Vivaro 100 U/ml 5 Pre-Filled Pen 3 ml Ref

Description

Vivaro is a clear, colorless 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. How to use Dosage 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. Seethe box at the end of this leaflet for further information. 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. Warnings and precautions Do not use Vivaro If you are allergic (hypersensitive) to insulin glargine or to any of the other ingredients of Vivaro. Take special care with Vivaro Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work and exercise). Injection technique as discussed with your doctor. Side Effects Like all medicines, Vivaro can cause side effects, although not everybody gets them. Hypoglycaemia (low blood sugar) can be very serious. If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause brain damage and may be life-threatening. If you have symptoms of low blood sugar, take actions to increase your blood sugar level immediately. If you experience the following symptoms, contact your doctor immediately: large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heartbeat and sweating. These could be symptoms of severe allergic reactions to insulins and may become life-threatening. Very common reported side effects (experienced in more than 1 in 10 patients) Hypoglycaemia As with all insulin therapy, the most frequent side effect is hypoglycaemia. Hypoglycaemia (low blood sugar) means that there is not enough sugar in the blood. For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet. Storage Information Not in-use pens Store in a refrigerator (2 °C-8 °C). Do not freeze. Do not put Vivaro Pen next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light. In use pens Pre-filled pens in use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C away from direct heat or direct light the pen in use must not be stored in the refrigerator. Do not use it after this time period. Drug Interactions Tell your doctor about all medicines that you are taking, including those you have bought without a prescription. Before taking a medicine ask your doctor if it can affect your blood sugar level and what action, if any, you need to take. Medicines that may cause your blood sugar level to fall (hypoglycemia) include: all other medicines to treat diabetes, angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure), disopyramide (used to treat certain heart conditions), fluoxetine (used to treat depression), fibrates (used to lower high levels of blood lipids), monoamine oxidase (MAO) inhibitors (used to treat depression), pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever), sulfonamide antibiotics. Ingredients The active substance is Insulin glargine. Specifications Vivaro 100 Units/ml solution for injection in a pre-filled pen