Vivaro^®

Insulin Glargine

Product leaflet summary

Therapeutic Indications:

Vivaro is a clear, colourless solution for injection containing insulin glargine. Insulin glargine is a modified insulin, very similar to human insulin. It is made by a biotechnology process. Insulin glargine
has a long and steady blood-sugar-lowering action.
Vivaro is used to reduce high blood sugar in adults, adolescents and children of 6 years or above with diabetes mellitus. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.

Dosage and Administration:

Based on your life-style and the results of your blood sugar (glucose) tests and your previous insulin usage, your doctor will
– Determine how much Vivaro per day you will need and at what time.
– Tell you when to check your blood sugar level, and whether you need to carry out urine tests,
– Tell you when you may need to inject a higher or lower dose of Vivaro.
Vivaro is a long-acting insulin. Your doctor may tell you to use it in combination with a short-acting insulin or with tablets used to treat high blood sugar levels.
Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low.

Frequency of administration
You need one injection of Vivaro every day, at the same time of the day.
In children, only evening injection has been studied.

Method of administration
Vivaro is injected under the skin. Do NOT inject Vivaro in a vein, since this will change its action and may cause hypoglycaemia.
Your doctor will show you in which area of the skin you should inject Vivaro. With each injection, change
the puncture site within the particular area of skin that you are using.

Contraindications:

Hypersensitivity to the active substance or to any of the excipients listed.

Pregnancy and Lactation:

Ask your doctor or pharmacist for advice before taking any medicine.
Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin
dosage may need to be changed during pregnancy and after giving birth. Particularly careful control
of your diabetes, and prevention of hypoglycemia, is important for the health of your baby.
If you are breast-feeding consult your doctor as you may require adjustments in your insulin doses and
your diet

Ability to Drive and Use Machinery:

Your ability to concentrate or react may be reduced if:
– you have hypoglycaemia (low blood sugar levels),
– you have hyperglycaemia (high blood sugar levels),
– you have problems with your sight.
Keep this possible problem in mind in all situations where you might put yourself and others at risk

Package Presentation:

– A box of 5 pre-filled pens of 3 ml, each pen contains 100 Units/ml Insulin Glargine.