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Glucagen® HypoKit




Product benefits 

Although diabetes management has improved dramatically, hypoglycaemic episodes can still happen. Almost everyone with diabetes will experience mild hypoglycaemia each year and more than 10% will suffer a severe episode.

Preparing patients and their families

People with diabetes - and their families, friends and colleagues - may have to deal with severe hypoglycaemia. GlucaGen® HypoKit enables anyone to treat such an emergency, even without medical training.

GlucaGen® HypoKit – safe and easy to use
GlucaGen® HypoKit contains everything needed for a lifesaving GlucaGen® injection.

Easy-to-follow instructions

A vial with 1 mg freeze-dried GlucaGen®

A syringe prefilled with GlucaGen® diluent

Small, compact and easy to store and carry, GlucaGen® HypoKit is the safe and easy solution to a hypoglycaemic emergency.


Prescribing information 

GLUCAGEN® HYPOKIT
Glucagon, biosynthetic.

ACTIVE INGREDIENT IN EACH ML
Glucagon hydrochloride 1 mg (corresponding to 1 IU), biosynthetic.

OTHER INGREDIENTS
Lactose monohydrate. Sterilised water for injections. Hydrochloric acid and/or Sodium hydroxide (to adjust pH).

PHARMACEUTICAL FORM
Powder and solvent for solution for injection in pre-filled syringe.

PRODUCT CHARACTERISTICS
GlucaGen® HypoKit 1 mg is supplied as a sterile, freeze-dried white powder of glucagon in a 2 ml vial and accompanying solvent in a 1.5 ml disposable syringe. When the glucagon powder is reconstituted with the sterilised water for injections it forms a solution of 1 mg (1 IU) glucagon in each ml to be injected under the skin or into a muscle. Glucagon is a hormone that increases blood sugar levels by releasing glucose from the liver.

PRODUCED BY
Novo Nordisk A/S.

WHAT IS GLUCAGEN® HYPOKIT USED FOR?
GlucaGen® HypoKit is used to treat severe hypoglycaemic (low blood sugar) reactions which may occur if you are a person with insulin treated diabetes.

BEFORE YOU TAKE GLUCAGEN® HYPOKIT
When you should not use GlucaGen® HypoKit
Do not use GlucaGen® HypoKit if you are allergic to glucagon or any of the other ingredients, or if you have an adrenal gland tumour.

Precautions
GlucaGen® HypoKit works to treat hypoglycaemia when there is liver glycogen. GlucaGen® will not work properly if you are fasting, or have low levels of adrenaline, chronic hypoglycaemia or hypoglycaemia caused by drinking too much alcohol. Because GlucaGen® depletes glycogen stores, you must be given sugar by mouth as soon as you are able to take it after you have responded to the treatment. This will prevent the occurrence of secondary hypoglycaemia. Take extra care if you use GlucaGen® HypoKit and have a tumour that releases glucagon or insulin. Do not use the solution if in rare cases it looks like a gel or if any of the powder has not dissolved properly. The vial has a protective, tamperproof plastic cap. To be able to reconstitute the glucagon powder you must remove the plastic cap. If it is loose or missing when you buy the vial, return it to your local pharmacy.

Other medicines
The effect of injected glucagon is not known to be influenced by other medicines than insulin and Indomethacin. Glucagon may increase the anticoagulant effect of warfarin.

Pregnancy and breast-feeding
Glucagon does not cross the human placenta barrier, and may be used in the treatment of severe hypoglycaemia during pregnancy. Breast-feeding following treatment of severe hypoglycaemic reactions with GlucaGen®
does not put your baby at risk.

Driving
GlucaGen® is not known to produce any effect on your ability to drive and to operate machines.

Warning
Keep out of reach of children.

HOW TO TAKE GLUCAGEN®

Treatment of severe hypoglycaemia (low blood sugar) in persons with diabetes

Administration to the patient by relative(s):

Make sure that your relatives or close friends know that if you get a severe hypoglycaemic reaction medical assistance must always be sought. Your doctor may have given you GlucaGen® HypoKit so that your friends or relatives can give you the injection if you become hypoglycaemic and are unable to take sugar by mouth. Inject all = 1 ml (adults and children over 25 kg) or half = 1/2 ml (children below 25 kg or 6-8 years) under the skin or into the upper and outer muscle of the thigh. Tell your friends or relatives that you must be given sugar by mouth as soon as you are able to take it after you have responded to treatment. This will prevent the return of the hypoglycaemia.

Administration by medical personnel:

Administer 1 mg (adults and children over 25 kg) or 0.5 mg (children below 25 kg or 6-8 years) by s.c. or i.m. injection. If the patient does not respond within 10 minutes a medical doctor must be contacted and intravenous glucose should be given. When the patient has responded to the treatment give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia.

Preparing the solution to inject

Snap the orange 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.
Taking the needle out of the vial, gently shake the vial until the GlucaGen® has completely dissolved, and the solution is clear.
Make sure the plunger is completely down. Draw all the solution back into the syringe. Be careful not to pull the plunger out of the syringe.
Make an air shot and inject. Please refer to the previous paragraph for instructions on dosage.

SIDE EFFECTS
Severe side effects are very rare, although nausea and vomiting may occur occasionally especially with doses above 1 mg or with rapid injection (less than 1 minute). You may also have rapid heart beat for a short while. Side effects indicating toxicity of GlucaGen® have not been reported. A few people may be allergic to GlucaGen®. If you have any other reactions which you think have been caused by GlucaGen®, please tell your doctor or local pharmacy.

OVERDOSE
If you have been given too much GlucaGen® it may cause nausea and vomiting. Specific treatment is not usually necessary. The serum potassium may decrease and should be monitored and corrected if needed.

EXPIRY DATE
Never use GlucaGen® after the expiry date printed on the pack.

STORAGE
GlucaGen® (as a powder) should be stored between 2°C and 8°C. Avoid freezing to prevent damage to the syringe. The GlucaGen® vial should be protected from light. GlucaGen® HypoKit can be stored at room temperature (up to 25° C) for 18 months provided that the expiry date is not exceeded. Reconstituted GlucaGen® should be used immediately after preparation. Do not store for later use.

GlucaGen® HypoKit is a trademark owned by Novo Nordisk A/S, Denmark.

 

For Prescribing information on the product please email us at prindia@novonordisk.com