United States - English - NLM (National Library of Medicine)

a-s medication solutions - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - humalog is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. humalog is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients who are hypersensitive to insulin lispro or to any of the excipients in humalog [see warnings and precautions (5.5)] . risk summary published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. no adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data human data published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. however, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups. animal data in a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through gestation day 19. there were no adverse effects on female fertility, implantation, or fetal viability and morphology. however, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter. in an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on gestation days 7 through 19. there were no adverse effects on fetal viability, weight, and morphology at any dose. risk summary available data from published literature suggests that exogenous human insulin products, including insulin lispro, are transferred into human milk. there are no adverse reactions reported in breastfed infants in the literature. there are no data on the effects of exogenous human insulin products, including insulin lispro, on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin, any potential adverse effects on the breastfed child from humalog or from the underlying maternal condition. the safety and effectiveness of humalog to improve glycemic control have been established in pediatric patients with diabetes mellitus. use of humalog for this indication is supported by evidence from adequate and well-controlled studies in 831 pediatric patients with type 1 diabetes mellitus aged 3 years and older and from studies in adults with diabetes mellitus [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)]. of the total number of patients (n=2,834) in eight clinical studies of humalog, twelve percent (n=338) were 65 years of age or over. the majority of these patients had type 2 diabetes. hba1c values and hypoglycemia rates did not differ by age. pharmacokinetic/pharmacodynamic studies to assess the effect of age on the onset of humalog action have not been performed. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent humalog dose adjustment and more frequent blood glucose monitoring [see clinical pharmacology (12.3)] . patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent humalog dose adjustment and more frequent blood glucose monitoring [see clinical pharmacology (12.3)] . instructions for use humalog ® (hu-ma-log) (insulin lispro) injection, for subcutaneous use 3 ml or 10 ml multiple-dose vial (100 units per ml, u-100) read this instructions for use before you start taking humalog and each time you get a new vial. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your needles or syringes with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. supplies needed to give your injection - a multiple-dose humalog vial - a u-100 insulin syringe and needle - 2 alcohol swabs - gauze - 1 sharps container for throwing away used needles and syringes. see “disposing of used needles and syringes” at the end of these instructions. preparing your humalog dose - wash your hands with soap and water. - check the humalog label to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - humalog should look clear and colorless. do not use humalog if it is thick, cloudy, or colored, or if you see lumps or particles in it. - do not use humalog past the expiration date printed on the label or 28 days after you first use it. - always use a new syringe and needle for each injection to prevent infections and blocked needles. do not reuse or share your syringes or needles with other people. you may give other people a serious infection or get a serious infection from them. if you use humalog with nph insulin: - nph insulin is the only type of insulin that can be mixed with humalog. do not mix humalog with any other type of insulin. - humalog should be drawn up into the syringe first, before you draw up your nph insulin. talk to your healthcare provider if you are not sure about the right way to mix humalog and nph insulin. - give your injection right away. giving your humalog injection with a syringe - inject your insulin exactly as your healthcare provider has shown you. your healthcare provider should tell you if you should pinch the skin before injecting. - humalog starts acting fast, so give your injection within 15 minutes before or right after you eat a meal. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - if you see blood after you take the needle out of your skin, press the injection site with a piece of gauze or an alcohol swab. do not rub the area. - do not recap the needle. recapping the needle can lead to a needle stick injury. giving your humalog using an insulin pump - humalog should be given into an area of your body recommended in the instructions that come with your insulin pump. - change your infusion set and rotate the infusion set insertion site according to the manufacturer's user manual. - change (rotate) your insertion sites within the area you choose for each insertion to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the insertion sites. do not insert into the exact same spot for each insertion. do not insert where the skin has pits, is thickened, or has lumps. do not insert where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - change the insulin in the reservoir at least every 7 days or according to the pump user manual, whichever is shorter, even if you have not used all of the insulin. - do not dilute or mix humalog with any other type of insulin in your insulin pump. - see your insulin pump manual for instructions or talk to your healthcare provider. disposing of used needles and syringes - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. how