PART III: CONSUMER INFORMATION
Contents
1. Patients over 65 years of age may be more sensitive to HUMATROPE and may require lower dose of HUMATROPE INTERACTIONS WITH THIS MEDICATION Tell the doctor if the patient is taking any of the following drugs e Steroid medications such as glucocorticoids e g cortisone or prednisone e Medications known to be metabolized by certain liver enzymes e g cyclosporine some anticonvulsants and hormones such as estrogen and birth control pills e Insulin and anti hyperglycemic agents Because HUMATROPE may affect how some hormones such as cortisol and cortisone are processed in the body people may discover that they have an underactive adrenal gland after starting HUMATROPE therapy In these cases glucocorticoid replacement therapy would need to be started If already on glucocorticoid therapy dosage may need to be adjusted PROPER USE OF THIS MEDICATION Be sure to change the injection site frequently to help prevent lipoatrophy loss of fat tissue under the skin In general HUMATROPE should be injected in the evening or before bedtime HUMATROPE Product Monograph Page 45 of 58 IMPORTANT PLEASE READ Usual dose Other possible side effects include headaches muscle or joint The doctor will instruct you on what is the best dose of pains in hips or knees swelling associated with tingling HUMATROPE for you or your child based on individual sensations in the hands feeling weak rarely high blood needs2. Remove and discard plastic caps from tops of vials of diluent and HUMATROPE Wipe tops of both vials with an alcohol swab Figure 1 Remove needle cover and save Pull back on syringe plunger to draw up an amount of air equal to the amount of diluent your doctor has prescribed Insert needle in stopper of diluent vial and inject air into vial AN 2 Hold vial upside down and making sure needle tip remains in solution withdraw the amount of diluent your doctor has prescribed Figure 2 After making sure that no air bubbles are in the syringe turn vial upright and holding barrel remove syringe HUMATROPE Product Monograph Page 48 of 58 IMPORTANT PLEASE READ 3 Insert same needle into vial of HUMATROPE and gently aim needle tip toward wall of vial Slowly inject the diluent by aiming the stream of liquid against the wall of vial Figure 3 Do not aim it at the white powder at the bottom of the vial To equalize the pressure withdraw a volume of air equal to the amount of diluent added before removing the syringe from the vial If the needle can be removed from the barrel of the syringe remove and discard the needle If the needle and syringe are made as unit discard the entire unit 4 Swirl the vial with a gentle rotary motion until contents are completely dissolved Figure 4 Do not shake Preparing the Injection l 2 sjes 8 Do not use reconstituted HUMATROPE if it is cloudy or contains particles If th
3. Use HUMATROPE exactly as the doctor tells you to pressure shortness of breath and sleep apnea pauses in breathing during sleep If the headaches are bad or frequent Reconstitution Instructions and accompanied by sickness or vision problems tell the doctor Please refer to the enclosed reconstitution instructions immediately Overdose For patients with Turner syndrome HUMATROPE therapy Long term overdosage or using HUMATROPE after the growth may increase the already high frequency of ear infections Your plates in the long bones have closed hardened may result in child should see her doctor if you think she has an ear infection joint pain and continued growth of fingers toes nose ears or jaw If you think this is happening tell the doctor This is not a complete list of side effects If any of the side effects gets serious or if you notice any unexpected side Overdose may change blood sugar levels and patients may effects while taking HUMATROPE contact your doctor or experience symptoms of hypoglycemia low blood sugar such healthcare professional as feeling shaky dizzy and unwell or hyperglycemia high blood sugar such as increased urination or thirst HOW TO STORE IT In case of drug overdose contact a health care practitioner hospital emergency department or regional Poison Control Centre immediately even if there are no symptoms Before it has been reconstituted mixed Store HUMATROPE vial and diluent i
