FORTUM FOR INJECTION 500MG

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Forrecommendedmaintenancedosesofceftazidimeinrenal impairment (including haemodialysis and peritoneal dialysis), follow the dosage recommendations in the SPC. Overdose Overdosage can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in . patientswithrenalimpairment.Serumlevelsofceftazidimecanbereducedbyhaemodialysis. . . Incompatibilities CeftazidimeislessstableinSodiumBicarbonateinjectionthanotherintravenousfluids.Itisnot recommended as a diluent. Ceftazidimeandaminoglycosidesshouldnot be mixed in the same giving set or syringe. Precipitationhasbeenreportedwhenvancomycinhasbeenaddedtoceftazidimeinsolution.Itisrecommendedthatgivingsets and intravenous lines are flushed between administration of these two agents. Instructions for use/handling Instructions for reconstitution: See table for addition volumes and solution concentrations, which may be useful when fractional doses are required. Preparation of solution Vialsize 500mg 1g 2g 3g Intramuscular Intravenous bolus Intramuscular Intravenous bolus Intravenous infusion Intravenous bolus Intravenous infusion Intravenous bolus Intravenous infusion Amount of diluent to be added (ml) 1.5 ml 5 ml 3ml 10 ml 50 ml* 10 ml 50 ml* 15 ml 75 ml* Approximate concentration (mg/ml) 260 90 260 90 20 170 40 170 40

Information for the Healthcare Professional for Injection 3 g, 2 g, 1 g and 500 mg ceftazidime Dosage and Administration Information Only Please refer to the Summary of Product Characteristics for further information Posology and method of administration Method of administration Fortum should be administered by intravenous injection or infusion, or by deep intramuscular injection. Recommended intramuscular injection sites are the upper quadrant of the gluteus maximus or lateral part of the thigh. Fortum solutions may be given directly into the vein or introduced into the tubing of a giving set if the patient is receiving parenteral fluids. The standard recommended route of administration is by intravenous intermittent injection or intravenous continuous infusion. Intramuscular administration should only be considered when the intravenous route is not possible or less appropriate for the patient. The dose depends on the severity, susceptibility, site and type of infection and on the age and renal function of the patient. Posology Adults and children > 40 kg Intermittent Administration Infection Dose to be administered Broncho-pulmonaryinfectionsincysticfibrosis 100 to 150mg/kg/day every 8 h, maximum 9g per day1 Febrile neutropenia 2g every 8 h Nosocomial pneumonia Bacterial meningitis Bacteraemia* Bone and joint infections 1-2gevery8h Complicated skin and soft tissue infections Complicatedintra-abdominalinfections Peritonitis associated with dialysis in patients on CAPD Complicated urinary tract infections 1-2gevery8hor12h Peri-operativeprophylaxisfortransuretheralresectionof 1g at induction of anaesthesia, prostate (TURP) and a second dose at catheter removal Chronic suppurative otitis media 1g to 2g every 8h Malignant otitis externa Continuous Infusion Infection Dose to be administered Febrile neutropenia Loading dose of 2g followed by a continuous infusion of 4 to 6g every 24h1 Nosocomial pneumonia Broncho-pulmonaryinfectionsincysticfibrosis Bacterial meningitis Bacteraemia* Bone and joint infections Complicated skin and soft tissue infections Complicatedintra-abdominalinfections Peritonitis associated with dialysis in patients on CAPD 1 In adults with normal renal function 9g/day has been used without adverse effects. * When associated with, or suspected to be associated with, any of the infections listed in section 4.1. Children < 40 kg Infants and toddlers> 2 months and children <40 kg Intermittent Administration Infection Complicated urinary tract infections Chronic suppurative otitis media Malignant otitis externa Neutropenic children Broncho-pulmonaryinfectionsincysticfibrosis Bacterial meningitis Bacteraemia* Bone and joint infections Complicated skin and soft tissue infections Complicatedintra-abdominalinfections Peritonitis associated with dialysis in patients on CAPD Continuous Infusion Febrile neutropenia Nosocomial pneumonia Broncho-pulmonaryinfectionsincysticfibrosis Bacterial meningitis Bacteraemia* Bone and joint infections Complicated skin and soft tissue infections Complicatedintra-abdominalinfections Peritonitis associated with dialysis in patients on CAPD Infection Most infections Loadingdoseof60-100mg/kg followed by a continuous infusion 100-200mg/kg/day,maximum6g/day Usual dose 100-150mg/kg/dayinthreedivided doses, maximum 6 g/day 150mg/kg/day in three divided doses, maximum 6g/day

Fortum

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*Note: Addition should be in two stages. Allsizesofvialsassuppliedareunderreducedpressure.Astheproductdissolves,carbondioxideisreleasedandapositivepressure develops. For ease of use, it is recommended that the following techniques of reconstitution are adopted: Preparation of solution 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.