should i store humalog? all unopened vials: - store all unopened vials in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze. do not use if humalog has been frozen. - keep away from heat and out of direct light. - unopened vials can be used until the expiration date on the carton and label, if they have been stored in the refrigerator. - unopened vials should be thrown away after 28 days, if they are stored at room temperature. after vials have been opened: - store opened vials in the refrigerator or at room temperature up to 86°f (30°c) for up to 28 days. - keep vials away from heat and out of direct light. - throw away all opened vials after 28 days of use, even if there is insulin left in the vial. humalog in an insulin pump: - throw away humalog in the pump reservoir if it has been exposed to temperatures higher than 98.6°f (37°c). keep humalog vials, syringes, needles and all medicines out of the reach of children. if you have any questions or problems with your humalog, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider for help. for more information on humalog and insulin, go to www.humalog.com . manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023 scan this code to launch the humalog.com website humalog® is a registered trademark of eli lilly and company. copyright © 1996, 2023, eli lilly and company. all rights reserved. logvl-0009-ifu-20230721 instructions for use humalog (hu-ma-log) kwikpen ® (insulin lispro) injection, for subcutaneous use 3 ml single-patient-use pen (100 units per ml) read the instructions for use before you start taking humalog® and each time you get another kwikpen® . there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your humalog kwikpen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. humalog kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units of humalog. you can give yourself more than 1 dose from the pen. each turn (click) of the dose knob dials 1 unit of insulin. you can give from 1 to 60 units in a single injection. if your dose is more than 60 units, you will need to give yourself more than 1 injection. the plunger only moves a little with each injection, and you may not notice that it moves. the plunger will only reach the end of the cartridge when you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the pen. how to recognize your humalog kwikpen - pen color: dark blue - dose knob: dark blue - labels: white label with burgundy stripe supplies you will need to give your injection - humalog kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab - gauze preparing your pen - wash your hands with soap and water. - check your pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. humalog should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units. - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat priming steps 6 to 8, no more than 4 times. - if you still do not see insulin, change the needle and repeat priming steps 6 to 8. selecting your dose - you can give from 1 to 60 units in a single injection. - if your dose is more than 60 units, you will need to give more than 1 injection. - if you need help with dividing up your dose the right way, ask your healthcare provider. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks. you may dial the wrong dose. this may lead to you getting too much insulin or not enough insulin. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers (for example, 12) are printed on the dial. - the odd numbers, (for example, 25) after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you can not inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - choose your injection site. humalog is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe your skin with an alcohol swab, and let your skin dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window. - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window, do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat the injection. monitor your blood glucose as instructed by your healthcare provider. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - the used pen may be discarded in your household trash after you have removed the needle. - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. storing your pen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze your insulin. do not use if it has been frozen. - unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)]. keep away from heat and light. - throw away the humalog pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the reach of children. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your humalog kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humalog kwikpen and insulin, go to www.humalog.com . manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023 scan this code to launch (www.humalog.com) humalog® and humalog kwikpen® are registered trademarks of eli lilly and company. copyright © 2007, 2023, eli lilly and company. all rights reserved. logkp-0009-ifu-20230721 instructions for use humalog ® (hu-ma-log) junior kwikpen ® (insulin lispro) injection, for subcutaneous use 3 ml single-patient-use pen (100 units per ml) read the instructions for use before you start taking humalog and each time you get another humalog® junior kwikpen® . there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your humalog junior kwikpen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. humalog junior kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units of humalog. - you can give yourself more than 1 dose from the pen. - each turn of the dose knob dials 0.5 (½) unit of insulin. you can give from 0.5 (½) to 30 units in a single injection. - if your dose is more than 30 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. the plunger will only reach the end of the cartridge when you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the pen. how to recognize your humalog junior kwikpen: - pen color:        blue - dose knob:        blue, with raised ridges on end and side - label:        white