Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
GlucaGen Hypokit 1 mg
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Glucagon may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
GlucaGen HypoKit contains the active substance "glucagon". GlucaGen HypoKit is for immediate, emergency use for children and adults with diabetes who use insulin. It is used when they have passed out (become unconscious) because of very low blood sugar. This is called "severe hypoglycaemia". GlucaGen HypoKit is used when they are not able to take sugar by mouth. Glucagon is a natural hormone, which has the opposite effect of insulin in the human body. It helps the liver to change something called "glycogen" into glucose (sugar). Glucose is then released into the blood stream – this makes the blood sugar level rise. For medical professionals: See section 7. 2.
What you need to know before you take it
e GlucaGen HypoKit
Important information •
Make sure that your family members, people you work with or close friends know about GlucaGen HypoKit. Tell them that if you pass out (become unconscious) they should use GlucaGen HypoKit straight away.
•
Show your family members and others where you keep this kit and how to use it. They must act quickly – if you are unconscious for a period of time it may be harmful. It is important they are trained and know how to use GlucaGen HypoKit before you need it.
1
•
The syringe does not contain GlucaGen. The water in the syringe must be mixed with the compacted GlucaGen powder in the vial before the injection. Tell your family members and others to follow the instructions in section 3: How to use GlucaGen HypoKit.
•
Any mixed GlucaGen that is not used must be thrown away.
•
After using GlucaGen HypoKit, you or someone else must contact your doctor or a healthcare provider. You need to find out why you had very low blood sugar and how to avoid it happening again.
Do not use GlucaGen HypoKit if: • •
you are allergic to glucagon or any of the other ingredients of this medicine (listed in section 6). you have a tumour in your adrenal gland.
If any of these apply, do not use GlucaGen HypoKit. Warnings and precautions Talk to your doctor, pharmacist or nurse before you use GlucaGen HypoKit. GlucaGen will not work properly if: • you have been fasting for a long time • you have low levels of adrenaline • you have low blood sugar caused by drinking too much alcohol • you have a tumour that releases glucagon or insulin If any of these apply, talk to your doctor or pharmacist. Other medicines and GlucaGen The following medicines can affect the way GlucaGen HypoKit works: • insulin – used to treat diabetes • indomethacin – used to treat joint pain and stiffness The following medicines may be affected by GlucaGen HypoKit: • warfarin – used to prevent blood clots. GlucaGen may increase the blood-thinning effect of warfarin. • beta-blockers – used to treat high blood pressure and irregular heart beat. GlucaGen HypoKit may increase blood pressure and pulse, this will only last a short time. If any of the above apply to you (or you are not sure), talk to your doctor or pharmacist before having GlucaGen Hypokit. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Pregnancy and breast-feeding If you experience very low blood sugar, when you are pregnant or breast-feeding, think you might be pregnant or are planning to have a baby, you can use GlucaGen HypoKit. Ask your doctor or pharmacist for advice before taking any medicine, if you are pregnant. Driving and using machines
2
Wait until the effects of very low blood sugar have worn off, before driving or using any tools or machines. GlucaGen contains sodium GlucaGen contains less than 1mmol sodium (23mg) per maximum dose (2 ml), that is to say essentially 'sodium-free'. 3.
How to take it
GlucaGen HypoKit
Always use this medicine exactly as described in this leaflet or as your doctor has told you. Check with your doctor or pharmacist if you are not sure. Preparing and giving the injection
1.
Remove the plastic cap from the vial. Pull the needle cover off the syringe. Do not remove the plastic back-stop from the syringe. Insert the needle through the rubber stopper (within the marked circle) of the vial containing GlucaGen and inject all the liquid from the syringe into the vial. 2
2.
Without taking the needle out of the vial, gently shake the vial until GlucaGen has completely dissolved, and the solution is clear. 3
3. • •
Make sure the plunger is completely down. While keeping the needle in the liquid, slowly withdraw all the solution back into the syringe. Do not pull the plunger out of the syringe. It is important to remove any air bubbles from the syringe: With the needle pointing upwards, tap the syringe with your finger Push the plunger slightly to release any air that has collected at the top of the syringe. Continue to push the plunger until you have the correct dose for injection. A small amount of liquid will be pushed out when you do this. See How much to use, below. 4
4.
