Basaglar Insulin Glargine 100Iu/Ml Kwikpen

Product Description:

• BASAGLAR contains insulin glargine. This is a modified insulin| very similar to human insulin.


• BASAGLAR is used to treat diabetes mellitus in adults| adolescents and children aged 2 years and


• Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of


• blood sugar. Insulin glargine has a long and steady blood sugar lowering action.

How to use:

• A new needle must be attached before each use. Only use needles that are compatible for use with


• BASAGLAR KwikPen.


• A safety test must be performed before each injection.


• Look at the cartridge before you use the pen. Do not use BASAGLAR KwikPen if you notice particles


• in it. Only use BASAGLAR KwikPen if the solution is clear| colorless and waterlike. Do not shake


• or mix it before use.


• To prevent the possible transmission of disease| each pen must be used by one patient only.


• Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.


• BASAGLAR is injected under the skin. Do NOT inject BASAGLAR in a vein| since this will change


• its action and may cause hypoglycemia.


• Your doctor will show you in which area of the skin you should inject BASAGLAR. With each


• injection| change the puncture site within the particular area of skin that you are using.


• Basaglar is administered subcutaneously by injection in the abdominal wall| the thigh| the upper


• arm| the deltoid region or the gluteal region. Injection sites should always be rotated within the


• same region in order to reduce the risk of lipodystrophy and cutaneous amyloidosis.


• Always use a new pen if you notice that your blood sugar control is unexpectedly getting worse. If you


• think you may have a problem with BASAGLAR KwikPen| consult your doctor| pharmacist or nurse.


• Empty pens must not be refilled and must be properly discarded.


• Do not use BASAGLAR KwikPen if it is damaged or not working properly| it has to be discarded and


• a new KwikPen has to be used.

Caution & Warnings:

• Talk to your doctor| pharmacist or nurse before using BASAGLAR.


• Follow closely the instructions for posology| monitoring (blood and urine tests)| diet and physical


• activity (physical work and exercise) as discussed with your doctor.

Skin changes at the injection site.

• The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin


• may not work well if you inject into a lumpy area (See How to use Basaglar). Contact your doctor if you are currently injecting into a lumpy area before you start injecting into a different area. Your


• doctor may tell you to check your blood sugar more closely| and to adjust your insulin or your other


• antidiabetic medications dose.

Travel

• Before travelling consult your doctor. You may need to talk about:


• the availability of your insulin in the country you are visiting|


• supplies of insulin etc.


• correct storage of your insulin while travelling|


• timing of meals and insulin administration while travelling|


• the possible effects of changing to different time zones|


• possible new health risks in the countries to be visited|


• what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

• In the following situations| the management of your diabetes may require a lot of care (for example|


• adjustment to insulin dose| blood and urine tests):


• If you are ill or have a major injury then your blood sugar level may increase (hyperglycemia).


• If you are not eating enough your blood sugar level may become too low (hypoglycemia).


• In most cases you will need a doctor. Make sure that you contact a doctor early.


• If you have type 1 diabetes (insulin dependent diabetes mellitus)| do not stop your insulin and continue


• to get enough carbohydrates. Always tell people who are caring for you or treating you that you


• require insulin.


• Insulin treatment can cause the body to produce antibodies to insulin (substances that act against


• insulin). However| only very rarely| this will require a change to your insulin dose.


• Some patients with longstanding type 2 diabetes mellitus and heart disease or previous stroke who


• were treated with pioglitazone and insulin experienced the development of heart failure. Inform your


• doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath


• or rapid increase in weight or localized swelling (oedema).

Ingredients:

• The active substance is insulin glargine. Each milliliter of the solution contains 100 units of the


• active substance insulin glargine (equivalent to 3.64 mg).


• The other ingredients are: zinc oxide| metacresol| glycerol| sodium hydroxide (see section 2