Belgija - engleski - 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

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

eli lilly and company - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - basaglar® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. limitations of use basaglar is not recommended for the treatment of diabetic ketoacidosis. basaglar is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any of the excipients in basaglar [see warnings and precautions (5.5)] . risk summary published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products 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, another insulin glargine product was administered to rats before, during and throughout pregnancy at doses up to 7 times the clinical dose of 10 units/day and to rabbits during organogenesis at doses approximately 2 times the clinical dose of 10 units/day. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats or rabbits (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 us 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 do not report a clear association with insulin glargine products and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine products are used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some with no comparative group. animal data subcutaneous reproduction and teratology studies have been performed with another insulin glargine product and with regular human insulin in rats and himalayan rabbits. this other insulin glargine product was given to female rats before mating, during mating, and throughout pregnancy at dose up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day) based on mg/m2 . in rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 , were administered during organogenesis. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats and rabbits. however, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. fertility and early embryonic development appeared normal. risk summary there are no data on the presence of insulin glargine in human milk, the effects on the breastfed infant, or the effects on milk production. endogenous insulin is present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for basaglar and any potential adverse effects on the breastfed child from basaglar or from the underlying maternal condition. the safety and effectiveness of basaglar have been established in pediatric patients (age 6 to 15 years) with type 1 diabetes based on an adequate and well-controlled trial of another insulin glargine product, 100 units/ml, in pediatric patients (age 6 to 15 years) with type 1 diabetes and additional data in adults with type 1 diabetes [see clinical studies (14.2)] . the safety and effectiveness of basaglar in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes has not been established. in the pediatric clinical trial, pediatric patients (age 6 to 15 years) with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in trials with type 1 diabetes [see adverse reactions (6.1)] . of the total number of subjects in clinical studies of patients with type 2 diabetes who were treated with basaglar or another insulin glargine product, 100 units/ml, each in combination with oral agents in a controlled clinical trial environment, 28.3% were 65 and over, while 4.5% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. nevertheless, caution should be exercised when basaglar is administered to geriatric patients. in elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in the elderly. the effect of renal impairment on the pharmacokinetics of basaglar 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 dose adjustment may be necessary for basaglar in patients with renal impairment [see warnings and precautions (5.3)] . the effect of hepatic impairment on the pharmacokinetics of basaglar has not been studied. however, as with all insulin products, more frequent glucose monitoring and dose adjustment may be necessary for basaglar in patients with hepatic impairment [see warnings and precautions (5.3)] . instructions for use basaglar® kwikpen® (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml single-patient-use pen read the instructions for use before you start using basaglar and each time you get another basaglar® 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 basaglar 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. basaglar kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 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. when the plunger reaches the end of the cartridge, 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 basaglar prefilled pen. how to recognize your basaglar kwikpen - pen color: light grey - dose knob: light grey with green ring on the end - labels: light grey with green color bars supplies needed to give your injection - basaglar kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab 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. basaglar 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 means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work 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 the priming steps, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps. small air bubbles are normal and will not affect your dose. selecting your dose - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - 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 because you may dial the wrong dose. - 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 are printed on the dial. - the odd numbers, 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. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site 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. note: 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 you did not receive your full dose. 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 and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - 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 - 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. - the used pen may be discarded in your household trash after you have removed the needle. storing your basaglar kwikpen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. 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)] and away from heat and light. - throw away the 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. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - 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 basaglar kwikpen, contact lilly at 1-800-lillyrx (1-800- 545-5979) or call your healthcare provider for help. for more information on basaglar kwikpen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® and basaglar® kwikpen® are trademarks of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2015, 2022, eli lilly and company. all rights reserved. baskp-0009-ifu-20221115 instructions for use basaglar® tempo pen™ (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml pen, single-patient-use read the instructions for use before you start using basaglar and each time you get another basaglar 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 basaglar 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. basaglar tempo pen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 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. when the plunger reaches the end of the cartridge, 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 basaglar prefilled pen. this basaglar tempo pen contains a component that allows for data connectivity when used with a compatible transmitter. how to recognize your basaglar tempo pen - pen color: light grey - dose knob: light grey - labels: light grey with green color bars supplies needed to give your injection - basaglar tempo pen - tempo pen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab 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. basaglar 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 means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work 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 the priming steps 6 to 8, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps 6 to 8. small air bubbles are normal and will not affect your dose. selecting your dose - you can give a dose of 1 to 80 units in a single injection. - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - 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 because you may dial the wrong dose. - 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 are printed on the dial. - the odd numbers, 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 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. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site 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. note: 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 you did not receive your full dose. 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 sugar (glucose) and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - 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 - 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. - the used pen may be thrown away (discarded) in your household trash after you have removed the needle. storing your basaglar tempo pen unopened pens - store unopened pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. 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)] and away from heat and light. - throw away the 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. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - 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 basaglar tempo pen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on basaglar tempo pen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® is a registered trademark and tempo pentm is a trademark of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2021, 2022, eli lilly and company. all rights reserved. bastp-0004-ifu-20221115

