CEFTAZIDIME 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION

Package Leaflet: Information for the user

Ceftazidime
500 mg powder for solution for injection

Ceftazidime
1 g powder for solution for injection

Ceftazidime
2 g powder for solution for injection/infusion (Ceftazidime) Read all of this leaflet carefully before you start using this medicine. Keep this leaet. You may need to read it again. If you have any further questions, ask your doctor or pharmacist. This medicine has been prescribed for you. Do 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 if you notice any side effects not listed in this leaet, please tell your doctor or pharmacist. In this leaflet: 1. What Ceftazidime is and what it is used for 2. Before you are given Ceftazidime 3. How Ceftazidime is given 4. Possible side effects 5. Storing Ceftazidime 6. Further information 1. What Ceftazidime is and what it is used for Ceftazidime is an antibiotic. It belongs to a group of antibiotics called cephalosporins. These antibiotics are similar to penicillin. Ceftazidime kills bacteria and can be used to treat some infections. Like all antibiotics, ceftazidime only works against some types of bacteria. So, it is only suitable for treating some types of infection. Ceftazidime is used to treat some infections of: respiratory tract layers covering the surface of the brain. This is called meningitis. In patients with a compromised immune system it is sometimes necessary to give another antibiotic in combination with ceftazidime. 2. Before you are given Ceftazidime Ceftazidime is not to be given if: You are allergic (hypersensitive) to ceftazidime if you are allergic (hypersensitive) to ceftazidime or any of the other ingredients of Ceftazidime, or to any other cephalosporin type of antibiotic. if you have had previous immediate and/or sever allergic (hypersensitive) reactions to penicillin or other antibiotics known as beta-lactam antibiotics. If you are not sure about anything, ask your doctor or pharmacist.

Take special care with Ceftazidime. Tell your doctor or pharmacist if: You have ever had an allergic reaction to antibiotics called penicillin or to other betalactam antibiotics. People that are allergic to penicillins or other beta-lactam antibiotics can sometimes have a so-called cross reaction and allergic reactions to ceftazidime (see section Ceftazidime is not to be given if). You have ever had a bowel problem called colitis, or any serious problem affecting your gut You have kidney problems You are on a low-sodium (low salt) diet If any of these apply to you, your doctor may want to change your treatment or give you special advice. This medicine can alter the results of some blood and urine tests. It is important to tell the doctor you are using this medicine if you have any tests. Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines you have obtained without a prescription. This is important because some medicines should not be taken together with Ceftazidime . In particular, tell your doctor or pharmacist if you are taking: Any other antibiotics, particularly aminoglycosides, such as gentamicin, or antibiotics such as chloramphenicol, tetracyclines or sulphonamides Water tablets (diuretics), such as furosemide Ceftazidime may cause diarrhoea (see Possible Side Effects). If you take other medicines such as oral contraceptives, diarrhoea may reduce their effects. Using Ceftazidime with food and drink You can take eat and drink as usual when taking this medicine. You do not need to change your diet unless suggested by a doctor. Pregnancy and breast feeding Please tell your doctor if you are pregnant or think you might be pregnant. This medicine is only given to pregnant women if absolutely necessary, especially during the rst trimester and during breastfeeding. Ask your doctor or pharmacist for advice before taking any medicine. Driving and using machines No studies have been performed on the effects on the ability to drive and use machines. However, you may get dizzy or have ts (convulsions) when taking this medicine. If you are affected you should not drive or operate machinery. Important information about some of the ingredients of Ceftazidime Ceftazidime 500 mg powder for solution for injection contains 1.1 mmol (26 mg) of sodium per dose.

Ceftazidime 1 g powder for solution for injection contains 2.3 mmol (52 mg) of sodium per dose. Ceftazidime 2 g powder for solution for injection/infusion contains 4.6 mmol (104 mg) of sodium per dose. To be taken into consideration by patients on a controlled sodium diet. 3. How Ceftazidime is given Ceftazidime powder for solution is normally given by a doctor or nurse. It is given: by slow injection into a vein (intravenous) or by infusion (a drip) into a vein (intravenous infusion) or by deep injection into a large muscle (intramuscular), such as the upper buttock or thigh. Doses above 1 g will not be given to you by deep injection into a large muscle The dose your doctor recommends depends on the infection you have and how bad it is. The dose also depends on your age, your weight, and how well your kidneys are working. Your doctor will explain this to you. Adults: The usual adult dose is either 1 g three times a day or 2 g twice a day. For severe infections and in patients who are at special risk of infections because they have a low white blood count, the usual dose is 2 g three times a day or 3 g twice a day. For the treatment of lung infections in patients with so called cystic brosis and with normal kidney function, the total dose each day is usually from 100 mg to 150 mg per kilogram of body weight with a maximum of 9 grams in any one day. This total daily dose is usually split into three doses over the day. Elderly: The total daily dose should not exceed 3 g, particularly for patients over 80 years of age. Adults (including the elderly) with moderate to severe kidney problems: The dose of ceftazidime and how often it is given each day may both need to be reduced. Your doctor will calculate the right dose for you according to the results of blood or urine tests that measure how well your kidneys are working and also according to the severity of your infection. People with renal failure who are being treated with continuous arteriovenous haemodialysis or high-ux or low-ux haemoltration also need a lower dose. This is often no more than 1 g daily in divided doses. For people who have haemodialysis on some days only, the usual dose has to be repeated after each haemodialysis session because ceftazidime is removed from your body during haemodialysis. In people who develop an infection in the peritoneum (the space into which the dialysis uid is placed) while having this type of dialysis treatment, ceftazidime can be mixed into the dialysis