4. the patient Health Canada has diabetes or a family history of diabetes Postal Locator 0701D Ottawa Ontario HUMATROPE may affect the way the body handles sugars K1A 0K9 from food and drink The doctor may need to check the amount Postage paid labels Canada Vigilance Reporting Form and the of sugar in the urine or blood adverse reaction reporting guidelines are available on the MedEffect Canada website at www healthcanada gc ca medeffect HUMATROPE can affect the amount of thyroid hormone in the blood so patients must have thyroid function tests from time to time If the thyroid is not working properly HUMATROPE may not work as well as it should NOTE Should you require information related to the management of side effects contact your health care professional The Canada Vigilance Program does not provide medical advice Any child who begins to limp must be examined by a doctor MORE INFORMATION HUMATROPE may cause intracranial hypertension increased For more information please contact your healthcare pressure within the skull Call the doctor if the patient has a professional or pharmacist first or Eli Lilly Canada Inc at headache that doesn t go away or is severe or has headaches 1 888 545 5972 or visit the website at www lilly ca that become more frequent problems with vision nausea feeling sick in the stomach or vomiting The information in this document is current as of the last revision date shown bel
5. IMPORTANT PLEASE READ PART II CONSUMER INFORMATION P HUMATROPE Vials somatropin for injection pronounced HYOO mah trope This leaflet is for patients and caregivers It is Part III of a three part Product Monograph published when HUMATROPE was approved for sale in Canada This leaflet is a summary and will not tell you everything about HUMATROPE Contact your doctor or pharmacist if you have any questions about the drug Please read this information carefully before you start to take your medicine even if you have just refilled your prescription Some of the information may have changed Keep this pamphlet since you may need to refer to it after starting treatment with HUMATROPE ABOUT THIS MEDICATION What the medication is used for HUMATROPE is used to treat children and teenagers who are short or growing too slowly due to a medical condition such as growth hormone deficiency Turner syndrome idiopathic short stature SHOX short stature homeobox containing gene deficiency or being born small for gestational age HUMATROPE is also used in some adults who had growth hormone deficiency when they were children and still have growth hormone deficiency after they finish growing or who do not make enough growth hormone as adults for some other reason What it does HUMATROPE is used to increase growth hormone levels It stimulates bone growth in children unless the ends of the bones have hardened closed epiphyses In
6. MATROPE may reduce the effectiveness of these drugs e ifthe patient especially a child develops abdominal pain e if the patient is or plans to become pregnant or is breast feeding e ifthe patient has hypothyroidism low levels of thyroid hormone because HUMATROPE may reduce the levels of thyroid hormone The patient may require a change in dosage of his or her thyroid hormone medication e if the patient suffers from a bad headache or frequent headaches or from problems with eyesight vomiting or feeling sick Very rarely swelling of the brain may develop and the doctor may want to examine the patient to look for signs of brain swelling If this occurs it may be necessary to stop HUMATROPE treatment e if the patient develops a limp or has hip or knee pain while being treated with HUMATROPE If the patient is sensitive to any component of the diluent the liquid used to mix with the HUMATROPE powder Sterile Water for Injection USP may be used to dissolve the HUMATROPE supplied in vials not cartridges Refer to How to Store It section for storage instructions If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems If the patient is growth hormone deficient and also has Prader Willi syndrome a genetic disorder the doctor should examine the patient for breathing problems and airway infections before starting HUMATROPE treatment especially if the
7. aph Page 50 of 58 IMPORTANT PLEASE READ PART III CONSUMER INFORMATION PHUMATROPF Cartridges somatropin for injection pronounced HYOO mah trope This leaflet is for patients and caregivers It is Part III of a three part Product Monograph published when HUMATROPE was approved for sale in Canada This leaflet is a summary and will not tell you everything about HUMATROPE Contact your doctor or pharmacist if you have any questions about the drug Please read this information carefully before you start to take your medicine even if you have just refilled your prescription Some of the information may have changed Keep this pamphlet since you may need to refer to it after starting treatment with HUMATROPE ABOUT THIS MEDICATION What the medication is used for HUMATROPE is used to treat children and teenagers who are short or growing too slowly due to a medical condition such as growth hormone deficiency Turner syndrome idiopathic short stature SHOX short stature homeobox containing gene deficiency or being born small for gestational age HUMATROPE is also used in some adults who had growth hormone deficiency when they were children and still have growth hormone deficiency after they finish growing or who do not make enough growth hormone as adults for some other reason What it does HUMATROPE is used to increase growth hormone levels It stimulates bone growth in children unless the ends of the bones have harden
