GlucaGen® HypoKit

Emergency Use for Low Blood Sugar
(glucagon [rDNA origin] for injection) 1 mg

BECOME FAMILIAR WITH THE FOLLOWING INSTRUCTIONS BEFORE AN EMERGENCY ARISES. DO NOT USE THIS PACKAGE AFTER THE EXPIRATION DATE. IF YOU HAVE QUESTIONS CONCERNING THE USE OF THIS PRODUCT, CONSULT A DOCTOR, NURSE OR PHARMACIST.

Make sure that your relatives or close friends know that if you become unconscious, medical assistance must always be sought GlucaGen® may have been prescribed so that members of your household can give the injection if you become hypoglycemic (low blood sugar) and are unable to take sugar by mouth. If you are unconscious, GlucaGen® can be given while awaiting medical assistance

Show your family members and others where you keep this kit and how to use it. They need to know how to prepare it before you need it. They can practice giving a shot by giving you your normal insulin shots. It is important that they practice. A person who has never given a shot probably will not be able to do it in an emergency.

IMPORTANT

• Act quickly. Prolonged unconsciousness may be harmful.
• These simple instructions will help you give glucagon successfully.
• Turn patient on his/her side to prevent choking
• The content of the syringe does not contain glucagon. You must mix the contents of the syringe with the glucagon in the accompanying bottle before giving injection. (see DIRECTIONS FOR USE)
• Do not mix GlucaGen® until you are ready to use it.
• Discard any unused portion.
• Become familiar with the technique of preparing glucagon before an emergency arises.
• WARNING: THE PATIENT MAY BE IN A COMA FROM SEVERE HYPERGLYCEMIA (HIGH BLOOD SUGAR) RATHER THAN HYPOGLYCEMIA (LOW BLOOD SUGAR). IN SUCH A CASE, THE PATIENT WILL NOT RESPOND TO GLUCAGON AND REQUIRES IMMEDIATE MEDICAL ATTENTION.

INDICATION FOR USE

GlucaGen® is used to treat severe hypoglycemic (low blood sugar) reactions which may occasionally occur in patients with diabetes. Symptoms of severe hypoglycemic reactions include disorientation, loss of consciousness, and seizures. You should only give GlucaGen® injection if (1) the patient is unconscious, (2) the patient is having a seizure, or (3) the patient is disoriented and unable to eat sugar or a sugar-sweetened product. Milder cases of hypoglycemia should be treated promptly by eating sugar or a sugar-sweetened product such as a regular soft drink or fruit juice. GlucaGen® does not work if it is taken by mouth.

DIRECTIONS FOR USE:

To Prepare GlucaGen® For Injection:

Use the enclosed prefilled disposable syringe with the attached needle to reconstitute GlucaGen® before giving the injection.

Step 1. Take off the orange plastic cap off the vial. Pull the needle cover off the syringe. Insert the needle through the rubber stopper of the vial containing GlucaGen® and inject all the liquid from the syringe into the vial.

Step 2. Without taking the syringe with a needle out of the vial, gently shake the vial in your hand until the powder has completely dissolved, and the solution is clear.

Step 3. While the needle is still inside the vial, turn the vial upside down and while keeping the needle in the liquid, slowly withdraw all the liquid into the syringe. Be careful not to pull the plunger out of the syringe. This will also help minimize the leakage of the fluid around the syringe. The usual dose for adult and children weighing more than 55 lbs is 1 mg (1 ml). Therefore, withdraw the solution to 1 ml mark on the syringe. The usual dose for children weighing less than 55 lb is 0.5 mg (1/2 adult dose). Therefore, withdraw Vi of the solution from the vial (0.5 ml mark on the syringe) for these children. DISCARD UNUSED PORTION.

Step 4. Turn the patient on his/her side. When an unconscious person awakens, he/she may vomit. Turning the patient on his/her side will prevent him/her from choking. Without removing the needle from the vial and while keeping the needle in the liquid, remove any air bubble(s) in the syringe by flicking the syringe with your finger and squirting any air bubbles out of the needle into the vial. Continue pushing the plunger until you have the correct dose as described in Step 3. In the event the plunger is pushed below the required dose, pull back the plunger until you have the correct dose. When you have a correct amount of glucagon in the syringe, pull the syringe with a needle from the vial. Insert the needle into the loose tissue under the injection site, and inject the glucagon solution. THERE IS NO DANGER OF OVERDOSE.