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

eli lilly and company - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 500 [iu] in 1 ml - humulin r u-500 is a concentrated human insulin indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day. the safety and efficacy of humulin r u-500 used in combination with other insulins has not been determined. the safety and efficacy of humulin r u-500 delivered by continuous subcutaneous infusion has not been determined. humulin r u-500 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.4)] - in patients who are hypersensitive to humulin r u-500 or any of its excipients [see warnings and precautions (5.5)] risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and 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). animal reproduction studies were not performed. 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 while available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. all available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size. risk summary available data from published literature suggests that exogenous human insulin products, including humulin r u-500, 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 humulin r u-500 on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for humulin r u-500 and any potential adverse effects on the breastfed child from humulin r u-500 or from the underlying maternal condition. the safety and effectiveness of humulin r u-500 in pediatric patients with diabetes mellitus requiring more than 200 units of insulin per day to improve glycemic control have been established. use of humulin r u-500 for this indication is supported by evidence from studies with other insulin human in pediatric patients with type 1 diabetes mellitus and from studies in adults with diabetes mellitus. standard precautions as applied to use of humulin r u-500 in adults are appropriate for use in pediatric patients. the effect of age on the pharmacokinetics and pharmacodynamics of humulin r u-500 has not been studied. caution should be exercised when humulin r u-500 is administered to geriatric patients. in elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia. frequent glucose monitoring and insulin dose reduction may be required in patients with renal impairment. frequent glucose monitoring and insulin dose reduction may be required in patients with hepatic impairment. please read these instructions before use. - for your safety, always inject humulin ®  r u - 500 insulin with a u - 500 syringe. - if you use another kind of syringe, you may get a dangerous overdose. important information - humulin r u-500 is a concentrated insulin. - know your dose. your health care provider will tell you the number of insulin units that you should take. - always inject humulin r u-500 insulin with a u-500 syringe. other syringes will not measure your dose correctly. - if you use the wrong syringe, you can give yourself a severe overdose. this can cause very low blood sugar, which may put your life in danger. for example, using a u-100 syringe can give you a 5 times overdose. - if you do not have a u-500 syringe, you should contact your health care provider or pharmacist. additional safety information - each line on the u-500 syringe measures 5 units of u-500 insulin. - you can give from 5 to 250 units in one injection. - if your dose is more than 250 units, you will need to give more than 1 injection. - make sure you know how to draw up your dose with a u-500 syringe. if you need help, call your health care provider. - do not reuse your u-500 syringe. - do not share your u - 500 syringes with other people. you may give other people a serious infection or get a serious infection from them. - do not mix humulin r u-500 with other insulins in the same syringe. - you can get more instructions by calling lilly at 1-800-lillyrx (1-800-545-5979). - humulin r u-500 multiple-dose vial - u-500 syringe (bd [becton, dickinson and company] syringes recommended) - 2 alcohol swabs - 1 sharps container before you start - check your vial. make sure it says humulin r u-500. - check the expiration date on the vial. do not use it if it is expired. throw away the opened vial after 40 days, even if there is still insulin left in the vial. - see if the insulin in the vial is clear. do not use if it is thick, cloudy, or colored or has solid particles. - make sure you have a new u-500 syringe. check for the green u-500 symbol and green needle shield. - check your supply. make sure you have enough humulin r u-500 insulin and u-500 syringes for several injections. always reorder before you run out. - check with your health care provider if you have any questions. use only a u-500 syringe to inject humulin r u-500 insulin prepare - wash your hands with soap and water. - always use a new syringe for each injection to help prevent infections and blocked needles. inject - inject your insulin exactly 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. - you may see blood after you take the needle out of your skin. this is normal. press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. - do not put the needle shield back on the needle, because you may get a needle stick injury. disposal of used syringes - put your used syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) 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. storage and handling - keep away from heat and out of direct light. - do not shake the vial. unopened vials: - store unopened vials in the refrigerator. - do not freeze humulin r u-500. if it has been frozen, do not use it. - if unopened vials have been stored in the refrigerator, you may use them until the expiration date. after the vial has been opened: - store opened vials in the refrigerator or at room temperature (up to 86°f [30°c]) for up to 40 days. - throw away the opened vial after 40 days, even if there is still insulin left in the vial. - always use a u-500 syringe to inject humulin r u-500 insulin. - never use other syringes. the lines and numbers on other syringes will not measure your dose correctly. - you can give yourself the wrong dose if you use any other syringe, such as a u-100, tuberculin or allergy syringe. for example, a u-100 syringe is made to measure u-100 insulin. if you use a u-100 syringe for your u-500 dose, you can give yourself a 5 times overdose. - do not make any changes to your dose or the type of insulin you use unless you are told to do so by