8. both adults and children with growth hormone deficiency it also increases the growth of muscle and reduces body fat When it should not be used Treatment should not be started e in children to promote growth when the ends of the long bones have hardened closed epiphyses Treatment should be stopped when adult height is reached Reevaluation to find out whether the patient still has growth hormone deficiency will determine if continued treatment with HUMATROPE at a lower dose would be beneficial e inpatients with any evidence of an active cancer either newly diagnosed or recurrent e while patients have a serious illness following heart or abdominal surgery or in patients who have just had a serious accident or those with acute respiratory failure low level of oxygen in the blood or high level of carbon dioxide in the blood e inpatients with Prader Willi syndrome who are very obese or have severe breathing problems There have been reports of deaths in children with Prader Willi syndrome who were treated with growth hormone and had one or more of the following risk factors severe obesity breathing problems colds or lung infections Treatment should not be started e in patients known to be allergic to somatropin the active substance in HUMATROPE or to any of the ingredients in the powder or the diluent listed below e inpatients who have undergone kidney transplant until one year post transplant e inpatients wi
9. changing the injection site and the doctor or nurse can tell you how Before using HUMATROPE the patient or caregiver should tell the doctor e ifthe patient has an active brain tumour or any other tumour either benign or cancerous However the HUMATROPE Product Monograph Page 44 of 58 IMPORTANT PLEASE READ doctor may prescribe HUMATROPE if the patient has had a brain tumour and needs no more anti tumour treatment for it The patient should be re examined frequently to make sure that the tumour has not come back or started to grow e ifthe patient is a survivor of childhood cancer e ifthe patient is very ill after a serious operation or after being treated for multiple injuries from an accident or if the patient has sudden serious breathing problems e ifthe patient has diabetes because more or less insulin may be needed when taking HUMATROPE e if amember of the patient s family has diabetes e ifthe patient is taking a steroid medication glucocorticoid such as cortisone or prednisone This is because the combination may reduce the success of the HUMATROPE treatment or because more of the steroid medication may be needed when the patient is also taking HUMATROPE e ifthe patient is taking a medication known to be metabolized by certain liver enzymes e g cyclosporine some anticonvulsants and hormones such as estrogen and birth control pills This is because the treatment with HUMATROPE may reduce the e
10. dges and diluent in the refrigerator at 2 8 C 36 46 F Missed Dose Contact your physician or pharmacist if you have missed a dose After it has been reconstituted mixed When the cartridge is prepared with the supplied diluent it may be stored in the refrigerator at 2 8 C 36 46 F and MUST be SIDE EFFECTS AND WHAT TO DO ABOUT THEM used within 28 DAYS Do NOT freeze Some people may be allergic to the diluent liquid used to mix with the HUMATROPE powder If there is any pain or redness Keep out of reach of children at the injection site or if there is any swelling tell your doctor Rarely more severe allergic reactions may occur Seek REPORTING SUSPECTED SIDE EFFECTS immediate medical help if you or your child experience any sepr a oe or a sudden trouble breathing with swelling of the hands feet or You can report any suspected adverse reactions associated with the face use of health products to the Canada Vigilance Program by one of the following 3 ways Children treated with HUMATROPE may have an increased risk of developing an inflammation of the pancreas called e Report online at www healthcanada gc ca medeffect pancreatitis If your child develops severe abdominal pain Call toll free at 1 866 234 2345 contact your doctor e Complete a Canada Vigilance Reporting Form and Fax toll free to 1 866 678 6789 or Mail to Canada Vigilance Program It is also important to have blood glucose checked if
