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Generic Name: Insulin Aspart Protamine and Insulin Aspart 70/30 (Cartridges, Prefilled Syringes, and Vials) (IN-su-lin AS-part)
Brand Name: NovoLog Mix 70/30

Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges is used for:

Treating diabetes mellitus.

Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges is a form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.

Do NOT use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges if:

• you are allergic to any ingredient in Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges
• 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 Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges:

Some medical conditions may interact with Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges. 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 or smoke
• if you have kidney or liver problems, nerve problems, or diabetic ketoacidosis
• if you are fasting, have high blood sodium levels, or are on a low-salt diet
• if you have had or will be having heart surgery

Some MEDICINES MAY INTERACT with Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine 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, niacin, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges's effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges 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 Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges:

Use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges within 15 minutes before meals, unless directed otherwise by your doctor.
• If you will be using Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges at home, a health care provider will teach you how to use it. Be sure you understand how to use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
• Carefully shake or rotate the vial, cartridge, or prefilled syringe as directed before each injection. This will ensure that the contents are evenly mixed. This combination insulin should look uniformly cloudy or milky.
• Do not use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges if it contains particles, is discolored, or if the vial or container is cracked or damaged.
• Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.
• Injection sites within an injection area (abdomen, thigh, upper arm) must be rotated from one injection to the next.
• Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe. Do not use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges in an insulin pump.
• 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.
• Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges begins lowering blood sugar within minutes after an injection. The peak effect occurs from 1 to 4 hours after a dose. The effects last up to 24 hours.
• Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for 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 Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges.

Important safety information:

• Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase the risk of developing high or low blood sugar.
• Do NOT take more than the recommended dose, use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges more often than prescribed, or change the type or dose of insulin you are using without checking with your doctor.
• Any change of insulin should be made cautiously and only under medical supervision. Changes in purity, strength, brand (manufacturer), type (regular, NPH, lente), species (beef, pork, beef-pork, human), and/or method of manufacture may require a change in dose.
• Illness, especially with nausea and vomiting, 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.
• Tell your doctor or dentist that you take Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges before you receive any medical or dental care, emergency care, or surgery.
• If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.
• Carry an ID card at all times that says you have diabetes.
• 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. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source or glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.
• Developing a fever or infection, eating significantly more than prescribed, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell you doctor right away.
• Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges.
• Lab tests, including fasting blood glucose levels and glycosylated hemoglobin levels, may be performed while you use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar.
• Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges is not recommended for use in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges while you are pregnant. It is not known if Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges is found in breast milk. If you are or will be breast-feeding, check with your doctor. You will need to discuss the risks to your baby.

Possible side effects of Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges:

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, itching, or mild pain at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur:

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

Proper storage of Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges:

VIALS: Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges. 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 Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges has been frozen or overheated, throw it away. Throw away unrefrigerated or opened vials after 28 days, even if they still contain medicine.

CARTRIDGE SYSTEMS and PREFILLED SYRINGES: Store new (unopened) cartridge systems or prefilled syringes in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges. Store used (open) cartridge systems or prefilled syringes at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) cartridges or prefilled syringes in the refrigerator. Store away from heat and light. If Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges has been frozen or overheated, throw it away. Throw away unrefrigerated or used cartridge systems or prefilled syringes after 14 days, even if they still contain medicine.

Do not leave Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges in a car on a warm or sunny day. Do not use Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges after the expiration date stamped on the label. Keep Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges, as well as syringes and needles, out of the reach of children and away from pets.

General information:

• If you have any questions about Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges, please talk with your doctor, pharmacist, or other health care provider.
• Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges 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 Insulin Aspart Protamine and Insulin Aspart 70/30 Cartridges. 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.