Levemir package insert pdf

One box of levemir flextouch contains 5 disposable pens, each prefilled with 300 units of levemir for a total of 1500 units of levemir insulin. Aranesp darbepoetin alfa injection, for intravenous or subcutaneous use initial u. Astrazeneca pharmaceuticals lp toprol xl metoprolol. Solostar is a prefilled pen for the injection of insulin. The recommended time between dose increases is 3 to 4 days the same amount of time it takes to reach steady state 1. Prescription toujeo is a longacting manmade insulin used to control high blood sugar in adults and children who are 6 years of age and older with diabetes mellitus. Type 2 patients adding levemir to glucagonlike peptide glp1 receptor agonist.

Plavix has been evaluated for safety in more than 54,000 patients, including over 21,000 patients treated for one year or more. Apr 05, 2018 levemir and lantus are both longacting forms of insulin that work for most of the day. Your health professional has decided that solostar is appropriate for you, based on your ability to handle solostar. Levemir insulin detemir injection 100 uml official. The recommended starting dose of levemir in patients with type 1 diabetes should be approximately onethird of the total daily insulin requirements. Levemir takes at least one hour to start working some sources state up to three hours, and its effects are dependent on the initial dosage given. Not recommended for treating diabetic ketoacidosis. Taking insulin or other diabetes medications is typically part of dealing with diabetes together with healthy food options and physical. Levemir flextouch 100 uml, solution for injection in a prefilled disposable pen.

Highlights of prescribing information these highlights do not. You can inject from 1 to 80 units in a single injection. Levemir insulin detemir rdna origin injection is a sterile solution of insulin. Starting on levemir levemir insulin detemir injection 100. Highlights of prescribing information administration under. Insulin detemir is a longacting basal insulin analog, with up to 24 hours duration of action, produced by a process that includes expression of recombinant dna in. Highlights of prescribing information these highlights do not include all the information needed to use relistor safely and effectively. Levemir insulin detemir rdna origin injection solution for subcutaneous injection. Both human insulin analogs levemir is a brand name for insulin detemir. The safety of novolog was evaluated in two treattotarget trials of 6 months duration, conducted in subjects with type 1 diabetes or type 2 diabetes see clinical studies 14.

When a user pushes the dose button, the force in the spring is released. In order to monitor the safety of astrazeneca products, we encourage reporting any side effects experienced while taking an astrazeneca product to the az information center at 18002369933. Sep 04, 2018 levemir is available in the following package sizes. Insulin detemir is a longacting recombinant human insulin analog. Getting started on levemir flextouch flextouchthe only prefilled insulin pen with no pushbutton extension1 accurate dosing from 1 to 80 units1 works with novo nordisk pen needlesa large, clear dosing window endofdose clickb prefilled with 300 units of levemir low injection force push button1. Hyperglycemia or hypoglycemia with changes in insulin regimen. Dosage and administration see full prescribing information for important administration instructions 2. Tresiba flextouch same dose in half the volume of u100. Time periods listed here are general guidelines only. Levemir flextouch levemir insulin detemir injection. Apidra insulin glulisine injection rdna origin is a recombinant human insulin analogue indicated for. Needles are sold separately and may require a prescription in some states. Dose is delivered when dial resets to 0 and the needle is held in the skin for 6 seconds.