11. e needle can be removed from the type of syringe you are using a new needle should be placed on the syringe before the injection If the syringe and needle are made as 1 unit another unit should be used for the injection Before and after injection the rubber stopper of the vial should be wiped with rubbing alcohol or an alcoholic antiseptic solution to prevent contamination of the contents by repeated needle insertions Remove the needle cover and draw an amount of air into the syringe equal to your dose of HUMATROPE Insert needle into vial of reconstituted HUMATROPE and inject the air into the vial Turn the vial upside down and making sure needle tip is in solution withdraw your correct dose see Figure 2 Make sure that no air bubbles are in the syringe Remove syringe and replace needle cover Write date of reconstitution on vial label and discard unused diluent Return unused portion of reconstituted HUMATROPE to refrigerator and use within 21 days Dispose of needle or the needle and syringe after use Injecting HUMATROPE l 2 Gently tap injection site several times with fingers Wipe the area thoroughly with an alcohol swab Use a circular motion and work outward from the inside of the circle 3 Subcutaneous Injection With the thumb and forefinger stabilize the skin by spreading or pinching up a large area of skin HUMATROPE Product Monograph Page 49 of 58 IMPORTANT PLEASE READ e Holding the s
12. ed closed epiphyses In both adults and children with growth hormone deficiency it also increases the growth of muscle and reduces body fat When it should not be used Treatment should not be started e in children to promote growth when the ends of the long bones have hardened closed epiphyses Treatment should be stopped when adult height is reached Reevaluation to find out whether the patient still has growth hormone deficiency will determine if continued treatment with HUMATROPE at a lower dose would be beneficial e inpatients with any evidence of an active cancer either newly diagnosed or recurrent e while patients have a serious illness following heart or abdominal surgery or in patients who have just had a serious accident or those with acute respiratory failure low level of oxygen in the blood or high level of carbon dioxide in the blood e inpatients with Prader Willi syndrome who are very obese or have severe breathing problems There have been reports of deaths in children with Prader Willi syndrome who were treated with growth hormone and had one or more of the following risk factors severe obesity breathing problems colds or lung infections Treatment should not be started e inpatients known to be allergic to somatropin the active substance in HUMATROPE or to any of the ingredients in the powder or the diluent listed below e inpatients who have undergone kidney transplant until one year post tran
13. efore important to keep changing the injection site and the doctor or nurse can tell you how Before using HUMATROPE the patient or caregiver should tell the doctor e ifthe patient has an active brain tumour or any other tumour either benign or cancerous However the doctor may prescribe HUMATROPE if the patient has HUMATROPE Product Monograph Page 51 of 58 IMPORTANT PLEASE READ had a brain tumour and needs no more anti tumour treatment for it The patient should be re examined frequently to make sure that the tumour has not come back or started to grow e ifthe patient is a survivor of childhood cancer e ifthe patient is very ill after a serious operation or after being treated for multiple injuries from an accident or if the patient has sudden serious breathing problems e ifthe patient has diabetes because more or less insulin may be needed when taking HUMATROPE e ifa member of the patient s family has diabetes e ifthe patient is taking a steroid medication glucocorticoid such as cortisone or prednisone This is because the combination may reduce the success of the HUMATROPE treatment or because more of the steroid medication may be needed when the patient is also taking HUMATROPE e ifthe patient is taking a medication known to be metabolized by certain liver enzymes e g cyclosporine some anticonvulsants and hormones such as estrogen and birth control pills This is because the treatment with HU