Inject the dose under the skin or into a muscle. 3
5.
Turn the unconscious person on their side to prevent choking.
6.
Give the person a high sugar snack like sweets, biscuits or fruit juice as soon as he or she regains consciousness and is able to swallow. The high sugar snack will stop the low blood sugar happening again.
After using GlucaGen HypoKit, you or someone else must contact your doctor or a healthcare provider. You need to find out why you had very low blood sugar and how to avoid it happening again. How much to use The recommended dose is: • Adults: inject all of the medicine (1 ml) – this is marked as "1" on the syringe. • Children younger than 8 years or children older than 8 years who weigh less than 25 kg: inject half of the medicine (0.5 ml) – this is marked as "0.5" on the syringe. • Children older than 8 years or children younger than 8 years who weigh more than 25 kg: inject all of the medicine (1 ml) – this is marked as "1" on the syringe. If you are given more GlucaGen than you should Too much GlucaGen may lead to nausea and cause you to be sick (vomit). Specific treatment is not usually necessary. 4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. The following side effects may happen with this medicine: Tell your doctor immediately if you notice any of the following serious side effects: Very rare: may affect up to 1 in 10,000 people • allergic reaction – the signs may include wheezing, sweating, rapid heart beat, rash, swollen face and collapse. ► Talk to a doctor immediately, if you notice any of the above serious side effects. Other side effects Common: may affect up to 1 in 10 people • feeling sick (nausea). Uncommon: may affect up to 1 in 100 people • being sick (vomiting). Rare: may affect up to 1 in 1,000 people • stomach (abdominal) pain. Not known: frequency cannot be estimated from the available data
- injection site reactions. ► If you get any side effects above, talk to your doctor. This includes any possible side effects not listed in this leaflet. Reporting of side effects If you get any side effects, talk to your doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.
4
United Kingdom Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store 5.
How to store it
GlucaGen HypoKit
• •
Keep this medicine out of the sight and reach of children Store either:
- in a refrigerator (2°C to 8°C), or
- out of a refrigerator below 25°C for up to 18 months within the shelf life period. Store in the original package to protect it from light Do not freeze, to prevent damage to the product Use immediately after mixing – do not store for later use Do not use this medicine after the expiry date – this is on the label. The expiry date refers to the last date of that month. Do not use if the mixed solution looks like a gel or if any of the powder has not dissolved properly. Do not use if the plastic cap is loose or missing when you receive the product – return the product to your local pharmacy. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
• • • • • • •
6.
Contents of the pack and other information
What GlucaGen contains • •
The active substance is glucagon 1 mg as hydrochloride, produced in yeast by recombinant DNA. The other ingredients are lactose monohydrate, water for injections, hydrochloric acid and/or sodium hydroxide (for pH adjustment).
What GlucaGen looks like and contents of the pack GlucaGen is supplied as a sterile white powder of glucagon in a vial, with a solvent in a disposable syringe. The powder is compacted. Once mixed, the solution contains glucagon 1 mg/ml. Marketing authorisation holder and manufacturer Novo Nordisk A/S Novo Allé DK-2880 Bagsværd, Denmark 7.
Additional information for medical professionals
Medical professionals should refer to all sections above before reading this additional information. Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution and must not be given as an intravenous infusion. Do not attempt to put the cap back on the needle of the used syringe. Place the used syringe in the orange box and dispose the used needle in a sharps container at the next available opportunity.
