Storbritannia - engelsk - VMD (Veterinary Medicines Directorate)

msd animal health uk limited - insulin - suspension for injection - hormone - cats, dogs

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 [iu] in 1 ml - humalog is an insulin analog indicated to improve glycemic control in adults and children with diabetes mellitus. humalog is contraindicated: - during episodes of hypoglycemia - in patients who are hypersensitive to humalog or to any of its excipients. 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. in patients with diabetes or gestational diabetes 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 physicians

USA - engelsk - NLM (National Library of Medicine)

eli lilly and company - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - basaglar® is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. limitations of use basaglar is not recommended for the treatment of diabetic ketoacidosis. basaglar is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any of the excipients in basaglar [see warnings and precautions (5.5)] . risk summary published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). in animal reproduction studies, another insulin glargine product was administered to rats before, during and throughout pregnancy at doses up to 7 times the clinical dose of 10 units/day and to rabbits during organogenesis at doses approximately 2 times the clinical dose of 10 units/day. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats or rabbits (see data). the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the us general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. data human data published data do not report a clear association with insulin glargine products and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin glargine products are used during pregnancy. however, these studies cannot definitely establish the absence of any risk because of methodological limitations including small sample size and some with no comparative group. animal data subcutaneous reproduction and teratology studies have been performed with another insulin glargine product and with regular human insulin in rats and himalayan rabbits. this other insulin glargine product was given to female rats before mating, during mating, and throughout pregnancy at dose up to 0.36 mg/kg/day, which is approximately 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day) based on mg/m2 . in rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 , were administered during organogenesis. the effects of this other insulin glargine product did not generally differ from those observed with regular human insulin in rats and rabbits. however, in rabbits, five fetuses from two litters of the high-dose group exhibited dilation of the cerebral ventricles. fertility and early embryonic development appeared normal. risk summary there are no data on the presence of insulin glargine in human milk, the effects on the breastfed infant, or the effects on milk production. endogenous insulin is present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for basaglar and any potential adverse effects on the breastfed child from basaglar or from the underlying maternal condition. the safety and effectiveness of basaglar have been established in pediatric patients (age 6 to 15 years) with type 1 diabetes based on an adequate and well-controlled trial of another insulin glargine product, 100 units/ml, in pediatric patients (age 6 to 15 years) with type 1 diabetes and additional data in adults with type 1 diabetes [see clinical studies (14.2)] . the safety and effectiveness of basaglar in pediatric patients younger than 6 years of age with type 1 diabetes and pediatric patients with type 2 diabetes has not been established. in the pediatric clinical trial, pediatric patients (age 6 to 15 years) with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in trials with type 1 diabetes [see adverse reactions (6.1)] . of the total number of subjects in clinical studies of patients with type 2 diabetes who were treated with basaglar or another insulin glargine product, 100 units/ml, each in combination with oral agents in a controlled clinical trial environment, 28.3% were 65 and over, while 4.5% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. nevertheless, caution should be exercised when basaglar is administered to geriatric patients. in elderly patients with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in the elderly. the effect of renal impairment on the pharmacokinetics of basaglar has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. frequent glucose monitoring and dose adjustment may be necessary for basaglar in patients with renal impairment [see warnings and precautions (5.3)] . the effect of hepatic impairment on the pharmacokinetics of basaglar has not been studied. however, as with all insulin products, more frequent glucose monitoring and dose adjustment may be necessary for basaglar in patients with hepatic impairment [see warnings and precautions (5.3)] . instructions for use basaglar® kwikpen® (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml single-patient-use pen read the instructions for use before you start using basaglar and each time you get another basaglar® kwikpen® . there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your basaglar kwikpen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. basaglar kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. when the plunger reaches the end of the cartridge, you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the basaglar prefilled pen. how to recognize your basaglar kwikpen - pen color: light grey - dose knob: light grey with green ring on the end - labels: light grey with green color bars supplies needed to give your injection - basaglar kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab preparing your pen - wash your hands with soap and water. - check the pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. basaglar should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat the priming steps, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps. small air bubbles are normal and will not affect your dose. selecting your dose - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks because you may dial the wrong dose. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers are printed on the dial. - the odd numbers, after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you can not inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where the skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. note: do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. - a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window you did not receive your full dose. do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection. monitor your blood glucose and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - the used pen may be discarded in your household trash after you have removed the needle. storing your basaglar kwikpen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. do not use if it has been frozen. - unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)] and away from heat and light. - throw away the pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your basaglar kwikpen, contact lilly at 1-800-lillyrx (1-800- 545-5979) or call your healthcare provider for help. for more information on basaglar kwikpen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® and basaglar® kwikpen® are trademarks of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2015, 2022, eli lilly and company. all rights reserved. baskp-0009-ifu-20221115 instructions for use basaglar® tempo pen™ (insulin glargine) injection, for subcutaneous use 100 units/ml, 3 ml pen, single-patient-use read the instructions for use before you start using basaglar and each time you get another basaglar tempo pen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your basaglar tempo pen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. basaglar tempo pen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units (3ml) of basaglar. one pen contains multiple doses of medicine. - your healthcare provider will tell you how many units to give as your dose and how to inject your prescribed dose of medicine. - you can give a dose of 1 to 80 units in a single injection. - if your prescribed dose is more than 80 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. when the plunger reaches the end of the cartridge, you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the basaglar prefilled pen. this basaglar tempo pen contains a component that allows for data connectivity when used with a compatible transmitter. how to recognize your basaglar tempo pen - pen color: light grey - dose knob: light grey - labels: light grey with green color bars supplies needed to give your injection - basaglar tempo pen - tempo pen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab preparing your pen - wash your hands with soap and water. - check the pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 28 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - check the liquid in the pen. basaglar should look clear and colorless. do not use if it is cloudy, colored, or has particles or clumps in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming means removing the air from the needle and cartridge that may collect during normal use. it is important to prime your pen before each injection so that it will work correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units . - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with the needle pointing up. push the dose knob in until it stops, and “0 ” is seen in the dose window. hold the dose knob in and count to 5 slowly . you should see insulin at the tip of the needle. - if you do not see insulin, repeat the priming steps 6 to 8, but not more than 4 times. - if you still do not see insulin, change the needle and repeat the priming steps 6 to 8. small air bubbles are normal and will not affect your dose. selecting your dose - you can give a dose of 1 to 80 units in a single injection. - if your dose is more than 80 units, you will need to give more than 1 injection. - talk to your healthcare provider about how to give your dose. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks because you may dial the wrong dose. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers are printed on the dial. - the odd numbers, after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you cannot inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - basaglar is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe the skin with an alcohol swab, and let the injection site dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. note: do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. - a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window you did not receive your full dose. do not redial . insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat that injection. monitor your blood sugar (glucose) and call your healthcare provider for further instructions. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. the plunger only moves a little with each injection, and you may not notice that it moves. if you see blood after you take the needle out of your skin, press the injection site lightly with a piece of gauze or an alcohol swab. do not rub the area. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section below). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - the used pen may be thrown away (discarded) in your household trash after you have removed the needle. storing your basaglar tempo pen unopened pens - store unopened pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze basaglar. do not use if it has been frozen. - unopened pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)] and away from heat and light. - throw away the pen you are using after 28 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the sight and reach of children. - always use a new needle for each injection. - do not share your pen or needles with other people. you may give other people a serious infection or get a serious infection from them. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you cannot remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your basaglar tempo pen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on basaglar tempo pen and insulin, go to www.basaglar.com. scan this code to launch www.basaglar.com this instructions for use have been approved by the u.s. food and drug administration. basaglar® is a registered trademark and tempo pentm is a trademark of eli lilly and company. instructions for use revised: november 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2021, 2022, eli lilly and company. all rights reserved. bastp-0004-ifu-20221115

USA - engelsk - NLM (National Library of Medicine)

eli lilly and company - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 [iu] in 1 ml - humalog is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. humalog is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients who are hypersensitive to insulin lispro or to any of the excipients in humalog [see warnings and precautions (5.5)] . risk summary published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data) . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations) . pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day.

