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

winthrop u.s, a business of sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine u-300 is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. limitations of use: insulin glargine u-300 is not recommended for the treatment of diabetic ketoacidosis. insulin glargine u-300 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any excipients in insulin glargine u-300 [see warnings and precautions (5.5)] . risk summary published studies with use of insulin glargine during pregnancy have not reported a clear association with insulin glargine and adverse developmental outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dose of 0.2 unit/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see data) . in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. the estimated background risk of major birth defects is 6% to 10% in women with pregestational diabetes with a peri-conceptional hba1c >7 and has been reported to be as high as 20% to 25% in women with a peri-conceptional hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal and/or embryo/fetal risk hypoglycemia and hyperglycemia occur more frequently during pregnancy in patients with pre-gestational diabetes. poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, 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 and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine is used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some lacking comparator groups. animal data subcutaneous reproduction and teratology studies have been performed with insulin glargine and regular human insulin in rats and himalayan rabbits. insulin glargine was given to female rats before mating, during mating, and throughout pregnancy at doses up to 0.36 mg/kg/day, which is approximately 50 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day). in rabbits, doses of 0.072 mg/kg/day, which is approximately 10 times the recommended human subcutaneous starting dosage of 0.2 units/kg/day (0.007 mg/kg/day), were administered during organogenesis. the effects of insulin glargine did not generally differ from those observed with regular human insulin in rats or 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 either no or only limited data on the presence of insulin glargine in human milk, the effects on 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 insulin glargine u-300, and any potential adverse effects on the breastfed child from insulin glargine u-300 or from the underlying maternal condition. the safety and effectiveness of insulin glargine u-300 to improve glycemic control in pediatric patients 6 years of age and older with diabetes mellitus have been established. the use of insulin glargine u-300 for this indication is supported by evidence from an adequate and well-controlled study in 463 pediatric patients 6 to 17 years of age with type 1 diabetes mellitus [see clinical studies (14.2)] and from studies in adults with diabetes mellitus [see clinical pharmacology (12.3), clinical studies (14.3)] . the safety and effectiveness of insulin glargine u-300 have not been established in pediatric patients less than 6 years of age. in controlled clinical studies, 30 of 304 (9.8%) insulin glargine-treated patients with type 1 diabetes and 327 of 1242 (26.3%) insulin glargine-treated patients with type 2 diabetes were ≥65 years of age, among them 2.0% of the patients with type 1 and 3.0% of the patients with type 2 diabetes were ≥75 years of age. no overall differences in safety or effectiveness of insulin glargine have been observed between patients 65 years of age and older and younger adult patients. nevertheless, caution should be exercised when insulin glargine u-300 is administered to geriatric patients. in geriatric patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemia [see warnings and precautions (5.3), adverse reactions (6), and clinical studies (14)] . the effect of kidney impairment on the pharmacokinetics of insulin glargine has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with kidney failure. frequent glucose monitoring and dose adjustment may be necessary for insulin glargine in patients with kidney impairment [see warnings and precautions (5.3)] . the effect of hepatic impairment on the pharmacokinetics of insulin glargine has not been studied. frequent glucose monitoring and dose adjustment may be necessary for insulin glargine u-300 in patients with hepatic impairment [see warnings and precautions (5.3)] . instructions for use insulin glargine u-300 solostar ® (in-su-lin-glar-gine) (insulin glargine) injection, for subcutaneous use 1.5 ml single-patient-use prefilled pen read this first do not share your insulin glargine u-300 solostar 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. insulin glargine u-300 contains 300 units/ml of insulin glargine - do not re-use needles. if you do, you might not get your dose (underdosing) or get too much (overdosing) as the needle could block. - do not use a syringe to remove insulin from your pen. if you do, you will get too much insulin. the scale on most syringes is made for u-100 (non-concentrated) insulin only. - the dose selector of your insulin glargine u-300 solostar pen dials by 1 unit. people who are blind or have vision problems should not use the insulin glargine u-300 solostar pen without help from a person trained to use the insulin glargine u-300 solostar pen. important information - do not use your pen if it is