your health care provider. - keep your vials and syringes out of the sight and reach of children. frequently asked questions - why do i need to use a u-500 syringe? humulin r u-500 insulin and a u-500 syringe work together to help you inject the correct dose. using any other syringe may result in dosing mistakes. this may put your life in danger. - do i have to convert my humulin r u-500 insulin dose when i use the u-500 syringe? no, you do not have to convert your dose. your health care provider should tell you how much humulin r u-500 insulin to take in units and when to take it. your health care provider should show you how to draw up your dose using the u-500 syringe. - what should i do if i run out of u-500 syringes? if you run out of u-500 syringes, do not use any other syringe to inject humulin r u-500 insulin. call your health care provider or pharmacist for help. you may also call lilly at 1-800-lilly-rx (1-800-545-5979). where to get more information and help - if you have any questions about humulin r u-500 insulin or u-500 syringes, contact lilly at 1-800-lilly-rx (1-800-545-5979). - you can also call your health care provider or pharmacist. - for more information on humulin r u-500 insulin, go to www.humulin.com scan this code to launch the humulin.com website these instructions for use have been approved by the u.s. food and drug administration. humulin® is a trademark of eli lilly and company. manufactured by: eli lilly and company, indianapolis, in 46285, usa us license number 1891 copyright © 1996, 2022, eli lilly and company. all rights reserved. literature revised: june 2022 linr500vl-0004-ifu-20220627 instructions for use humulin® r u-500 kwikpen® (insulin human) injection, for subcutaneous use 3 ml single-patient-use pen (500 units/ml, u-500) - know your dose of humulin r u-500 insulin. the pen delivers your dose in insulin units . insulin units may not be the same as syringe markings. ask your health care provider what your dose should be for your pen. - your humulin®  r u-500 kwikpen® (pen) works differently from other pens. it dials 5 insulin units with each click. do not count clicks of the dose knob to select your dose. you may get too much insulin or you may not get enough insulin. - humulin r u-500 is a concentrated insulin. do not transfer humulin r u-500 insulin from your pen into a syringe. a severe overdose can happen, causing very low blood sugar, which may put your life in danger. read the instructions for use before you start taking humulin r u-500 and each time you get another 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 humulin r u-500 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. humulin r u-500 kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 1500 units of humulin r. you can give yourself more than 1 dose from the pen. each turn (click) of the dose knob dials 5 units of insulin. you can give from 5 to 300 units in a single 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 1500 units in the pen. inject humulin r u-500 only with your pen. do not transfer insulin from your pen to a syringe. 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 humulin r u-500 kwikpen - pen color: aqua - dose knob: aqua with raised ridges on the end - label: humulin r u-500 and 500 units/ml in a green box supplies needed to give your injection - humulin r u-500 kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab 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 kwikpen label. - wipe the rubber seal with an alcohol swab. humulin r u-500 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 5 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 5 to 7, no more than 8 times. – if you still do not see insulin, change the needle and repeat priming steps 5 to 7. selecting your dose this pen has been made to deliver the dose in insulin units that is shown in the dose window. ask your healthcare provider what your dose should be for this pen. - you can give from 5 to 300 units in a single injection. - if your dose is more than 300 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 dose knob clicks as you turn it. each click of the dose knob dials 5 insulin units at a time. – 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, 80) are printed on the dial. – the odd numbers (for example, 125) are shown as lines between the even numbers. - always check the number in the dose window to make sure you have dialed the correct dose. example: 80 units shown in dose window example: 125 units shown in dose window - the pen will not let you dial more than the number of units left in the pen. - if your dose is 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 your full dose. - it is normal to see a small amount of insulin left in the pen that you cannot inject. do not transfer this to a syringe. severe overdose can happen. 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. humulin 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 your injection . monitor your blood glucose as instructed by your healthcare provider. 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 - 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. - the used pen may be discarded in your household trash after you have removed the needle. 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 humulin r u-500. 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 pen you are using after 28 days, even if it still has insulin left in it. what you should know if you are switching to humulin r u-500 kwikpen ask your healthcare provider what your dose should be for your pen in insulin units . always follow your healthcare provider's instructions for dosing. 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 cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if it is hard to push the dose knob: – 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 humulin r u-500 kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humulin r u-500 kwikpen and insulin, go to www.humulin.com. scan this code to launch www.humulin.com these instructions for use have been approved by the u.s. food and drug administration. humulin® and humulin®  kwikpen® are trademarks of eli lilly and company. manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2015, 2022, eli lilly and company. all rights reserved. humulin r u-500 kwikpen meets the current dose accuracy and functional requirements of iso 11608-1. document revision date: june 2022 linr500kp-0005-ifu-20220627