14. ffectiveness of these drugs e if the patient especially a child develops abdominal pain e if the patient is or plans to become pregnant or is breast feeding e ifthe patient has hypothyroidism low levels of thyroid hormone because HUMATROPE may reduce the levels of thyroid hormone The patient may require a change in dosage of his or her thyroid hormone medication e ifthe patient suffers from a bad headache or frequent headaches or from problems with eyesight vomiting or feeling sick Very rarely swelling of the brain may develop and the doctor may want to examine the patient to look for signs of brain swelling If this occurs it may be necessary to stop HUMATROPE treatment e ifthe patient develops a limp or has hip or knee pain while being treated with HUMATROPE If the patient is sensitive to any component of the diluent the liquid used to mix with the HUMATROPE powder Sterile Water for Injection USP may be used to dissolve the HUMATROPE supplied in vials not cartridges Refer to How to Store It section for storage instructions If the patient has Turner syndrome and develops an ear infection or headaches her doctor should be told about these problems If the patient is growth hormone deficient and also has Prader Willi syndrome a genetic disorder the doctor should examine the patient for breathing problems and airway infections before starting HUMATROPE treatment especially if the patient is overweight ha
15. larly during treatment Patients over 65 years of age may be more sensitive to HUMATROPE and may require lower dose of HUMATROPE INTERACTIONS WITH THIS MEDICATION Tell the doctor if the patient is taking any of the following drugs e Steroid medications such as glucocorticoids e g cortisone or prednisone e Medications known to be metabolized by certain liver enzymes e g cyclosporine some anticonvulsants and hormones such as estrogen and birth control pills e Insulin and anti hyperglycemic agents Because HUMATROPE may affect how some hormones such as cortisol and cortisone are processed in the body people may discover that they have an underactive adrenal gland after starting HUMATROPE therapy In these cases glucocorticoid replacement therapy would need to be started If already on glucocorticoid therapy dosage may need to be adjusted PROPER USE OF THIS MEDICATION Be sure to change the injection site frequently to help prevent lipoatrophy loss of fat tissue under the skin In general HUMATROPE should be injected in the evening or before bedtime HUMATROPE Product Monograph Page 52 of 58 IMPORTANT PLEASE READ Usual dose Other possible side effects include headaches muscle or joint The doctor will instruct you on what is the best dose of pains in hips or knees swelling associated with tingling HUMATROPE for you or your child based on individual sensations in the hands feeling weak ra
16. line at www healthcanada gc ca medeffect has diabetes or a family history of diabetes e Call toll free at 1 866 234 2345 e Complete a Canada Vigilance Reporting Form and Fax toll free to 1 866 678 6789 or Mail to Canada Vigilance Program HUMATROPE may affect the way the body handles sugars from food and drink The doctor may need to check the amount Heal ealth Canada of sugar in the urine or blood Postal Locator 0701D Ottawa Ontario HUMATROPE can affect the amount of thyroid hormone in the K1A 0K9 blood so patients must have thyroid function tests from time to Postage paid labels Canada Vigilance Reporting Form and the time If the thyroid is not working properly HUMATROPE adverse reaction reporting guidelines are available on the may not work as well as it should MedEffect Canada website at www healthcanada gc ca medeffect NOTE Should you require information related to the management of side effects contact your health care professional The Canada Vigilance Program does not provide medical advice Any child who begins to limp must be examined by a doctor HUMATROPE may cause intracranial hypertension increased pressure within the skull Call the doctor if the patient has a headache that doesn t go away or is severe or has headaches MORE INFORMATION that become more frequent problems with vision nausea feeling sick in the stomach or vomiting For more information please contact your healthca
17. n the refrigerator at 2 8 C 36 46 F Missed Dose Contact your physician or pharmacist if you have missed a dose After it has been reconstituted mixed When the vial is prepared with the supplied diluent it may be stored in the refrigerator at 2 8 C 36 46 F and MUST be used SIDE EFFECTS AND WHAT TO DO ABOUT THEM within 21 DAYS Do NOT freeze Some people may be allergic to the diluent liquid used to mix with the HUMATROPE powder If there is any pain or redness When the vial is prepared with Sterile Water for Injection USP at the injection site or if there is any swelling tell your doctor it should be used immediately Although not recommended it may be stored in the refrigerator at 2 8 C 36 46 F but must Rarely more severe allergic reactions may occur Seek be used within 24 HOURS Do NOT freeze immediate medical help if you or your child experience any sudden trouble breathing with swelling of the hands feet or Keep out of reach of children face REPORTING SUSPECTED SIDE EFFECTS Children treated with HUMATROPE may have an increased risk of developing an inflammation of the pancreas called You can report any suspected adverse reactions associated with the pancreatitis If your child develops severe abdominal pain use of health products to the Canada Vigilance Program by one of the contact your doctor following 3 ways It is also important to have blood glucose checked if the patient e Report on