USA - engelsk - NLM (National Library of Medicine)

sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use lantus is not recommended for the treatment of diabetic ketoacidosis. lantus is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to insulin glargine or any of the excipients in lantus [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 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 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), on a mg/kg basis. 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 on a mg/kg basis, 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 lantus, and any potential adverse effects on the breastfed child from lantus or from the underlying maternal condition. the safety and effectiveness of lantus to improve glycemic control in pediatric patients with diabetes mellitus have been established. use of lantus for this indication is supported by evidence from an adequate and well-controlled study (study d) in 174 lantus-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate and well-controlled studies of lantus in adults with diabetes mellitus [see clinical pharmacology (12.3), clinical studies (14.2)]. in the pediatric clinical study, pediatric patients with type 1 diabetes had a higher incidence of severe symptomatic hypoglycemia compared to the adults in studies with type 1 diabetes [see adverse reactions (6.1)] . of the total number of subjects in controlled clinical studies of patients with type 1 and type 2 diabetes who were treated with lantus, 15% (n=316) were ≥65 years of age and 2% (n=42) were ≥75 years of age. no overall differences in safety or effectiveness of lantus have been observed between patients 65 years of age and older and younger adult patients. nevertheless, caution should be exercised when lantus is administered to geriatric patients. in geriatric patients with diabetes, the initial dosing, dosage increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in geriatric patients. the effect of kidney impairment on the pharmacokinetics of lantus 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 dosage adjustment may be necessary for lantus in patients with kidney impairment [see warnings and precautions (5.3)]. the effect of hepatic impairment on the pharmacokinetics of lantus has not been studied. frequent glucose monitoring and dosage adjustment may be necessary for lantus in patients with hepatic impairment [see warnings and precautions (5.3)] . these instructions for use contain information on how to inject lantus using the vial. read these instructions for use before you start taking lantus and each time you get a new lantus 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 lantus 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 lantus 10 ml 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 to inject lantus: - wash your hands with soap and water or clean your hands with alcohol. - check the lantus 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. - check the lantus in the vial to make sure it is clear and colorless. do not use lantus if it is colored or cloudy, or if you see particles in the solution. - do not use lantus after the expiration date stamped on the label or 28 days after you first use it. - always use a syringe that is marked for u-100 insulin. if you use a syringe other than a u-100 insulin syringe, you may get the wrong dose of lantus. - always use a new syringe and a new needle for each injection to help prevent infections and prevent blocked needles. step 1: if you are using a new lantus vial, remove the protective cap. do not remove the stopper. step 2: wipe the top of the vial with an alcohol swab. you do not have to shake the vial of lantus before use. step 3: draw air into the syringe equal to your lantus dose. put the needle through the rubber top of the vial and push the plunger to inject the air into the vial. step 4: leave the syringe in the vial and turn both upside down. hold the syringe and vial firmly in one hand. make sure the tip of the needle is in the lantus solution. with your free hand, pull the plunger to withdraw the correct dose into the syringe. step 5: before you take the needle out of the vial, check the syringe for air bubbles. if bubbles are in the syringe, hold the syringe straight up and tap the side of the syringe until the bubbles float to the top. push the bubbles out with the plunger and draw insulin back in until you have the correct dose. step 6: remove the needle from the vial. do not let the needle touch anything. you are now ready to inject. injecting lantus - inject your lantus (with a syringe) exactly as your healthcare provider has shown you. - lantus is injected once daily at any time of the day but at the same time every day. step 7: choose your injection site: - lantus is injected under the skin (subcutaneously) of your upper arms, thighs, or stomach area (abdomen). - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in the 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. - wipe the skin with an alcohol swab to clean the injection site. let the injection site dry before you inject your dose. step 8: - pinch the skin. - insert the needle under the skin in the way your healthcare provider showed you. - release the skin. - slowly push in the plunger of the syringe all the way, making sure you have injected all the lantus. - leave the needle in the skin for about 10 seconds. step 9: - pull the needle straight out of your skin. - gently press the injection site for several seconds. do not rub the area. - do not recap the used 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 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. storing and disposing lantus? unopened (not in-use) lantus vials - store unused lantus vials in the refrigerator from 36°f to 46°f (2°c to 8°c). - do not freeze lantus. - keep lantus away from direct heat and light. - if a vial has been frozen or overheated, throw it away. - unopened vials can be used until the expiration date on the carton and vial label if they have been stored in the refrigerator (they can be stored past 28 days in the refrigerator). - unopened vials should be thrown away after 28 days if they are stored at room temperature. after lantus vials have been opened (in-use) - store in-use (opened) lantus vials in a refrigerator from 36°f to 46°f (2°c to 8°c) or at room temperature below 86°f (30°c) for up to 28 days . - do not freeze lantus. if a vial has been frozen, throw it away. - keep lantus out of direct heat and light. - the lantus vial you are using should be thrown away after 28 days or if the expiration date has passed, even if it still has insulin left in it. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company u.s. license no. 1752 ©2022 sanofi-aventis u.s. llc. revised: june 2023 read these instructions for use before you start taking the lantus solostar pen and each time you get a new lantus solostar pen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your lantus 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. people who are blind or have vision problems should not use the lantus solostar prefilled pen without help from a person trained to use the lantus solostar prefilled pen. lantus solostar is a disposable prefilled pen used to inject lantus. each lantus solostar pen has 300 units of insulin which can be used for multiple injections. you can select doses from 1 to 80 units in steps of 1 unit. the pen plunger moves with each dose. the plunger will only move to the end of the cartridge when 300 units of lantus have been given. important information you need to know before injecting lantus - do not use your pen if it is damaged or if you are not sure that it is working properly. - do not use a syringe to remove lantus from your pen. - do not reuse needles. if you do, you might get the wrong dose of lantus and/or increase the chance of getting an infection. - always perform a safety test (see step 3 ). - always carry a spare pen and spare needles in case they got 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. - ask for help if you have problems handling the pen, for example if you have problems with your sight. - read all these instructions before using your pen. if you do not follow all 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, or go to www.lantus.com or call sanofi-aventis at 1-800-633-1610. extra items you will need - a new sterile needle (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 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. 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. 1a 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. 1b pull off the pen cap. 1c check that the insulin is clear. - do not use the pen if the insulin looks cloudy, colored or contains particles. 1d 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 reuse needles. always use a new sterile needle for each injection. this helps stop blocked needles, contamination, and infection. only use needles2 that are compatible for use with lantus solostar, such as bd ultra-fine® . 2a take a new needle and peel off the protective seal. 2b keep the needle straight and screw it onto the pen until fixed. do not over-tighten. 2c pull off the outer needle cap. keep this for later. 2d pull off the inner needle cap and throw away. handling needles - take care when handling needles to prevent needle-stick injury and cross-infection. 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 lantus dose. 3a select 2 units by turning the dose selector until the dose pointer is at the 2 mark. 3b press the injection button all the way in. 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 (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. 4a make sure a needle is attached and the dose is set to "0." 4b turn the dose selector until the dose pointer lines up with your dose. - 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, use a new pen or inject the remaining units and use a new pen to complete your dose. how to read the dose window even numbers are shown in line with dose pointer. odd numbers are shown as a line between even numbers. units of lantus in your pen: - your pen contains a total of 300 units of lantus. you can select doses from 1 to 80 units in steps of 1 unit. 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: injecting your lantus 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. 5a choose a place to inject as shown in the picture above. 5b push the needle into your skin as shown by your healthcare provider. do not touch the injection button yet. 5c 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. 5d keep the injection button held in and when you see "0" in the dose window, slowly count to 10. - this will make sure you get your full dose. 5e after holding and slowly counting to 10, release the injection button. then remove the needle from your skin. if you find it hard to press the 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-stick injury and cross-infection. - do not put the inner needle cap back on. 6a 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. 6b 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. 6c throw away the used needle in a puncture-resistant container (see "throwing your pen away" at the end of this instructions for use). 6d put your pen cap back on. - do not put the pen back in the refrigerator. storing the lantus solostar pen before first use - keep new pens in the refrigerator between 36°f to 46°f (2°c to 8°c) . - do not freeze. do not use lantus if it has been frozen. after first use - keep your pen at room temperature below 86°f (30°c) . - keep your pen away from heat or light. - store your pen with the pen cap on. - do not put your pen back in the refrigerator. - do not store your pen with the needle attached. - keep out of the reach of children. - only use your pen for up to 28 days after its first use. throw away the lantus solostar pen you are using after 28 days, even if it still has insulin left in it. caring for your lantus solostar 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 lantus solostar pen may be thrown away in your household trash after you have removed the needle. - put the used needle in an fda-cleared sharps disposal container right away after use. do not throw away (dispose of) the used 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. this instructions for use has been approved by the u.s. food and drug administration. manufactured by: sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company u.s. license no. 1752 ©2023 sanofi-aventis u.s. llc. revised: june 2023