uid. The amount is usually 125-250 mg for 2 L of dialysis uid. People who are having peritoneal dialysis or continuous ambulatory peritoneal dialysis (CAPD) can also have ceftazidime through the veins at a lower dose than for people with healthy kidneys. A loading dose of 1 g may be given, followed by 0.5 g every 24 hours. Newborns, infants, children and adolescents: The dose is based on body weight. As in adults, children with kidneys that are not working properly need a lower dose that is calculated according to the results of blood and urine tests. The doses given here are for children with normal kidneys. Infants and children older than 2 months: the usual dose for most infections is 30 mg to 100 mg per kilogram of body weight daily and this is usually divided into 2 or 3 separate doses. Severely ill children may receive up to 150 mg per kilogram of body weight daily (to a maximum of 6 g daily), divided into 3 separate doses. New-borns and infants less than 2 months old: The usual dose is 25 mg to 60 mg per kilogram of body weight daily divided into 2 separate doses. If you receive more Ceftazidime than you should If you think you have been given too much Ceftazidime, tell your doctor straight away. Signs of an overdose include: pain and swelling at the injection site; dizziness; pins and needles, headaches, ts, disease of the brain and loss of consciousness. There can also be effects on your liver and the numbers of different cells in the blood. If you think you have missed an injection, speak to your doctor or nurse. If you have any further questions on the use of this product, ask your doctor or other health care staff. 4. Possible side effects Like all medicines Ceftazidime can cause side effects, although not everybody gets them. The following side effects may occur during treatment with Ceftazidime: Very common (affects more than 1 out of 10 people) Skin rash, hives (nettle rash) Common (affects less than 1 out of 10 people) Painful swelling and inflammation where the injection is given Diarrhoea Blood problems, including high numbers of some white cells and platelets Changes in blood tests that check how the liver and kidneys are working Uncommon (affects less than 1 out of 100 people) Itching Feeling sick or being sick, tummy pain Fever Headache, dizziness

An infection called candidiasis which can affect the vagina or mouth and is caused by a fungus Blood problems, including low numbers of some white cells and platelets, with an increased risk of infection or bleeding Very rare (affects less than 1 out of 10000 people) Abnormal sensations, including tingling, burning or pricking Tremor, muscle spasms or ts (convulsions), mainly in people who also have kidney problems Bad taste Liver problems, including jaundice which can cause yellow skin, dark urine, tiredness. Blood problems, including low numbers or damaged red blood cells, leading to severe anaemia and weakness Severe allergic reaction (called anaphylaxis) associated with sudden wheezing or breathlessness, swelling of face or body, a rash or severe blistering or peeling skin, fainting (loss of consciousness). Seek medical help immediately if this occurs An inammation of the bowel, called colitis (or antibiotic-associated colitis), causing severe longlasting watery diarrhoea with stomach cramps and fever. Seek medical help immediately if this occurs If you are having a blood test for any reason, tell the person who is taking your blood sample that you are having Ceftazidime for Injection / infusion as it may affect your result. If a side effect gets serious, or if you notice any side effects not listed in this leaet, please tell your doctor, nurse or pharmacist. 5. How to store Ceftazidime Keep out of the reach and sight of children. Do not use Ceftazidime after the expiry date which is stated on the pack. The expiry date refers to the last day of that month. Do not store above 25C. Protect from light. Once Ceftazidime powder is reconstituted into a solution, it should be used immediately. The solution should not be given if it is cloudy; it should be completely clear. Any unused solution should be thrown away. Medicines should not be disposed of via wastewater or household waste. Your doctor or health care staff know how to dispose of medicines no longer required. These measures will help protect the environment.