18. on please contact your healthcare professional or pharmacist first or Eli Lilly Canada Inc at 1 888 545 5972 or visit the website at www lilly ca The information in this document is current as of the last revision date shown below For the most current information please visit our website or contact us directly HUMATROPE and HUMATROPEN are trademarks owned or licensed by Eli Lilly and Company its subsidiaries or affiliates This leaflet was prepared by Eli Lilly Canada Inc Toronto Ontario M1N 2E8 Last revised August 19 2013 HUMATROPE Product Monograph Page 58 of 58
19. ow For the most current information HUMATROPE Product Monograph Page 53 of 58 IMPORTANT PLEASE READ please visit our website or contact us directly HUMATROPE and HUMATROPEN are trademarks owned or licensed by Eli Lilly and Company its subsidiaries or affiliates This leaflet was prepared by Eli Lilly Canada Inc Toronto Ontario MIN 2E8 Last Revised August 19 2013 HUMATROPE Product Monograph Page 54 of 58 Reconstitution Instructions for HUMATROPE Cartridges Plunger Humatrope Cartridge Diluent Syringe White Tip Cap Only use parts from this kit to prepare the drug cartridge Diluent Needle Cover Note The liquid is coloriess it is shown here as blue for illustration purposes only HUMATROPE Product Monograph Page 55 of 58 Preparing Your New Cartridge Remove ALL contents from the tray Grasp Needle Cover which is at Remove Needle Cover Hold cartridge Black Triangles PUSH the cartridge Note This product is designed for left the bottom of the Diluent Syringe and discard DO NOT towards the Diluent Syringe STRAIGHT in or right handed use Please feel free depress Plunger yet Itis Align the cartridge and Diluent until it stops AND the to use whichever hand is most okay if a drop of fluid is Syringe in a straight line DO Black Triangles ARE comfortable for you lost It is not necessary to NOT insert the cartridge at an COVERED release angle You may hear o
20. patient is overweight has previously experienced severe breathing problems especially during sleep or suffered infection of the lungs or airways If during treatment the patient has signs of breathing problems snoring treatment should be interrupted and the cause assessed by the doctor Treatment with HUMATROPE can change blood sugar levels The doctor should check the patient s blood sugar regularly while taking HUMATROPE especially if there are risk factors for diabetes Patients who have diabetes or impaired glucose tolerance should have their blood sugar closely monitored during HUMATROPE therapy Leukemia has been reported in a small number of pediatric patients who have been treated with growth hormone including growth hormone of pituitary origin and man made growth hormone products such as somatrem and somatropin The relationship if any between leukemia and growth hormone is uncertain Progression of pre existing scoliosis curvature of the spine can occur in children who have rapid growth HUMATROPE has not been shown to increase the occurrence of scoliosis If the patient has hypopituitarism and is receiving standard hormone replacement therapy the doctor should monitor the hormone replacement therapy closely during HUMATROPE treatment If the patient has a growth disorder associated with being born small for gestational age the blood sugar and insulin levels should be checked before starting treatment and regu
