Humulin N Recall
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
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.
Uses
INSTRUCTIONS FOR INSULIN VIAL USE
NEVER SHARE NEEDLES AND SYRINGES.
Correct Syringe Type
Doses of insulin are measured in units. U–100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin N, it is important to use a syringe that is marked for U–100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.
Syringe Use
To help avoid contamination and possible infection, follow these instructions exactly.
Disposable syringes and needles should be used only once and then discarded by placing the used needle in a puncture-resistant disposable container. Properly dispose of the puncture-resistant container as directed by your Health Care Professional.
Preparing the Dose
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Wash your hands.
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Carefully shake or rotate the bottle of insulin several times to completely mix the insulin.
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Inspect the insulin. Humulin N suspension should look uniformly cloudy or milky. Do not use Humulin N if you notice anything unusual in its appearance.
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If using a new Humulin N bottle, flip off the plastic protective cap, but do not remove the stopper. Wipe the top of the bottle with an alcohol swab.
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If you are mixing insulins, refer to the “Mixing Humulin N and Regular Human Insulin” section below.
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Draw an amount of air into the syringe that is equal to the Humulin N dose. Put the needle through rubber top of the Humulin N bottle and inject the air into the bottle.
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Turn the Humulin N bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently.
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Making sure the tip of the needle is in the Humulin N suspension, withdraw the correct dose of Humulin N into the syringe.
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Before removing the needle from the Humulin N bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
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Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
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If you do not need to mix your Humulin N with Regular human insulin, go to the “Injection Instructions” section below and follow the directions.
Mixing Humulin N and Regular Human Insulin (Humulin R)
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Humulin N should be mixed with Humulin R only on the advice of your doctor.
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Draw an amount of air into the syringe that is equal to the amount of Humulin N you are taking. Insert the needle into the Humulin N bottle and inject the air. Withdraw the needle.
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Draw an amount of air into the syringe that is equal to the amount of Humulin R you are taking. Insert the needle into the Humulin R bottle and inject the air, but do not withdraw the needle.
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Turn the Humulin R bottle and syringe upside down.
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Making sure the tip of the needle is in the Humulin R solution, withdraw the correct dose of Humulin R into the syringe.
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Before removing the needle from the Humulin R bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.
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Remove the syringe with the needle from the Humulin R bottle and insert it into the Humulin N bottle. Turn the Humulin N bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the Humulin N, withdraw the correct dose of Humulin N.
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Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.
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Follow the directions under “Injection Instructions” section below.
Follow your doctor’s instructions on whether to mix your insulins ahead of time or just before giving your injection. It is important to be consistent in your method.
Syringes from different manufacturers may vary in the amount of space between the bottom line and the needle. Because of this, do not change:
Injection Instructions
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To avoid tissue damage, choose a site for each injection that is at least 1/2 inch from the previous injection site. The usual sites of injection are abdomen, thighs, and arms.
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Cleanse the skin with alcohol where the injection is to be made.
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With one hand, stabilize the skin by spreading it or pinching up a large area.
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Insert the needle as instructed by your doctor.
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Push the plunger in as far as it will go.
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Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
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Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your Health Care Professional.
History
There is currently no drug history available for this drug.
Other Information
NPH HUMAN INSULIN
Description
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 N [Human insulin (rDNA origin) isophane suspension] is a crystalline suspension of human insulin with protamine and zinc providing an intermediate-acting insulin with a slower onset of action and a longer duration of activity (up to 24 hours) than that of Regular human insulin. 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 N is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin N is a sterile suspension and is for subcutaneous injection only. It should not be used intravenously or intramuscularly. The concentration of Humulin N is 100 units/mL (U–100).
Identification
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 N before withdrawing each dose. Before each injection the Humulin N bottle must be carefully shaken or rotated several times to completely mix the insulin. Humulin N suspension should look uniformly cloudy or milky after mixing. If not, repeat the above steps until contents are mixed. Do not use Humulin N:
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if the insulin substance (the white material) remains at the bottom of the bottle after mixing or
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if there are clumps in the insulin after mixing, or
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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 N suspension in your bottle or notice your insulin requirements changing, talk to your doctor.
Sources