6. Further information What Ceftazidime contains: Ceftazidime 500 mg powder for solution for injection contains the active substance ceftazidime (500 mg) as ceftazidime pentahydrate. Ceftazidime 1 g powder for solution for injection contains the active substance ceftazidime (1000 mg) as ceftazidime pentahydrate. Ceftazidime 2g powder for solution for injection/ infusion contains the active substance ceftazidime (2000 mg) as ceftazidime pentahydrate. The sodium content is 26 mg sodium per dose for 500 mg Ceftazidime, 52 mg sodium per dose for 1 g Ceftazidime and 104 mg sodium per dose for 2 g Ceftazidime. This should be considered if you are restricting or measuring your sodium (salt) intake. All powders contain sodium carbonate anhydrous. What Ceftazidime looks like and contents of the pack: Ceftazidime powder is normally mixed with water for injection to make up a clear solution for injection or infusion. Once made up, your doctor may mix the Ceftazidime solution with other suitable uids for infusion. Solutions can range from amber to light yellow in colour. Ceftazidime 500 mg,1 g and 2 g powder for solution for injection/infusion comes in packs containing 1 and 10 glass vials of powder, closed with a rubber stopper, aluminium cap and plastic ip-off cap. Not all the pack sizes may be marketed. Marketing Authorisation holder and manufacturer: Marketing Authorisation holder: Fresenius Kabi Limited Cestrian Court Eastgate Way Manor Park Runcorn Cheshire WA7 1NT UK Manufacturer: LABESFAL - Laboratorios Almiro S.A.
Lagedo, 3465-157 Santiago de Besteiros, Portugal



This medicinal product is authorised in the member states of the EEA under the following names: Austria Ceftazidim 0,5g - Pulver zur Herstellung einer Injektionslsung Ceftazidim 1g - Pulver zur Herstellung einer Injektionslsung Ceftazidim 2g - Pulver zur Herstellung einer Injektionslsung oder Infusionslsung Germany Ceftazidim 0,5 g - Pulver zur Herstellung einer Injektionslsung Ceftazidim 1 g - Pulver zur Herstellung einer Injektionslsung Ceftazidim 2 g Pulver zur Herstellung einer Injektionslsung oder Infusionslsung Belgium Ceftazidim Fresenius 500mg, poeder voor oplossing voor injectie Ceftazidim Fresenius 1000mg, poeder voor oplossing voor injectie. Ceftazidim Fresenius 2000mg, poeder voor oplossing voor injectie/infusie Czech Republic Ceftazidime 500 mg Ceftazidime 1g Ceftazidim 2g Denmark Ceftazidim Fresenius 500 mg, pulver til infusionsvske, oplsning Ceftazidim Fresenius 1g, pulver til injektionsvske, oplsning Ceftazidim Fresenius 2g, pulver til injektions- og infusionsvske, oplsning Estonia Ceftazidime Fresenius 500 mg Ceftazidime Fresenius 1000 mg Ceftazidime Fresenius 2000 mg Greece Ceftazidime Fresenius, , 1000mg Ceftazidime, a da p es/ s, 2000mg Finland Ceftazidim Fresenius 1 g injektiokuiva-aine, liuosta varten Ceftazidim Fresenius 2 g injektio-/infuusiokuivaaine, liuosta varten Hungary Ceftazidim 1 g por oldatos injekcihoz Ceftazidim 2 g por oldatos injekcihoz vagy infzihoz

Latvia Ceftazidime Fresenius 500 mg Ceftazidime Fresenius 1000 mg Ceftazidime Fresenius 2000 mg Luxemburg Ceftazidim 0,5 g Pulver zur Hersellung einer Injektionslsung Ceftazidim 1 g Pulver zur Hersellung einer Injektionslsung Ceftazidim 2 g Pulver zur Herstellung einer Injektionslsung oder Infusionslsung Latvia Ceftazidime Fresenius 500 mg Ceftazidime Fresenius 1000 mg Ceftazidime Fresenius 2000 mg Netherlands Ceftazidim 500mg, poeder voor oplossing voor injectie. Ceftazidim 1000mg, poeder voor oplossing voor injectie. Ceftazidim Fresenius 2000mg, poeder voor oplossing voor injectie/infusie Norway Ceftazidim Fresenius 500 mg pulver til injeksjonsvske, opplsning Ceftazidim Fresenius 1g, pulver til injeksjonsvske, opplsning Ceftazidim Fresenius 2g, pulver til injeksjons-/ infusjonsvske, opplsning Poland Ceftazidime Slovenia Ceftazidim Fresenius 1000 mg praek za raztopino za injiciranje Ceftazidim Fresenius 2000mg praek za raztopino za injiciranje ali infundiranje Slovakia Ceftazidime 500 mg Ceftazidime 1g Ceftazidim 2g UK Ceftazidime 500 mg Ceftazidime 1 g Ceftazidime 2 g This leaflet was last approved in
04/2009.