21. r feel a air from the Diluent click DO NOT twist the Syringe cartridge HUMATROPE Product Monograph Page 56 of 58 Hold the Diluent Syringe and the Remove thumb from the Plunger With thumb OFF the Place the End Cap on a hard cartridge together with TWO HANDS and check that the Diluent Syringe plunger pull the cartridge flat surface Push the Diluent Push and release the Plunger 2 or 3 is empty it is normal for away from the Syringe onto the End Cap and times until the small drops of Diluent to remain in Diluent Syringe immediately discard the Diluent Diluent is in the cartridge the Diluent Syringe Syringe as instructed by your healthcare professional HUMATROPE Product Monograph Page 57 of 58 Mix the cartridge by gently inverting10 times and let sit for 3 minutes DO NOT SHAKE Inspect the solution The HUMATROPE solution should be clear If the solution is clear your cartridge is now prepared and ready to be attached to your HUMATROPEN see the User Manual for your HUMATROPEN After the cartridge has been reconstituted mixed with the supplied diluent it may be stored in the refrigerator at 2 8 C 36 46 F and MUST be used within 28 DAYS Do NOT freeze If the solution is cloudy or contains particles gently invert the cartridge 10 additional times Let the cartridge sit for 5 more minutes If the solution remains cloudy or contains particles DO NOT USE THE CARTRIDGE For more informati
22. re HUMATROPE Product Monograph Page 46 of 58 IMPORTANT PLEASE READ professional or pharmacist first or Eli Lilly Canada Inc at 1 888 545 5972 or visit the website at www lilly ca The information in this document is current as of the last revision date shown below For the most current information please visit our website or contact us directly HUMATROPE and HUMATROPEN are trademarks owned or licensed by Eli Lilly and Company its subsidiaries or affiliates This leaflet was prepared by Eli Lilly Canada Inc Toronto Ontario MIN 2E8 Last Revised August 19 2013 HUMATROPE Product Monograph Page 47 of 58 IMPORTANT PLEASE READ Reconstitution Instructions for HUMATROPE Vials Do not mix reconstitute the drug or inject it until you have been thoroughly trained in the proper techniques by your doctor Use sterile techniques as instructed by your doctor Discard syringes and or needles after each use When the vial has been prepared with the supplied diluent it may be stored in the refrigerator at 2 8 C 36 46 F and MUST be used within 21 DAYS Do NOT freeze Reconstituting the Vial of HUMATROPE Reconstitute HUMATROPE only with Diluent for HUMATROPE Do not use other solutions for reconstitution unless instructed to do so by your doctor Your doctor will also tell you what size syringe and needle to use and how much diluent to add to the vial of HUMATROPE Always start by washing your hands 1
23. rely high blood needs Use HUMATROPE exactly as the doctor tells you to pressure shortness of breath and sleep apnea pauses in breathing during sleep If the headaches are bad or frequent Reconstitution Instructions and accompanied by sickness or vision problems tell the doctor Please refer to the enclosed reconstitution instructions immediately Overdose For patients with Turner syndrome HUMATROPE therapy Long term overdosage or using HUMATROPE after the growth may increase the already high frequency of ear infections Your plates in the long bones have closed hardened may result in child should see her doctor if you think she has an ear infection joint pain and continued growth of fingers toes nose ears or jaw If you think this is happening tell the doctor This is not a complete list of side effects If any of the side effects gets serious or if you notice any unexpected side Overdose may change blood sugar levels and patients may effects while taking HUMATROPE contact your doctor or experience symptoms of hypoglycemia low blood sugar such healthcare professional as feeling shaky dizzy and unwell or hyperglycemia high blood sugar such as increased urination or thirst HOW TO STORE IT In case of drug overdose contact a health care practitioner hospital emergency department or regional Poison Control Centre immediately even if there are no symptoms Before it has been reconstituted mixed Store HUMATROPE cartri
24. s previously experienced severe breathing problems especially during sleep or suffered infection of the lungs or airways If during treatment the patient has signs of breathing problems snoring treatment should be interrupted and the cause assessed by the doctor Treatment with HUMATROPE can change blood sugar levels The doctor should check the patient s blood sugar regularly while taking HUMATROPE especially if there are risk factors for diabetes Patients who have diabetes or impaired glucose tolerance should have their blood sugar closely monitored during HUMATROPE therapy Leukemia has been reported in a small number of pediatric patients who have been treated with growth hormone including growth hormone of pituitary origin and man made growth hormone products such as somatrem and somatropin The relationship if any between leukemia and growth hormone is uncertain Progression of pre existing scoliosis curvature of the spine can occur in children who have rapid growth HUMATROPE has not been shown to increase the occurrence of scoliosis If the patient has hypopituitarism and is receiving standard hormone replacement therapy the doctor should monitor the hormone replacement therapy closely during HUMATROPE treatment If the patient has a growth disorder associated with being born small for gestational age the blood sugar and insulin levels should be checked before starting treatment and regularly during treatment
