intravenous fluids:

At ceftazidime concentrations between 90 mg/ml and 260 mg/ml for Ceftazidime 500 mg, 90 mg/ml and 260 mg/ml for Ceftazidijme 1 g and 40 mg/ml and 170 mg/ ml for Ceftazidime 2g, the Ceftazidime powders for injection may be mixed in commonly used solutions for infusion:

-    sodium chloride 9 mg/ml (0.9%) solution (physiological saline solution),

-    Ringer Lactate Solution

-    Glucose 100 mg/ml (10%) solution

When reconstituted for intramuscular use, the Ceftazidime powder for injection can also be diluted with lidocaine 10 mg/ml (1%) solutions.

When ceftazidime is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use, the recommended techniques of reconstitution described below should be followed.

Instructions for reconstitution:

For 500mg MIN and 1g IM/IV Preparation of solutions for bolus injection

1.    Insert the syringe needle through the vial closure and inject the recommended volume of diluent. The vacuum may assist entry of the diluent. Remove the syringe needle.

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

3.    invert the 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. The withdrawn solution may contain small bubbles of carbon dioxide; they may be disregarded.

These solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids. Ceftazidime is compatible with above mentioned intravenous fluids.

For 2g infusion vials

Preparation of solutions for iv infusion from ceftazidime injection in standard vial presentation (minibag or burette-type set):

1.    Introduce the syringe needle through the vial closure and inject 10 ml of diluent.

2.    Withdraw the needle and shake the vial to give a clear solution.

3.    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.

4.    Transfer the reconstituted solution to final delivery vehicle (e.g. mini-bag or burette-type set) making up a total volume of at least 50 ml and administer by intravenous infusion over 15 to 30 min.

NOTE: To preserve product sterility, it is important that a gas relief needle is not inserted through the vial closure before the product has dissolved.

For single use only.

Reconstituted solution: Chemical and physical in use stability has been demonstrated up to 6 h at 25°C and 12 h at 5°C after reconstitution of the product with water for injection, 1 % lidocain solution, 0.9 % sodium chloride solution, ringer lactate and 10 % glucose solution. From a microbiological point of view, the product should be used immediately".

Discard any unused solution in accordance with local requirements.

The dilution is to be made under aseptic conditions.

The solution is to be inspected visually for particulate matter and discoloration prior to administration.

The solution should only be used if the solution is clear and free from particles.

Solutions range 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.

FRESENIUS

KABI

1

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 nurse.

•    If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Ceftazidime is and what it is used for

2.    What you need to know before you use Ceftazidime

3.    How to use Ceftazidime

4.    Possible side effects

5.    How to store Ceftazidime

6.    Contents of the pack and other information

1. What Ceftazidime 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

2

   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.