leaflet MAH BRAND_PL 00006-0300
Contents
1. 5 An alcohol swab Wash your hands before you continue with the next steps Black Triangles Humatrope Diluent Syringe Cartridge Diluent White Tip Note The liquid is colourless It is shown here as blue for illustration purposes only Only use parts from this kit to prepare the drug cartridge Needle Cover 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 1c Plunger 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 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 You may hear or feel a click Do not twist the c2. in the fridge for no longer than 30 minutes each day at room temperature Medicines should not be disposed of via waste water or household waste Ask your pharmacist how to dispose of medicines that are no longer required These measures will help to protect the environment 6 FURTHER 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 1 9 mg somatropin per ml solution e Humatrope 12 mg gives 3 8 mg somatropin per ml solution e Humatrope 24 mg gives 7 6 mg somatropin per ml solution The above mentioned concentrations after reconstitution are theoretical values 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 cartridge 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 1
3. 5 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 Phone 44 0 1256 315999 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 step Parts Getting started 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
4. THHHIL PACKAGE LEAFLET INFORMATION FOR THE USER Humatrope 6 mg 12 mg 24 mg powder and solvent for solution for injection e Keep this leaflet You may need to read it again Somatropin e If you have any further questions ask your doctor or pharmacist e 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 e If any of the side effects gets serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist In this leaflet 1 What Humatrope is and what it is used for 2 Before you use Humatrope 3 How to use Humatrope PAMAQ046UKF Read all of this leaflet carefully before you start using this medicine 4 Possible side effects 5 How to store Humatrope 6 Further 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 growth hormone deficiency growth hormone also increases the bone mineral content the number and size of the m
5. artridge in a straight line DO NOT insert the cartridge at an angle 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 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 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 car
6. d 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 calculated 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 da
7. egular thyroid function tests regardless whether you receive thyroid hormone therapy or not e are a child make sure that you continue treatment until the end of growth has been reached e 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 e have growth disorder due to kidney damage treatment with Humatrope should be stopped prior to kidney transplantation e have acute critical illness your treating doctor should be notified Deaths have been reported in patients receiving somatropin during critical illness e 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 be interrupted and the cause assessed by your doctor e have diabetes mellitus your doctor will check the amount of sugar in your blood and may adjust your diabetes therapy Humatrope may affect the way your body handles sugar from food and drink by interfering with the way you
8. ily 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 mg Dose requirements may decline with increasing age Women especially those on oral oestrogen replacement may require higher doses than men 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 4 POSSIBLE SIDE EFFECTS Like all medicines Humatrope can cause side effects altho
9. metacresol or and glycerol doctor immediately if this happens Localised muscle pain myalgia Low levels of thyroid hormone Sugar in urine Difficulties sleeping glucosuria insomnia Numbness and tingling paresthesia Numbness and tingling in fingers and palm of the hand due to squeezed nerve at hand wrist carpal tunnel syndrome Localised muscle pain myalgia High blood pressure hypertension Shortness of breath Dyspnea Temporary interruption of breathing during sleep Sleep Apnea 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 If any of the side effects get serious or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist 5 HOW TO STORE HUMATROPE Keep out of the reach and sight of children Do not use after the expiry date stated on the label and carton The expiry date EXP refers to the last day of the month indicated Do not use Humatrope if you notice that the 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
10. r body uses insulin e 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 e are elderly over 65 years as you may be more sensitive to Humatrope and may be prone to side effects e are a child and you are treated with somatropin You have an increased risk of developing an inflammation of your pancreas pancreatitis compared to adults treated with somatropin Although rare pancreatitis should be considered in somatropin treated children who develop abdominal pain Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any of the following medicines including those obtained without a prescription e medicines for the treatment of diabetes mellitus which 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 unle
11. ries from an accident or require mechanical breathing treatment following acute lung failure Take special care with Humatrope if you e 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 e 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 e had cancer as a child 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 e 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 e develop a limp or pain in the hip please ask your doctor for advice During periods of growth you may develop bone disorders in your hips e 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 r
12. ss 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 Important information about some of the ingredients of Humatrope e Humatrope contains less than 1 mmol per daily dose of sodium it is therefore considered essentially sodium free 3 HOW TO USE HUMATROPE Always take Humatrope exactly as your doctor has told you You should check with your doctor or pharmacist if you are not sure how to use Humatrope 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 medicines 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 provide
13. tridge 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 approved in January 2011 PAMAQ046UKF
14. ugh 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 side 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 Children Injection site pain Weakness Bad or frequent headaches Difficulties sleeping with nausea and or vision insomnia problems are signs of increased brain pressure benign intracranial hypertension Tell your doctor immediately if this happens Swelling Oedema High blood pressure High blood sugar hypertension hyperglycaemia Breast enlargement Hypersensitivity to gynaecomastia metacresol or and glycerol Sugar in urine Low levels of thyroid glucosuria hormone Numbness and tingling paresthesia Development of anti growth hormone antibodies Adults Headache Injection site pain Weakness Bad or frequent headaches Joint pain arthralgia Swelling Oedema Breast enlargement hier meen and or V i l ti problems are signs o pe En gynaecomastia increased brain pressure cats benign intracranial Hypersensitivity to hypertension Tell your
15. uscle 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 BEFORE YOU USE HUMATROPE DO NOT use Humatrope if you e are allergic hypersensitive to somatropin or any of the other ingredients of Humatrope e g metacresol glycerol in the solvent see Section 6 e currently have a brain tumour or any form of cancer Tumours must be inactive and anti tumour therapy completed before starting growth hormone therapy e 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 require Humatrope after your bones have stopped growing e are very ill and require intensive medical care for a serious heart or abdominal operation being treated for multiple inju
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