Document: leaflet MAH GENERIC_PL 26928-0011 change

• leaflet CONSILIENT HEALTH (UK)_PL 15413-0046
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• leaflet MAH GENERIC_PL 15413-0046
• leaflet MAH GENERIC_PL 26928-0011

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Package leaflet: Information for the user

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.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    I f 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.

Ceftazidime 1 g

powder for solution for injection / infusion

Ceftazidime 2 g

powder for solution for injection / infusion

Ceftazidime

In this leaflet:

1.    What Ceftazidime is and what it is used for

2.    What you need to know before you are given Ceftazidime

3.    How Ceftazidime is given

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

-    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 are given Ceftazidime

You must not be given Ceftazidime:

-    if you are allergic (hypersensitive) to ceftazidime or any

of the other ingredients of this medicine (listed in section 6).

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

^ Tell 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 ("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.

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 or pharmacist if you are taking, have recently taken or might take any other medicines. 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 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.

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.

3. How Ceftazidime is given

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 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 are given 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 forgotten dose.

If you stop using Ceftazidime

Don't stop using Ceftazidime unless your doctor tells you to. If you have any further questions on the use of this medicine, ask your doctor, pharmacist 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.

This leaflet was last revised in 02/2015.

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:

-    i nflammation 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 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 reach and sight of children.

Do not use this medicine after the expiry date which is stated on the label and on the carton after “EXP”. The expiry date refers to the last day of that month.

Do not store above 30°C. Keep the vial in the outer carton in order to protect from light.

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. Content of the pack and other information

What Ceftazidime contains

-    The active substance is ceftazidime. Each vial contains 1 g or 2 g ceftazidime (as pentahydrate), respectively.

-    The other ingredient is sodium carbonate, anhydrous.

What Ceftazidime looks like and contents of the pack

White or pale yellow powder

Ceftazidime 1 g is available in 15 ml glass vials with a rubber stopper and a flip-off cap.

Ceftazidime 2 g is available in 50 ml glass vials with a rubber stopper and a flip-off cap.

Pack sizes: Packages with 1, 5 or 10 glass vials.

Not all pack sizes may be marketed.

Marketing authorisation holder

MIP Pharma GmbH Kirkeler Str. 41 66440 Blieskastel Germany

Phone 0049 (0) 6842 9609 0 Fax 0049 (0) 6842 9609 355

Manufacturer

MIP Pharma GmbH Kirkeler Str. 41 66440 Blieskastel Germany

The following information is intended for healthcare professionals only:

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.

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.

Compatibility with intravenous liquids

The following solvents are suitable for preparation of the

solution:

-    water for injections

-    5% glucose solution

-    0.9% sodium chloride solution

Ceftazidime may be constituted for intramuscular use with 1% Lidocaine Hydrochloride Injection.

Preparation of solutions for bolus injection

1.    Insert the syringe needle through the vial closure and inject the recommended volume of 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 the most commonly used intravenous fluids.

Preparation of solutions for iv infusion

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

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 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.

Important incompatibilities

Ceftazidime is less stable in sodium bicarbonate injection than other intravenous fluids. It is not recommended as a diluent.

Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.

Precipitation has been reported when vancomycin has been added to ceftazidime in solution. It is recommended that giving sets and intravenous lines are flushed between administration of these two agents.

Storage after reconstitution

Shelf-life of the prepared solution

The chemical and physical stability of the prepared solution has been demonstrated for 6 hours at 25°C and for 12 hours at 2-8°C. After reconstitution with lidocaine: use immediately (within 2 hours). From a microbiological point of view, the prepared solution should be used immediately.

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MIP Pharma GmbH • Kirkeler Str. 41    •    D-66440 Blieskastel

Ceftazidime MIP 1g,2g GBR - 210 x 400 mm - Pantone 288C / Pantone 288C - 30%