What you should know about GlucaGen® HypoKit 1mg

Please read this leaflet carefully before using this medicine. This leaflet does not contain all of the information about the product that you may need to know, so please ask your doctor or pharmacist if you have any questions.

What is in your medicine

The active ingredient is glucagon biosynthetic (rys) 1mg. Other ingredients are lactose monohydrate, hydrochloric acid, sodium hydroxide and water for injections.

GlucaGen® HypoKit 1mg consists of a powder for injection (GlucaGen 1mg) with accompanying diluent (Diluent for GlucaGen 1mg) for preparation of glucagon injection. The pack contains:

• 1 vial with white powder containing 1mg glucagon (rys)
• 1 syringe containing 1ml diluent (water for injections, Ph.Eur.) for reconstitution

The reconstituted product contains 1mg/ml (1iu/ml) glucagon (rys).

Glucagon is a hyperglycaemic agent (i.e. increases blood glucose). It works by releasing glucose into the bloodstream from glycogen stored in the liver. Independently of this effect, glucagon also inhibits the motility (natural movement) of the smooth muscles in the gastrointestinal tract.

Conditions where GlucaGen® should not be used

GlucaGen should not be used if you have phaeochromocytoma (high blood pressure due to a tumour near the kidney). You should not use GlucaGen if you are allergic to glucagon or any of the constituents (these are listed above).

Precautions

• For GlucaGen to work in the treatment of hypoglycaemia, sugar (as glycogen) must be present in your liver. GlucaGen will not work properly if you are fasting, if you have underactive adrenal glands, hypoglycaemia lasting a long time or hypoglycaemia caused by drinking too much alcohol. Take extra care if you use GlucaGen and have an insulinoma or glucagonoma (tumours of the pancreas which secrete insulin or glucagon respectively).
• It should be kept in mind that glucagon has the opposite effect to insulin.
• Caution must be observed when GlucaGen is used in diabetics, or in elderly patients with a heart condition, in connection with endoscopy or radiography.

Other medicines

Indomethacin (used in treatment of rheumatic diseases and gout) may prevent or even reverse the hyperglycaemic effect of glucagon.

The effect of injected GlucaGen is not known to be influenced by medicines other than insulin or indomethacin.

GlucaGen may increase the anticoagulant effect of warfarin.

Pregnancy and lactation

Glucagon does not cross the placenta and may be used in the treatment of severe hypoglycaemia during pregnancy.

Breastfeeding following treatment of severe hypoglycaemic reactions with GlucaGen does not put your baby at risk.

Driving or operating machinery

GlucaGen is not known to produce any effect on your ability to drive or operate machinery. However, you should not drive or operate machinery immediately following recovery from severe hypoglycaemia because symptoms, such as blurred vision, may still be present and because of the possibility of recurrence of hypoglycaemia.

1 Treatment of severe hypoglycaemia

Administration to the patient by relatives or friends

• Glucagon is often prescribed for treatment of hypoglycaemia so that close friends or relatives can give the injection if you become hypoglycaemic and are unable to take sugar by mouth. Under these circumstances glucagon is usually injected under the skin or into the upper and outer muscle of the thigh, but follow your doctor's instructions on how to give the injection.
• Follow your doctor's instructions concerning the appropriate dose for treating hypoglycaemia. [The recommended dose for treatment of hypoglycaemia in diabetics is 1mg ( = 1ml, all of solution) for adults and children over 25 kg or aged 6 -8 years and 0.5mg ( = ½ml, half of solution) for children under 25 kg or aged 6 -8 years.
• Following injection of glucagon, carbohydrate must be given (eg glucose tablets or sugar) by mouth as soon as sufficient recovery has taken place. This will restore the stored sugar (glycogen) in the liver and prevent the blood sugar falling again.
• If recovery has not taken place within 10 minutes of the glucagon injection a doctor must be called immediately so that intravenous glucose can be given.
• Make sure that your relatives or close friends know that if you become unconscious medical assistance must always be sought.

Administration by medical personnel

• Administer 1mg (adults and children over 25kg or aged 6 -8 years) or 0.5mg (children below 25kg or aged 6 -8 years) by subcutaneous, intramuscular, or intravenous injection. If the patient does not respond within 10 minutes 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.

2 Diagnostic Indications

Examination of the Gastrointestinal Tract

• a)The dose ranges from 0.2 to 2mg depending on the diagnostic techniques used and the route of administration. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2 to 0.5mg given intravenously or 1mg given intramuscularly; the usual dose to relax the colon is 0.5 to 0.75mg intravenously or 1 to 2mg intramuscularly. Onset of action after an intravenous injection of 0.2 -0.5mg occurs within one minute and the duration of effect is between 5 and 20 minutes depending on the organ under examination. The onset of action after an intramuscular injection of 1 -2mg occurs after 5 -15 minutes and lasts approximately 10 -40 minutes depending on the organ.
• (b) In computerised tomography (CT), nuclear magnetic resonance scanning (NMR) and digital subtraction angiography (DSA) intravenous doses of up to 1mg are used.

Preparing the solution for injection

• The GlucaGen 1mg vial has a protective, tamper-evident plastic cap. This must be pushed off before use. The cap cannot be replaced once taken off. If the cap is not securely fastened to a new vial the pack should be returned to the pharmacy.

1. Push the orange plastic cap off the vial. Pull the needle cover off the syringe and insert the needle through the rubber disc of the vial. Inject all of the liquid from the syringe into the vial.	2. Without withdrawing the syringe and needle, gently shake the vial until the GlucaGen is completely dissolved and the solution is clear. Do not use if the solution has a viscous appearance or there are solid particles present.	3. Make sure that the plunger is completely down. Draw back all of the solution into the syringe. Be careful that the plunger is not pulled out of the syringe.	4. The solution is used for injection. Ensure there is no air remaining in the syringe before giving the injection. When the patient responds administer oral carbohydrate (eg dextrosol, sweet biscuits or a sweet drink) to prevent a further "hypo".

Side effects

• Severe side effects are very rare, although nausea and vomiting may occur occasionally, especially with doses above 1mg or with rapid injection (less than 1 minute).
• You may have a rapid heartbeat for a short time after injection of GlucaGen.
• Side effects suggesting toxicity of GlucaGen have not been reported.
• If you experience a rash, itching or shortness of breath following an injection of GlucaGen contact your doctor immediately and do not use the product again until your doctor has advised you that it is safe to do so.
• If you experience any other reaction which is likely to have been caused by GlucaGen please tell your doctor or pharmacist.

Overdose

Overdosage of GlucaGen may cause nausea and vomiting. Serum potassium levels may also decrease and should be monitored and corrected if necessary.