Norditropin SimpleXx 5mg, 10mg, and 15mg - Novo Nordisk ...

Norditropin ® SimpleXx ® 5mg, 10mg, and 15mgSomatropin (rbe)Consumer Medicine InformationWhat is in this leafletWhat Norditropin ® SimpleXx ®is used for .................................. 1Before using Norditropin ®SimpleXx ® ................................. 1Using Norditropin ® SimpleXx ® 2While you or your child is usingNorditropin ® SimpleXx ® .......... 3Side effects................................. 3Storage....................................... 3Product Description ................. 4Further information................. 4This leaflet answers somecommon questions aboutNorditropin ® SimpleXx ® . It doesnot contain all the availableinformation. It does not take theplace of talking to your doctor orpharmacist.All medicines have risks andbenefits. Your doctor hasweighed the risks of you or yourchild using Norditropin ®SimpleXx ® against the benefitsthey expect it will have.If you have any concerns aboutusing this medicine, ask yourdoctor or pharmacist.Keep this leaflet with themedicine. You may need to readit again.What Norditropin ®SimpleXx ® is used forNorditropin ® SimpleXx ® ishuman growth hormone [alsocalled somatropin (rbe)], used totreat:1. growth failure in children,which may be due to:• a condition called GrowthHormone Deficiency, wherethe gland at the base of thebrain (pituitary gland) doesnot make enough growthhormone• a condition called eitherSmall for Gestational Age(SGA) or Intrauterine GrowthRetardation (IUGR), wheregrowth failure started duringthe mother’s pregnancy.Children with SGA/IUGRdo not lack growth hormoneand are therefore not treatedfor growth hormonedeficiency. Treatment withNorditropin ® SimpleXx ®promotes catch-up growthand increases final height.• Chronic kidney disease• Turner syndrome, a geneticcondition in girls2. growth hormone deficiencyin adultsYou or your child may have beenprescribed Norditropin ®SimpleXx ® for another reason.Ask your doctor if you have anyquestions about whyNorditropin ® SimpleXx ® hasbeen prescribed.There is no evidence thatNorditropin ® SimpleXx ® isaddictive.Before usingNorditropin ® SimpleXx ®When you or your childmust not use itYou or your child should notuse Norditropin ® SimpleXx ® ifyou/your child:• are allergic to phenol or anyother ingredient listed in theingredient section of thisleafletSome of the symptoms of anallergic reaction may include:• rash• wheezing• swelling of the eyelids,face or lips• complete collapse• have cancer or another formof active tumour• have not finished treatmentfor cancer or another form oftumour• have slow growth for reasonsother than a lack of growthhormone, except wherespecific uses are describedabove• have had a kidney transplantin the last 12 months or havehad more than one episode ofacute rejection (ask yourdoctor if unsure what thismeans)• have an acute critical illnessdue to complicationsfollowing open heart orabdominal surgery ormultiple accident trauma• have acute respiratory failureDo not use Norditropin ®SimpleXx ® if:• it is after the expiry date(Expiry) printed on the labeland carton• the packaging is torn, showssigns of tampering or doesnot look quite right• the solution is not clear andcolourless, or does not lookquite rightBefore you or your childstarts to use itTell your doctor if you or yourchild has any medicalconditions, especially thefollowing:• diabetes• cancer or any other kind oftumour• impaired kidney functionNorditropin ® SimpleXx ® Page 1 of 4Lnorcmi10.doc

