European Union - English - EMA (European Medicines Agency)

sanofi-aventis deutschland gmbh - insulin human - diabetes mellitus - drugs used in diabetes - diabetes mellitus where treatment with insulin is required. insulin human winthrop rapid is also suitable for the treatment of hyperglycaemic coma and ketoacidosis, as well as for achieving pre-, intra- and postoperative stabilisation in patients with diabetes mellitus.

Philippines - English - FDA (Food And Drug Administration)

pnf pharmaceutical, inc.; distributor: multicare pharmaceuticals phils. inc. - insulin human (rdna) - suspension for injection (im/sc) - 100 iu/ml (100% isophane insulin human)

Philippines - English - FDA (Food And Drug Administration)

pnf pharmaceutical, inc.; distributor: duopharma trade phils., inc. - insulin human (rdna) - suspension for injection (im/sc) - 100 iu/ml (100% isophane insulin human)

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: pnf pharmaceutical, inc; distributor: jackpharma inc - insulin human (rdna) - suspension for injection (im/sc) (100% isophane insulin human) - 100 iu/ml

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: pnf pharmaceutical, inc; distributor: mega lifesciences limited inc - insulin human (rdna) - suspension for injection (im/sc) (100% isophane insulin human) - 100 iu/ml

Malta - English - Medicines Authority

eli lilly nederland b.v papendorpseweg 83, 3528 bj, utrecht, nl-3991, netherlands - insulin human, rdna - suspension for injection - insulin human (rdna) 100 iu - drugs used in diabetes

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

pfizer inc. - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - kit - 1 mg - exubera is indicated for the treatment of adult patients with diabetes mellitus for the control of hyperglycemia. exubera has an onset of action similar to rapid-acting insulin analogs and has a duration of glucose-lowering activity comparable to subcutaneously administered regular human insulin. in patients with type 1 diabetes, exubera should be used in regimens that include a longer-acting insulin. in patients with type 2 diabetes, exubera can be used as monotherapy or in combination with oral agents or longer-acting insulins. exubera is contraindicated in patients hypersensitive to exubera or one of its excipients. exubera is contraindicated in patients who smoke or who have discontinued smoking less than 6 months prior to starting exubera therapy. if a patient starts or resumes smoking, exubera must be discontinued immediately due to the increased risk of hypoglycemia, and an alternative treatment must be utilized (see clinical pharmacology, special populations, smoking). the safety and efficacy of exube

