Lantus SoloSTAR Скачать руководство пользователя страница 1

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Please see additional Important Safety Information for Lantus

on page 9.

Please see accompanying full prescribing information for Lantus

How to Use the
Lantus

SoloSTAR

Pre-filled Insulin Pen

A Quick Reference Guide

Go online to

www.lantussolostar.com

for a free video

demonstration or call the 24-hour helpline

1-800-633-1610

to talk to a Lantus

SoloSTAR

expert

Leave a message and a Lantus

SoloSTAR

expert will call you back.

STARring the #1-prescribed insulin

Indications and Usage for Lantus

Prescription Lantus

is a long-acting insulin used to treat adults with type 2 diabetes and

adults and children (6 years and older) with type 1 diabetes for the control of high blood sugar.
It should be taken once a day at the same time each day to lower blood glucose. Do not use
Lantus

to treat diabetic ketoacidosis.

Important Safety Information for Lantus

Do not take Lantus

if you are allergic to insulin or any of the inactive ingredients in Lantus

Based on TRx data from IMS Health, NPA

Monthly database, time period from

May 2003 to November 2011.

Содержание SoloSTAR

Страница 1: ... back STARring the 1 prescribed insulinb Indications and Usage for Lantus Prescription Lantus is a long acting insulin used to treat adults with type 2 diabetes and adults and children 6 years and older with type 1 diabetes for the control of high blood sugar It should be taken once a day at the same time each day to lower blood glucose Do not use Lantus to treat diabetic ketoacidosis Important Sa...

Страница 2: ...he full instruction leaflet accompanying the pen before you use Lantus SoloSTAR for the first time To help ensure an accurate dose each time follow all steps in the leaflet If there s anything you don t understand or if you have any questions ask your healthcare providers You can also go online to www lantussolostar com or call the 24 hour support line at 1 800 633 1610 Before starting take a look...

Страница 3: ...re UNOPENED Lantus SoloSTAR pens in the refrigerator Why The cooler temperature will protect the insulin in the pen until you are ready to use it Don t inject cold insulin Wait until the pen has been out of the refrigerator and warms up to room temperature After opening the pen you should not refrigerate it and you can use it for up to 28 days Why Injecting cold insulin could make it feel more unc...

Страница 4: ...to do Always use a new needle Remember needles are not supplied with the pen See page 11 or talk to your healthcare provider Why Re using a needle can block the insulin from injecting correctly and can also cause contamination and infection Also the needle can become dull and make the injection less comfortable The needle for the pen is available as a screw on needle or as a push on needle Importa...

Страница 5: ...another needle if no insulin comes out after doing the test 3 times DON T use the pen if no insulin comes out after using a second needle What to do It is very important to always do a safety test before an injection Why The safety test removes air bubbles which helps you get the most accurate dose It also makes sure that the pen and needle are working right The safety test does not waste insulin ...

Страница 6: ...the injection button while dialing your dose DON T try to set the dose selector to half units or the pen may jam What to do Make sure the dose window is at 0 before dialing your dose Why If the dose window is not at 0 you will inject more insulin than you need That can affect your blood sugar level Make sure to remove the protective seal Check to see that you have enough insulin in the pen for you...

Страница 7: ...e Why These areas have more fat and less nerve endings You may feel less discomfort in these areas Choose a new spot in the area each time you inject a dose Why Injecting in the same spot can make a small depression in your skin or make it thicken This may cause more discomfort Never force the needle Why Forcing the needle can hurt and may damage it It can also affect how much insulin you get Impo...

Страница 8: ...eria and infection from you to another person or from another person to you Please see additional Important Safety Information for Lantus on page 9 Please see accompanying full prescribing information for Lantus How to remove the needle How to do it 1 Put the outer needle cap back on the needle 2 Use the outer needle cap to unscrew or pull the needle from the pen 3 Discard the needle and the needl...

Страница 9: ...people may experience symptoms such as shaking sweating fast heartbeat and blurred vision Severe hypoglycemia may be serious and life threatening It may cause harm to your heart or brain Other possible side effects may include injection site reactions including changes in fat tissue at the injection site and allergic reactions including itching and rash In rare cases some allergic reactions may be...

Страница 10: ...st always use a new needle Storing and Caring for the Pen 7 What should I do with the pen if I have been using it for 28 days You should throw the pen away if you have opened it and have been using it for 28 days even if there is still insulin left in the pen 8 Does the 28 day limit for using the pen also apply to unopened pens Unopened pens can be stored at room temperature for up to 28 days and ...