The active ingredient in levemir is insulin detemir. Levemir insulin detemir rdna origin injection description levemir insulin detemir rdna origin injection is a sterile solution of insulin detemir for use as an injection. Levemir flextouch and vial levemir insulin detemir. Once in use, the device must be kept at room temperature and should not be refrigerated. Although most levemir side effects are minor, this medication can also cause serious side effects. Highlights of prescribing information these highlights do not include all the information needed to use levemir safely and effectively. Levemir received its original fda approval in 2005 and was subsequently available as a 10ml multidose vial or as levemir flexpen, a prefilled pen device. Long acting insulin toujeo insulin glargine injection. Levemir, inninsulin detemir european medicines agency europa. How to store levemir unopened levemir should be kept in the refrigerator at a temperature range between 36 and 46f 2 and 8c do not freeze levemir or use if frozen keep unopened levemir in the carton to protect from light unopened levemir can stay in the refrigerator until expiration. Relistor methylnaltrexone bromide tablets, for oral use. Highlights of prescribing information these highlights do not include all the information needed to use toujeo safely and effectively. Download leaflet view the patient leaflet in pdf format below is a text only representation of the patient information leaflet, the original can be viewed in pdf format using the link above. It is used once or twice a day to lower blood sugar.

Mar 24, 2020 levemir insulin detemir injection is a solution for subcutaneous use. Highlights of prescribing information these highlights do not include all the information needed to use basaglar safely and effectively. Flextouch may be available for other novo nordisk products in the future important safety information contd warnings and precautions contd. Highlights of prescribing information hyperglycemia or. Insulin detemir is a longacting insulin that works slowly over 24 hours. Levemir is used to treat patients with diabetes for the control of high blood sugar. Relistor methylnaltrexone bromide injection, solution.

Rapidacting or shortacting, premeal insulin should be used to satisfy the remainder of the daily insulin requirements. If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell. Dosing and titration soliqua 10033 insulin glargine. Lantus insulin glargine 100 unitsml is the most prescribed long acting insulin. Levemir insulin detemir levemir penfill 100 uml, solution for injection in a cartridge. Highlights of prescribing information these highlights do not include all the information needed to use aranespsafely and effectively. Any reference in these archives to astrazeneca products or their uses may not reflect current medical knowledge and should not be used as a source of information on the present product label, efficacy data or safety data. General information for both human insulin and analog insulin products. Levemir flextouch pen pen is a prefilled disposable, singlepatientuse pen containing 300 units of u100 levemir insulin detemir injection insulin. Product monograph 100 uml, solution for injection in a pre. Highlights of prescribing information adjust adult.

Levemir is a clear, colorless, sterile solution for injection under the skin subcutaneously. Tresiba u100 concentrations remained stable from day to day at steady state. Levemir fda prescribing information, side effects and uses. A large and clear dose display shows the units you have selected. Prescription lantus is a longacting insulin used to treat adults with type 2 diabetes and adults and pediatric patients children 6 years and older with type 1 diabetes for the control of high blood sugar. Highlights of prescribing information administration. Toujeo is not for use to treat diabetic ketoacidosis. Levemir is a longacting human insulin analog indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus 1. Talk with your health professional about proper injection technique before using solostar.

It is not known if toujeo is safe and effective in children under 6 years of age. Levemir is produced by a process that includes expression of recombinant dna in saccharomyces cerevisiae followed by chemical modification. Relistor methylnaltrexone bromide injection, solution salix pharmaceuticals, inc. Levemir insulin detemir injection is a solution for subcutaneous use. Getting started on levemir flextouch flextouchthe only prefilled insulin pen with no pushbutton extension1 accurate dosing from 1 to 80 units1 works with novo nordisk pen needlesa large, clear dosing window. Product monograph 100 uml, solution for injection in a. Alternatively, you can report any side effects of prescription drugs directly to the fda.

Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for levemir insulin detemir. Patient may or may not hear an audible click at end of dose. How to use your lantus solostar pen what is lantus. Delivers a maximum dose of 80 units in a single injection. Fetal toxicity when pregnancy is detected, discontinue entresto as soon as possible 5. Lantus can be refrigerated until the expiration date. Adding levemir as a treatment can help keep your blood sugar within your target range for up to 24 hours. Sections or subsections omitted from the full prescribing information are not listed.

