Humalog 70/30 Recall
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Questions & Answers
Side Effects & Adverse Reactions
INFORMATION FOR THE PATIENT
10 mL Vial (1000 Units per vial)
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL–SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY’S PANCREAS AND BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.
ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH, MANUFACTURER, TYPE (E.G., REGULAR, NPH, ANALOG), SPECIES, OR METHOD OF MANUFACTURE MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.
SOME PATIENTS TAKING HUMULIN® (HUMAN INSULIN, rDNA ORIGIN) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH OTHER INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.
Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This hormone is necessary for the body’s correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet your body’s needs.
To control your diabetes, your doctor has prescribed injections of insulin products to keep your blood glucose at a near–normal level. You have been instructed to test your blood and/or your urine regularly for glucose. Studies have shown that some chronic complications of diabetes such as eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is maintained as close to normal as possible. The American Diabetes Association recommends that if your pre–meal glucose levels are consistently above 130 mg/dL or your hemoglobin A1c (HbA1c) is more than 7%, you should talk to your doctor. A change in your diabetes therapy may be needed. If your blood tests consistently show below–normal glucose levels, you should also let your doctor know. Proper control of your diabetes requires close and constant cooperation with your doctor. Despite diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin injections as prescribed by your doctor.
Always keep an extra supply of insulin as well as a spare syringe and needle on hand. Always wear diabetic identification so that appropriate treatment can be given if complications occur away from home.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
For subcutaneous use only.
There is currently no drug history available for this drug.
70/30 HUMAN INSULIN
Humulin is synthesized in a special non–disease–producing laboratory strain of Escherichia coli bacteria that has been genetically altered to produce human insulin. Humulin 70/30 is a mixture of 70% Human Insulin Isophane Suspension and 30% Human Insulin Injection (rDNA origin). It is an intermediate-acting insulin combined with the more rapid onset of action of Regular human insulin. The duration of activity may last up to 24 hours following injection. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin 70/30 is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin 70/30 is a sterile suspension and is for subcutaneous injection only. It should not be used intravenously or intramuscularly. The concentration of Humulin 70/30 is 100 units/mL (U–100).
Human insulin from Eli Lilly and Company has the trademark Humulin. Your doctor has prescribed the type of insulin that he/she believes is best for you.
DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DOCTOR’S ADVICE AND DIRECTION.
Always check the carton and the bottle label for the name and letter designation of the insulin you receive from your pharmacy to make sure it is the same as prescribed by your doctor.
Always check the appearance of your bottle of Humulin 70/30 before withdrawing each dose. Before each injection the Humulin 70/30 bottle must be carefully shaken or rotated several times to completely mix the insulin. Humulin 70/30 suspension should look uniformly cloudy or milky after mixing. If not, repeat the above steps until contents are mixed.
Do not use Humulin 70/30:
if the insulin substance (the white material) remains at the bottom of the bottle after mixing or
if there are clumps in the insulin after mixing, or
if solid white particles stick to the bottom or wall of the bottle, giving a frosted appearance.
If you see anything unusual in the appearance of Humulin 70/30 suspension in your bottle or notice your insulin requirements changing, talk to your doctor.