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

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

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

sanofi-aventis australia pty ltd - insulin glargine, quantity: 3.6378 mg/ml - injection, solution - excipient ingredients: zinc chloride; polysorbate 20; metacresol; glycerol; hydrochloric acid; water for injections; sodium hydroxide - insulin glargine is an insulin analogue indicated for once-daily subcutaneous administration in the treatment of type 1 diabetes mellitus in adults and children and type 2 diabetes mellitus in adults who require insulin for control of hyperglycaemia.

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

eli lilly and company - insulin lispro (unii: gfx7qis1ii) (insulin lispro - unii:gfx7qis1ii) - insulin lispro protamine and insulin lispro mix75/25 is indicated to improve glycemic control in adults with diabetes mellitus. limitations of use: the proportions of rapid-acting and intermediate-acting insulins in insulin lispro protamine and insulin lispro mix75/25 are fixed and do not allow for basal versus prandial dose adjustments. insulin lispro protamine and insulin lispro mix75/25 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients who have had hypersensitivity reactions to insulin lispro protamine and insulin lispro mix75/25 or to any of its excipients. [see warnings and precautions (5.5)] risk summary published studies with insulin lispro used during pregnancy have not reported an association between insulin lispro and the induction of major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). pregnant rats and rabbits were exposed to insulin lispro in animal reproduction studies during organogenesis. no adverse effects on embryo/fetal viability or morphology were observed in offspring of rats exposed to insulin lispro at a dose approximately 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day. no adverse effects on embryo/fetal development were observed in offspring of rabbits exposed to insulin lispro at doses up to approximately 0.2 times the human subcutaneous dose of 1 unit/kg/day (see data) . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7 and has been reported to be as high as 20-25% in women with a hba1c >10. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. data human data published data from retrospective studies and meta-analyses do not report an association with insulin lispro and major birth defects, miscarriage, or adverse maternal or fetal outcomes when insulin lispro is used during pregnancy. however, these studies cannot definitely establish or exclude the absence of any risk because of methodological limitations including small sample size, selection bias, confounding by unmeasured factors, and some lacking comparator groups. animal data animal reproduction studies have not been performed with insulin lispro protamine and insulin lispro mix75/25. however, subcutaneous reproduction and teratology studies have been conducted with insulin lispro (a component of insulin lispro protamine and insulin lispro mix75/25). in a combined fertility and embryo-fetal development study, female rats were given subcutaneous insulin lispro injections of 1, 5, and 20 units/kg/day (0.2, 0.8, and 3 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) from 2 weeks prior to cohabitation through gestation day 19. there were no adverse effects on female fertility, implantation, or fetal viability and morphology. however, fetal growth retardation was produced at the 20 units/kg/day-dose as indicated by decreased fetal weight and an increased incidence of fetal runts/litter. in an embryo-fetal development study in pregnant rabbits, insulin lispro doses of 0.1, 0.25, and 0.75 unit/kg/day (0.03, 0.08, and 0.2 times the human subcutaneous dose of 1 unit insulin lispro/kg/day, based on units/body surface area, respectively) were injected subcutaneously on gestation days 7 through 19. there were no adverse effects on fetal viability, weight, and morphology at any dose. risk summary available data from published literature suggests that exogenous human insulin products, including insulin lispro protamine and insulin lispro mix75/25, are transferred into human milk. there are no adverse reactions reported in breastfed infants in the literature. there are no data on the effects of exogenous human insulin products, including insulin lispro protamine and insulin lispro mix75/25, on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for insulin, any potential adverse effects on the breastfed child from insulin lispro protamine and insulin lispro mix75/25 or from the underlying maternal condition. safety and effectiveness of insulin lispro protamine and insulin lispro mix75/25 in pediatric patients have not been established. clinical studies of insulin lispro protamine and insulin lispro mix75/25 did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger patients. in patients aged 65 and over with diabetes, the initial dosing, dose increments, and maintenance dosage should be conservative to reduce the risk of hypoglycemia [see warnings and precautions (5.3)]. the effect of renal impairment on the pharmacokinetics of insulin lispro protamine and insulin lispro mix75/25 has not been studied. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent insulin lispro protamine and insulin lispro mix75/25 dose adjustment and more frequent glucose monitoring [see warnings and precautions (5.3)] . the effect of hepatic impairment on the pharmacokinetics of insulin lispro protamine and insulin lispro mix75/25 has not been studied. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent insulin lispro protamine and insulin lispro mix75/25 dose adjustment and more frequent glucose monitoring [see warnings and precautions (5.3)] . instructions for use insulin lispro protamine and insulin lispro [ihn-soo-lihn liys-proh] mix75/25™ kwikpen ® injectable suspension, for subcutaneous use 3 ml single-patient-use pen (100 units per ml) this product is humalog® mix75/25™ (insulin lispro protamine and insulin lispro). read this instructions for use before you start taking insulin lispro protamine and insulin lispro mix75/25 and each time you get another kwikpen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your insulin lispro protamine and insulin lispro mix75/25 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. insulin lispro protamine and insulin lispro mix75/25 kwikpen (“pen”) is a disposable single-patient-use prefilled pen containing 300 units of insulin lispro protamine and insulin lispro mix75/25. - you can give yourself more than 1 dose from the pen. - by turning the dose knob, you can dial doses from 1 to 60 units in 1 unit increments. - if your dose is more than 60 units, you will need to give yourself more than 1 injection. - the plunger only moves a little with each injection, and you may not notice that it moves. the plunger will only reach the end of the cartridge when you have used all 300 units in the pen. people who are blind or have vision problems should not use this pen without help from a person trained to use the pen. how to recognize your insulin lispro protamine and insulin lispro mix75/25 kwikpen - pen color: dark blue - dose knob: dark blue - labels: white label with yellow stripe supplies you will need to give your injection - insulin lispro protamine and insulin lispro mix75/25 kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab - gauze preparing your pen - wash your hands with soap and water. - check your pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - do not attach the needle before mixing. - gently roll the pen between your hands at least 10 times. - move the pen up and down (invert) at least 10 times. mixing by rolling and inverting the pen is important to make sure you get the right dose. after mixing insulin lispro protamine and insulin lispro mix75/25, inject your dose right away. if you wait to inject your dose, the insulin will need to be mixed again. - check the liquid in the pen. insulin lispro protamine and insulin lispro mix75/25 should look white and cloudy after mixing. do not use if it looks clear or has any lumps or particles in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime your pen before each injection. - priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units. - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . - you should see insulin at the tip of the needle. - if you do not see insulin, repeat priming steps 8 to 10, no more than 4 times. - if you still do not see insulin, change the needle and repeat priming steps 8 to 10. selecting your dose - you can give from 1 to 60 units in a single injection. - if your dose is more than 60 units, you will need to give more than one injection. - if you need help with dividing up your dose the right way, ask your healthcare provider. - use a new needle for each injection and repeat the priming steps. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks. you may dial the wrong dose. this may lead to you getting too much insulin or not enough insulin. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers (for example, 12) are printed on the dial. - the odd numbers, (for example, 25) after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. - it is normal to see a small amount of insulin left in the pen that you can not inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. - do not inject where the skin has pits, is thickened, or has lumps. - do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - choose your injection site. insulin lispro protamine and insulin lispro mix75/25 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe your skin with an alcohol swab, and let your skin dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. do not try to inject your insulin by turning the dose knob. you will not receive your insulin by turning the dose knob. - pull the needle out of your skin. a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window. - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window, do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat the injection. monitor your blood glucose as instructed by your healthcare provider. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - the used pen may be discarded in your household trash after you have removed the needle. - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. storing your pen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze your insulin. do not use if insulin lispro protamine and insulin lispro mix75/25 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. - unused pens stored at room temperature, up to 86°f (30°c), should be thrown away after 10 days. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)]. keep away from heat and light. - throw away the insulin lispro protamine and insulin lispro mix75/25 pen you are using after 10 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the reach of children. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your insulin lispro protamine and insulin lispro mix75/25 kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 this instructions for use has been approved by the u.s. food and drug administration. revised: 07/2023 humalog® mix75/25™ and kwikpen® are trademarks of eli lilly and company. copyright © 2007, 2023, eli lilly and company. all rights reserved. ilpilis7525kp-0003-ifu-20230721