Insulin detemir rys is produced by recombinant dna technology using saccharomyces cerevisiae. Dec 01, 2019 levemir insulin detemir injection is a solution for subcutaneous use. The data in table 1 reflect the exposure of 596 patients with type 1 diabetes to novolog in one clinical trial with a mean exposure duration to novolog of 24. Notify your healthcare provider immediately if you experience symptoms of low blood sugar while taking it, such as difficulty speaking, loss of coordination, or seizures. Insulin pocketcard concentrated insulins available see next page for details. Before taking levemir, tell your health care provider about all your medical conditions including, if you are. Limitations of use 5not recommended for the treatment of diabetic ketoacidosis. Apidra insulin glulisine injection, for subcutaneous or.

The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to aspirin alone are discussed below. The clinically important adverse reactions observed in trials comparing plavix plus aspirin to placebo plus aspirin and trials comparing plavix alone to. Dailymed levemir insulin detemir injection, solution. You may have to use insulin detemir in combination with another type of insulin or with oral diabetes medicine to keep your blood sugar under control. See the end of this leaflet for a complete list of ingredients. Toprol xl metoprolol succinate tablet, extended release astrazeneca pharmaceuticals lphighlights of prescribing information these highlights do not include all the information needed to use toprolxl safely and effectively. Levemir insulin detemir rdna origin injection dailymed. Page 4 of 66 lantus is also indicated in the treatment of pediatric patients. This medicine is available only with your doctors prescription. See full prescribing information for basaglar basaglar insulin glargine injection, for subcutaneous use initial u.

Millions of people every day count on lantus to help them manage their a1c and control their blood sugar. Highlights of prescribing information adjust adult doses. Patients who need higher doses can take up to 160 units in a single injection. The time course of action of any insulin may vary considerably in different individuals or at different times within the same individual humalog package insert, 2017. Flextouch can be used with novofine or novotwist disposable needles.

Important notice for users you are about to access astrazeneca historic archive material. Never share an apidra solostar pen between patients, even if the needle is changed. For detailed user instructions, please refer to the package leaflet. Levemir insulin detemir injection 100 uml is indicated to improve glycemic control in adults and children with diabetes mellitus. Levemir insulin detemir rdna origin injection is a sterile solution of insulin detemir for use as an injection. Tresiba flextouch u100 video tresiba insulin degludec. Highlights of prescribing information thiazolidinediones. Tresiba nsun degudec njection 2 full prescribing information 1 indications and usage tresiba is indicated to improve glycemic control in patients 1 year of age and older with diabetes mellitus. Soliqua 10033 is a combination of a longacting human insulin analog with a glucagonlike peptide1 glp1 receptor agonist ra indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Levemir insulin detemir injection, for subcutaneous use. Getting started on novolog flexpen a discreet, prefilled, dialadose insulin pen please see additional important safety information on next page.

Levemir is available in the following package sizes. Highlights of prescribing information hyperglycemiaor. Taking insulin or other diabetes medications is typically part of dealing with diabetes together with healthy food options and physical activity, medication can assist you manage the illness. You probably will discover some useful info in this article, come have a glimpse.

Medscape diabetes mellitus dosing for levemir insulin detemir, frequencybased adverse effects, comprehensive interactions, contraindications, pregnancy, lactation schedules, and cost information. Activity profiles in patients with type 2 diabetes in a 16hour glucose clamp study for doses in the interval of 0. Package insert template for acetylsalicylic acidaspirin tablet brand or product name product name tablet 500mg name and strength of active substances acetylsalicylic acid. Intravenous rapidacting or shortacting insulin is the preferred treatment for this condition.

Turn the dose selector to select the number of units you need to inject, from 180 units. Combigan brimonidine tartratetimolol maleate ophthalmic solution 0. Levemir is a soluble, basal insulin analogue with a prolonged duration of effect. Levemir flextouch faq for health care professionals hcps, payers, and institutions about levemir flextouch at this time, flextouch will only be available for levemir. Levemir is not recommended for the treatment of diabetic ketoacidosis. In patients with known hypersensitivity to the active substances or to any of the product components.