GlucaGen ® Hypokit ® 1 mg Injection

GlucaGen ® Hypokit ® is for immediate, emergency use in children and adults with very low blood sugar (hypoglycaemia). It is intended to treat people with diabetes using insulin that have become unconscious or are unable to ingest a source of sugar. GlucaGen ® Hypokit ® is also used during medical investigations of the gastrointestinal tract to relax and slow down the movements of the stomach and bowel in adults. This makes it easier for your doctor to investigate your digestive tract. Glucagon is a natural hormone, which has the opposite effect of insulin in the human body. It helps the body to convert glycogen into glucose in the liver. Glucose is then released into the blood stream.

Do not administer GlucaGen ® Hypokit ®:

• If you are hypersensitive (allergic) to glucagon or any of the other ingredients of GlucaGen ® Hypokit ®.
• If you have phaeochromocytoma (a tumour of the adrenal gland).

Warnings and precautions

Talk to your doctor before you get GlucaGen ® Hypokit ®. GlucaGen ® Hypokit ® will not work properly:

• If you have been fasting for a long time;
• If you have low levels of adrenaline;
• If you have low blood sugar (possibly caused by drinking too much alcohol);
• If you have a tumour that releases glucagon or insulin.

If any of these apply, get medical advice.

Always take GlucaGen ® Hypokit ® exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure. Do not share medicines prescribed for you with others.

Treatment of severe hypoglycaemia:

Administer by subcutaneous or intramuscular injection. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia.

Diagnostic procedures:

In (a) endoscopy and (b) radiography of the gastro-intestinal tract, the dosage of GlucaGen ® Hypokit ® will be prescribed by your doctor who will administer it. Oral carbohydrates should be given when the procedure has ended, if this is compatible with the diagnostic procedure concerned. Remember that GlucaGen ® Hypokit ® has the opposite effect of insulin. With endoscopy or radiography procedures, take extra care in administering GlucaGen ® Hypokit ® to patients with diabetes or to people with a heart condition.

How much to use

The recommended dose is:

• Adults: inject all (1 ml), marked as 1 on the syringe;
• Children above 25 kg or older than 6 to 8 years: inject all (1 ml), marked as 1 on the syringe;
• Children below 25 kg or younger than 6 to 8 years: inject half (0, 5 ml), marked as 0, 5 on the syringe.

GlucaGen ® Hypokit ® 1 mg should be used immediately after preparation.

GlucaGen ® Hypokit ® can have side effects. Not all side effects reported for GlucaGen ® Hypokit ® are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other healthcare professional for advice.

Other side effects include:

Frequent

• Feeling you are about to be sick (nausea).

Less frequent

• Being sick (vomiting).

Rare side effects (less than 1 in 1 000 people)

• Stomach (abdominal) pain.

Very rare side effects (less than 1 in 10 000 people)

• Allergic reaction – the signs may include wheezing, sweating, rapid heartbeat, rash, swollen face and collapse. Get medical help immediately, if any of these occur.

Not known side effects

(frequency cannot be estimated from the available data):

• injection site reactions.

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of GlucaGen ® Hypokit ®.

• Keep this medicine out of the sight and reach of children.

• Do not use this medicine after the expiry date which is stated on the pen label and carton after ‘EXP’. The expiry date refers to the last day of that month.

GlucaGen ® Hypokit ® should be stored at a temperature of 2 – 8 °C (in a refrigerator). The user can store GlucaGen ® Hypokit ® at a temperature not exceeding 25 °C for 18 months provided that the expiry date is not exceeded. Store in the original package in order to protect from light. Avoid freezing to prevent damage to the syringe. If, in rare cases, the reconstituted product shows any signs of fibril formation (viscous appearance) or insoluble matter, it should be discarded. Do not use after the expiry date stated on the label. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).