5
Treatment of severe hypoglycaemia Administer by subcutaneous or intramuscular 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. Diagnostic procedures Oral carbohydrates should be given when the procedure has ended, if this is compatible with the diagnostic procedure concerned. Remember that GlucaGen has the opposite effect of insulin. With endoscopy or radiography procedures, take extra care in administering GlucaGen to patients with diabetes or to people with a heart condition. Note that a syringe with a thinner needle and a finer graduation may be more suitable for use in diagnostic procedures. Examination of the gastrointestinal tract: Doses vary from 0.2 – 2 mg depending on the diagnostic technique used and the route of administration. The diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2 – 0.5 mg given intravenously or 1 mg given intramuscularly. The dose to relax the colon is 0.5 – 0.75 mg intravenously or 1 – 2 mg intramuscularly. The onset of effect after an intravenous injection of 0.2 – 0.5 mg occurs within one minute and the duration of the effect is between 5 – 20 minutes. The onset of action after an intramuscular injection of 1 – 2 mg occurs after 5 – 15 minutes and lasts approximately 10 – 40 minutes. Additional side effects after use in diagnostic procedures Blood pressure changes, rapid heartbeat, hypoglycaemia and hypoglycaemic coma. This leaflet was last revised in 11/2022 GlucaGen® is a trademark owned by Novo Nordisk A/S, Denmark © 2022 Novo Nordisk A/S
6
Frequently asked questions about GlucaGen Hypokit 1 mg
What is the active substance in GlucaGen Hypokit 1 mg?
The active substance in GlucaGen Hypokit 1 mg is glucagon.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for GlucaGen Hypokit 1 mg, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get GlucaGen Hypokit 1 mg without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: glucagon
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Therapeutic indication
GlucaGen is indicated for treatment of severe hypoglycaemic reactions, which may occur in the management of insulin treated children and adults with diabetes mellitus.
Diagnostic indication
GlucaGen is indicated for motility inhibition in examinations of the gastrointestinal tract in adults.
4.2. Posology and method of administration
Posology
• Therapeutic indication (Severe hypoglycaemia)
Dosage for adult patients: Administer 1 mg by subcutaneous or intramuscular injection.
Special populations
Paediatric population (<18 years old): GlucaGen can be used for the treatment of severe hypoglycaemia in children and adolescents.
Dosage for paediatric patients: Administer 0.5 mg (children below 25 kg or younger than 6–8 years) or 1 mg (children above 25 kg or older than 6–8 years).
Elderly (≥ 65 years old): GlucaGen can be used in elderly patients.
Renal and hepatic impairment: GlucaGen can be used in patients with renal and hepatic impairment.
• Diagnostic indication (Inhibition of gastrointestinal motility)
Dosage for adult patients: The diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum and small bowel is 0.2–0.5 mg given as intravenous injection or 1 mg given intramuscularly; the dose to relax the colon is 0.5–0.75 mg intravenously or 1–2 mg intramuscularly.
Special populations
Paediatric population (<18 years old): The safety and efficacy of GlucaGen for inhibition of gastrointestinal motility in children and adolescents have not been established. No data are available.
Elderly (≥ 65 years old): GlucaGen can be used in elderly patients.
Renal and hepatic impairment: GlucaGen can be used in patients with renal and hepatic impairment.
Method of administration
Dissolve the compacted powder in the accompanying solvent, as described in section 6.6.
Therapeutic indication (Severe hypoglycaemia):
Administer by subcutaneous or intramuscular injection. The patient will normally respond within 10 minutes. When the patient has responded to the treatment, give oral carbohydrate to restore the liver glycogen and prevent relapse of hypoglycaemia. If the patient does not respond within 10 minutes, intravenous glucose should be given.
Diagnostic indication (Inhibition of gastrointestinal motility):
GlucaGen must be administered by medical personnel. Onset of action after an intravenous injection of 0.2–0.5 mg occurs within one minute and the duration of effect is between 5 and 20 minutes. The onset of action after an intramuscular injection of 1–2 mg occurs after 5–15 minutes and lasts approximately 10–40 minutes.
After end of the diagnostic procedure oral carbohydrate should be given, if this is compatible with the diagnostic procedure applied.
4.3. Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Phaeocromocytoma.
4.4. Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Due to the instability of GlucaGen in solution, the product should be given immediately after reconstitution and must not be given as an intravenous infusion.
