CEFTAZIDIME 2 G POWDER FOR SOLUTION FOR INJECTION OR INFUSION - patient leaflet, side effects, dosage

Ceftazidime 1 g Powder for Solution for Injection Ceftazidime 2 g Powder for Solution for Injection or Infusion

Ceftazidime

Please read all of this leaflet carefully. It includes important information on how you should take this medicine correctly and safely.

Keep this leaflet. You may need to read it again.

If you are the parent of a child who is to be given this medicine, read the leaflet replacing “you” with “your child” throughout.

The medicine is prescribed only for you, and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If any of the side effects get serious, or you notice any side effects not listed in the leaflet, please tell your doctor, nurse or pharmacist.

If you have further questions, please ask your nurse, doctor or pharmacist.

The name of your medicine is Ceftazidime Powder for Solution for Injection or Infusion.

In the rest of this leaflet Ceftazidime Powder for Solution for Injection or Infusion is called Ceftazidime.

In this leaflet:

• 1. What Ceftazidime is and what it is used for

• 2. Before you take Ceftazidime

• 3. How to take Ceftazidime

• 4. Possible side-effects

• 5. How to store Ceftazidime

• 6. Further information

1. what ceftazidime is and what it is used for

Ceftazidime is a type of medicine called an antibiotic. Antibiotics work by killing the bacteria (germs) that cause an infection.

If the infection is not treated by your medicine, the bacteria (germs) can continue to grow in your body, which will make you feel very unwell, and could even be life-threatening.

Ceftazidime is used to treat infections caused by bacteria (germs) including infections of:

• the lungs and breathing airways, including infections in patients with cystic fibrosis
• the urinary tract (such as your bladder or tubes leading to the kidneys)
• the skin and soft tissue (such as wound infections)
• the biliary tract (such as your gall bladder or its tubes)
• the abdomen (such as your stomach)
• the bones and joints (such as osteomyelitis and infected arthritis)
• infections that may occur after dialysis. This is a procedure to clean your blood when you have kidney problems
• the brain or spinal cord (also called meningitis)

Ceftazidime may be given to you with another type of antibiotic. This is because you have a certain type of infection which needs two types of antibiotics to treat the different germs causing the infection.

2. Before you take Ceftazidime

The doctor or nurse giving you this medicine will ask some questions about you. They need the following information before you have this medicine for the first time.

Do not take Ceftazidime

• If you are allergic to this medicine, or any other cephalosporin antibiotic (such as ceftriaxone, cefotaxime or cefuroxime).
• If you are allergic to a substance called sodium carbonate, which is found in this medicine.
• If you are allergic to another type of antibiotic called “penicillin”.

Do not take Ceftazidime if any of the above statements are true.

Take special care with Ceftazidime

Before treatment starts, tell your doctor or nurse if:

• You have gastro-intestinal disease including colitis or diarrhoea.
• You have problems with your kidneys.
• You have been treated with any antibiotic before you were given this medicine.
• You are on a low sodium (salt) diet.
• If you develop severe and persistent diarrhoea which may contain blood. These symptoms may mean that you are suffering from a condition called pseudomembranous colitis.
• If you think you are developing a serious allergic reaction to your medicine.

Taking other medicines

Please tell your doctor about any medicines you may be taking or have recently been taking. Remember also any medicines you may be taking that do not need a prescription.

If you are taking any of the following medicines, it is very important to tell your doctor:

• Aminoglycoside antibiotics such as gentamicin (may affect your kidneys).
• Chloramphenicol, an antibiotic (may stop your ceftazidime from working properly).
• Diuretics, such as furosemide (may affect your kidneys).

Ceftazidime may also cause certain blood and urine tests to have an unusual result. Coombs’ test, a test done before a blood transfusion is given, may be affected. Tests to check for sugar in your urine such as Benedict’s test, Fehling’s test and Clinitest may also be affected. If you are not sure about this, please ask your nurse or doctor for advice.

Pregnancy and breast-feeding

• If you are pregnant, or think you may be pregnant you must tell your doctor.
• If you are breast-feeding you must tell your doctor.

Your doctor will advise you if you should receive this medicine.

Driving and using Machines

You should not drive or operate machinery while taking ceftazidime as it can make you dizzy.

Important information about some of the ingredients of Ceftazidime

If you are on a low sodium diet, it is important to know how much sodium is in your medicine.