Страница 11: ...e in the following sizes 4 mm 5 32 32G Nano NDC HRI No 08290 3201 22 5 mm 3 16 31G Mini NDC HRI No 08290 3201 19 8 mm 5 16 31G Short NDC HRI No 08290 3201 09 For additional help visit www lantussolostar com or call 1 800 633 1610 Please see Important Safety Information for Lantus on page 9 Please see accompanying full prescribing information for Lantus US GLA 12 03 160 2012 Sanofi U S LLC A SANOFI...

Страница 12: ...CATIONS 5 WARNINGS AND PRECAUTIONS 5 1 Dosage adjustment and monitoring 5 2 Administration 5 3 Hypoglycemia 5 4 Hypersensitivity and allergic reactions 5 5 Renal impairment 5 6 Hepatic impairment 5 7 Drug interactions 6 ADVERSE REACTIONS 6 1 Clinical trial experience 6 2 Postmarketing experience 7 DRUG INTERACTIONS 8 USE IN SPECIFIC POPULATIONS 8 1 Pregnancy 8 3 Nursing Mothers 8 4 Pediatric Use 8...

Страница 13: ...aution in patients with hypoglycemia unawareness and in patients who may be predisposed to hypoglycemia e g the pediatric population and patients who fast or have erratic food intake The patient s ability to concentrate and react may be impaired as a result of hypoglycemia This may present a risk in situations where these abilities are especially important such as driving or operating other machin...

Страница 14: ... generalized skin reactions an gioedema bronchospasm hypotension and shock may occur with any insulin including LANTUS and may be life threatening Antibody production All insulin products can elicit the formation of insulin antibodies The presence of such insulin antibodies may increase or decrease the efficacy of insulin and may require adjustment of the insulin dose In phase 3 clinical trials of...

Страница 15: ...ration time profile has been demonstrated The duration of action after abdominal deltoid or thigh subcutaneous administration was similar Metabolism A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two active metabolites with in vitro activity similar to that of insulin M1 21A Gly insulin an...

Страница 16: ...NPH insulin either continued on the same total daily NPH insulin dose or started LANTUS at a dose that was 80 of the total previous NPH insulin dose The primary endpoint for this study was a comparison of the progression of diabetic retinopathy by 3 or more steps on the Early Treatment Diabetic Retinopathy Study ETDRS scale HbA1c change from baseline was a secondary endpoint Similar glycemic contr...

Страница 17: ...rless with no particles visible Mixing and diluting LANTUS must NOT be diluted or mixed with any other insulin or solution See Warnings and Precautions 5 2 Vial The syringes must not contain any other medicinal product or residue Cartridge system SoloStar If OptiClik the Insulin Delivery Device used with the LANTUS cartridge system or SoloStar disposable insulin device malfunctions LANTUS may be d...

Страница 18: ...her medicines or changes in diet or activity level Talk to your healthcare provider about how to adjust your insulin dose You may take LANTUS at any time during the day but you must take it at the same time every day Only use LANTUS that is clear and colorless If your LANTUS is cloudy or slightly colored return it to your pharmacy for a replacement Follow your healthcare provider s instructions fo...

Страница 19: ... healthcare provider about the amount of carbohydrates you should eat to treat mild to moderate hypoglycemia Severe hypoglycemia may require the help of another person or emergency medical people A person with hypoglycemia who is unable to take foods or liquids with sugar by mouth or is unconscious needs medical help fast and will need treatment with a glucagon injection or glucose given intraveno...

Страница 20: ...TUS under your skin subcutaneously in your upper arm abdomen stomach area or thigh upper leg Never inject it into a vein or muscle Change rotate injection sites within the same body area What kind of insulin Pen should I use Always use the OptiClik device distributed by sanofi aventis If you use any other device than OptiClik insulin Pen with this cartridge you may get the wrong dose of insulin ca...

Страница 21: ...ave any side effects that bother you These are not all the side effects of LANTUS Ask your healthcare provider or pharmacist for more information How should I store LANTUS Unopened cartridge system Store new unopened LANTUS cartridge systems in a refrigerator not the freezer between 36 F to 46 F 2 C to 8 C Do not freeze LANTUS Keep LANTUS out of direct heat and light If a cartridge system has been...

Страница 22: ...her medicines Know all the medicines you take including prescription and non prescription medicines vitamins and herbal supplements You may want to keep a list of the medicines you take You can show this list to your healthcare provider and pharmacists anytime you get a new medicine or refill Your healthcare provider will tell you if your insulin dose needs to be changed Meals The amount of food y...

Страница 23: ...ay Open In Use SoloStar Once SoloStar is opened in use SoloStar should NOT be refrigerated but should be kept at room temperature below 86 F 30 C away from direct heat and light The opened in use SoloStar kept at room temperature must be discarded after 28 days These storage conditions are summarized in the following table Not in use unopened Refrigerated Not in use unopened Room Temperature In us...

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