leaflet MAH BRAND_PL 00006-0299
Contents
1. Step 7 Gently Mix Mix the solution by gently rotating the cartridge 10 times DO NOT SHAKE THE CARTRIDGE Let the cartridge sit for 3 minutes then inspect the solution carefully If the solution is cloudy or contains particles gently mix the cartridge another 10 times Let the cartridge sit for 5 more minutes If the solution remains cloudy or contains particles DO NOT USE THE CARTRIDGE Gently mix the cartridge 10 times and let sit for 3 minutes DO NOT SHAKE Inspect the solution The Humatrope solution should be clear Step 8 Injecting Humatrope using a suitable pen injection system If the solution is clear your cartridge is now ready to be attached to the suitable Humatrope pen Put the cartridge in the pen see the user manual for the pen Always use a new sterile needle for each injection Wipe the skin thoroughly with an alcohol swab Let the skin dry Set the correct dose see the user manual of the pen Inject slowly under the skin subcutaneous in the way you have been taught by your doctor Remove the needle from the skin and safely dispose of the needle as you have been shown by your doctor or health care professional Keep your pen with the rest of the Humatrope in the fridge Do not use any Humatrope left over in the pen after 28 days of mixing Humatrope is a trademark of Eli Lilly and Company Limited This leaflet was last revised in May 2014 PA012FSAA002. bone disorders in your hips If you start treatment Humatrope can affect the amount of thyroid hormones in your blood If the thyroid hormone level is low it may reduce your response to Humatrope Therefore you must have regular thyroid function tests regardless whether you receive thyroid hormone therapy or not If you are a child make sure that you continue treatment until the end of growth has been reached If you take a higher than prescribed dose of Humatrope you may experience overgrowth of some parts of your body such as ears nose jaw hands and feet Overdose may also lead to increased levels of blood sugar and sugar in the urine Always use Humatrope as recommended by your doctor FOR SUBMISSION ONLY If you have growth disorder due to kidney damage treatment with Humatrope should be stopped prior to kidney transplantation If you have acute critical illness your treating doctor should be notified Deaths have been reported in patients receiving somatropin during critical illness If you are growth hormone deficient and also have Prader Willi syndrome a genetic disorder your doctor should examine you for breathing problems and airway infections before starting Humatrope treatment especially if you are overweight have previously experienced severe breathing problems especially during sleep or suffered infection of the lungs or airways If during treatment you have signs of breathing problems snoring treatment should
3. Hold cartridge PUSH the cartridge Black Triangles up STRAIGHT in until it stops Align the cartridge AND the Black Triangles and Diluent Syringe ARE COVERED in a straight line DO NOT insert the cartridge at an angle You may hear or feel a click DO NOT twist the cartridge Step 4 Mixing Humatrope Hold the Diluent Syringe and the cartridge together with TWO HANDS Push and release the Plunger 2 or 3 times until the Diluent is in the cartridge Remove thumb from the Plunger and check that the Diluent Syringe is empty it is normal for small drops of Diluent to remain in the Diluent Syringe Item Code Previous Item Code to be destroyed PAO12FSAA00 PA621FSUKO3 PPD Information Box ALRP Information Box Start Date Proof No Printing Colours Technical Colours Affiliate Barcode Translations of 21 NOV 2013 2a Type N A Variable Data 1 3 BLACK Die Cut Code N A Size mm lot N A 474x280 2 3 CYAN Other Regulated Elements Folded Size mm 3 3 PMS 485 N A 158x56 No of Pages 2 2 Technical Information Layout name FEG PA027 A CACAO No Sick Code FEG13R187 445 Feed Direction For labels only Step 5 amp 6 Release Cartridge and Discard Diluent With thumb OFF Place the End Cap the plunger pull the on a hard flat surface cartridge from the Push the Diluent Syringe Diluent Syringe onto the End Cap and immediately discard the Diluent Syringe as instructed by your healthcare professional
4. Package leaflet Information for the user Humatrope 6 mg 12 mg 24 mg powder and solvent for solution for injection Somatropin Read all of this leaflet carefully before you start using this medicine because it contains important information for you e Keep this leaflet You may need to read it again e If you have any further questions ask your doctor or pharmacist e This medicine has been prescribed for you only Do not pass it on to others It may harm them even if their signs of illness are the same as yours e If you get any side effects talk to your doctor or pharmacist This includes any possible side effects not listed in this leaflet See section 4 What is in this leaflet 1 What Humatrope is and what it is used for 2 What you need to know before you use Humatrope 3 How to use Humatrope PA012FSAA00 4 Possible side effects 5 How to store Humatrope 6 Contents of the pack and other information 1 What Humatrope is and what it is used for Your medicine or the medicine of the person in your care is called Humatrope It contains human growth hormone also called somatropin Humatrope is made by a special process known as recombinant DNA technology It has the same structure as the growth hormone that your body produces Growth hormone regulates the growth and development of cells in your body When it stimulates growth of cells in the spine and in the long bones of the legs it causes an increase in height In