Each 1 g container of this medicine contains 2.26 millimoles (mmol) of sodium.

Each 2 g container contains 4.52 mmol of sodium.

3. how to take ceftazidime

A doctor or a nurse will usually give you this medicine.

Your doctor or nurse will give you the correct dose as an injection or a drip infusion (your doctor or nurse may call this an IV or intravenous infusion). The injection may be given into your vein (an IV injection) or into your muscle (an IM injection).

Your doctor will decide the amount (dose) of your medicine to give you. This will depend on a number of things. These things include the nature of your illness, your body weight, your age and your individual response to your medicine.

Your doctor will also decide how long you need to take your medicine for. This will depend on the nature of your illness and your individual response to the medicine.

Adults (less than 65 years old)

The usual dose is 1 gram (g) every 8 hours or 2 gram (g) every 12 hours.

Doses for other infections are:

• Severe infection: 2 g every 8 or 12 hours, or 3 g every 12 hours.
• Urinary tract infection: 500 mg or 1 g every 12 hours.
• Prevention of infection before prostate surgery: 1 g before surgery and 1 g may also when your catheter is removed.
• Cystic fibrosis: 100 – 150 per kg bodyweight per day, divided into three doses every 8 hours. The maximum dose in one day is 9 g.

Elderly (over 65 years old)

The total dose in a day should usually not be more than 3 g, especially in those over 80 years of age.

Infants over two months old and children

The usual dose is 30 to 100 mg per kg of bodyweight per day every 8 or 12 hours.

In severe infections, up to 150 mg per kg of bodyweight per day can be given in three divided doses every 8 hours.

The maximum dose in one day is 6 g.

Young babies (neonates) and infants up to two months of age

The usual dose is 25 to 60 mg per kg bodyweight per day. This will be given in two divided doses every 12 hours.

Peritoneal dialysis and continuous ambulatory peritoneal dialysis (CAPD)

An initial dose of 1g may be given followed by 500mg every 24 hours. Ceftazidime can also be added directly to the dialysis fluid in some cases, usually 125 to 250 mg per 2 litres of dialysis fluid.

Patients with kidney problems

If you have problems with your kidneys the usual dosage will be reduced by your doctor to make sure you receive the dose that is correct for you.

If you have a severe infection and problems with your kidneys, your doctor may also want to test your blood to decide on the best dose for you.

If you take more Ceftazidime than you should

A doctor or a nurse will usually give you this medicine. If you think you may have received too much medicine, please tell your doctor or nurse at once.

Too much ceftazidime in your blood will cause you problems. Please read carefully the important advice at the beginning of the next section, Section 4, about how to spot the signs of too much ceftazidime in your blood.

If you forget to take Ceftazidime

A doctor or a nurse will usually give you this medicine. If you think you have missed a dose, please tell your doctor or nurse.

If you stop taking Ceftazidime

It is very important to finish the course of treatment your doctor has prescribed, even if you start to feel better.

If you do not finish the course of treatment, your infection may get worse again.

If you have any further questions on the use of your medicine, ask your doctor, nurse or pharmacist.

Please read the other side of this leaflet.

4. Possible side-effects

Like all medicines, Ceftazidime may have side effects, although not everybody gets them.

The chance of having a side-effect is described in this leaflet using words that have the following meaning:

more than 1 in 10 people taking the medicine are likely to experience the side effect.

between 1 in 10 and 1 in 100 people are likely to be affected.

between 1 in 100 and 1 in 1000 people are likely to be affected.

between 1 in 1000 and 1 in 10000 people are likely to be affected.

fewer than 1 in 10000 people are likely to be affected.

As with other antibiotics, some people find they have an allergy to it.

Tell your doctor immediately if any of the following rare severe allergy symptoms occur:

• Sudden wheeziness and tightness of chest.
• Swelling of eyelids, face or lips.
• Skin lumps or hives.
• Skin rash (red spots), itchiness, fever.
• Collapse.

