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.

What you need to know 2 before you are given

Ceftazidime

Pregnancy, breast-feeding and fertility If you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby ask your doctor or pharmacist 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

250 mg powder for solution for injection: This medicine contains 12.6 mg sodium (main component of cooking/table salt) per vial. This is equivalent to 0.63% of the recommended maximum daily dietary intake of sodium for an adult.

500 mg powder for solution for injection: This medicine contains 25.2 mg sodium (main component of cooking/table salt) per vial. This is equivalent to 1.26% of the recommended maximum daily dietary intake of sodium for an adult.

• 1 g powder for solution for injection/ infusion:

This medicine contains 50.5 mg sodium (main component of cooking/table salt) per vial. This is equivalent to 2.53% of the recommended maximum daily dietary intake of sodium for an adult.

• 2 g powder for solution for injection/ infusion:

This medicine contains 101 mg sodium (main component of cooking/table salt) per vial. This is equivalent to 5.05% of the recommended maximum daily dietary intake of sodium for an adult.

• 3 How Ceftazidime is given

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

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.

Continued on the next page >>

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

Method and route of administration of Ceftazidime

Method of Administration

• – intravenously

• – deep intramuscular injection into a large muscle mass

Incompatibilities

Ceftazidime should not be mixed with solutions with a pH above 7.5 for example sodium bicarbonate solution for injection.

Ceftazidime and aminoglycosides should not be mixed in the solution for injection because of the risk for precipitation.

Cannulae and catheters for intravenous use should be flushed with physiological salt-solution between administrations of ceftazidime and vancomycin to avoid precipitation.

Instructions for use and handling

Intramuscular administration:

Ceftazidime should be reconstituted with Water for Injections PhEur or 0.5% or 1% Lidocaine Hydrochloride Injection BP as indicated in the table below. The Product Information for Lidocaine should be consulted before reconstitution of ceftazidime with lidocaine.

Intravenous administration:

For direct intermittent intravenous administration, reconstitute ceftazidime with Water for Injections PhEur (see table below). Slowly inject the solution directly into the vein over a period of up to 5 minutes or give through the tubing of a giving set. 000000000

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For intravenous infusion, reconstitute the 1 g or 2 g infusion vial with 40 ml Water for Injections PhEur or one of the compatible intravenous fluids. Alternatively, reconstitute the 250 mg, 500 mg, 1 g or 2 g vial and add an appropriate quantity of the resulting solution to an IV container with one of the compatible intravenous fluids. 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.

Preparation of Solutions of Ceftazidime

	Amount of diluent to be added (ml)	Approx available volume (ml)	Approx ceftazidime concentration (mg/ml)
Intramuscular 250 mg	1.0	1.20	208
500 mg	1.5	2.10	238
1 g	3.0	3.80	263
Intravenous 250 mg	2.5	2.80	89
500 mg	5	5.50	91
1 g	10	11.00	91
2 g	10	11.50	174
Infusion 1 g	40	41	25
2 g	40	42	50

• * Note: Addition should be in 2 stages (see ‘Instructions for reconstitution’ be­low)

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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 take 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 take 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 questions ask your doctor, pharmacist or nurse.

• 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

Not known: frequency cannot be estimated from the available data:

• 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 pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (). By reporting side effects you can help provide more information on the safety of this medicine.

5

How to store Ceftazidime

4

Possible side effects

Like all medicines Ceftazidime 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

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 carton and label after “EXP”. The expiry date refers to the last day of that month.

Keep the vial in the outer carton in order to protect it from light.

• The solutions should be used immediately after their reconstitution
• Only clear solutions should be used
• The contents of the vials, once opened, should be used immediately
• Any unused injection or infusion solutions should be disposed of.

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.

Contents of the pack and other information

What Ceftazidime contains

The active substance is ceftazidime.

Each 0.3203 g vial contains 0.2912 g ceftazidime pentahydrate, corresponding to 250 mg ceftazidime.

Each 0.6406 g vial contains 0.5824 g ceftazidime pentahydrate, corresponding to 500 mg ceftazidime.

Each 1.2813 g vial contains 1.1648 g ceftazidime pentahydrate, corresponding to 1 g ceftazidime.

Each 2.5625 g vial contains 2.3296 g ceftazidime pentahydrate, corresponding to 2 g ceftazidime.

Other ingredients: sodium carbonate anhydrous

What Ceftazidime looks like and contents of the pack

Ceftazidime is a white to cream-coloured powder.

The reconstituted solution is light yellow to amber.

Do not use Ceftazidime if you notice the following: The solution is not clear.

Ceftazidime is supplied in individual packs of 1 vial as well as in hospital packs for 5/10/25/50.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Sandoz Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Sandoz GmbH,

Biochemiestrasse 10, 6250 Kundl, Austria.

This leaflet was last revised in 02/2020.

SZ00000LT000

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

Instructions for reconstitution:

For 250 mg im/IV, 500 mg im/IV, 1 g im/IV and 2 g IV vials

• 1. Inject the diluent and shake well to dissolve. The vials may contain a vacuum to assist injection of the diluent

• 2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes

• 3. Invert the vial and completely depress the syringe plunger prior to insertion

• 4. Insert the needle through the vial stopper. Be sure the needle remains within the solution and withdraw contents of the vial in the usual manner. Pressure in the vial may aid withdrawal

• 5. The withdrawn solution may contain carbon dioxide bubbles, which should be expelled from the syringe before injection.