with an orange color bar and orange-to-yellow color band supplies needed to give your injection: - humalog junior kwikpen - kwikpen compatible needle (bd [becton, dickinson and company] pen needles recommended) - alcohol swab - gauze preparing your pen - wash your hands with soap and water. - check the pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. – do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. humalog should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units. - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat priming steps 6 to 8, no more than 4 times. - if you still do not see insulin, change the needle and repeat priming steps 6 to 8. selecting your dose - you can give from 0.5 (½) to 30 units in a single injection. - if your dose is more than 30 units, you will need to give more than 1 injection. – if you need help with dividing up your dose the right way, ask your healthcare provider. – you must use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. – the pen dials 0.5 (½) unit at a time. – the dose knob clicks as you turn it. – do not dial your dose by counting the clicks. you may dial the wrong dose. this may lead to you getting too much insulin or not enough insulin. – the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. – the whole unit numbers (for example, 4) are printed on the dial. – the half units are shown as lines between the whole unit numbers. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: – inject the amount left in your pen and then use a new pen to give the rest of your dose, or – get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you can not inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - choose your injection site. humalog is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe your skin with an alcohol swab, and let your skin dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. - pull the needle out of your skin. – a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window – if you see “0” in the dose window, you have received the full amount you dialed. – if you do not see “0” in the dose window, do not redial. insert the needle into your skin and finish your injection. – if you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection . monitor your blood glucose as instructed by your healthcare provider. – if you normally need to give 2 injections for your full dose, be sure to give your second injection. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - the used pen may be discarded in your household trash after you have removed the needle. - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: – made of a heavy-duty plastic, – can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, – upright and stable during use, – leak-resistant, and – properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle the container. storing your pen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze your insulin. do not use if it has been frozen. - unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)]. keep away from heat and light. - throw away the humalog pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: – pushing the dose knob more slowly will make it easier to inject. – your needle may be blocked. put on a new needle and prime the pen. – you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your humalog junior kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humalog junior kwikpen and insulin, go to www.humalog.com . manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023 scan this code to launch (www.humalog.com) humalog® and humalog® junior kwikpen® are trademarks of eli lilly and company. copyright © 2017, 2023, eli lilly and company. all rights reserved. logjrkp-0004-ifu-20230721 instructions for use humalog ® (hu-ma-log) tempo pen™ (insulin lispro) injection, for subcutaneous use 3 ml single-patient-use pen, (100 units per ml) read the instructions for use before you start taking humalog and each time you get another humalog tempo pen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your humalog tempo pen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. humalog tempo pen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units of humalog. you can give yourself more than 1 dose from the pen. each turn (click) of the dose knob dials 1 unit of insulin. you can give from 1 to 60 units in a single injection. if your dose is more than 60 units, you will need to give yourself more than 1 injection. the plunger only moves a little with each injection, and you may not notice that it moves. the plunger will only reach the end of the cartridge when you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the pen. this humalog tempo pen contains a component that allows for data connectivity when used with a compatible transmitter. how to recognize your humalog tempo pen - pen color: dark blue - dose knob: burgundy - labels: white label with burgundy stripe supplies you will need to give your injection - humalog tempo pen - tempo pen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab - gauze preparing your pen - wash your hands with soap and water. - check your pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. humalog should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with the needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat priming steps 6 to 8, but no more than 4 times. - if you still do not see insulin, change the needle and repeat priming steps 6 to 8. selecting your dose - you can give from 1 to 60 units in a single injection. - if your dose is more than 60 units, you will need to give more than 1 injection. - if you need help with dividing up your dose the right way, ask your healthcare provider. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks. you may dial the wrong dose. this may lead to you getting too much insulin or not enough insulin. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers (for example, 12) are printed on the dial. - the odd numbers, (for example, 25) after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you cannot inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - choose your injection site. humalog is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe your skin with an alcohol swab, and let your skin dry before you inject your dose. - pull the needle out of your skin. a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window. - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window, do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat the injection. monitor your blood sugar (glucose) as instructed by your healthcare provider. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - the used pen may be discarded in your household trash after you have removed the needle. - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. storing your pen unopened pens - store unopened pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze your insulin. do not use if it has been frozen. - unopened pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)]. keep away from heat and light. - throw away the humalog tempo pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the reach of children. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your humalog tempo pen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humalog tempo pen and insulin, go to www.humalog.com . manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023 scan this code to launch (www.humalog.com) humalog® is a registered trademark and tempo pentm is a trademark of eli lilly and company. copyright © 2019, 2023, eli lilly and company. all rights reserved. logtp-0002-ifu-20230721 instructions for use humalog (hu-ma-log) kwikpen ® (insulin lispro) injection, for subcutaneous use 3 ml single-patient-use pen (200 units per ml) read the instructions for use before you start taking humalog® and each time you get another kwikpen® . there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your humalog kwikpen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. humalog kwikpen 200 units/ml (“pen”) is a disposable single-patient-use prefilled pen containing 600 units of humalog. you can give yourself more than 1 dose from the pen. each turn (click) of the dose knob dials 1 unit of insulin. you can give from 1 to 60 units in a single injection. if your dose is more than 60 units, you will need to give yourself more than 1 injection. the plunger only moves a little with each injection, and you may not notice that it moves. the plunger will only reach the end of the cartridge when you have used all 600 units in the pen. inject humalog 200 units/ml only with your pen. do not transfer insulin from your pen to a syringe. syringes will not measure 200 units/ml insulin correctly. a severe overdose can result, causing very low blood sugar which may put your life in danger. people who are blind or have vision problems should not use the pen without help from a person trained to use the pen. how to recognize your humalog 200 units/ml kwikpen - pen color: dark grey - dose knob: dark grey with burgundy ring on the end - label: burgundy label with “200 units per ml (u-200)” in white stripe and a grey and burgundy checker board design. supplies needed to give your injection - humalog kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab - gauze preparing your pen - wash your hands with soap and water. - check your pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. humalog should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0 ” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat priming steps 6 to 8, no more than 8 times. - if you still do not see insulin, change the needle and repeat priming steps 6 to 8. selecting your dose this pen has been made to deliver the dose that is shown in the dose window. dial your usual dose as instructed by your healthcare provider. - you can give from 1 to 60 units in a single injection. - if your dose is more than 60 units, you will need to give more than 1 injection. - if you need help with dividing up your dose the right way, ask your healthcare provider. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks. you may dial the wrong dose. this may lead to you getting to much insulin or not enough insulin. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers (for example, 12) are printed on the dial. - the odd numbers, (for example, 25) after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you can not inject. do not transfer this to a syringe. severe overdose can result. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not use the exact same spot for each injection. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - choose your injection site. humalog is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe your skin with an alcohol swab, and let your skin dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. - pull the needle out of your skin. - a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window, do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat the injection. monitor your blood glucose as instructed by your healthcare provider. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - the used pen may be discarded in your household trash after you have removed the needle. - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. storing your pen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze your insulin. do not use if it has been frozen. - unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)]. keep away from heat and light. - throw away the humalog pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your humalog kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humalog kwikpen and insulin, go to www.humalog.com . manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 this instructions for use has been approved by the u.s. food and drug administration. revised: july 2023 scan this code to launch (www.humalog.com) humalog® and humalog kwikpen® are trademarks of eli lilly and company. copyright © 2015, 2023, eli lilly and company. all rights reserved. logkp200-0005-ifu-20230721