100-150mg/kg/dayinthreedivided doses, maximum 6 g/day

Neonates and infants 2 months Intermittent Administration

Usual dose

25-60mg/kg/dayintwodivided doses1 1Inneonatesandinfants2months,theserumhalflifeofceftazidimecanbethreetofourtimesthatinadults. * Where associated with, or suspected to be associated with, any of the infections listed in section 4.1. Elderly Inviewoftheagerelatedreducedclearanceofceftazidimeinelderlypatients,thedailydosageshouldnotnormallyexceed3gin those over 80 years of age. Paediatric population The safety and efficacy of Fortum administered as continuous infusion to neonates and infants 2 months has not been established. Hepatic imparment Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment. There are no study data in patients with severe hepatic impairment. Close clinical monitoring for safety and efficacy is advised. Renal impairment Ceftazidimeisexcretedunchangedbythekidneys.Therefore,inpatientswithimpairedrenalfunction,thedosageshouldbe reduced. An initial loading dose of 1 g should be given. Maintenance doses should be based on creatinine clearance.

Preparation of solutions for iv infusion from ceftazidime injection in standard vial presentation (mini-bag or burette-type set): Prepareusingatotalof50ml(for2gvials)and75ml(for3gvials)ofcompatiblediluent,addedinTWOstagesasbelow:1. Introducethesyringeneedlethroughthevialclosureandinject10mlofdiluentfor2gvialand15mlfor3gvial. 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. Transferthereconstitutedsolutiontofinaldeliveryvehicle(e.g.mini-bagorburette-typeset)makingupatotalvolumeofat least50ml(75mlforthe3gvial),andadministerbyintravenousinfusionover15-30minutes. 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. 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.Ceftazidimeiscompatiblewiththemostcommonlyusedintravenousfluids. Any unused product or waste material should be disposed of in accordance with local requirements. Ceftazidimeatconcentrationsbetween1mg/mland40mg/mliscompatiblewith: sodium chloride 9mg/ml (0.9%) solution for injection M/6 sodium lactate injection compound sodium lactate injection (Hartmanns 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. Ceftazidimeatconcentrationsbetween0.05mg/mland0.25mg/mliscompatiblewithIntraperitonealDialysisFluid(Lactate). Ceftazidimemaybeconstitutedforintramuscularusewith0.5%or1%LidocaineHydrochlorideInjection. When admixed at 4 mg/ml with (both components retain satisfactory potency): Hydrocortisone (hydrocortisone sodium phosphate) 1 mg/ml in 0.9% Sodium Chloride Injection BP or 5% Dextrose Injection BP Cefuroxime(cefuroximesodium)3mg/mlin0.9%SodiumChlorideInjectionBP Cloxacillin (cloxacillin sodium) 4 mg/ml in 0.9% Sodium Chloride Injection BP Heparin 10 u/ml or 50 u/ml in 0.9% Sodium Chloride Injection BP Potassium Chloride 10 mEq/L or 40 mEq/L in 0.9% Sodium Chloride Injection BP Thecontentsofa500mgvialofFortumforInjection,reconstitutedwith1.5mlWaterforInjections,maybeaddedtometronidazole injection (500 mg in 100 ml) and both retain their activity. 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. Leaflet last updated September 2012. The information in this leaflet applies only to Fortum for Injection Fortum is a registered trademark of the GlaxoSmithKline group of companies 2012 GlaxoSmithKline group of companies

Package Leaflet: Information for the User

Fortum

for Injection 3 g, 2 g, 1 g and 500 mg ceftazidime

Read all of this leaflet carefully before you start using this medicine. Keepthisleaflet.Youmayneedtoreaditagain. Ifyouhaveanyfurtherquestions,askyourdoctor. Ifanyofthesideeffectsgetsserious,orifyounotice any side effects not listed in this leaflet, please tell your doctor. In this leaflet: 1 What Fortum is and what it is used for 2 Before you are given Fortum 3 HowFortumisgiven 4 Possible side effects 5 How to store Fortum 6 Further information

1. What Fortum is and what it is used for
Fortum 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. Fortum is used to treat severe bacterial infections of: thelungsorchest thelungsandbronchiinpatientssufferingfromcystic fibrosis thebrain(meningitis) . theear . . theurinarytract theskinandsofttissues theabdomenandabdominalwall(peritonitis) thebonesandjoints. Fortum can also be used: topreventinfectionsduringprostate surgery in men totreatpatientswithlowwhitebloodcell counts (neutropenia) who have a fever due to a bacterial infection.