Long term overdosage couldresult in signs and symptoms ofgrowth hormone excess. Extremegrowth hormone excess can resultin overgrowth of bones andenlargement of hands and feet.While you or yourchild is usingNorditropin ® SimpleXx ®Things you must doCheck each new Norditropin ®SimpleXx ® cartridge before youuse it. Do not use any cartridgethat is damaged or cracked.Things you must not doDo not give Norditropin ®SimpleXx ® to anyone else, evenif they have the same conditionas you or your child.Do not use Norditropin ®SimpleXx ® to treat any othercomplaints unless your doctortells you to. `Do not stop using Norditropin ®SimpleXx ® or lower the dosage,without first checking with yourdoctor.Things to be careful ofTell your doctor if you or yourchild is scheduled to havesurgery.If you or your child has a kidneycondition, your doctor will closelymonitor the kidney function (howwell the kidneys are working). Ifthere is any decrease in function,it may be necessary to stop usingNorditropin.Side effectsAll medicines can have sideeffects. Sometimes they areserious, most of the time they arenot.Tell your doctor or pharmacistas soon as possible if you oryour child do not feel well whiletaking Norditropin ® SimpleXx ® .Ask your doctor or pharmacistto answer any questions youmay have.Tell your doctor or pharmacistif you notice any of thefollowing and they worry you:• swollen hands and feet due tofluid retention• redness and itching aroundthe area you inject. Somepatients may develop localskin reactions at the injectionsite which appear anddisappear during treatment.If you inject too often in thesame small area, damage mayoccur to the fat and tissuesunder the skin(lipodystrophy).The above list includes the morecommon side effects ofNorditropin ® SimpleXx ® . Theyare usually mild and temporary.Tell you doctor as soon aspossible if you notice any of thefollowing:• joint and muscle pain• skin rash• headache• curvature of the spine• fluid retentionIf you or your child experiencesany of these symptoms, thedosage of Norditropin ®SimpleXx ® may need to bereduced. Discuss this with yourdoctor.If any of the following happen,tell your doctor immediately orgo to Accident and Emergencyat your nearest hospital• allergic reaction. Symptomsof this may include rash;wheezing; swelling of theeyelids, face or lips; completecollapse.• benign raised pressure of thefluid around the brain.Symptoms of this can includesevere or recurringheadaches, problems with eyesight, feeling sick orvomiting.The above list includes seriousside effects. You may need urgentmedical attention. These sideeffects are very rare.In rare cases, the body may formantibodies to Norditropin ®SimpleXx ® . These antibodiescould reduce further growth withNorditropin ® SimpleXx ®treatment.In very rare cases, children treatedwith growth hormone have feltpain in the hip or knee, or haveexperienced limping. Thesesymptoms may be caused byLegg-Calvé-Perthes disease(disease at the top of the thighbone) or slipped capital femoralepiphysis (the end of the boneslips from the cartilage) and maynot be due to the medicine.In a small number of patientstreated with growth hormone,cancer, including leukaemia orrelapse of brain tumours, or raisedlevels of glucose in the blood (acondition called ‘impaired glucosetolerance’ (IGT)) have beenreported. However, there is noevidence that growth hormone isresponsible for causing theseconditions.If you think that you or yourchild are suffering from any ofthese symptoms or from anyother side effects not mentionedhere, speak to your doctor orpharmacist.Do not be alarmed by this list ofpossible side effects. You oryour child may not experience anyof them.StorageNorditropin ® SimpleXx ® must bestored between 2°C and 8°C, in arefrigerator, but not in or near thefreezingcompartment.Norditropin ® SimpleXx ® must notbe frozen or exposed to heat ordirect light.Norditropin ® SimpleXx ® that youare using (in NordiPen) should bestored in the refrigerator between2°C and 8°C and used within 28days.Keep out of the reach ofchildren.Do not use Norditropin ®SimpleXx ® which has beenfrozen or exposed to excess heat.Norditropin ® SimpleXx ® Page 3 of 4Lnorcmi10.doc

Never use Norditropin ®SimpleXx ® after the expiry dateprinted on the label and carton.The expiry date refers to the lastday of that month.DisposalIf your doctor tells you or yourchild to stop using Norditropin ®SimpleXx ® , or the medicine haspassed its expiry date, return anyunused medicine to yourpharmacist for disposal.Product DescriptionWhat it looks likeNorditropin ® SimpleXx ® is a1.5mL clear solution for injectioninto the layer under the skin. It isavailable in a glass cartridge,ready to go into NordiPen ® .Three NordiPen ® are available - adifferent one for each strength ofNorditropin ® SimpleXx ® .Norditropin ® SimpleXx ®cartridges MUST be used with thematching colour coded NordiPen ®to give the correct dose. Forexample:• Norditropin ® SimpleXx ® 5mg(yellow) MUST be used withNordiPen 5mg (yellow)• Norditropin ® SimpleXx ®10mg (blue) MUST be usedwith NordiPen 10mg (blue)• Norditropin ® SimpleXx ®15mg (green) MUST be usedwith NordiPen 15mg (green)NordiPen ® is for use withNovoFine ® needles.IngredientsNorditropin ® SimpleXx ® containsthe active ingredient, biosynthetichuman growth hormone, which iscalled somatropin (rbe). It isidentical to the growth hormoneproduced in the human body. Theabbreviation ‘rbe’ indicates themethod of genetic engineeringused to manufacture the growthhormone.Other ingredients in Norditropin ®SimpleXx ® are: mannitol,histidine, poloxamer, phenol, andwater for injections. The quantityof each ingredient is on the labelof the box.Norditropin ® SimpleXx ® isavailable in three strengths: 5mg,10mg, and 15mg. Your doctorwill decide which strength issuitable for you or your child.ManufacturerNorditropin ® SimpleXx ® issupplied in Australia by:Novo Nordisk PharmaceuticalsPty. Ltd.Level 3, 21 Solent Circuit,Baulkham Hills NSW 2153.This leaflet was prepared on 17February 2011.Australian Registration Numbers:Norditropin ® SimpleXx ® 5mg:AUST R 69360Norditropin ® SimpleXx ® 10mg:AUST R 69361Norditropin ® SimpleXx ® 15mg:AUST R 69362Norditropin ® , SimpleXx ® ,NordiPen ® and NordiCare ® areregistered trademarks of NovoNordisk Health Care AG.NovoFine ® is a registeredtrademark of Novo Nordisk A/S.© 2011Novo Nordisk A/S2880 Bagsvaerd, DenmarkFurther informationFor further information call theNordiCare ® Hotline on 1800 632362.www.novonordisk.com.auNorditropin ® SimpleXx ® Page 4 of 4Lnorcmi10.doc