Therapeutic indication
To prevent relapse of the hypoglycaemia, oral carbohydrates should be given to restore the liver glycogen, when the patient has responded to the treatment.
Glucagon will not be effective in patients whose liver glycogen is depleted. For that reason, glucagon has little or no effect when the patient has been fasting for a prolonged period, or is suffering from adrenal insufficiency, chronic hypoglycaemia or alcohol induced hypoglycaemia.
Glucagon, unlike adrenaline, has no effect upon muscle phosphorylase and therefore cannot assist in the transference of carbohydrate from the much larger stores of glycogen that are present in the skeletal muscle.
Diagnostic indication
Persons who have been given glucagon in connection with diagnostic procedures may experience discomfort, in particular if they have been fasting. Nausea, hypoglycaemia, and blood pressure changes have been reported in these situations. After the end of a diagnostic procedure, oral carbohydrates should be given to patients who have been fasting, if this is compatible with the diagnostic procedure applied. If fasting is needed post-examination or in case of severe hypoglycaemia, glucose given intravenously may be required.
GlucaGen may increase myocardial oxygen demand, blood pressure, and pulse rate. Monitor patients with cardiac disease during use of GlucaGen as a diagnostic aid and treat if indicated.
GlucaGen may cause short term hyperglycaemia in patients with diabetes mellitus when used as a diagnostic aid. Monitor patients with diabetes for changes in blood glucose levels during use and treat if indicated.
Caution should be observed in patients with glucagonoma when used as diagnotic aid.
Therapeutic and diagnostic indications
Glucagon reacts antagonistically towards insulin and caution should be observed if GlucaGen is used in patients with insulinoma.
Glucagon stimulates the release of catecholamines. In the presence of phaeocromocytoma, glucagon can cause the tumour to release large amounts of catecholamines, which will cause an acute hypertensive reaction. Glucagon is contraindicated in patients with phaeochromocytoma (see section 4.3).
Excipients
GlucaGen contains less than 1mmol sodium (23mg) per maximum dose (2 ml), that is to say essentially 'sodium-free'.
4.5. Interaction with other medicinal products and other forms of interaction
Insulin: Reacts antagonistically towards glucagon.
Indomethacin: Glucagon may lose its ability to raise blood glucose or paradoxically may even produce hypoglycaemia.
Warfarin: Glucagon may increase the anticoagulant effect of warfarin.
Beta-blockers: Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of glucagon's short half-life. The increase in blood pressure and pulse rate may require therapy in patients with coronary artery disease.
Interactions between GlucaGen and other drugs are not known when GlucaGen is used in the approved indications.
4.6. Fertility, pregnancy and lactation
Pregnancy
Glucagon does not cross the human placenta barrier. The use of glucagon has been reported in pregnant women with diabetes and no harmful effects are known with respect to the course of pregnancy and the health of the unborn and the neonate. GlucaGen can be used during pregnancy.
Breast-feeding
Glucagon is cleared from the bloodstream very fast (mainly by the liver) (t1/2= 3–6 min.); thus the amount excreted in the milk of nursing mothers following treatment of severe hypoglycaemic reactions is expected to be extremely small. As glucagon is degraded in the digestive tract and cannot be absorbed in its intact form, it will not exert any metabolic effect in the child. GlucaGen can be used during breast-feeding.
Fertility
Animal reproduction studies have not been conducted with GlucaGen. Studies in rats have shown that glucagon does not cause impaired fertility.
4.7. Effects on ability to drive and use machines
After a severe hypoglycaemic event, the patient's ability to concentrate and react may be impaired. Therefore the patient should not drive or operate machinery after a severe hypoglycaemic event until the patient has stabilised.
After diagnostic procedures hypoglycaemia has been reported infrequently. Therefore driving a vehicle and operating machinery should be avoided until the patient has had a meal with oral carbohydrates.