After Giving the Injection

Step 5. Withdraw the needle and press on the injection site. Used syringe and needle should be placed in sharps containers (such as red biohazard containers), hard plastic containers (such as detergent bottles), or metal containers (such as an empty coffee can). Such containers should be sealed and disposed of properly

Step 6. FEED THE PATIENT AS SOON AS HE/SHE AWAKENS AND IS ABLE TO SWALLOW. Give the patient a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers and cheese or a meat sandwich). If the patient does not awaken within 15 minutes, give another dose of GlucaGen® and INFORM A DOCTOR OR EMERGENCY SERVICES IMMEDIATELY.

Step 7. Even if the GlucaGen® awakens the patient, his/her doctor should be promptly notified. A doctor should be notified whenever severe hypoglycemic reactions happen.

How GlucaGen Works

GlucaGen® (glucagon [rDNA origin] for injection) is quickly absorbed after injection under the skin or into the muscle. Glucagon action causes glucose (sugar) to be released from the liver where it is stored as glycogen. Blood sugar levels increase within 10 minutes of injection and reach the highest amount approximately half an hour after injection. Glucagon works by promoting the release of glycogen (stored sugar in the liver).

When GlucaGen® Should Not Be Used

Do not use GlucaGen® if a patient is allergic to glucagon.

WARNINGS

Hypoglycemia may occur again following glucagon treatment. Tell your friends or relatives that you must be given a fast-acting source of sugar (such as regular soft drink or fruit juice), followed by a long acting source of sugar (carbohydrates) by mouth as soon as you are able to take it after you have responded to treatment - this will prevent the return of hypoglycemia (low blood sugar). Early symptoms of hypoglycemia may include:

• perspiration
• drowsiness
• dizziness
• sleep disturbances
• palpitation
• anxiety
• tremor
• blurred vision
• hunger
• slurred speech
• restlessness
• depressed mood
• tingling in the hands, feet, lips, or tongue
• irritability
• abnormal behavior
• lightheadedness
• unsteady movement
• inability to concentrate
• personality changes
• headache

Allergic reactions may occur rarely and include generalized rash, anaphylactic shock, breathing difficulties and hypotension (low blood pressure).

Keep this kit out of reach of children.

PRECAUTIONS

General - GlucaGen® is only of benefit in hypoglycemia (low blood sugar) when the liver has sufficient glucose (in the form of glycogen) to release. For that reason GlucaGen® has little or no effect if you are fasting, or if you are suffering from adrenal insufficiency, chronic hypoglycemia or alcohol induced hypoglycemia. Remember GlucaGen® has the opposite effect of insulin. If the GlucaGen solution shows any sign of gel formation or particles it should be discarded. Your GlucaGen® HypoKit for hypoglycemia (low blood sugar) includes:

• One vial of 1 mg GlucaGen® (glucagon [rDNA origin] for injection)
• One prefilled disposable syringe with attached needle containing 1 ml Sterile Water for Reconstitution

The vial has a protective plastic cap. You must remove the plastic cap to inject the water and reconstitute the freeze-dried GlucaGen®. If the cap is loose or missing when you buy the package, return it to your local pharmacy

Pregnancy - GlucaGen® is glucagon which is a hormone that is always present in humans. GlucaGen® is intended for infrequent use during acute, severe hypoglycemic attacks, and may be used during pregnancy.

Nursing Mothers - Breast feeding following treatment with GlucaGen® for your hypoglycemic attack should not put your baby at risk. GlucaGen® does not stay very long in the body. Also, because glucagon is a protein, even if the infant ingested glucagon, it would be unlikely to have any effect on the infant because it would be digested.

POSSIBLE PROBLEMS WITH GlucaGen® TREATMENT

Severe side effects are very rare, although nausea and vomiting may occur occasionally. Side effects indicating toxicity of GlucaGen® have not been reported.

A few people may be allergic to glucagon or to one of the inactive ingredients in GlucaGen®, or may experience rapid heart beat for a short while.

If you experience any other reactions which are likely to have been caused by GlucaGen®, please contact your doctor.

EXPIRATION DATE

Before mixing - The GlucaGen® package may be stored up to 24 months at controlled room temperature 20° to 25° C (68° to 77° F) prior to reconstitution. Avoid freezing and protect from light. Never use GlucaGen® after the expiration date printed on the package. GlucaGen® does not contain preservatives and is for single use only.

After mixing - Reconstituted GlucaGen® should be used immediately. Discard any unused portion.

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