5. be interrupted and the cause assessed by your doctor Humatrope may affect the way your body handles sugar from food and drink by interfering with the way your body uses insulin Therefore if you take Humatrope your doctor should check if your body is dealing with the sugars correctly If you have diabetes mellitus your insulin dose may need to be adjusted after starting Humatrope treatment Your doctor will check the amount of sugar in your blood and may adjust your diabetes therapy If you have a growth disorder associated with being born small for gestational age your blood sugar and insulin levels will be checked before starting the treatment and regularly during treatment Elderly patients over 65 years may be more sensitive to Humatrope and may be prone to side effects Children who are treated with somatropin have an increased risk of developing an inflammation of the pancreas pancreatitis compared to adults treated with somatropin Although rare pancreatitis should be considered in somatropin treated children who develop abdominal pain Scoliosis an increase in sideways curvature of the spine may progress in any child during rapid growth Signs of scoliosis should be monitored during treatment Other medicines and Humatrope Tell your doctor or pharmacist if you are taking have recently taken or might take any other medicines and especially any of the following medicines e medicines for the treatment of diabetes mellitus which
6. dge with white powder for solution for injection e 3 17 ml of clear colourless solvent solution in a pre filled syringe Pack size of 1 5 and 10 e cartridge with white powder for solution for injection e 3 15 ml of clear colourless solvent solution in a pre filled syringe Pack size of 1 5 and 10 e cartridge with white powder for solution for injection e 3 15 ml of clear colourless solvent solution in a pre filled syringe Pack size of 1 5 and 10 Humatrope 24 mg Not all pack sizes may be available in your country Manufacturer Lilly France Rue du Colonel Lilly F 67640 Fegersheim France Marketing Authorisation Holder Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom For any information about this medicine please contact the Marketing Authorisation Holder or the local representative Eli Lilly and Company Limited Lilly House Priestley Road Basingstoke Hampshire RG24 9NL United Kingdom Pone 44 0 1256 315000 This medicinal product is authorised in the Member States of the EEA under the following names In member states of the EEA where this medicinal product is authorized it is authorized under the name Humatrope except in France where it is authorized under Umatrope How to inject Humatrope 6 mg 12 mg 24 mg The following instructions explain how to inject Humatrope Please read the instructions carefully and follow them step by st
7. ed according to the following recommendations and administered once daily Children and adolescents with e Growth hormone deficiency 0 025 0 035 mg kg body weight daily e Turner syndrome 0 045 0 050 mg kg body weight daily e Chronic problems with the way the kidneys work 0 045 0 050 mg kg body weight daily e Small for gestational age at birth 0 035 mg kg body weight daily Treatment should be discontinued after the first year of treatment if the growth rate is insufficient e SHOX gene deficiency 0 045 0 050 mg kg body weight daily Growth hormone deficiency in adults Treatment should be started with a low dose of 0 15 0 30 mg daily Lower starting doses may be required in older and overweight patients The starting dose may be increased gradually according to your individual requirements Total daily dose usually does not exceed 1 mg Dose requirements may decline with increasing age Women especially those on oral oestrogen replacement may require higher doses than men Item Code PA012FSAA00 Previous Item Code to be destroyed PA621FSUK03 PPD Information Box ALRP Information Box Proof No Printing Colours 2a 1 3 BLACK Affiliate Barcode Translations of Type N A Variable Data Die Cut TEE Code N A ize mm lot N A 474x280 2 3 CYAN Other Regulated Elements Folded Size mm 3 3 PMS 485 N A 158x56 No of Pages 1 2 CACAO No Sick Code FEG13R187 445 Feed Direction For labels only Start Date Techn
8. ep Getting started Parts You will require five items 1 Humatrope cartridge of the correct strength 2 A syringe filled with diluent 3 A CE marked Humatrope pen 4 A sterile pen needle and 5 An alcohol swab Wash your hands before you continue with the next steps Black Triangles Humatrope Diluent Syringe Cartridge Diluent Only use parts from this kit to prepare the drug cartridge Needle Cover Note The liquid is colourless It is shown here as blue for illustration purposes only FOR SUBMISSION ONLY The following steps will guide you to prepare your new cartridge for use Step 1 Unpackin e You must only mix Humatrope with the diluent provided Never mix it with anything else unless your doctor tells you to e Please read the user manual that comes with your pen This will remind you what you have been taught by your doctor or health care professional e Please follow the instruction underneath the diagrams Remove ALL contents from the tray Remove Needle Cover and discard Grasp Needle Cover which is at the bottom Note This product of the Diluent Syringe DO NOT depress is designed for left or Plunger yet right handed use It is okay if a drop Please feel free to use of fluid is lost whichever hand is It is not necessary most comfortable for to release air from the you Diluent Syringe Step 2 amp 3 Connecting the cartridge a ll Black Triangles