damaged or if you are not sure that it is working properly. - always perform a safety test (see step 3 ). - always carry a spare pen and spare needles in case they are lost or stop working. - change (rotate) your injection sites within the area you choose for each dose (see " places to inject" ). learn to inject - talk with your healthcare provider about how to inject, before using your pen. - read all of these instructions before using your pen. if you do not follow all of these instructions, you may get too much or too little insulin. need help? if you have any questions about your pen or about diabetes, ask your healthcare provider, go to www.winthropus.com or call sanofi-aventis at 1-800-633-1610 . extra items you will need: - a new sterile needle (not included with the pen) (see step 2 ). - an alcohol swab. - a puncture-resistant container for used needles and pens (see " throwing your pen away" ). places to inject - inject your insulin exactly as your healthcare provider has shown you. - inject your insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting pits or thickening of the skin (lipodystrophy) and lumps in the skin (localized cutaneous amyloidosis) 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 inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. get to know your pen step 1: check your pen take a new pen out of the refrigerator at least 1 hour before you inject. cold insulin is more painful to inject. - check the name and expiration date on the label of your pen. make sure you have the correct insulin. do not use your pen after the expiration date printed on the label. - make sure you have the correct insulin. - do not use your pen after the expiration date printed on the label. - pull off the pen cap. - check that the insulin is clear. do not use the pen if the insulin looks cloudy, colored or contains particles. - do not use the pen if the insulin looks cloudy, colored or contains particles. - wipe the rubber seal with an alcohol swab. if you have other injector pens - making sure you have the correct medicine is especially important if you have other injector pens. step 2: attach a new needle - do not re-use needles. always use a new sterile needle for each injection. this helps stop blocked needles, contamination and infection. - always use needles 2from bd (such as bd ultra-fine ® ), ypsomed (such as clickfine ® ), or owen mumford (such as unifine ® pentips ® ). - take a new needle and peel off the protective seal. - keep the needle straight and screw it onto the pen until fixed. do not over-tighten. - pull off the outer needle cap. keep this for later. - pull off the inner needle cap and throw away. handling needles - be careful when you are handling needles to help prevent accidental needle-stick injury. you may give other people a serious infection, or get a serious infection from them. step 3: do a safety test always do a safety test before each injection to: - check your pen and the needle to make sure they are working properly. - make sure that you get the correct insulin dose. if the pen is new, you must perform safety tests before you use the pen for the first time until you see insulin coming out of the needle tip. if you see insulin coming out of the needle tip, the pen is ready to use. if you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. this could cause high blood sugar. - select 3 units by turning the dose selector until the dose pointer is at the mark between 2 and 4. - press the injection button all the way in. when insulin comes out of the needle tip, your pen is working correctly. - when insulin comes out of the needle tip, your pen is working correctly. if no insulin appears: - you may need to repeat this step up to 3 times before seeing insulin. - if no insulin comes out after the third time, the needle may be blocked. if this happens: change the needle (see step 6 and step 2 ), then repeat the safety test (see step 3 ). - change the needle (see step 6 and step 2 ), - then repeat the safety test (see step 3 ). - do not use your pen if there is still no insulin coming out of the needle tip. use a new pen. - do not use a syringe to remove insulin from your pen. if you see air bubbles - you may see air bubbles in the insulin. this is normal, they will not harm you. step 4: select the dose - do not select a dose or press the injection button without a needle attached. this may damage your pen. - insulin glargine u-300 solostar is made to deliver the number of insulin units that your healthcare provider prescribed. you do not need to do any dose calculations . - the dose selector of your insulin glargine u-300 solostar pen dials by 1 unit. - make sure a needle is attached and the dose is set to "0." - turn the dose selector until the dose pointer lines up with your dose. set the dose by turning the dose selector to a line in the dose window. each line equals 1 unit. the dose selector clicks as you turn it. always check the number in the dose window to make sure you dialed the correct dose. 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. if you turn past your dose, you can turn back down. if there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left. if you cannot select your full prescribed dose, split the dose into 2 injections or use a new pen. if you use a new pen, perform a safety test (see step 3 ). - set the dose by turning the dose selector to a line in the dose window. each line equals 1 unit. - the dose selector clicks as you turn it. - always check the number in the dose window to make sure you dialed the correct dose. - 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. - if you turn past your dose, you can turn back down. - if there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left. - if you cannot select your full prescribed dose, split the dose into 2 injections or use a new pen. if you use a new pen, perform a safety test (see step 3 ). how to read the dose window the dose selector dials by 1 unit. even numbers are shown in line with the dose pointer: odd numbers are shown as a line between even numbers: units of insulin in your pen - your pen contains a total of 450 units of insulin. you can select doses from 1 to 80 units. each pen contains more than 1 dose. - you can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale. step 5: inject your dose if you find it hard to press the injection button in, do not force it as this may break your pen. see the section below for help. - choose a place to inject as shown in the picture labeled "places to inject." the site you choose for the injection should be clean and dry. if your skin is dirty, clean it as instructed by your healthcare provider. - the site you choose for the injection should be clean and dry. - if your skin is dirty, clean it as instructed by your healthcare provider. - push the needle into your skin as shown by your healthcare provider. do not touch the injection button yet. - do not touch the injection button yet. - place your thumb on the injection button. then press all the way in and hold. do not press at an angle. your thumb could block the dose selector from turning. - do not press at an angle. your thumb could block the dose selector from turning. - keep the injection button held in and when you see "0" in the dose window, slowly count to 5. this will make sure you get your full dose. - this will make sure you get your full dose. - after holding and slowly counting to 5, release the injection button. then remove the needle from your skin. if you find it hard to press the injection button in: - change the needle (see step 6and step 2) then do a safety test (see step 3). - if you still find it hard to press in, get a new pen. - do not use a syringe to remove insulin from your pen. step 6: remove the needle - take care when handling needles to prevent needle injury and cross-infection. - do not put the inner needle cap back on. - grip the widest part of the outer needle cap. keep the needle straight and guide it into the outer needle cap. then push firmly on. the needle can puncture the cap if it is recapped at an angle. - the needle can puncture the cap if it is recapped at an angle. - grip and squeeze the widest part of the outer needle cap. turn your pen several times with your other hand to remove the needle. try again if the needle does not come off the first time. - try again if the needle does not come off the first time. - throw away the used needle in a puncture-resistant container (see " throwing your pen away" at the end of this instructions for use). - put the pen cap back on. do not put the pen back in the refrigerator. - do not put the pen back in the refrigerator. use by - only use your pen for up to 56 days after its first use. how to store your pen before first use - keep new pens in the refrigerator between 36°f and 46°f (2°c and 8°c). - do not freeze. throw away your pen if it has been frozen (see " throwing your pen away "). after first use - keep your pen at room temperature up to 86°f (30°c) . - protect your pen from direct heat and light. - do not put your pen back in the refrigerator. - do not store your pen with the needle attached. - store your pen with the pen cap on. - keep insulin glargine u-300 solostar pens and needles out of the reach of children. how to care for your pen handle your pen with care - do not drop your pen or knock it against hard surfaces. - if you think that your pen may be damaged, do not try to fix it. use a new one. protect your pen from dust and dirt - you can clean the outside of your pen by wiping it with a damp cloth (water only). do not soak, wash or lubricate your pen. this may damage it. throwing your pen away - the used insulin glargine u-300 solostar pen may be thrown away in your household trash after you have removed the needle. - put the used needle in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) 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. - 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. manufactured by: sanofi-aventis u.s. llc bridgewater, nj 08807 u.s. license no. 1752 manufactured for: winthrop u.s., a business of sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company ©2022 sanofi-aventis u.s. llc this instructions for use has been approved by the u.s. food and drug administration. revised: august 2022 instructions for use insulin glargine u-300 max solostar ® (in-su-lin-glar-gine) (insulin glargine) injection, for subcutaneous use 3 ml single-patient-use prefilled pen read this first do not share your insulin glargine u-300 max solostar 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. insulin glargine u-300 contains 300 units/ml of insulin glargine - do not re-use needles. if you do, you might not get your dose (underdosing) or get too much (overdosing) as the needle could block. - do not use a syringe to remove insulin from your pen. if you do, you will get too much insulin. the scale on most syringes is made for u-100 (non-concentrated) insulin