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - admelog is indicated to improve glycemic control in adults and pediatric patients 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. admelog is contraindicated: - during episodes of hypoglycemia. - in patients who are hypersensitive to insulin lispro or to any of the excipients. risk summary the limited available data with admelog in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with another insulin lispro product used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . pregnant rats and rabbits were exposed to another insulin lispro product i

New Zealand - English - Ministry for Primary Industries

schering-plough animal health limited - insulin - insulin 0.04 thou iu/ml - endocrine agent (hormone)

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - insulin porcine 40 iu/ml - suspension for injection - 40 iu/ml - insulin zinc suspension, crystalline 28 iu/ml; insulin zinc suspension, amorphous 12 iu/ml - insulin (pork) - dog; cat

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

intervet international b.v. - insulin porcine 40 iu/ml - suspension for injection - 40 iu/ml - insulin zinc suspension, amorphous 12 iu/ml; insulin zinc suspension, crystalline 28 iu/ml - insulin (pork) - dog; cat

United States - English - NLM (National Library of Medicine)

mannkind corporation - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 4 - afrezza® is a rapid acting inhaled human insulin indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: - afrezza is not recommended for the treatment of diabetic ketoacidosis [see warning and precautions (5.6)] . - the safety and effectiveness of afrezza in patients who smoke have not been established. the use of afrezza is not recommended in patients who smoke or who have recently stopped smoking. afrezza is contraindicated: - during episodes of hypoglycemia [see warning and precautions (5.3)]. - chronic lung disease, such as asthma or chronic obstructive pulmonary disease (copd), because of the risk of acute bronchospasm [see warnings and precautions (5.1)] - hypersensitivity to regular human insulin or any of the excipients in afrezza [see warnings and precautions (5.7)] risk summary limited available data with afrezza use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. available information from published studies with human insulin use during pregnancy has not reported a clear association with human insulin and adverse developmental outcomes (see data ). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations ). in animal reproduction studies, there were no adverse developmental outcomes with subcutaneous administration of carrier particles (vehicle without insulin) to pregnant rats during organogenesis at doses 21 times the human daily dose of 99 mg afrezza, based on auc (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with hba1c >7 and has been reported to be as high as 20-25% in women with hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, stillbirth, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia- related morbidity. data human data there are limited data with afrezza use in pregnant women. published data do not report a clear association with human insulin and major birth defects, miscarriage, or adverse maternal or fetal outcomes when human insulin is used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and lack of blinding. animal data in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 6 through 17 (organogenesis), no major malformations were observed at doses up to 100 mg/kg/day (21 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). in pregnant rabbits given subcutaneous doses of 2, 10, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through 19 (organogenesis), adverse maternal effects were observed in all dose groups (at human systemic exposure following a daily dose of 99 mg afrezza, based on auc). in pregnant rats given subcutaneous doses of 10, 30, and 100 mg/kg/day of carrier particles (vehicle without insulin) from gestation day 7 through lactation day 20 (weaning), decreased epididymis and testes weights were observed in f1 male offspring, however, no decrease in fertility was noted, and impaired learning were observed in f1 pups at ³ 30 mg/kg/day (6 times the human systemic exposure at a daily dose of 99 mg afrezza, based on auc). risk summary there are no data on the presence of afrezza in human milk, the effects on the breastfed infant, or the effects on milk production. one small published study reported that exogenous subcutaneous insulin was present in human milk. no adverse effects in infants were noted. the carrier particles are present in rat milk (see data ). potential adverse reactions that are related to inhalational administration of afrezza are unlikely to be associated with potential exposure of afrezza through breast milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for afrezza and any potential adverse effects on the breastfed infant from afrezza or from the underlying maternal condition. data subcutaneous administration of the carrier particle in lactating rats resulted in excretion of the carrier particle in rat milk at levels that were approximately 10% of the maternal exposure. given the results of the rat study, it is highly likely that the insulin and carrier in afrezza are excreted in human milk. the safety and effectiveness of afrezza to improve glycemic control in pediatric patients with diabetes mellitus has not been established. afrezza has not been studied in pediatric patients. in the afrezza clinical studies, 671 (12%) patients were 65 years of age or older, of which 42 (0.8%) were 75 years of age or older. in these studies, 381 (13%) of afrezza-treated patients were 65 years of age or older, of which 20 (0.7%) were 75 years of age or older. no overall differences in effectiveness of afrezza have been observed between patients 65 years of age and older and younger adult patients [see clinical studies (14)] . clinical studies of afrezza did not include sufficient numbers of patients 65 years of age and older to determine whether there were differences in safety between these patients and younger adult patients. pharmacokinetic and pharmacodynamic studies to assess the effect of age on pharmacokinetics or pharmacodynamics on insulin human, respectively, have not been conducted. the effect of hepatic impairment on the pharmacokinetics of afrezza has not been studied. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with hepatic impairment [see warnings and precautions (5.3)] . the effect of renal impairment on the pharmacokinetics of afrezza has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. frequent glucose monitoring and a lower dosage may be necessary in afrezza-treated patients with renal impairment [see warnings and precautions (5.3)] . instructions for use afrezza® (uh-frezz-uh) (insulin human) inhalation powder, for oral inhalation use this “instructions for use” contains information on how to use afrezza® (insulin human) inhalation powder. read this instructions for use before you start using afrezza and each time you get a new afrezza inhaler. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. your healthcare provider should show you how to use your afrezza inhaler the right way before you use it for the first time. important information about afrezza: - afrezza comes in 3 strengths (see figure a): 4 units (blue cartridge) 8 units (green cartridge) 12 units (yellow cartridge) - 4 units (blue cartridge) - 8 units (green cartridge) - 12 units (yellow cartridge) - if your prescribed afrezza dose is higher than 12 units, you will need to use more than 1 cartridge. - if you need to use more than 1 cartridge for your dose, throw away the used cartridge before getting a new one. you can tell when a cartridge has been used, because the cup has moved to the center. - do not try to open the afrezza cartridges. the afrezza inhaler opens the cartridge automatically during use. - afrezza cartridges should only be used with the afrezza inhaler. do not try to breathe in the afrezza insulin powder in any other way. do not put cartridges in your mouth and do not swallow cartridges. - use only 1 afrezza inhaler at a time. the same inhaler should be used for the 4 unit, 8 unit or 12 unit cartridges. - store the inhaler in a clean, dry place with the mouthpiece cover on until your next dose. - throw away your afrezza inhaler after 15 days and get a new one. if you are having problems with your afrezza inhaler or if it breaks and you need a new one, call 1-877-323-8505. know your afrezza inhaler: know your afrezza cartridges: manufactured by: mannkind corporation danbury, ct 06810 us license no. #2190 © 2016 – 2023 mannkind corporation this instructions for use has been approved by the u.s. food and drug administration. revised: 02/2023 afrezza is a registered trademark of mannkind corporation patent: www.mannkindcorp.com/patent-notices

