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Ryzodeg™ is used to treat diabetes in adults, adolescents, and children 2 years of age and older. Ryzodeg™ helps the body lower blood sugar levels. Ryzodeg™ contains two types of insulin: • Basal insulin called insulin degludec, which has a long-acting effect on lowering blood sugar. • Rapid-acting insulin called insulin aspart, which lowers blood sugar immediately after an insulin injection. How to use • Always use this medicine exactly as your doctor has told you. • Insulin degludec/aspart is injected subcutaneously (under the skin). It can be injected into the abdominal wall, thigh, upper arm, or by continuous infusion into the abdominal wall. • The effect will be a little faster if the insulin is injected into your belly. For all types of insulin, Injection sites and injection sites should be within the injection area (abdomen, thigh, or upper arm). Alternate from one injection to another. • Insulin degludec/aspart should be taken before or shortly after meals (0-15 minutes). Warnings and precautions • Low blood sugar (hypoglycaemia) • High blood sugar (hyperglycemia) • Changing from other insulin products - Your insulin dose may need to be changed if you switch from another type, brand, or manufacturer of insulin. Consult your doctor. • Use of thiazolidinedione drugs with insulin • Eye disorder - Rapid improvements in blood sugar control may cause a temporary worsening of diabetic eye disorder. If you have eye problems, consult your doctor. • Ensure you are using the correct type of insulin; always check the insulin identification label before each injection to avoid accidentally mixing Ryzodeg TM with other insulin products. Side Effects Common Local reactions: Local reactions may occur at the injection site in the body. Signs of these reactions may include: pain, redness, hives, swelling and itching. These reactions usually go away after a few days. Consult your doctor if these symptoms do not go away after a few weeks. Stop using Ryzodeg TM and see your doctor immediately if these symptoms get worse. For more information see the section Severe allergic reaction above. Uncommon Swelling around joints: When you first start using this medicine, your body may retain more water than usual. This causes swelling around your ankles and other joints. This is usually temporary. Storage Information Store the pen in the refrigerator at a temperature of 2-8°C. Do not return the pen to the refrigerator after use. Keep the pen away from direct heat and light. Keep the pen in its outer cover to protect it from light. Check the expiration date on the box and do not use the pen after this period Drug Interactions • Other diabetes medications (oral and injectable) • Sulfonamides - for injection • Anabolic steroids • Beta-blockers • Acetylsalicylic acid (and other salicylates) • Monoamine oxidase inhibitors (MAOIs) • Angiotensin-converting enzyme (ACE) inhibitors • Danazole • Oral contraceptives • Thyroid hormones • Growth hormone • Glucocorticoid medications such as cortisone • Sympathomimetics such as epinephrine (adrenaline), salbutamol or terbutaline • Thiazide medications Octreotide and lanreotide Thiazolidinediones Ingredients • The active substance is insulin degludec and insulin aspart. Each ml of solution contains 100 units of insulin degludec/insulin aspart in a ratio of 30/70 . Each pre-filled injection pen (3 ml) contains 300 units of insulin degludec/insulin aspart. • Other ingredients are: Glycerin, metacresol, phenol, sodium chloride, zinc acetate, hydrochloric acid and sodium hydroxide (to adjust pH) and water for injection. Specifications Ryzodeg TM is a clear, colourless solution for injection in a pre-filled pen (300 units per 3 ml).
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