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|Levemir Vial

Levemir Vial

Levemir Vial is used for:

Treating diabetes mellitus.

Levemir Vial is a hormone that is produced by the pancreas and is necessary for the body"s correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet the body"s needs. Insulin helps to keep blood glucose at a nearly normal level.

Do NOT use Levemir Vial if:

• you are allergic to any ingredient in Levemir Vial
• you are having an episode of low blood sugar

Contact your doctor or health care provider right away if any of these apply to you.

Before using Levemir Vial:

Some medical conditions may interact with Levemir Vial. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you drink alcoholic beverages
• if you have kidney or liver problems, diabetic ketoacidosis, or nerve problems
• if you have high blood sodium levels or you are on a low sodium diet

Some MEDICINES MAY INTERACT with Levemir Vial. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), clonidine, or lithium because the risk of high or low blood sugar may be increased
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase (MAO) inhibitors (eg, phenelzine), oral medicines for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased
• Corticosteroids (eg, propranolol), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Levemir Vial"s effectiveness, resulting in high blood sugar
• Beta-blockers (eg, propranolol), clonidine, guanethidine, or reserpine because they may decrease or hide the signs and symptoms of low blood sugar if it occurs

This may not be a complete list of all interactions that may occur. Ask your health care provider if Levemir Vial may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Levemir Vial:

Use Levemir Vial as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An additional patient leaflet is available with Levemir Vial. Talk to your pharmacist if you have questions about this information.
• Levemir Vial may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• If you are using Levemir Vial at home, carefully follow the injection procedures taught to you by your health care provider. Inject deep under the skin, NOT into a vein or muscle.
• Injection sites within an injection area (eg, abdomen, thigh, upper arm) must be rotated from one injection to the next.
• Levemir Vial is a clear, colorless solution. If the medicine contains particles or is discolored, or if the vial/ is cracked or damaged in any way, do not use it.
• Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.
• Do not mix this insulin with any other type of insulin or medicine in the same syringe.
• Do not use Levemir Vial in an insulin infusion pump.
• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
• It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Levemir Vial.

Important safety information:

• Levemir Vial may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Levemir Vial. Using Levemir Vial alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.
• Illness, especially with nausea and vomiting, emotional problems, stress, or changes in diet or activity level may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.
• If you will be traveling across time zones, ask your doctor about adjustments to your insulin schedule.
• Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Levemir Vial. Follow your doctor"s instructions carefully. If your blood sugar level is often higher than it should be and you are taking Levemir Vial according to the directions, check with your doctor.
• Carry an identification card at all times that says you have diabetes.
• Do not exceed the recommended dose, use Levemir Vial more often than prescribed, or change the type or dose of insulin you are taking without first checking with your doctor.
• An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Signs of hypoglycemia include increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, or fainting. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you do not have a reliable source of glucose available, eat a quick source of sugar such as table sugar, honey, or candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction.
• Developing a fever or infection, eating significantly more than usual, or missing your dose of insulin may cause high blood sugar (hyperglycemia). Symptoms of hyperglycemia include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor immediately. If not treated, loss of consciousness, coma, or death may occur.
• Lab tests, such as fasting blood glucose levels or glycosylated hemoglobin levels, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Levemir Vial with caution in the ELDERLY because they may be more sensitive to its effects, especially low blood sugar.
• Use Levemir Vial with extreme caution in CHILDREN younger than 6 years of age. Safety and effectiveness in this age group have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Levemir Vial during pregnancy. It is unknown if Levemir Vial is excreted in breast milk. If you are or will be breast-feeding, check with your doctor to discuss the benefits and risks to your baby.

Possible side effects of Levemir Vial:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Depression in the skin; enlargement or thickening of the skin; redness, swelling, mild pain, or itching at the injection site.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath; swelling of arms or legs; tremor; weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm) or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.

Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Levemir Vial. Store used (open) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Levemir Vial has been frozen or overheated, throw it away.

Do not leave Levemir Vial in a car on a warm or sunny day. Do not use Levemir Vial after the expiration date stamped on the label. Throw away opened vials 28 days after the first use, even if they still contain medicine. Keep Levemir Vial, as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Levemir Vial, please talk with your doctor, pharmacist, or other health care provider.
• Levemir Vial is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Levemir Vial. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.