4.8. Undesirable effects
Summary of the safety profile
Severe adverse reactions are very rare, although nausea, vomiting and abdominal pain may occur occasionally. Hypersensitivity reactions, including anaphylactic reactions, have been reported as 'very rare' (less than 1 case per 10,000 patients). When used in the diagnostic indication, hypoglycaemia/hypoglycaemic coma have been reported, especially in patients who have fasted. Cardiovascular adverse events, such as tachycardia and blood pressure changes have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.
Tabulated summary of adverse reactions
Frequencies of undesirable effects considered related to treatment with GlucaGen during clinical trials and/or post-marketing surveillance are presented below. Undesirable effects which have not been observed in clinical trials, but have been reported spontaneously, are presented as 'very rare'. During marketed use reporting of adverse drug reactions is very rare (< 1/10,000). However, post-marketing experience is subject to under-reporting and this reporting rate should be interpreted in that light.
Therapeutic indication
System Organ Class
Subject incidence
Adverse drug reaction
Immune system disorders
Very rare < 1/10,000
Hypersensitivity reactions including anaphylactic reaction/shock
Gastrointestinal disorders
Common ≥ 1/100 to < 1/10
Uncommon ≥ 1/1,000 to < 1/100
Rare ≥ 1/10,000 to < 1/1,000
Nausea
Vomiting
Abdominal pain
General disorders and administration site conditions
Not known (cannot be estimated from the available data)
Injection site reactions
Paediatric population
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in children are expected to be the same as in adults.
Other special populations
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.
Diagnostic indication
System Organ Class
Subject incidence
Adverse drug reaction
Immune system disorders
Very rare < 1/10,000
Hypersensitivity reactions including anaphylactic reaction/shock
Metabolism and nutrition disorders
Uncommon ≥ 1/1,000 to < 1/100
Very rare < 1/10,000
Hypoglycaemia*1
Hypoglycaemic coma
Cardiac disorders
Very rare < 1/10,000
Tachycardia*2
Vascular disorders
Very rare < 1/10,000
Very rare < 1/10,000
Hypotension*2
Hypertension*2
Gastrointestinal disorders
Common ≥ 1/100 to < 1/10
Uncommon ≥ 1/1,000 to < 1/100
Rare ≥ 1/10,000 to < 1/1,000
Nausea
Vomiting
Abdominal pain
General disorders and administration site conditions
Not known (cannot be estimated from the available data)
Injection site reactions
*1 After a diagnostic procedure this could be more pronounced in patients that have fasted (see section 4.4).
*2 Cardiovascular adverse events have only been reported when GlucaGen is used as an adjunct in endoscopic or radiographic procedures.
Paediatric population
There are no data available on the diagnostic use of GlucaGen in children.
Other special populations
Based on data from clinical trials and post-marketing experience, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with renal or hepatic impairment are expected to be the same as in the general population.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
4.9. Overdose
In the case of overdose, the patient may experience nausea and vomiting. Due to the short half life of glucagon, these symptoms will be transient.
In case of dosages substantially above the approved range, the serum potassium may decrease and should be monitored and corrected, if needed.
🇷🇴 Known in Romania as
Medicines sold in Romania with the same active substance: Cunoscut în România ca
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- BAQSIMI 3 mg prescriptionGLUCAGONUM · eye / ear / nose
- GLUCAGEN HYPOKIT 1 mg prescriptionGLUCAGONUM · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Romanian medicines in the UK →
🇵🇱 Known in Poland as
Medicines sold in Poland with the same active substance: W Polsce znany jako
⚠ Same active substance, but a different pharmaceutical form (for example a gel instead of a tablet). Not interchangeable — ask a pharmacist.
- GlucaGen 1 mg HypoKitGlucagoni hydrochloridum · injection / infusion
- BaqsimiGlucagonum · eye / ear / nose
- OgluoGlucagonum · injection / infusion
Same active substance. The strength, the form and whether you need a prescription can differ. Always ask a pharmacist before you switch. Polish medicines in the UK →
💬 Ask about this leaflet
Ask anything about GlucaGen Hypokit 1 mg. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.