United States - English - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz), lixisenatide (unii: 74o62bb01u) (lixisenatide - unii:74o62bb01u) - insulin glargine 100 u in 1 ml - soliqua 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use : - soliqua 100/33 has not been studied in patients with a history of pancreatitis [see warnings and precautions (5.2)] . consider other antidiabetic therapies in patients with a history of pancreatitis. - soliqua 100/33 is not recommended for use in combination with any other product containing a glp-1 receptor agonist [see warnings and precautions (5.5)] . - soliqua 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - soliqua 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - soliqua 100/33 has not been studied in combination with prandial insulin. soliqua 100/33 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.6)] . - in patients w

United States - English - NLM (National Library of Medicine)

novo nordisk - insulin degludec (unii: 54q18076qb) (insulin degludec - unii:54q18076qb), liraglutide (unii: 839i73s42a) (liraglutide - unii:839i73s42a) - insulin degludec 100 [iu] in 1 ml - xultophy 100/3.6 is a combination of insulin degludec and liraglutide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. limitations of use: xultophy 100/3.6 is contraindicated: risk summary based on animal reproduction studies, there may be risks to the fetus from exposure to liraglutide during pregnancy. xultophy 100/3.6 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no available data with xultophy 100/3.6, insulin degludec or liraglutide in pregnant women to inform a drug associated risk for major birth defects and miscarriage. there are clinical considerations regarding the risks of poorly controlled diabetes in pregnancy [see clinical considerations]. for insulin degludec, rats and rabbits were exposed in animal reproduction studies at 5 times (rat) and 10 times (rabbit) the human exposure at a dose of 0.75 u/kg/day. no adverse outcomes were observed for pregnant ani

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: water for injections; metacresol; glycerol; zinc chloride; sodium hydroxide; hydrochloric acid - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

Australia - English - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: metacresol; sodium hydroxide; zinc chloride; glycerol; hydrochloric acid; water for injections - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.