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

eli lilly and company - insulin human (unii: 1y17cti5sr) (insulin human - unii:1y17cti5sr) - insulin human 100 [iu] in 1 ml - humulin 70/30 is a fixed ratio insulin formulation indicated to improve glycemic control in adults with diabetes mellitus. humulin 70/30 is contraindicated: - during episodes of hypoglycemia [see warnings and precautions (5.3)], and - in patients who have had hypersensitivity reactions to humulin 70/30 or any of its excipients [see warnings and precautions (5.5)] . risk summary available data from published studies over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes (see data). there are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see clinical considerations). animal reproduction studies were not performed. the estimated background risk of major birth defects is 6-10% in women with pre-gestational diabetes with a hba1c >7% and has been reported to be as high as 20-25% in women with a hba1c >10%. the estimated background risk of miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, pre-eclampsia, spontaneous abortions, preterm delivery, and delivery complications. poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia-related morbidity. data human data while available studies cannot definitively establish the absence of risk, published data from retrospective studies, open-label, randomized, parallel studies and meta-analyses over decades have not established an association with human insulin use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes. all available studies have methodological limitations, including lack of blinding, unclear methods or randomization, and small sample size. the safety and effectiveness of humulin 70/30 in pediatric patients have not been established. the effect of age on the pharmacokinetics and pharmacodynamics of humulin 70/30 has not been studied [see clinical pharmacology (12.3)] . patients with advanced age using any insulin, including humulin 70/30, may be at increased risk of hypoglycemia due to co-morbid disease and polypharmacy [see warnings and precautions (5.3)] . instructions for use humulin® (hu-mu-lin) 70/30 (insulin isophane human and insulin human) injectable suspension, for subcutaneous use 3 ml or 10 ml multiple-dose vial (100 units/ml) read the instructions for use before you start taking humulin 70/30 and each time you get a new humulin 70/30 vial. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your syringes with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. supplies needed to give your injection: - a 3 ml or 10 ml multiple-dose humulin 70/30 vial - a u-100 insulin syringe and needle - 2 alcohol swabs - 1 sharps container for throwing away used needles and syringes. see “disposing of used needles and syringes” at the end of these instructions. preparing your humulin 70/30 dose: - wash your hands with soap and water. - check the humulin 70/30 label to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use humulin 70/30 past the expiration date printed on the label or 31 days after you first use it. - always use a new syringe or needle for each injection to help ensure sterility and prevent blocked needles. do not reuse or share your syringes or needles with other people. you may give other people a serious infection or get a serious infection from them. giving your humulin 70/30 injection: - inject your insulin exactly as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where the skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - if you see blood after you take the needle out of your skin, press the injection site with a piece of gauze or an alcohol swab. do not rub the area. - do not recap the needle. recapping the needle can lead to a needle stick injury. disposing of used needles and syringes: - put your used needles and syringes in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles and syringes in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal. - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. how should i store humulin 70/30? all unopened humulin 70/30 vials: - store all unopened vials in the refrigerator. - do not freeze. do not use if it has been frozen. - keep away from heat and out of direct light. - unopened vials can be used until the expiration date on the carton and label, if they have been stored in the refrigerator. - unopened vials should be thrown away after 31 days, if they are stored at room temperature. after humulin 70/30 vials have been opened: - store opened vials in the refrigerator or at room temperature up to 86°f (30°c) for up to 31 days. - keep away from heat and out of direct light. - throw away all opened vials after 31 days of use, even if there is still insulin left in the vial. general information about the safe and effective use of humulin 70/30. - keep humulin 70/30 vials, syringes, needles, and all medicines out of the reach of children. - always use a new syringe or needle for each injection. - do not reuse or share your syringes or needles with other people. you may give other people a serious infection or get a serious infection from them. if you have any questions or problems with your humulin, contact lilly at 1-800-lilly-rx (1-800-545-5979) or call your healthcare provider for help. for more information on humulin and insulin, go to www.humulin.com. scan this code to launch the humulin.com website this instructions for use has been approved by the u.s. food and drug administration. humulin® is a trademark of eli lilly and company. instructions for use revised: june 2022 manufactured by: eli lilly and company, indianapolis, in 46285, usa us license number 1891 copyright © 1992, 2022, eli lilly and company. all rights reserved. lin7030vl-0005-ifu-20220627 instructions for use humulin® 70/30 kwikpen® (insulin isophane human and insulin human) injectable suspension, for subcutaneous use 3 ml single-patient-use pen (100 units/ml) read the instructions for use before you start taking humulin 70/30 and each time you get another kwikpen. there may be new information. this information does not take the place of talking to your healthcare provider about your medical condition or your treatment. do not share your humulin 70/30 kwikpen with other people, even if the needle has been changed. you may give other people a serious infection or get a serious infection from them. humulin®  70/30 kwikpen® (“pen”) is a disposable single-patient-use prefilled pen containing 300 units of humulin 70/30. you can give yourself more than 1 dose from the pen. each turn (click) of the dose knob dials 1 unit of insulin. you can give from 1 to 60 units in a single injection. if your dose is more than 60 units, you will need to give yourself more than 1 injection. the plunger only moves a little with each injection, and you may not notice that it moves. the plunger will only reach the end of the cartridge when you have used all 300 units in the pen. people who are blind or have vision problems should not use the pen without help from a person trained to use the pen. how to recognize your humulin 70/30 kwikpen - pen color: beige - dose knob: brown - labels: white label with brown stripe supplies you will need to give your injection - humulin 70/30 kwikpen - kwikpen compatible needle (becton, dickinson and company pen needles recommended) - alcohol swab - gauze preparing your pen - wash your hands with soap and water. - check your pen to make sure you are taking the right type of insulin. this is especially important if you use more than 1 type of insulin. - do not use your pen past the expiration date printed on the label or for more than 10 days after you first start using the pen. - always use a new needle for each injection to help prevent infections and blocked needles. do not reuse or share your needles with other people. you may give other people a serious infection or get a serious infection from them. - pull the pen cap straight off. - do not remove the pen label. - wipe the rubber seal with an alcohol swab. - do not attach the needle before mixing. - gently roll the pen between your hands 10 times. - move the pen up and down (invert) 