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

physicians total care, inc. - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog mix 70/30 is an insulin analog indicated to improve glycemic control in patients with diabetes mellitus.   important limitations of use:   in premix insulins, such as novolog mix 70/30, the proportions of rapid acting and long acting insulins are fixed and do not allow for basal versus prandial dose adjustments. novolog mix 70/30 is contraindicated - during episodes of hypoglycemia - in patients with hypersensitivity to novolog  mix 70/30 or one of its excipients. enter section text here pregnancy category b. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. insulin requirements may decrease during the first trimester, generally increase during

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

dispensing solutions, inc. - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 14.2 mg in 1 ml - levemir is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long acting) insulin for the control of hyperglycemia. levemir is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

novo nordisk - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin n is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolin n is contraindicated: risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and 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). animal reproduction studies were not performed. 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 diseas

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

tya pharmaceuticals - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin r is indicated to improve glycemic control in adults and children with diabetes mellitus. novolin r is contraindicated: pregnancy category b: all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good glycemic control. it is essential for patients with diabetes or a history of gestational diabetes to maintain good glycemic control before conception and throughout pregnancy. insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is important during pregnancy in patients with diabetes. therefore, women should be advised to tell their healthcare provider if they intend to become, or if they become, pregnant while taking novolin r. no reproductive toxicity studies have been performed with novolin r. it 

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

tya pharmaceuticals - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. novolog is contraindicated pregnancy category b. all pregnancies have a background risk of birth defects, loss, or other adverse outcome regardless of drug exposure. this background risk is increased in pregnancies complicated by hyperglycemia and may be decreased with good metabolic control. it is essential for patients with diabetes or history of gestational diabetes to maintain good metabolic control before conception and throughout pregnancy. insulin requirements may decrease during the first trimester, generally increase during the second and third trimesters, and rapidly decline after delivery. careful monitoring of glucose control is essential in these patients. therefore, female patients should be advised to tell their physician if they intend to become, or if they become pregnant while taking novolog. an open-label, randomized study compared the safety and efficacy of novolog (n=157) vers

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

novo nordisk - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - novolin r is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolin r is contraindicated: risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and 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). animal reproduction studies were not performed. 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 diseas

Sjedinjene Američke Države - engleski - NLM (National Library of Medicine)

physicians total care, inc. - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - insulin detemir 14.2 mg in 1 ml - levemir is indicated to improve glycemic control in adults and children with diabetes mellitus. important limitations of use: - levemir is not recommended for the treatment of diabetic ketoacidosis. intravenous rapid-acting or short-acting insulin is the preferred treatment for this condition. levemir is contraindicated in patients with hypersensitivity to levemir or any of its excipients. reactions have included anaphylaxis [see warnings and precautions (5.4) and adverse reactions (6.1) ] pregnancy category c: in a fertility and embryonic development study, insulin detemir was administered to female rats before mating, during mating, and throughout pregnancy at doses up to 300 nmol/kg/day (3 times a human dose of 0.5 units/kg/day, based on plasma area under the curve (auc) ratio). doses of 150 and 300 nmol/kg/day produced numbers of litters with visceral anomalies. doses up to 900 nmol/kg/day (approximately 135 times a human dose of 0.5 units/kg/day based on auc ratio) were given to rabbits during organoge