-----------------------------------------------------------------The following information is intended for medical or healthcare professionals only: This medicinal product is for single use only. Discard any unused contents. Reconstitute immediately before use Intravenous use injection: For direct intermittent intravenous administration, ceftazidime should be reconstituted with water for injections (see table below). The solution has to be injected slowly directly into the vein over a period of up to 5 minutes or given through the tubing of a giving set. lntramuscular use: Ceftazidime should be reconstituted with water for injections or Lidocaine Hydrochloride 10 mg/ml (1%) solution for injection as indicated in the table below. Information for Lidocaine should be consulted before reconstitution of ceftazidime with lidocaine. Intravenous use infusion (see section 3): For intravenous infusion, the content of the 2 g infusion vial should be reconstituted with 10 ml of water for injections (for bolus) and 50 ml of water for injections (intravenous infusion) or one of the compatible intravenous uids. Administer by intravenous infusion over 15-30 minutes. Alternatively, the content of the 500 mg or 1 g vial should be reconstituted and an appropriate quantity of the resulting solution should be added to an IV container with one of the compatible intravenous uids. 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 APPROXIMATE SOLVENT TO CEFTAZIDIME BE ADDED (ML) CONCENTRATION (MG/ML) 500 mg Intramuscular Intravenous 1g Intramuscular Intravenous 1.5 5.0 3.0 10.0 260 90 260 90

Preparation of solutions of Ceftazidime for use in children Posology: 25 to 60 mg/kg b.w./day given as two divided doses 500 mg for injection (450mg in 5 ml) and 1000 mg for injection (900mg in 10 ml) 2 doses per day volume per partial dose Body weight [kg] 3 4 5 6 25 mg 0.45 ml 0.55 ml 0.70 ml 0.85 ml 60 mg 1.00 ml 1.30 ml 1.65 ml 2.00 ml

Compatible intravenous uids: At ceftazidime concentrations between 40 mg/ml and 260 mg/ml the Ceftazidime powders for injection may be mixed in commonly used solutions for infusion: - sodium chloride 9 mg/ml (0.9%) solution (physiological saline solution), - Ringer Lactate Solution - Glucose 10 mg/ml (10%) solution When reconstituted for intramuscular use, the Ceftazidime powder for injection can also be diluted with lidocaine 10 mg/ml (1%) solutions. When ceftazidime is dissolved, carbon dioxide is released and a positive pressure develops. For ease of use, the recommended techniques of reconstitution described below should be followed. Instructions for reconstitution: For 500 mg IM/IV and 1g IM/IV: 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 2g infusion vials 1. Inject 10ml 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. For single use only. Discard any unused solution in accordance with local requirements. The dilution is to be made under aseptic conditions. The solution is to be inspected visually for particulate matter and discoloration prior to administration.

The solution should only be used if the solution is clear and free from particles. Solutions range 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.

Strength 2000 mg for iv bolus (1700mg in 10 ml) 2 doses per day volume per partial dose Body weight [kg] 3 4 5 6 25 mg 0.25 ml 0.30 ml 0.40 ml 0.50 ml 60 mg 0.55 ml 0.70 ml 0.85 ml 1.00 ml

Posology: 30 to 100 mg/kg b.w./day given as 2 or 3 divided doses 500 mg for injection (450mg in 5 ml) and 1000 mg for injection (900mg in 10 ml) 2 doses per day volume per partial dose Body weight [kg] 10 20 30 40 50 60 30 mg 1.65 ml 3.30 ml 5.00 ml 6.65 ml 8.30 ml 10.00 ml 100 mg 5.55 ml 11.10 ml 16.65 ml 22.20 ml 27.75 ml 33.30 ml 3 doses per day volume per partial 30 mg 1.10 ml 2.20 ml 3.30 ml 4.40 ml 5.55 ml 6.65 ml 100 mg 3.70 ml 7.40 ml 11.10 ml 14.80 ml 18.50 ml 22.20 ml

Strength 2000 mg for iv bolus (1700mg in 10 ml) 2 doses per day volume per partial dose Body weight [kg] 10 20 30 40 50 60 30 mg 0.90 ml 1.80 ml 2.70 ml 3.60 ml 4.45 ml 5.30 ml 100 mg 2.95 ml 5.90 ml 8.85 ml 11.75 ml 14.70 ml 17.65 ml 3 doses per day volume per partial 30 mg 0.55 ml 1.15 ml 1.75 ml 2.35 ml 2.95 ml 3.50 ml 100 mg 1.95 ml 3.90 ml 5.90 ml 7.85 ml 9.80 ml 11.75 ml

2g IV bolus 10.0 170 Infusion 50.0* 40 * Addition should be in 2 stages (see lnstructions for reconstitution below)

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