Document: leaflet MAH GENERIC_PL 39655-0004 change

• leaflet MAH GENERIC_PL 04416-0562
• leaflet MAH GENERIC_PL 08828-0194
• leaflet MAH GENERIC_PL 24598-0004
• leaflet MAH GENERIC_PL 24780-0010
• leaflet MAH GENERIC_PL 29831-0031
• leaflet MAH GENERIC_PL 39655-0004
• leaflet MAH GENERIC_PL 42671-0003

---

PACKAGE LEAFLET: INFORMATION FOR THE USER Ceftazidime 500 mg powder for solution for injection Ceftazidime 1 g and 2 g powder for solution for injection or infusion

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 Injection is and what it is used for

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

3.    How Ceftazidime Injection is given

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 Injection 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 Injection 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 Injection 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 INJECTION

You must not be given Ceftazidime injection:

•    if you are allergic 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.

Take special care with Ceftazidime Injection

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 Injection 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 Injection

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 Injection 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, breast-feeding and fertility

Ask your doctor for advice before you are given Ceftazidime Injection:

•    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 Injection against the risk to your baby.

Driving and using machines

Ceftazidime Injection 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 Injection contains sodium

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

3. HOW CEFTAZIDIME INJECTION IS GIVEN 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 recommended dose

The correct dose of Ceftazidime Injection 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 Injection 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 Injection 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 Injection 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 Injection 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.

INFORMATION FOR THE DOCTOR Ceftazidime 500 mg Injection and 1 g, 2 g Injection or Infusion INFORMATION FOR THE HEALTH CARE PROFESSIONAL

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 constitution

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. Ceftazidime at concentrations between 1 mg/ml and 40 mg/ ml is compatible with:

•    sodium chloride 9 mg/ml (0.9%) solution for injection.

•    M/6 sodium lactate injection

•    compound sodium lactate injection (Hartmann's solution).

•    5% dextrose injection

•    0.225% sodium chloride and 5% dextrose injection.

•    0.45% sodium chloride and 5% dextrose injection.

•    0.9% sodium chloride and 5% dextrose injection.

•    0.18% sodium chloride and 4% dextrose injection.

•    10% dextrose Injection.

•    Dextran 40 injection 10% in 0.9% sodium chloride injection

•    Dextran 40 injection 10% in 5% dextrose Injection.

•    Dextran 70 injection 6% in 0.9% sodium chloride injection.

•    Dextran 70 injection 6% in 5% dextrose injection.

Ceftazidime at concentrations between 0.05 mg/ml and

0.25 mg/ml is compatible with Intra-peritoneal Dialysis Fluid (Lactate).

Ceftazidime may be constituted for intramuscular use with

0.5% or 1% Lidocaine Hydrochloride Injection.

If you are given more Ceftazidime Injection 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 Injection

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 use a double dose (two injections at the same time) to make up for a missed dose.

Don't stop using Ceftazidime Injection

Don't stop using Ceftazidime Injection 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.

•    There have been rare reports of severe hypersensitivity reactions with severe rash, which may be accompanied by fever, fatigue, swelling of the face or lymph glands, increase of eosinophils (type of white blood cells), effects on liver, kidney or lung (a reaction called DRESS).

^ 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 itchy.

•    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.

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/vellowcard.

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

5.    HOW TO STORE CEFTAZIDIME INJECTION

Keep out of the sight and reach of children.

Do not use Ceftazidime Injection after the expiry date which is stated on the vial and carton after EXP. The expiry date refers to the last day of that month. Store the unopened vial below 25°C. Keep container in the outer carton.

Once the powder has been dissolved; the solution should be used immediately or stored at 2-8°C and discarded after 24 hours. 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 protect the environment.

6.    CONTENTS OF THE PACK AND OTHER INFORMATION

What Ceftazidime Injection contains

The active substance in Ceftazidime Injection is ceftazidime pentahydrate. The other ingredients are sodium carbonate. The total sodium (salt) content is approximately 26, 52 or 104 mg respectively.

What Ceftazidime Injection looks like and contents of the pack

Ceftazidime is a white to almost white crystalline powder. It is supplied in 500mg, 1g or 2g vials with 1, 5, or 10 vials in a carton.

PL 39655/0003 Ceftazidime 500 mg

Powder for Solution for Injection PL 39655/0004 Ceftazidime 1 g

Powder for Solution for Injection or Infusion PL 39655/0006 Ceftazidime 2 g

Powder for Solution for Injection or Infusion

Marketing Authorisation Holder:

Stravencon Ltd, Landmark House, 17 Hanover Square, Mayfair, London, W1S 1HU, UK.

Manufacturer:

IPG Pharma Ltd, Atrium Court, The Ring, Bracknell, Berkshire, RG12 1BW, UK

This leaflet was last revised in September 2016

A062/UK/G

The contents of a 500 mg vial of ceftazidime for injection, constituted with 1.5 ml water for injections, may be added to metronidazole injection (500 mg in 100 ml) and both retain their activity.

500 mg powder for solution for injection, 1 g, 2 g powder for solution for injection or 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 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.

1 g, 2 g powder for solution for injection or infusion.:

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

Prepare using a total of 50 ml (for 1 g and 2 g vials) of compatible diluent, added in TWO stages as 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 at least 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.

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