Tell the person taking the sample that you have been given Fortum. Taking other medicines Tell your doctor if you are taking any other medicines, if youve started taking any recently or you start taking new ones. This includes medicines you can obtain without a prescription. You shouldnt be given Fortum without talking to your doctor if you are also taking: anantibioticcalledchlorampenicol atypeofantibioticcalled aminoglycosides e.g. gentamicin, tobramycin watertabletscalledfurosemide Tell your doctor if this applies to you. Pregnancy and breast-feeding Tell your doctor before you are given Fortum: Ifyouarepregnant,thinkyoumightbepregnantor are planning to become pregnant Ifyouarebreast-feeding Your doctor will consider the benefit of treating you with Fortum against the risk to your baby. Driving and using machines Fortum can cause side effects that affect your ability todrive,suchasdizziness.Dontdriveorusemachines unless you are sure youre not affected. Important information about some of the ingredients of Fortum Fortum contains sodium You need to take this into account if you are on a controlled sodium diet. Fortum Strength Fortum 500 mg Fortum 1 g Fortum 2 g Fortum3g Amount per vial 26 mg 52 mg 104 mg 156 mg

If you are given more Fortum than you should If you accidentally use more Fortum than your prescribed dose, contact your doctor or nearest hospital straight away. If you forget to use Fortum 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. Dont take a double dose (two injections at the same time) to make up for a missed dose. If you stop using Fortum Dont stop taking Fortum unless your doctor tells you to. If you have any questions ask your doctor or nurse.

unpleasanttasteinthemouth yellowingofthewhitesoftheeyesorskin. Other side effects that may show up in blood tests: redbloodcellsdestroyedtooquickly anincreaseinacertaintypeofwhitebloodcells severedecreaseinthenumberofwhitebloodcells. If you get side effects Tell your doctor or pharmacist if any of the effects become severe or troublesome, or if you notice any side effects not listed in this leaflet.

5. How to store Fortum
Keep out of the reach and sight of children. Fortum is for use in hospital only and the expiry date and storage instructions stated on the vial label and carton are for the doctor, nurse or pharmacists information. The doctor, pharmacist or nurse will make up your medicine.

4. Possible side effects
Like all medicines, Fortum 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. Common side effects These may affect up to 1 in 10 people: diarrhoea swellingandrednessalongavein redraisedskinrashwhichmaybeitchy pain,burning,swellingorinflammationatthe injection site. Tell your doctor if any of these are troubling you. Common side effects that may show up in blood tests: anincreaseinatypeofwhitebloodcell(eosinophilia) anincreaseinthenumberofcellsthathelptheblood to clot anincreaseinliverenzymes. Uncommon side effects These may affect up to 1 in 100 people: inflammationofthegutwhichcancausepain,or diarrhoea which may contain blood thrush(fungalinfectionsinthemouthorvagina) headache dizziness stomachache feelingsickorbeingsick feverandchills. Tell your doctor if you get any of these. Uncommon side effects that may show up in blood tests: adecreaseinthenumberofwhitebloodcells adecreaseinthenumberofbloodplatelets (cells that help the blood to clot) anincreaseinthelevelofurea,ureanitrogenorserum creatinine in the blood. Other side effects Other side effects have occurred in a small number of people but their exact frequency is unknown: inflammationorfailureofthekidneys pinsandneedles

6. Further information
What Fortum contains Fortumisavailableinthefollowingstrengths:3g, 2g,1gand500mg.Theactivesubstanceis3g,2g, 1gor500mgofceftazidime(presentasceftazidime pentahydrate). Theonlyotheringredientissodiumcarbonate (anhydrous sterile). Seesection2forfurtherimportantinformationabout sodium, one of the ingredients of Fortum. What Fortum looks like and contents of the pack Fortum3g,2g,1gand500mgissuppliedassterile powder in glass vials. Each individual vial is packed in a carton. These are supplied to the hospital in packs of1or5forallexceptthe3gstrengthwhichisonly available as a single pack. Your doctor, pharmacist or nurse will make the injection or infusion up with Water for Injections or a suitable infusion fluid. When made up, Fortum varies in colour from light yellow to amber. This is perfectly normal. Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex. UB11 1BT Manufacturer: GlaxoSmithKline Manufacturing S.p.A., Verona, Italy. Other formats To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:

3. How Fortum is used
Fortum is usually given by a doctor or a nurse. It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle. Fortum 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 Fortum 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, theyll be given 25 to 60 mg Fortum 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, theyll be given 100 to 150 mg of Fortum 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 Fortum three times daily. Maximum of 9 g per day. Patients over 65 Thedailydoseshouldnotnormallyexceed3gperday, 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 Fortum 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.

2. Before you are given Fortum
You must not be given Fortum: Ifyouareallergic(hypersensitive) to ceftazidime,oranyoftheotheringredients of this medicine (listed in section 6). Ifyouhavehadasevere allergic reaction to any other antibiotic (penicillins, monobactams and carbapenems) as you may also be allergic to Fortum. Tell your doctor before you start on Fortum if you think that this applies to you. You must not be given Fortum. Take special care with Fortum 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 Fortum. 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 Fortum. If you need a blood or urine test Fortum can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests:

0800 198 5000 (UK Only)
Please be ready to give the following information: Product names Fortum for Injection 3 g, 2 g, 1 g or 500 mg Referencenumbers 00004/0294(3gand2g), 00004/0293(1g)or 00004/0292 (500 mg) This is a service provided by the Royal National Institute of Blind People. Leaflet date: September 2012 Fortum is a registered trademark of the GlaxoSmithKline group of companies 2012 GlaxoSmithKline group of companies . . .

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