9. growth hormone deficiency growth hormone also increases the bone mineral content the number and size of the muscle cells and reduces the body fat stores Humatrope is used for e Treatment of children and adolescents with any of the following growth disorders Insufficient production of growth hormone Growth hormone deficiency Absence of all or some of the X sex chromosomes in females with short stature Turner syndrome A condition in which the kidneys are damaged chronic problems with the way the kidneys work in children before puberty with growth retardation Small at birth SGA Small for gestational age with failure to catch up height by 4 years of age or later an alteration to a gene called SHOX SHOX deficiency e Treatment of adults who have confirmed growth hormone deficiency beginning in either childhood or adulthood 2 What you need to know before you use Humatrope Do not use Humatrope e if you are allergic hypersensitive to somatropin or any of the other ingredients of Humatrope e g metacresol glycerol in the solvent see Section 6 e and tell your doctor if you have an active tumour cancer Tumours must be inactive and you must have finished your anti tumour treatment before you start your treatment with Humatrope e if you have already stopped growing and want to promote further growth in height closed growth plates at the end of long bones Your doctor will examine you to decide if you still requ
10. he solution is cloudy or has any particles in it Always store Humatrope in a refrigerator 2 C 8 C Do not freeze After mixing Humatrope do not leave it out of the refrigerator for longer than 30 minutes each day Humatrope can be used for up to 28 days after mixing if you keep it in the fridge and no longer than 30 minutes each day at room temperature Do not throw away any medicines via waste water or household waste Ask your pharmacist how to throw away medicines you no longer use These measures will help protect the environment 6 Content of the pack and other information What Humatrope contains Powder in a cartridge The active substance is somatropin Each cartridge contains 6 mg 12 mg or 24 mg depending on the strength When reconstituted e Humatrope 6 mg gives 2 08 mg somatropin per ml solution e Humatrope 12 mg gives 4 17 mg somatropin per ml solution e Humatrope 24 mg gives 8 33 mg somatropin per ml solution The other ingredients are mannitol glycine dibasic sodium phosphate Phosphoric acid or sodium hydroxide or both may have been used in the manufacturing process to adjust acidity Sterile Diluent Syringe The pre filled solvent syringe contains glycerol metacresol water for injection Hydrochloric acid or sodium hydroxide or both may have been used in the manufacturing process to adjust acidity What Humatrope looks like and contents of the pack Humatrope 6 mg Humatrope 12 mg e cartri
11. ical Colours 21 NOV 2013 Technical Information Layout name FEG PA027 A N A If you use more Humatrope than you should If you have injected more Humatrope than you should have please ask your doctor for advice e If you have injected too much Humatrope initially your blood sugar may decrease and become too low hypoglycaemia and subsequently increase and become too high hyperglycaemia e If you inject too much Humatrope over a longer period years you may experience overgrowth of some parts of your body such as ears nose jaw hands and feet acromegaly If you forget to use Humatrope Do not inject a double dose to make up for a forgotten dose Continue with the prescribed dosage If you forget to inject Humatrope and have any doubts about what to do please contact your doctor If you stop using Humatrope Please ask your doctor for advice before stopping treatment Interruption or early stopping of treatment with Humatrope may impair the success of the Humatrope treatment If you have any further questions on the use of this medicine ask your doctor or pharmacist 4 Possible side effects Like all medicines this medicine can cause side effects although not everybody gets them You may experience any of the following side effects after injecting Humatrope The following convention has been used for the classification of the adverse reactions Very common side effects may happen in more than in 10 patients Common s
12. ide effects may happen in 1 in 100 to 1 in 10 patients Uncommon side effects may happen in 1 in 1 000 to 1 in 100 patients Rare side effects may happen in 1 in 10 000 to 1 in 1 000 patients Very rare side effects may happen in fewer than 1 in 10 000 patients including isolated reports Other possible side effects frequency cannot be estimated from the available data Children Injection site pain Weakness Bad or frequent headaches Difficulties sleeping insomnia Swelling Oedema Type 2 diabetes mellitus with nausea and or vision High blood pressure hypertension l i f a ee E Breast enlargement gynaecomastia benign intracranial Hypersensitivity to hypertension Tell your metacresol or and glycerol doctor immediately 1f this happens Numbness and tingling paraesthesia Localised muscle pain myalgia Sugar in urine glucosuria Low levels of thyroid hormone Development of anti growth hormone antibodies Progression of scoliosis an increase in sideways curvature of the spine Adults Headache Joint pain arthralgia Injection site pain Weakness Swelling Oedema High blood sugar hyperglycaemia Bad or frequent headaches with nausea and or vision problems are signs of increased brain pressure benign intracranial hypertension Tell your doctor immediately if this happens Type 2 diabetes Breast enlargement mellitus gynaecomastia Hypersensitivity to metacresol or and glyce
