GYLAVA


(Insulin glargine)


What is it?

What is Gylava®?

Gylava® is the brand name of insulin glargine. This is a modified insulin, very similar to human insulin. Each prefilled pen contains 100 units/mL insulin glargine in 3 mL for subcutaneous use.

How does Gylava® work?

Gylava® is used to control high blood sugar in adults and children with diabetes mellitus. Insulin glargine has a long and steady blood-sugar-lowering action.

Indications

What is Gylava® used for?

  • Gylava® is used to treat diabetes mellitus in adults, adolescents, and children aged 2 years and above.

Contraindications

Who should not use Gylava®?

Do not use Gylava® if:

  • You are allergic to insulin glargine or any of the other ingredients of this medicine.

  • Gylava® in pre-filled pen is only suitable for injecting just under the skin.Speak to your doctor if you need to inject your insulin by another method.

  • ● Talk to your doctor, pharmacist or nurse before using Gylava®. Follow closely the instructions for posology, monitoring (blood and urine tests), diet and physical activity (physical work and exercise), injection technique as discussed with your doctor.Children and Adolescents:

Gylava® can be used in adolescents and children aged 2 years and above. Use this medicine exactly as your doctor has told you.

Pregnancy and breast-feeding

Inform your doctor if you are planning to become pregnant or if you are already pregnant. Your insulin dose 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 breastfeeding, consult your doctor, as you may require adjustments in your insulin doses and your diet.

Driving and Using Machines:

You should contact your doctor for advice on driving if:

  • You have frequent episodes of hypoglycemia.

  • The first warning symptoms which help you to recognize hypoglycemia are reduced or absent.

If you use more Gylava® than you should:

If you have injected too much Gylava®, your blood sugar level may become too low (hypoglycemia). Check your blood sugar frequently and inform your doctor.

If you forget to use Gylava®:

If you have missed a dose of Gylava® or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycemia). Check your blood sugar frequently and inform your doctor.

If you stop using Gylava®:

Do not stop Gylava® without speaking to a doctor. If you stop treatment, this could lead to severe hyperglycemia and ketoacidosis (build-up of acid in the blood because the body Is breaking down fat instead of sugar).

What other drugs could affect Gylava®?

Some medicines cause changes in the blood sugar level. Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

How to Use?

How to use Gylava®?

  • Based on your lifestyle, blood sugar, and previous insulin usage, your doctor will tell you how much Gylava® to use and when to use it.

  • Always use this medicine exactly as your doctor has told you. Check with your doctor, nurse, or pharmacist if you are not sure.

  • Gylava® is injected under the skin. Do not inject Gylava® in a vein since this may cause hypoglycemia.

  • Your doctor will show you in which area of the skin you should inject Gylava®.

  • Only use Gylava® if the solution is clear, colorless, and without particles.

  • Do not use the exact same spot for each injection.

Side Effects

What are the possible side effects of Gylava®?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common side effects (may affect more than 1 in 10 people):

  • Hypoglycemia

Common side effects (may affect up to 1 in 10 people):

  • Skin and allergic reactions at the injection site

Storage

How to store Gylava®?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date.

  • Not-in-use prefilled pens: Store in a refrigerator (2-8°C). Do not freeze. Keep the prefilled pen in the outer carton in order to protect from light.

  • In-use prefilled pens: In-use pens may be stored for a maximum of 4 weeks, not above 30°C, and away from direct heat and or direct light. The pen in-use must not be stored in the refrigerator. Do not use it after this time period

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