10 times. mixing by rolling and inverting the pen is important to make sure you get the right dose. - check the liquid in the pen . humulin 70/30 should look white and cloudy after mixing. do not use if it looks clear or has any lumps or particles in it. - select a new needle. - pull off the paper tab from the outer needle shield. - push the capped needle straight onto the pen and twist the needle on until it is tight. - pull off the outer needle shield. do not throw it away. - pull off the inner needle shield and throw it away. priming your pen prime before each injection. - priming your pen means removing the air from the needle and cartridge that may collect during normal use and ensures that the pen is working correctly. - if you do not prime before each injection, you may get too much or too little insulin. - to prime your pen, turn the dose knob to select 2 units. - hold your pen with the needle pointing up. tap the cartridge holder gently to collect air bubbles at the top. - continue holding your pen with needle pointing up. push the dose knob in until it stops, and “0” is seen in the dose window. hold the dose knob in and count to 5 slowly . - you should see insulin at the tip of the needle. - if you do not see insulin, repeat priming steps 8 to 10, no more than 4 times. - if you still do not see insulin, change the needle and repeat priming steps 8 to 10. selecting your dose - you can give from 1 to 60 units in a single injection. - if your dose is more than 60 units, you will need to give more than 1 injection. - if you need help with dividing up your dose the right way, ask your healthcare provider. - use a new needle for each injection and repeat the priming step. - turn the dose knob to select the number of units you need to inject. the dose indicator should line up with your dose. - the pen dials 1 unit at a time. - the dose knob clicks as you turn it. - do not dial your dose by counting the clicks. you may dial the wrong dose. this may lead to you getting too much insulin or not enough insulin. - the dose can be corrected by turning the dose knob in either direction until the correct dose lines up with the dose indicator. - the even numbers (for example, 12) are printed on the dial. - the odd numbers, (for example, 25) after the number 1, are shown as full lines. - always check the number in the dose window to make sure you have dialed the correct dose. - the pen will not let you dial more than the number of units left in the pen. - if you need to inject more than the number of units left in the pen, you may either: - inject the amount left in your pen and then use a new pen to give the rest of your dose, or - get a new pen and inject the full dose. or - it is normal to see a small amount of insulin left in the pen that you can not inject. giving your injection - inject your insulin as your healthcare provider has shown you. - change (rotate) your injection sites within the area you choose for each dose to reduce your risk of getting lipodystrophy (pits in skin or thickened skin) and localized cutaneous amyloidosis (skin with lumps) at the injection sites. do not inject where the skin has pits, is thickened, or has lumps. do not inject where the skin is tender, bruised, scaly or hard, or into scars or damaged skin. - do not try to change your dose while injecting. - choose your injection site. humulin 70/30 is injected under the skin (subcutaneously) of your stomach area, buttocks, upper legs or upper arms. - wipe your skin with an alcohol swab, and let your skin dry before you inject your dose. - insert the needle into your skin. - push the dose knob all the way in. - continue to hold the dose knob in and slowly count to 5 before removing the needle. - pull the needle out of your skin. a drop of insulin at the needle tip is normal. it will not affect your dose. - check the number in the dose window. - if you see “0” in the dose window, you have received the full amount you dialed. - if you do not see “0” in the dose window, do not redial. insert the needle into your skin and finish your injection. - if you still do not think you received the full amount you dialed for your injection, do not start over or repeat the injection. monitor your blood glucose as instructed by your healthcare provider. - if you normally need to give 2 injections for your full dose, be sure to give your second injection. after your injection - carefully replace the outer needle shield. - unscrew the capped needle and throw it away (see disposing of pens and needles section). - do not store the pen with the needle attached to prevent leaking, blocking the needle, and air from entering the pen. - replace the pen cap by lining up the cap clip with the dose indicator and pushing straight on. disposing of pens and needles - put your used needles in a fda-cleared sharps disposal container right away after use. do not throw away (dispose of) loose needles in your household trash. - if you do not have a fda-cleared sharps disposal container, you may use a household container that is: - made of a heavy-duty plastic, - can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out, - upright and stable during use, - leak-resistant, and - properly labeled to warn of hazardous waste inside the container. - when your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. there may be state or local laws about how you should throw away used needles and syringes. for more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the fda's website at: http://www.fda.gov/safesharpsdisposal - do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. do not recycle your used sharps disposal container. - the used pen may be discarded in your household trash after you have removed the needle. storing your pen unused pens - store unused pens in the refrigerator at 36°f to 46°f (2°c to 8°c). - do not freeze your insulin. do not use if it has been frozen. - unused pens may be used until the expiration date printed on the label, if the pen has been kept in the refrigerator. in-use pen - store the pen you are currently using at room temperature [up to 86°f (30°c)]. keep away from heat and light. - throw away the humulin 70/30 pen you are using after 10 days, even if it still has insulin left in it. general information about the safe and effective use of your pen - keep your pen and needles out of the reach of children. - do not use your pen if any part looks broken or damaged. - always carry an extra pen in case yours is lost or damaged. troubleshooting - if you can not remove the pen cap, gently twist the cap back and forth, and then pull the cap straight off. - if the dose knob is hard to push: - pushing the dose knob more slowly will make it easier to inject. - your needle may be blocked. put on a new needle and prime the pen. - you may have dust, food, or liquid inside the pen. throw the pen away and get a new pen. if you have any questions or problems with your humulin 70/30 kwikpen, contact lilly at 1-800-lillyrx (1-800-545-5979) or call your healthcare provider for help. for more information on humulin 70/30 kwikpen and insulin, go to www.lilly.com. scan this code to launch www.humulin.com this instructions for use has been approved by the u.s. food and drug administration. humulin® and humulin® kwikpen® are trademarks of eli lilly and company. revised: june 2022 manufactured by: eli lilly and company indianapolis, in 46285, usa us license number 1891 copyright © 2013, 2022, eli lilly and company. all rights reserved. lin7030kp-0008-ifu-20220627

Malta - English - Medicines Authority

eli lilly & co. limited - insulin human (rdna) - suspension for injection - insulin human (rdna) 100 iu - drugs used in diabetes

New Zealand - English - Medsafe (Medicines Safety Authority)

novo nordisk pharmaceuticals ltd - isophane insulin, human, pyr 70 iu/ml;  ; neutral insulin, human, pyr 30 iu/ml;   - suspension for injection - active: isophane insulin, human, pyr 70 iu/ml   neutral insulin, human, pyr 30 iu/ml   excipient: dibasic sodium phosphate dihydrate glycerol hydrochloric acid metacresol phenol protamine sulfate sodium hydroxide water for injection zinc - treatment of diabetes mellitus.