only. - the dose selector of your insulin glargine u-300 max solostar pen dials by 2 units . people who are blind or have vision problems should not use the insulin glargine u-300 max solostar pen without help from a person trained to use the insulin glargine u-300 max solostar pen. important information - do not use your pen if it is damaged or if you are not sure that it is working properly. - always perform a safety test (see step 3 ). - always carry a spare pen and spare needles in case they are lost or stop working. - change (rotate) your injection sites within the area you choose for each dose (see " places to inject" ). learn to inject - talk with your healthcare provider about how to inject, before using your pen. - read all of these instructions before using your pen. if you do not follow all of these instructions, you may get too much or too little insulin. need help? if you have any questions about your pen or about diabetes, ask your healthcare provider, go to www.winthropus.com or call sanofi-aventis at 1-800-633-1610 . extra items you will need: - a new sterile needle (not included with the pen) (see step 2 ). - an alcohol swab. - a puncture-resistant container for used needles and pens (see " throwing your pen away" ). places to inject - inject your insulin exactly as your healthcare provider has shown you. - inject your insulin under the skin (subcutaneously) of your upper legs (thighs), upper arms, or stomach area (abdomen). - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting pits or thickening of the skin (lipodystrophy) and lumps in the skin (localized cutaneous amyloidosis) 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 inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. get to know your pen step 1: check your pen take a new pen out of the refrigerator at least 1 hour before you inject. cold insulin is more painful to inject. - check the name and expiration date on the label of your pen. make sure you have the correct insulin. do not use your pen after the expiration date printed on the label. - make sure you have the correct insulin. - do not use your pen after the expiration date printed on the label. - pull off the pen cap. - check that the insulin is clear. do not use the pen if the insulin looks cloudy, colored or contains particles. - do not use the pen if the insulin looks cloudy, colored or contains particles. - wipe the rubber seal with an alcohol swab. if you have other injector pens - making sure you have the correct medicine is especially important if you have other injector pens. step 2: attach a new needle - do not re-use needles. always use a new sterile needle for each injection. this helps stop blocked needles, contamination and infection. - always use needles 3from bd (such as bd ultra-fine ® ), ypsomed (such as clickfine ® ), or owen mumford (such as unifine ® pentips ® ) that are 8 mm long or shorter. - take a new needle and peel off the protective seal. - keep the needle straight and screw it onto the pen until fixed. do not over-tighten. - pull off the outer needle cap. keep this for later. - pull off the inner needle cap and throw away. handling needles - be careful when you are handling needles to help prevent accidental needle-stick injury. you may give other people a serious infection, or get a serious infection from them. step 3: do a safety test always do a safety test before each injection to: - check your pen and the needle to make sure they are working properly. - make sure that you get the correct insulin dose. if the pen is new, you must perform safety tests before you use the pen for the first time until you see insulin coming out of the needle tip. if you see insulin coming out of the needle tip, the pen is ready to use. if you do not see insulin coming out before taking your dose, you could get an underdose or no insulin at all. this could cause high blood sugar. - select 4 units by turning the dose selector until the dose pointer is at the 4 mark. - press the injection button all the way in. when insulin comes out of the needle tip, your pen is working correctly. - when insulin comes out of the needle tip, your pen is working correctly. if no insulin appears: - you may need to repeat this step up to 6 times before seeing insulin. - if no insulin comes out after the sixth time, the needle may be blocked. if this happens: change the needle (see step 6 and step 2 ), then repeat the safety test (see step 3 ). - change the needle (see step 6 and step 2 ), - then repeat the safety test (see step 3 ). - do not use your pen if there is still no insulin coming out of the needle tip. use a new pen. - do not use a syringe to remove insulin from your pen. if you see air bubbles - you may see air bubbles in the insulin. this is normal, they will not harm you. step 4: select the dose - do not select a dose or press the injection button without a needle attached. this may damage your pen. - insulin glargine u-300 max solostar is made to deliver the number of insulin units that your healthcare provider prescribed. you do not need to do any dose calculations . - the dose selector of your insulin glargine u-300 max solostar pen dials by 2 units and can only dial even doses of insulin. - make sure a needle is attached and the dose is set to "0." - turn the dose selector until the dose pointer lines up with your dose. set the dose by turning the dose selector to a line in the dose window. each line equals 2 units. the dose selector clicks as you turn it. always check the number in the dose window to make sure you dialed the correct dose. 