13. ines in your Humatrope pen e Each cartridge of Humatrope comes with a syringe containing a diluent solvent for solution for injection for reconstitution mixing and preparing of the injection solution e You must not mix or inject Humatrope until you have received appropriate training from your doctor or other qualified health care professionals e For detailed instructions on how prepare and inject Humatrope please see Section How to inject Humatrope at the end of this leaflet You must only mix Humatrope with the diluent provided Never mix it with anything else unless your doctor tells you to e After reconstitution Humatrope should be injected into the fat tissue just beneath the skin using a short needle and a pen injection system e The injection sites should be varied in order to avoid local reduction and hardening of the fat tissue under the skin lipoatrophy e After mixing Humatrope do not leave it out of the refrigerator for longer than 30 minutes each day e Keep your pen with the rest of the Humatrope in the fridge Do not use any Humatrope left over in the pen after 28 days of mixing Dosage Your doctor will advise you on your dosage and administration schedule Do not change your dosage without talking to your doctor Usually treatment with Humatrope is a long term treatment your doctor may need to adjust your dose over time depending on your body weight and response to treatment In general the dose is calculat
14. ire Humatrope after your bones have stopped growing e if you are very ill and require intensive medical care for a serious heart or abdominal operation being treated for multiple injuries from an accident or require mechanical breathing treatment following acute lung failure Warnings and Precautions Talk to your doctor or pharmacist before using Humatrope If you have been treated for growth hormone deficiency during childhood your doctor will re examine you for growth hormone deficiency to decide if you require further Humatrope treatment during adulthood If you have completed previous anti tumour therapy a scan of your brain may be required before the start of Humatrope treatment You should be examined regularly to make sure that the tumour does not come back or start growing A higher risk for having a second tumour benign and malignant has been reported in patients that survived their cancer and were treated with somatropin Of these second tumours in particular brain tumours were the most common If you have symptoms such as frequent or bad headache with nausea and or vision problems occur tell your doctor immediately Your doctor should perform an examination of the eyes to look for evidence of increased brain pressure Depending on the results of this examination treatment with Humatrope may have to be interrupted If you develop a limp or pain in the hip please ask your doctor for advice During periods of growth you may develop
15. may have to be adjusted e adrenal steroid hormone glucocorticoid such as cortisone or prednisolone your doctor may need to adjust the dose because the combination of these medicines with Humatrope may reduce the effect of both treatments e oestrogen replacement therapy as it may affect the response to growth hormone treatment If there is a change to the way oestrogen is taken e g oral to transdermal through the skin Humatrope dose may need to be adjusted e medicines to prevent seizure anticonvulsants or cyclosporine Pregnancy and breast feeding Humatrope should not be used during pregnancy unless your doctor tells you to do so If you become pregnant tell your doctor immediately It is not known whether somatropin enters the breast milk If you are breast feeding or intend to breast feed please ask your doctor for advice before using Humatrope Driving and using machines Humatrope has no known effect on ability to drive or use machines Humatrope contains sodium Humatrope contains less than 1 mmol per daily dose of sodium it is therefore considered essentially sodium free 3 How to use Humatrope Always use this medicine exactly as your doctor has told you Check with your doctor or pharmacist if you are not sure e Always make sure you use the strength of cartridge your doctor prescribed either 6 mg 12 mg or 24 mg strength and the appropriate CE marked Humatrope pen injection system Never use cartridges of other medic
16. rol Low levels of thyroid hormone Difficulties sleeping insomnia Numbness and tingling paraesthesia Numbness and tingling in fingers and palm of the hand due to squeezed nerve at hand wrist carpal tunnel syndrome Sugar in urine glucosuria Localised muscle pain myalgia High blood pressure hypertension Shortness of breath Dyspneoa Temporary interruption of breathing during sleep Sleep Apneoa The effect of insulin may be reduced Leukaemia has been reported in a small number of children who have been treated with growth hormone However there is no proof that leukaemia occurrence is elevated in patients receiving growth hormone Reporting of side effects If you get any of the side effects talk to your doctor or pharmacist This includes any side effects not listed in this leaflet You can also report side effects directly via UK www mhra gov uk yellowcard Malta ADR Reporting The Medicines Authority Post Licensing Directorate 203 Level 3 Rue D Argens GZR 1368 Gzira www medicinesauthority gov mt postlicensing medicinesauthority gov mt By reporting side effects you can help provide more information on the safety of this medicine 5 How to store Humatrope 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 label and carton The expiry date EXP refers to the last day of the month Do not use this medicine if you notice that t
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