25. splant e inpatients with diabetic retinopathy a complication of diabetes that results from damage to the blood vessels of the light sensitive tissue at the back of the eye retina What the medicinal ingredient is Somatropin recombinant human growth hormone What the important nonmedicinal ingredients are The HUMATROPE powder contains freeze dried somatropin dibasic sodium phosphate glycine and mannitol The diluent solution for dissolving somatropin contains metacresol and glycerin Phosphoric acid and or sodium hydroxide may have been added at the time of manufacture to adjust the acidity of the liquid What dosage forms it comes in HUMATROPE is supplied as follows Vial 5 mg vial plus 5 mL diluent Cartridges 6 mg 12 mg or 24 mg cartridges each with 3 15 mL of diluent HUMATROPE cartridges require the use of a HumatroPen to inject the drug HumatroPens are supplied separately WARNINGS AND PRECAUTIONS Serious Warnings and Precautions A doctor trained in hormone and growth disorders must examine the patient to decide if it is safe to use HUMATROPE After the HUMATROPE powder has been dissolved it must be water clear and free of particles This medicine has been prescribed for you Do not pass it on to others It may harm them even if their symptoms seem the same as yours When medicine is injected into the same place over a long time it can cause loss of fat tissue under the skin It is ther
26. th diabetic retinopathy a complication of diabetes that results from damage to the blood vessels of the light sensitive tissue at the back of the eye retina What the medicinal ingredient is Somatropin recombinant human growth hormone What the important nonmedicinal ingredients are The HUMATROPE powder contains freeze dried somatropin dibasic sodium phosphate glycine and mannitol The diluent solution for dissolving somatropin contains metacresol and glycerin Phosphoric acid and or sodium hydroxide may have been added at the time of manufacture to adjust the acidity of the liquid What dosage forms it comes in HUMATROPE is supplied as follows Vial 5 mg vial plus 5 mL diluent Cartridges 6 mg 12 mg or 24 mg cartridges each with 3 15 mL of diluent HUMATROPE cartridges require the use of a HumatroPen to inject the drug HumatroPens are supplied separately WARNINGS AND PRECAUTIONS Serious Warnings and Precautions A doctor trained in hormone and growth disorders must examine the patient to decide if it is safe to use HUMATROPE After the HUMATROPE powder has been dissolved it must be water clear and free of particles This medicine has been prescribed for you Do not pass it on to others It may harm them even if their symptoms seem the same as yours When medicine is injected into the same place over a long time it can cause loss of fat tissue under the skin It is therefore important to keep
27. yringe at a 90 degree angle to injection site quickly insert the needle all the way into the skin e Slowly inject the solution e Remove the needle quickly and apply pressure over the injection site with a dry gauze pad or cotton ball Rub for several seconds e Dispose of needle or the needle and syringe after use 4 Intramuscular Injection With the thumb and first 2 fingers press the skin down firmly against a large muscle mass such as the thigh e Holding the syringe at a 90 degree angle to injection site quickly insert the needle all the way into the skin e When the needle is in place slowly pull back on the plunger If blood enters the syringe remove needle discard syringe and drug and prepare another injection e If no blood enters the syringe slowly inject the solution e Dispose of needle or the needle and syringe after use as per your doctor s instructions For more information please contact your healthcare professional or pharmacist first or Eli Lilly Canada Inc at 1 888 545 5972 or visit the website at www lilly ca The information in this document is current as of the last revision date shown below For the most current information please visit our website or contact us directly HUMATROPE is a trademark owned or licensed by Eli Lilly and Company its subsidiaries or affiliates This leaflet was prepared by Eli Lilly Canada Inc Toronto Ontario M1N 2E8 Last revised August 19 2013 HUMATROPE Product Monogr
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