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

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

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, solution - excipient ingredients: water for injections; sodium hydroxide; metacresol; hydrochloric acid; glycerol - other conditions: refrigerate - do not freeze. indications: for the treatment of insulin dependent diabetic patients.

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, solution - excipient ingredients: metacresol; glycerol; water for injections; hydrochloric acid; sodium hydroxide - indications as at 05 feb 2002 : humulin is indicated for the treatment of insulin - dependant diabetic patients.

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: water for injections; sodium hydroxide; protamine sulfate; phenol; dibasic sodium phosphate heptahydrate; glycerol; metacresol; hydrochloric acid; zinc oxide - for the treatment of insulin dependent diabetic patients.

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide; protamine sulfate; metacresol; zinc oxide; glycerol; dibasic sodium phosphate heptahydrate; phenol - for the treatment of insulin dependent diabetic patients.

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: zinc oxide; water for injections; phenol; sodium hydroxide; glycerol; metacresol; protamine sulfate; hydrochloric acid; dibasic sodium phosphate heptahydrate - for the treatment of insulin dependent diabetic patients.

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

eli lilly australia pty ltd - insulin, quantity: 100 iu/ml - injection, suspension - excipient ingredients: sodium hydroxide; glycerol; metacresol; zinc oxide; phenol; dibasic sodium phosphate heptahydrate; protamine sulfate; hydrochloric acid; water for injections - this product accepted for registration as 'currently supplied' at the time of commencement of the act. humulin is indicated for the treatment of insulin-dependent diabetic patients.

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)

remedyrepack inc. - insulin aspart (unii: d933668qvx) (insulin aspart - unii:d933668qvx) - insulin aspart protamine and insulin aspart mix 70/30 is a mixture of insulin aspart protamine and insulin aspart indicated to improve glycemic control in adult patients with diabetes mellitus. limitations of use: - insulin aspart protamine and insulin aspart mix 70/30 is not recommended for the treatment of diabetic ketoacidosis. - the proportions of rapid-acting and long-acting insulins in insulin aspart protamine and insulin aspart mix 70/30 are fixed and do not allow for basal versus prandial dose adjustments. insulin aspart protamine and insulin aspart mix 70/30 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions ( 5.3)] - in patients with hypersensitivity to insulin aspart protamine and insulin aspart mix 70/30 or one of its excipients [see warnings and precautions ( 5.5)] risk summary there are no available data with insulin aspart protamine and insulin aspart mix 70/30 (referred to as insulin aspart protamine and insulin aspart ) in pregnant women to inform a drug-associated risk for major birth defects and miscarriage. available information from published randomized controlled trials with insulin aspart use during the second trimester of pregnancy have not reported an association with insulin aspart and major birth defects or adverse maternal or fetal outcomes [see data] . there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see clinical considerations] . in animal reproduction studies, administration of subcutaneous insulin aspart to pregnant rats and rabbits during the period of organogenesis did not cause adverse developmental effects at exposures 8-times and equal to the human subcutaneous dose of 1 unit/kg/day, respectively. pre- and post-implantation losses and visceral/skeletal abnormalities were seen at higher exposures, which are considered secondary to maternal hypoglycemia. these effects were similar to those observed in rats administered regular human insulin [see data] . the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba 1c >7% and has been reported to be as high as 20-25% in women with a hba 1c >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, preeclampsia, 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 5 randomized controlled trials of 441 pregnant women with diabetes mellitus treated with insulin aspart during the late 2 nd trimester of pregnancy did not identify an association of insulin aspart with major birth defects or adverse maternal or fetal outcomes. however, these studies cannot definitely establish the absence of any risk because of methodological limitations, including a variable duration of treatment and small size of the majority of the trials. animal data fertility, embryo-fetal and pre- and postnatal development studies have been performed with insulin aspart and regular human insulin in rats and rabbits. in a combined fertility and embryo-fetal development study in rats, insulin aspart was administered before mating, during mating, and throughout pregnancy. further, in a pre- and postnatal development study insulin aspart was given throughout pregnancy and during lactation to rats. in an embryo-fetal development study insulin aspart was given to female rabbits during organogenesis. the effects of insulin aspart did not differ from those observed with subcutaneous regular human insulin. insulin aspart, like human insulin, caused pre- and post-implantation losses and visceral/skeletal abnormalities in rats at a dose of 200 units/kg/day (approximately 32 times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents) and in rabbits at a dose of 10 units/kg/day (approximately three times the human subcutaneous dose of 1 unit/kg/day, based on human exposure equivalents). no significant effects were observed in rats at a dose of 50 units/kg/day and in rabbits at a dose of 3 units/kg/day. these doses are approximately 8 times the human subcutaneous dose of 1 unit/kg/day for rats and equal to the human subcutaneous dose of 1 unit/kg/day for rabbits, based on human exposure equivalents. the effects are considered secondary to maternal hypoglycemia. risk summary there are no data on the presence of insulin aspart protamine and insulin aspart in human milk, the effects on the breastfed infant, or the effect on milk production. one small published study reported that exogenous insulin, including insulin aspart, was present in human milk. however, there is insufficient information to determine the effects of insulin aspart on the breastfed infant. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for insulin aspart protamine and insulin aspart, and any potential adverse effects on the breastfed infant from insulin aspart protamine and insulin aspart, or from the underlying maternal condition. safety and effectiveness of insulin aspart protamine and insulin aspart have not been established in pediatric patients with diabetes mellitus. clinical studies of insulin aspart protamine and insulin aspart did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently than younger adult patients. in geriatric patients with diabetes, the initial dosing, dose increments should be conservative to avoid hypoglycemic reactions. hypoglycemia may be difficult to recognize in geriatric patients. the effect of renal impairment on the pharmacokinetics of insulin aspart protamine and insulin aspart has not been studied. some studies with human insulin have shown increased circulating levels of insulin in patients with renal failure. patients with renal impairment may be at increased risk of hypoglycemia and may require more frequent insulin aspart protamine and insulin aspart dose adjustment and more frequent blood glucose monitoring [see warnings and precautions ( 5.3)]. the effect of hepatic impairment on the pharmacokinetics of insulin aspart protamine and insulin aspart has not been studied. patients with hepatic impairment may be at increased risk of hypoglycemia and may require more frequent insulin aspart protamine and insulin aspart dose adjustment and more frequent blood glucose monitoring [see warnings and precautions ( 5.3)].

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

novo nordisk pharmaceuticals pty ltd - insulin, quantity: 70 iu/ml; insulin, quantity: 30 iu/ml - injection, suspension - excipient ingredients: protamine sulfate; dibasic sodium phosphate dihydrate; hydrochloric acid; glycerol; zinc chloride; sodium hydroxide; metacresol; water for injections; phenol - the treatment of insulin-requiring diabetes.