الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

dispensing solutions, inc. - 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

imclone llc - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro injection is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin lispro injection is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to insulin lispro injection or to any of its excipients. risk summary the limited available data with insulin lispro injection in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were obser

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

eli lilly and company - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. insulin lispro is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients who are hypersensitive to insulin lispro or to any of the excipients in insulin lispro [see warnings and precautions (5.5)] . risk summary published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit i

الولايات المتحدة - الإنجليزية - 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

إسرائيل - الإنجليزية - Ministry of Health

novo nordisk ltd., israel - insulin aspart - suspension for injection - insulin aspart 100 u/ml - insulin aspart - insulin aspart - novomix 50 is indicated for treatment of diabetes mellitus in adults.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. insulin aspart is contraindicated: risk summary available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects 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] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those observed in rats administered 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 pre-gestational diabetes with a periconceptional hba1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptional hba1c >10%. the estimated background risk of miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal and/or embryo-fetal risk 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 from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials. animal data fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. in a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. in an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. the effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). no significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. these doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. the effects are considered secondary to maternal hypoglycemia. risk summary there are no data on the presence of insulin aspart in human milk, the effects on the breastfed infant, or the effect on milk production. one small published study reported that exogenous insulin, including insulin aspart, was present in human milk. however, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for insulin aspart, and any potential adverse effects on the breastfed infant from insulin aspart, or from the underlying maternal condition. the safety and effectiveness of insulin aspart to improve glycemic control have been established in pediatric patients with diabetes mellitus. use of insulin aspart for this indication is supported by evidence from an adequate and well-controlled study in 283 pediatric patients with type 1 diabetes mellitus aged 6 to 18 years and from studies in adults with diabetes mellitus [see adverse reactions ( 6.1), clinical pharmacology (12.3), and clinical studies (14)] . of the total number of patients (n=1,375) treated with insulin aspart in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. one-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). the hba1c response to insulin aspart, as compared to regular human insulin, did not differ by age. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent insulin aspart dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3) and clinical pharmacology (12.3)]. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent insulin aspart dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3) and clinical pharmacology (12.3)].

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart is a rapid acting human insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. insulin aspart is contraindicated: risk summary available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects 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] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effec

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: novolog mix 70/30 is contraindicated: risk summary there are no available data with novolog mix 70/30 in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects 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] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day,

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

a-s medication solutions - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart 100 [iu] in 1 ml - novolog is indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus. novolog is contraindicated: risk summary available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects 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] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those observed in rats administered 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 pre-gestational diabetes with a periconceptional hba1c >7% and has been reported to be as high as 20 to 25% in women with a periconceptional hba1c >10%. the estimated background risk of miscarriage for the indicated population is unknown. clinical considerations disease-associated maternal and/or embryo-fetal risk 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 from 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials. animal data fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. in a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. in an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. the effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). no significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. these doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. the effects are considered secondary to maternal hypoglycemia. risk summary there are no data on the presence of novolog in human milk, the effects on the breastfed infant, or the effect on milk production. one small published study reported that exogenous insulin, including insulin aspart, was present in human milk. however, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for novolog, and any potential adverse effects on the breastfed infant from novolog, or from the underlying maternal condition. the safety and effectiveness of novolog to improve glycemic control have been established in pediatric patients with diabetes mellitus. use of novolog for this indication is supported by evidence from an adequate and well-controlled study in 283 pediatric patients with type 1 diabetes mellitus aged 6 to 18 years and from studies in adults with diabetes mellitus [see adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . of the total number of patients (n=1,375) treated with novolog in 3 controlled clinical studies, 2.6% (n=36) were 65 years of age or over. one-half of these patients had type 1 diabetes (18/1285) and the other half had type 2 diabetes (18/90). the hba1c response to novolog, as compared to regular human insulin, did not differ by age. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent novolog dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3) and clinical pharmacology (12.3)]. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent novolog dose adjustment and more frequent blood glucose monitoring [see warnings and precautions (5.3) and clinical pharmacology (12.3)].

أستراليا - الإنجليزية - Department of Health (Therapeutic Goods Administration)

sanofi-aventis australia pty ltd - insulin aspart, quantity: 3.5 mg/ml - injection, solution - excipient ingredients: metacresol; phenol; polysorbate 20; sodium hydroxide; hydrochloric acid; water for injections; zinc chloride; sodium chloride - for the treatment of diabetes mellitus