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sanofi-aventis u.s. llc - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 300 u in 1 ml - toujeo is indicated to improve glycemic control in adults and pediatric patients 6 years of age and older with diabetes mellitus. limitations of use: toujeo is not recommended for the treatment of diabetic ketoacidosis. toujeo is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] . - in patients with hypersensitivity to insulin glargine or any excipients in toujeo [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 obser

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. important limitations of use: - lantus is not recommended for the treatment of diabetic ketoacidosis. intravenous short-acting insulin is the preferred treatment for this condition. lantus is contraindicated in patients with hypersensitivity to lantus or one of its excipients. enter section text here pregnancy category c: 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 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 . in rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 units/day

USA - engelsk - NLM (National Library of Medicine)

dispensing solutions, inc. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adults and children with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. important limitations of use: - lantus is not recommended for the treatment of diabetic ketoacidosis. intravenous short-acting insulin is the preferred treatment for this condition. lantus is contraindicated in patients with hypersensitivity to lantus or one of its excipients. pregnancy category c: 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 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 . in rabbits, doses of 0.072 mg/kg/day, which is approximately 2 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m2 ,

USA - engelsk - NLM (National Library of Medicine)

tya pharmaceuticals - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 100 [iu] in 1 ml - lantus is indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. important limitations of use: - lantus is not recommended for the treatment of diabetic ketoacidosis. intravenous short-acting insulin is the preferred treatment for this condition. lantus is contraindicated - in patients with hypersensitivity to lantus or one of its excipients [see ]. warnings and precautions (5.4) pregnancy category c: 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 7 times the recommended human subcutaneous starting dose of 10 units/day (0.008 mg/kg/day), based on mg/m . in rabbits, doses of 0.072 mg/kg/day, which is approx

USA - engelsk - NLM (National Library of Medicine)

physicians total care, inc. - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro 100 [iu] in 1 ml - humalog mix75/25, a mixture of 75% insulin lispro protamine suspension and 25% insulin lispro injection, (rdna origin), is indicated in the treatment of patients with diabetes mellitus for the control of hyperglycemia. humalog mix75/25 has a more rapid onset of glucose–lowering activity compared with humulin 70/30 while having a similar duration of action. this profile is achieved by combining the rapid onset of humalog with the intermediate action of insulin lispro protamine suspension. humalog mix75/25 is contraindicated during episodes of hypoglycemia and in patients sensitive to insulin lispro or any of the excipients contained in the formulation.