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. if you turn past your dose, you can turn back down. if there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left. if you cannot select your full prescribed dose, split the dose into 2 injections or use a new pen. if you use a new pen, perform a safety test (see step 3 ). - set the dose by turning the dose selector to a line in the dose window. each line equals 2 units. - the dose selector clicks as you turn it. - always check the number in the dose window to make sure you dialed the correct dose. - 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. - if you turn past your dose, you can turn back down. - if there are not enough units left in your pen for your dose, the dose selector will stop at the number of units left. - if you cannot select your full prescribed dose, split the dose into 2 injections or use a new pen. if you use a new pen, perform a safety test (see step 3 ). how to read the dose window the dose selector dials by 2 units. each line in the dose window is an even number. units of insulin in your pen - your pen contains a total of 900 units of insulin. you can select doses from 2 to 160 units. the dose is adjusted by 2 units at a time. each pen contains more than 1 dose. - you can see roughly how many units of insulin are left by looking at where the plunger is on the insulin scale. step 5: inject your dose if you find it hard to press the injection button in, do not force it as this may break your pen. see the section below for help. - choose a place to inject as shown in the picture labeled "places to inject." the site you choose for the injection should be clean and dry. if your skin is dirty, clean it as instructed by your healthcare provider. - the site you choose for the injection should be clean and dry. - if your skin is dirty, clean it as instructed by your healthcare provider. - push the needle into your skin as shown by your healthcare provider. do not touch the injection button yet. - do not touch the injection button yet. - place your thumb on the injection button. then press all the way in and hold. do not press at an angle. your thumb could block the dose selector from turning. - do not press at an angle. your thumb could block the dose selector from turning. - keep the injection button held in and when you see "0" in the dose window, slowly count to 5. this will make sure you get your full dose. - this will make sure you get your full dose. - after holding and slowly counting to 5, release the injection button. then remove the needle from your skin. if you find it hard to press the injection button in: - change the needle (see step 6 and step 2 ) then do a safety test (see step 3 ). - if you still find it hard to press in, get a new pen. - do not use a syringe to remove insulin from your pen. step 6: remove the needle - take care when handling needles to prevent needle injury and cross-infection. - do not put the inner needle cap back on. - grip the widest part of the outer needle cap. keep the needle straight and guide it into the outer needle cap. then push firmly on. the needle can puncture the cap if it is recapped at an angle. - the needle can puncture the cap if it is recapped at an angle. - grip and squeeze the widest part of the outer needle cap. turn your pen several times with your other hand to remove the needle. try again if the needle does not come off the first time. - try again if the needle does not come off the first time. - throw away the used needle in a puncture-resistant container (see " throwing your pen away" at the end of this instructions for use). - put the pen cap back on. do not put the pen back in the refrigerator. - do not put the pen back in the refrigerator. use by - only use your pen for up to 56 days after its first use. how to store your pen before first use - keep new pens in the refrigerator between 36°f and 46°f (2°c and 8°c) . - do not freeze. throw away your pen if it has been frozen (see " throwing your pen away" ). after first use - keep your pen at room temperature up to 86°f (30°c) . - protect your pen from direct heat and light. - do not put your pen back in the refrigerator. - do not store your pen with the needle attached. - store your pen with the pen cap on. - keep insulin glargine u-300 max solostar pens and needles out of the reach of children. how to care for your pen handle your pen with care - do not drop your pen or knock it against hard surfaces. - if you think that your pen may be damaged, do not try to fix it. use a new one. protect your pen from dust and dirt - you can clean the outside of your pen by wiping it with a damp cloth (water only). do not soak, wash or lubricate your pen. this may damage it. throwing your pen away - the used insulin glargine u-300 max solostar pen may be thrown away in your household trash after you have removed the needle. - put the used needle in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) 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. - 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. manufactured by: sanofi-aventis u.s. llc bridgewater, nj 08807 u.s. license no. 1752 manufactured for: winthrop u.s., a business of sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company ©2022 sanofi-aventis u.s. llc this instructions for use has been approved by the u.s. food and drug administration. revised: august 2022