For 1 g and 2 g infusion vials

• 1. Inject 10 ml of the diluent and shake to dissolve. The vials may contain a vacuum to assist injection of the diluent

• 2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes

• 3. Insert a vent needle to release pressure before adding additional diluent to the vial. Add diluent and

then remove the vent needle

• 4. Additional pressure that may develop in the vial, especially after storage, should be relieved prior to administration to the patient.

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.

Single use only.

Unused solution should be discarded. Only clear solutions practically free from particles should be used.

Free from bacterial endotoxins.

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

At ceftazidime concentrations between 25 mg/ml and 263 mg/ml the Ceftazidime Sandoz powders for injection/infusion may be mixed in commonly used solutions for infusion:

0.9% sodium chloride solution (physiological saline solution), 5% glucose solution, 0.9% sodium chloride + 5% glucose solution, Ringer Lactate Solution

When reconstituted for intramuscular use, the Ceftazidime Sandoz powder for injection/infusion can also be diluted with 1% lidocaine solutions.

00000000 SZ00­000LT000

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Proof no. Date prepared: Font size:

006.0 17/02/2020 9pt

Colours: Fonts:

■ Black □ Helvetica

Black 20% □

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 take 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 take 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 questions ask your doctor, pharmacist or nurse.

• 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

Not known: frequency cannot be estimated from the available data:

• 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 pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (). By reporting side effects you can help provide more information on the safety of this medicine.

5 How to store Ceftazidime

4 Possible side effects

Like all medicines Ceftazidime 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

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 carton and label after “EXP”. The expiry date refers to the last day of that month.

Keep the vial in the outer carton in order to protect it from light.

• The solutions should be used immediately after their reconstitution
• Only clear solutions should be used
• The contents of the vials, once opened, should be used immediately
• Any unused injection or infusion solutions should be disposed of.

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.

Contents of the pack and other information

What Ceftazidime contains

The active substance is ceftazidime.

Each 0.3203 g vial contains 0.2912 g ceftazidime pentahydrate, corresponding to 250 mg ceftazidime.

Each 0.6406 g vial contains 0.5824 g ceftazidime pentahydrate, corresponding to 500 mg ceftazidime.

Each 1.2813 g vial contains 1.1648 g ceftazidime pentahydrate, corresponding to 1 g ceftazidime.

Each 2.5625 g vial contains 2.3296 g ceftazidime pentahydrate, corresponding to 2 g ceftazidime.

Other ingredients: sodium carbonate anhydrous

What Ceftazidime looks like and contents of the pack

Ceftazidime is a white to cream-coloured powder.

The reconstituted solution is light yellow to amber.

Do not use Ceftazidime if you notice the following: The solution is not clear.

Ceftazidime is supplied in individual packs of 1 vial as well as in hospital packs for 5/10/25/50.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Sandoz Ltd., Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, UK.

Manufacturer:

Sandoz GmbH,

Biochemiestrasse 10, 6250 Kundl, Austria.

This leaflet was last revised in 02/2020.

SZ00000LT000

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

Instructions for reconstitution:

For 250 mg im/IV, 500 mg im/IV, 1 g im/IV and 2 g IV vials

• 1. Inject the diluent and shake well to dissolve. The vials may contain a vacuum to assist injection of the diluent

• 2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes

• 3. Invert the vial and completely depress the syringe plunger prior to insertion

• 4. Insert the needle through the vial stopper. Be sure the needle remains within the solution and withdraw contents of the vial in the usual manner. Pressure in the vial may aid withdrawal

• 5. The withdrawn solution may contain carbon dioxide bubbles, which should be expelled from the syringe before injection.

For 1 g and 2 g infusion vials

• 1. Inject 10 ml of the diluent and shake to dissolve. The vials may contain a vacuum to assist injection of the diluent

• 2. Carbon dioxide is released as the antibiotic dissolves, generating pressure within the vial. The solution will become clear within 1 to 2 minutes

• 3. Insert a vent needle to release pressure before adding additional diluent to the vial. Add diluent and

then remove the vent needle

• 4. Additional pressure that may develop in the vial, especially after storage, should be relieved prior to administration to the patient.

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.

Single use only.

Unused solution should be discarded. Only clear solutions practically free from particles should be used.

Free from bacterial endotoxins.

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

At ceftazidime concentrations between 25 mg/ml and 263 mg/ml the Ceftazidime Sandoz powders for injection/infusion may be mixed in commonly used solutions for infusion:

0.9% sodium chloride solution (physiological saline solution), 5% glucose solution, 0.9% sodium chloride + 5% glucose solution, Ringer Lactate Solution

When reconstituted for intramuscular use, the Ceftazidime Sandoz powder for injection/infusion can also be diluted with 1% lidocaine solutions.

00000000 SZ00­000LT000

Artwork Proof Box

Ref: V018: Update with excipient guidance

Proof no. Date prepared: Font size:

006.0 17/02/2020 9pt

Colours: Fonts:

■ Black □ Helvetica

Black 20% □

Dimensions: 140 × 630 mm

• 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)

if you have ever 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.

Warnings and precautions Talk to your doctor or pharmacist before taking 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.

• 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.