Check with your doctor as soon as possible if any of the following side effects occur:

Uncommon

• Pain or inflammation at the site of injection
• Headache, dizziness, „pins and needles“ and a bad taste in the mouth
• Feeling sick (nausea) or being sick (vomiting), stomach pain
• Diarrhoea
• Thrush in the mouth or vagina
• Severe diarrhoea from colitis (inflamed lower end of the bowel)
• Skin reactions where the skin appears to look scalded. If you think you are getting this rare reaction contact your doctor immediately, especially if the reaction is widespread and affects other parts of your body including mouth, eyes, vagina or anus
• Jaundice; if you notice your skin or eyes becoming yellow coloured tell your doctor
• Severe, persistent diarrhoea that may contain blood – a possible sign of pseudomembranous colitis
• Ceftazidime may cause changes to certain blood test results. If you are having a blood test for any reason, tell the person who is taking your blood sample that you are taking Ceftazidime and that Ceftazidime may affect your results
• If your urine is being tested for sugar, Ceftazidime may cause a false positive result
• When too much is given, especially in people whose kidneys are not working properly, Ceftazidime may cause trembling fits and, in a few cases, loss of consciousness or coma.

If you feel unwell or have any unusual discomfort you don't understand, tell the doctor as soon as possible.

5. how to store ceftazidime

Your doctor, nurse or pharmacist will usually store your medicine for you.

Keep your medicine out of the reach and sight of children.

Do not use your medicine after the expiry date (EXP) given on the carton and container label.

The expiry date is the last day of the month written on the packaging.

Store below 25oC.

Always keep your medicine in the outer carton.

Open it and use it straight away. From a microbiological point of view, unless the method of opening/ reconstitution precludes the risk of microbial contamination, the product should be used immediately. Your medicine should not be mixed with certain other medicines that may also be given by injection.

Please ask your doctor, nurse, or pharmacist if you want any more information about this.

Any leftover medicine should be returned to your doctor, nurse or pharmacist.

If you do this, it will help protect the environment. Do not dispose the medicine in the dustbin or in the drain.

6. Further Information

Ceftazidime contains

The active medicine is ceftazidime pentahydrate.

Each vial (container) contains either 1 g of 2 g of ceftazidime.

The other ingredient is sodium carbonate.

What Ceftazidime looks like and contents of the pack

Ceftazidime is a powder which can be mixed by your doctor, nurse or pharmacist with other liquids to make an injection or an infusion (drip).

Each vial (container) of Ceftazidime contains 1 g or 2 g of your medicine.

Vials come in boxes of 1, 5, 10, 20 or 50.

Marketing Authorisation Holder: Noridem Enterprises Ltd., Evagorou & Makariou, Mitsi Building 3, Suit.115, 1065 Nicosia, Cyprus.

Manufacturer: DEMO S.A., 21st km National Road Athens-Lamia, 14568 Athens, Greece.

This leaflet was prepared in September 2015.

Instructions for use and other handling

The use of freshly prepared solutions is recommended (see section 6.3). The reconstituted solution should be clear. Do not use if particles are present. Ceftazidime solutions range from a light yellow to amber solution depending on the concentration, diluent and storage conditions used. Within the stated recommendations, variations in the intensity of the colour will not affect the potency of the drug.

Ceftazidime 1g

Each 1 g vial contains 52 mg (2.26 mmol) of sodium. As the product dissolves, carbon dioxide is released and a positive pressure develops. For ease of use, it is recommended that the following techniques of reconstitution are adopted.

1g Intramuscular/In­travenous 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.

Intramuscular injection: Ceftazidime 1 g Powder for Solution for Injection should be dissolved in 3 ml of 0.5% or 1.06% Lidocaine Hydrochloride BP. The resulting solution contains approximately 260 mg/ml ceftazidime. Solutions in Lidocaine should not be administered intravenously.

Intravenous injection: Ceftazidime 1 g Powder for Solution for Injection should be dissolved in 10 ml of Water for Injections Ph. Eur. The resulting solution contains approximately 90 mg/ml ceftazidime.

Ceftazidime 2g

Each 2 g vial contains 104 mg (4.52 mmol) of sodium. As the product dissolves, carbon dioxide is released and a positive pressure develops. For ease of use, it is recommended that the following techniques of reconstitution are adopted.

• 2 g Intravenous 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.

• 2 g Intravenous infusion:

• 1. Insert the syringe needle through the vial closure and inject 10ml 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 obtained in about 1 to 2 minutes.

• 3. Insert a gas relief needle through the vial closure to relieve the internal pressure and, with the gas relief in position, add a further 40ml of diluent. Remove the gas relief needle and syringe needle; shake the vial and set up for infusion use in the normal way.