Israel - English - Ministry of Health

novo nordisk ltd., israel - insulin (human) - suspension for injection - insulin (human) 100 iu/ml - insulin (human) - insulin (human) - therapeutic indications mixtard is indicated for treatment of diabetes mellitus.

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

eli lilly and company - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - humulin 70/30 is a fixed ratio insulin formulation indicated to improve glycemic control in adults with diabetes mellitus. humulin 70/30 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)], and - in patients who have had hypersensitivity reactions to humulin 70/30 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. the safety and effectiveness of humulin 70/30 in pediatric patients have not been established. the effect of age on the pharmacokinetics and pharmacodynamics of humulin 70/30 has not been studied [see clinical pharmacology (12.3)] . patients with advanced age using any insulin, including humulin 70/30, may be at increased risk of hypoglycemia due to co-morbid disease and polypharmacy [see warnings and precautions (5.3)] . instructions for use humulin® (hu-mu-lin) 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous use 3 ml or 10 ml multiple-dose vial (100 units/ml) read the instructions for use before you start taking humulin 70/30 and each time you get a new humulin 70/30 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 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 3 ml or 10 ml multiple-dose humulin 70/30 vial - a u-100 insulin syringe and needle - 2 alcohol swabs - 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 humulin 70/30 dose: - wash your hands with soap and water. - check the humulin 70/30 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. - do not use humulin 70/30 past the expiration date printed on the label or 31 days after you first use it. - always use a new syringe or needle for each injection to help ensure sterility and prevent 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. giving your humulin 70/30 injection: - 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. - 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. 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 humulin 70/30? all unopened humulin 70/30 vials: - store all unopened vials in the refrigerator. - do not freeze. do not use if it 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 31 days, if they are stored at room temperature. after humulin 70/30 vials have been opened: - store opened vials in the refrigerator or at room temperature up to 86°f (30°c) for up to 31 days. - keep away from heat and out of direct light. - throw away all opened vials after 31 days of use, even if there is still insulin left in the vial. general information about the safe and effective use of humulin 70/30. - keep humulin 70/30 vials, syringes, needles, and all medicines out of the reach of children. - always use a new syringe or needle for each injection. - 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 have any questions or problems with your humulin, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider for help. for more information on humulin and insulin, go to www.humulin.com. scan this code to launch the humulin.com website this instructions for use has been approved by the u.s. food and drug administration. humulin® is a trademark of eli lilly and company. instructions for use revised: june 2022 manufactured by: eli lilly and company, indianapolis, in 46285, usa us license number 1891 copyright © 1992, 2022, eli lilly and company. all rights reserved. lin7030vl-0005-ifu-20220627 instructions for use humulin® 70/30 kwikpen® (insulin isophane human and insulin human) injectable suspension, for subcutaneous use 3 ml single-patient-use pen (100 units/ml) read the instructions for use before you start taking humulin 70/30 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 humulin 70/30 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. humulin®  70/30 kwikpen® (“pen”) is a disposable single-patient-use prefilled pen containing 300 units of humulin 70/30. 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 humulin 70/30 kwikpen - pen color: beige - dose knob: brown - labels: white label with brown stripe supplies you will need to give your injection - humulin 70/30 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 10 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. - do not attach the needle before mixing. - gently roll the pen between your hands 10 times. - move the pen up and down (invert) 10 times. mixing by rolling and inverting the pen is important to make sure you get the right dose. - check the liquid in the pen . humulin 70/30 should look white and cloudy after mixing. do not use if it looks clear or has any lumps or particles 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 8 to 10, no more than 4 times. - if you still do not see insulin, change the needle and repeat priming steps 8 to 10. 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. or - 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. humulin 70/30 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 - 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 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 humulin 70/30 pen you are using after 10 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 humulin 70/30 kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humulin 70/30 kwikpen and insulin, go to www.lilly.com. scan this code to launch www.humulin.com this instructions for use has been approved by the u.s. food and drug administration. humulin® and humulin® kwikpen® are trademarks of eli lilly and company. revised: june 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2013, 2022, eli lilly and company. all rights reserved. lin7030kp-0008-ifu-20220627

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

mylan specialty l.p. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use insulin glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. insulin glargine-yfgn is contraindicated: 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). rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically r

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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: dibasic sodium phosphate dihydrate; sodium hydroxide; zinc chloride; phenol; hydrochloric acid; glycerol; water for injections; protamine sulfate; metacresol - the treatment of insulin-requiring diabetes.

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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: dibasic sodium phosphate dihydrate; phenol; hydrochloric acid; water for injections; metacresol; zinc chloride; protamine sulfate; sodium hydroxide; glycerol - the treatment of insulin-requiring diabetes.

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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: hydrochloric acid; zinc chloride; protamine sulfate; sodium hydroxide; metacresol; dibasic sodium phosphate dihydrate; water for injections; glycerol; phenol - the treatment of insulin-requiring diabetes.

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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 100 iu/ml - injection, solution - excipient ingredients: metacresol; glycerol; hydrochloric acid; zinc chloride; water for injections; sodium hydroxide - the treatment of insulin-requiring diabetes.

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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 100 iu/ml - injection, solution - excipient ingredients: metacresol; sodium hydroxide; glycerol; hydrochloric acid; water for injections; zinc chloride - the treatment of insulin-requiring diabetes.

Singapore - English - HSA (Health Sciences Authority)

novo nordisk pharma (singapore) pte ltd - insulin human, rdna (as isophane insulin); insulin human, rdna (as soluble insulin) - injection - 70iu/ml - insulin human, rdna (as isophane insulin) 70iu/ml; insulin human, rdna (as soluble insulin) 30iu/ml