Front

110 mm

82,5 mm

1 mm 9 mm 1 mm

Package leaflet: Information for the patient

Ceftazidime 1 g powder for solution for injection / infusion Ceftazidime 2 g

powder for solution for injection / infusion

Ceftazidime

-i=i O CD O

45 mm

LULU 009

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.

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 cephalosporin.

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 YOU NEED TO KNOW BEFORE YOU USE CEFTAZIDIME Do not use Ceftazidime:

-    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.

Warnings and precautions

Talk to your doctor or nurse before using 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 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. This includes medicines that you have bought 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

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.

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

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 is:

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.

Use in children:

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 are given more Ceftazidime than you should

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

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The following information is intended for healthcare professionals only:

In-use storage conditions

After reconstitution and further dilution, the drug product should be used immediately.

Special precautions for disposal and other handling

All 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 reconstitution/dilution:

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 may 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.

Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with the following solutions for injection:

-    0.9% sodium chloride

-    0.9% sodium chloride and 5% dextrose

-    10% dextrose

Ceftazidime may be reconstituted for intramuscular use with 0.5% or 1% Lidocaine Hydrochloride solution for injection, obtained solutions should be used immediately after preparation

Reverse

110 mm

11 mm

LULU 009

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, 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 (up to 1 in 10 people are affected)

•    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 (up to 1 in 100 people are affected)

•    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 or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system:

Yellow Card Scheme

Website: 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 and carton after EXP.

Store below 25°C.

Before reconstitution store in the original carton in order to protect from light.

The hospital will keep Ceftazidime according to the correct storage conditions, and will ensure that it will be used within its validity.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Ceftazidime contains

-    The active substance is ceftazidime.

Ceftazidime 1 g

Each vial contains ceftazidime 1 g (as pentahydrate).

Ceftazidime 2 g

Each vial contains ceftazidime 2 g (as pentahydrate).

-    The other ingredient is sodium carbonate.

What Ceftazidime looks like and contents of the pack

Ceftazidime is a white or pale yellow powder. It is available in glass vials (1 or 10 vials per pack).

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Hikma Farmaceutica (Portugal), S.A.

Estrada do Rio da Mo, n°8, 8A, 8B, Fervenga

2705-906 Terrugem SNT

Portugal

This medicinal product is authorised in the Member States of the EEA under the following names:

Austria:    Ceftazidim Hikma 500 mg Pulver zur Herstellung einer Injektionslosung

Ceftazidim Hikma 1 g Pulver zur Herstellung einer Injektionslosung oder Infusionslosung

Ceftazidim Hikma 2 g Pulver zur Herstellung einer Injektionslosung oder Infusionslosung

Germany:    Ceftazidim Hikma 500 mg Pulver zur Herstellung einer

Injektionslosung

Ceftazidim Hikma 1 g Pulver zur Herstellung einer Injektionslosung oder Infusionslosung

Ceftazidim Hikma 2 g Pulver zur Herstellung einer Injektionslosung oder Infusionslosung

Ireland:    Ceftazidime 500 mg, Powder for solution for injection

Ceftazidime 1 g, Powder for solution for injection/infusion Ceftazidime 2 g, Powder for solution for injection/infusion Portugal:    Ceftazidima Hikma 500 mg, Po para solugao injetavel

Ceftazidima Hikma 1 g, Po para solugao injetavel ou para perfusao Ceftazidima Hikma 2 g, Po para solugao injetavel ou para perfusao United Kingdom: Ceftazidime 1 g, Powder for solution for injection/infusion Ceftazidime 2 g, Powder for solution for injection/infusion This leaflet was last revised in 07/2014.

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•    Ceftazidime 1 g, 2 g powder for solution for injection / infusion:

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 5 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 an infusion set if the patient is receiving parenteral fluids.

•    Ceftazidime 1 g, 2 g powder for solution for injection / infusion:

Preparation of solutions for intravenous infusion from ceftazidime powder for solution for injection in standard vial presentation (mini-bag or burette-type set):

Prepare using a total of 50 ml of compatible diluent, added in TWO stages as described below.

1.    Introduce the syringe needle through the vial closure and inject 10 ml of diluent for the 1 g and 2 g vials.

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 50 ml, and administer by intravenous infusion over 15 to 30 min.

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

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