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

mylan specialty l.p. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine-yfgn is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use insulin glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. insulin glargine-yfgn is contraindicated: risk summary published studies with use of insulin glargine products during pregnancy have not reported a clear association with insulin glargine products and adverse developmental outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). rats and rabbits were exposed to insulin glargine in animal reproduction studies during organogenesis, respectively 50 times and 10 times the human subcutaneous dosage of 0.2 units/kg/day. overall, the effects of insulin glargine did not generally differ from those observed with regular human insulin (see data). in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically r

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

winthrop u.s. - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use insulin glargine is not recommended for the treatment of diabetic ketoacidosis. insulin glargine 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 insulin glargine [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 insulin glargine, and any potential adverse effects on the breastfed child from insulin glargine or from the underlying maternal condition. the safety and effectiveness of insulin glargine to improve glycemic control in pediatric patients with diabetes mellitus have been established. use of insulin glargine for this indication is supported by evidence from an adequate and well-controlled study (study d) in 174 insulin glargine-treated pediatric patients aged 6 to 15 years with type 1 diabetes mellitus, and from adequate and well-controlled studies of insulin glargine 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 insulin glargine, 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 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 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 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 dosage 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 dosage adjustment may be necessary for insulin glargine in patients with hepatic impairment [see warnings and precautions (5.3)]. these instructions for use contain information on how to inject insulin glargine using the vial. read these instructions for use before you start taking insulin glargine and each time you get a new insulin glargine 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 insulin glargine 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: - an insulin glargine 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 insulin glargine: - wash your hands with soap and water or clean your hands with alcohol. - check the insulin glargine 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 insulin glargine in the vial to make sure it is clear and colorless. do not use insulin glargine if it is colored or cloudy, or if you see particles in the solution. - do not use insulin glargine 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 insulin glargine. - 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 insulin glargine 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 insulin glargine before use. step 3: draw air into the syringe equal to your insulin glargine 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 insulin glargine 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 insulin glargine: - inject your insulin glargine (with a syringe) exactly as your healthcare provider has shown you. - insulin glargine is injected once daily at any time of the day but at the same time every day. step 7: choose your injection site: - insulin glargine 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 insulin glargine. - 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 insulin glargine? unopened (not in-use) insulin glargine vials - store unused insulin glargine vials in the refrigerator from 36°f to 46°f (2°c to 8°c). - do not freeze insulin glargine. - keep insulin glargine 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 insulin glargine vials have been opened (in-use) - store in-use (opened) insulin glargine 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 insulin glargine. if a vial has been frozen, throw it away. - keep insulin glargine out of direct heat and light. - the insulin glargine 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 u.s. license no. 1752 manufactured for: winthrop u.s., a business of sanofi-aventis u.s. llc a sanofi company ©2023 sanofi-aventis u.s. llc revised: june 2023 read these instructions for use before you start taking the insulin glargine solostar pen and each time you get a new insulin glargine 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 insulin glargine 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 insulin glargine solostar prefilled pen without help from a person trained to use the insulin glargine solostar prefilled pen. insulin glargine solostar is a disposable prefilled pen used to inject insulin glargine. each insulin glargine 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 insulin glargine have been given. important information you need to know before injecting insulin glargine - 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 insulin glargine from your pen. - do not reuse needles. if you do, you might get the wrong dose of insulin glargine 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.winthropus.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 insulin glargine 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 insulin glargine 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 insulin glargine in your pen: - your pen contains a total of 300 units of insulin glargine. 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 insulin glargine 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 insulin glargine 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 insulin glargine 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 insulin glargine solostar pen you are using after 28 days, even if it still has insulin left in it. caring for your insulin glargine 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 insulin glargine 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 u.s. license no. 1752 manufactured for: winthrop u.s., a business of sanofi-aventis u.s. llc bridgewater, nj 08807 a sanofi company ©2023 sanofi-aventis u.s. llc lantus is a registered trademark of sanofi-aventis u.s. llc. revised: june 2023

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

sanofi-aventis deutschland gmbh - insulin glargine (unii: 2zm8cx04rz) (insulin glargine - unii:2zm8cx04rz) - insulin glargine 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 insulin glargine is not recommended for the treatment of diabetic ketoacidosis. insulin glargine is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)] - in patients with hypersensitivity to insulin glargine or one of its excipients [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 g

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

a-s medication solutions - insulin detemir (unii: 4ft78t86xv) (insulin detemir - unii:4ft78t86xv) - levemir is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. limitations of use levemir is not recommended for the treatment of diabetic ketoacidosis. levemir is contraindicated: risk summary available data from published studies and postmarketing case reports with levemir use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in a randomized, parallel-group, open-label clinical trial that included 152 pregnant women with type 1 diabetes who were administered levemir once or twice daily, beginning in gestational weeks 8 to 12 or prior to conception, no clear evidence of maternal or fetal risk associated with levemir was observed (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were conducted in non-diabetic pregnant rats and rabbits with insulin detemir administrat

Ireland - English - HPRA (Health Products Regulatory Authority)

intervet ireland limited - insulin porcine - suspension for injection - 40 iu/ml - insulin (pork) - canine, feline - hormone

Israel - English - Ministry of Health

eli lilly israel ltd - insulin lispro; insulin lispro as protamine - suspension for injection - insulin lispro 25 %; insulin lispro as protamine 75 % - insulin lispro - insulin lispro - humalog mix 25 kwikpen is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.

Israel - English - Ministry of Health

eli lilly israel ltd, israel - insulin lispro; insulin lispro as protamine - suspension for injection - insulin lispro 50 %; insulin lispro as protamine 50 % - insulin lispro - insulin lispro - humalog mix 50 kwikpen is indicated for the treatment of patients with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis.