Glucagen

Patient Information Leaflet: Information for the User

GlucaGen 1 mg

Powder and solvent for injectable solution
glucagon
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

1. What GlucaGen is and what it is used for
2. What you need to know before using GlucaGen
3. How to use GlucaGen
4. Possible side effects
5. How to store GlucaGen
6. Contents of the pack and other information
7. Additional information for medical personnel

1. What GlucaGen is and what it is used for

GlucaGen contains the active substance "glucagon".
GlucaGen is used for the immediate and emergency treatment of children and adults with diabetes who are
using insulin. It is used when they lose consciousness (are unconscious) due to very low blood sugar levels.
This is called "severe hypoglycaemia". GlucaGen is used when the person is unable to take sugar orally.
Glucagon is a natural hormone that has the opposite effect of insulin in the human body. It helps the liver convert
glycogen into glucose (sugar). The glucose is then released into the bloodstream – resulting in an increase in
blood sugar levels.
For medical personnel: see section 7.

2. What you need to know before using GlucaGen

Important information

• Make sure all your family members, coworkers, or close friends are informed about GlucaGen. Explain that if you should faint (lose consciousness), they must use GlucaGen immediately.

• Show your family members and those close to you where you keep GlucaGen and how to use it. They must act quickly—remaining unconscious for a period of time can be dangerous.
  It is important that they receive instructions and know how to use GlucaGen before you need it.

• Before injection, mix GlucaGen powder with the solvent. Inform your family members and those close to you to follow the instructions provided in section 3: How to use GlucaGen.

• Any mixed GlucaGen that is not used must be discarded.

• After using GlucaGen, you or someone else must contact your doctor or a healthcare professional. It is important that you understand why your blood sugar became very low and how to prevent it from happening again.

Do not use GlucaGen if:

• you are allergic to glucagon or to any of the other ingredients of this medicine (listed in section 6)
• you have a tumor of the adrenal gland.

Do not use GlucaGen if any of these situations apply to you.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GlucaGen.
GlucaGen may not work properly if:

• you have been fasting for a prolonged period
• you have low levels of adrenaline
• your low blood sugar is caused by excessive alcohol consumption
• you have a tumor that releases glucagon or insulin. If any of these apply, speak with your doctor or pharmacist.

Other medicines and GlucaGen
The following medicines may affect how GlucaGen works:

• insulin – used to treat diabetes
• indomethacin – used to treat joint pain and rheumatism. The following medicines may be affected by GlucaGen:
• warfarin – used to prevent blood clots. GlucaGen may increase the anticoagulant effect of warfarin.
• beta-blockers – used to treat high blood pressure and irregular heartbeat. GlucaGen may temporarily increase blood pressure and heart rate.

If any of the above situations apply (or if you are unsure), speak with your doctor or pharmacist before taking GlucaGen.
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, and experience very low blood sugar, GlucaGen may be used.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.

Driving and using machines
Before driving or operating machinery, wait until the effects of low blood sugar have passed.

GlucaGen contains sodium
GlucaGen contains less than 1 mmol of sodium (23 mg) per maximum dose (2 ml), which is essentially “sodium-free”.

3. How to use GlucaGen

Use this medicine exactly as described in this leaflet or as instructed by your
doctor. If you have any doubts, consult your doctor or pharmacist.
Preparation and administration of the injection

1. Remove both plastic protective caps from the vials. Draw all the water into a single-use syringe. Insert the needle through the rubber stopper (within the marked circle) of the vial containing GlucaGen and inject all the solvent from the syringe into the vial.

2. Without removing the needle from the vial, gently shake the vial until GlucaGen is completely dissolved and the solution appears clear.

3. Ensure the syringe plunger is fully pushed forward. While keeping the needle in the liquid, slowly draw all the solution into the syringe. Be careful not to let the plunger come out of the syringe. It is important to remove any air bubbles from the syringe:
   • With the needle pointing upwards, tap the syringe gently with your fingers.
   • Slightly press the plunger to expel the air collected at the top of the syringe. Continue pushing the plunger until it reaches the correct dose for injection. A small amount of liquid will come out.

See Dosage.

4. Inject the dose under the skin or into the muscle.
5. Turn the unconscious person onto their side to prevent choking.
6. As soon as the person regains consciousness and if able to swallow, give them a high-sugar snack such as sweets, biscuits, or fruit juice. A high-sugar snack will help prevent another episode of low blood sugar.

After using GlucaGen, you or someone else must contact a doctor or healthcare professional.
It is important that you understand why your blood sugar became very low and how to prevent
it from happening again.
Dosage
The recommended dose is:

• Adults: inject the entire contents of the medicine (1 ml).
• Children under 8 years of age or over 8 years of age but weighing less than 25 kg: inject half of the medicine (0.5 ml).
• Children over 8 years of age or under 8 years of age but weighing 25 kg or more: inject the entire contents of the medicine (1 ml).

If you use more GlucaGen than you should
Too much GlucaGen may cause nausea and prolonged vomiting.
Usually, no specific treatment is required.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following side effects may occur 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 – signs may include shortness of breath, sweating, rapid heartbeat, rash, facial swelling, and collapse. ► Speak to your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Common: may affect up to 1 in 10 people

• Feeling unwell (nausea).

Uncommon: may affect up to 1 in 100 people

• Feeling unwell (vomiting).

Rare: may affect up to 1 in 1,000 people

• Stomach ache (abdominal pain).

Not known: frequency cannot be estimated from the available data

• reactions at the injection site

► If you experience any of the side effects listed above, including those not listed in this leaflet, contact your doctor.
Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor. You can also report side effects directly via the national adverse reaction reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GlucaGen

• Keep this medicine out of the sight and reach of children.
• Store in a refrigerator (2°C to 8°C).
• Keep in the original packaging to protect from light.
• Do not freeze, to prevent damage to the product.
• Use immediately after reconstitution – do not store for later use.
• Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month indicated.
• Do not use the reconstituted solution if it appears gelatinous or if any of the powder has not dissolved properly.
• Do not use if the plastic caps are loose or missing when you receive the package – return the package to the pharmacy.
• Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What GlucaGen contains

• The active substance is glucagon 1 mg as hydrochloride, produced in yeast by recombinant DNA technology.
• The other ingredients are monohydrate lactose, water for injections, hydrochloric acid and/or sodium hydroxide (for pH adjustment).

Description of the appearance of GlucaGen and contents of the pack
GlucaGen is supplied as a sterile white glucagon powder in a vial, accompanied by solvent contained in another vial. The powder is compact. Once mixed, the solution contains glucagon 1 mg/ml.
It is available in packs of 1 x 1 mg and 10 x 1 mg. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark

This medicinal product is authorized in the European Economic Area Member States and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland): GlucaGen
Norway and Sweden: Glucagon Novo Nordisk

7. Additional information for medical personnel

Medical personnel must review all previous sections before reading this additional information.
The medicinal product must be administered immediately after reconstitution due to
the instability of GlucaGen in solution, and must not be administered by intravenous infusion.
Treatment of severe hypoglycemia
Administer by subcutaneous or intramuscular route. If the patient does not respond within 10 minutes,
intravenous glucose must be administered. Once the patient has responded to treatment, oral carbohydrates
should be given to restore hepatic glycogen stores and prevent recurrence of hypoglycemia.
Diagnostic indications
After completion of the procedure, oral carbohydrates should be administered, provided this is compatible
with the diagnostic procedure used. Remember that GlucaGen has an effect opposite to that of insulin. When
performing endoscopic or radiological investigations, particular caution should be exercised when
administering GlucaGen to diabetic patients or to individuals with cardiac problems.
Examination of the gastrointestinal tract:
Dosages range from 0.2 – 2 mg, depending on the diagnostic technique and route of administration.
The dose used in diagnostic examinations to inhibit motility of the stomach, duodenal bulb, duodenum, and
small intestine is 0.2 – 0.5 mg intravenously or 1 mg intramuscularly. The dose to inhibit colonic motility is
0.5 – 0.75 mg intravenously or 1–2 mg intramuscularly. Onset of effect after intravenous administration of
0.2 – 0.5 mg occurs within one minute, and duration of effect lasts between 5 and 20 minutes. Onset of effect
after intramuscular administration of 1 – 2 mg occurs after 5 – 15 minutes and lasts approximately 10 – 40 minutes.
Additional adverse effects following use in diagnostic indications
Blood pressure changes, tachycardia, hypoglycemia, and hypoglycemic coma.
This summary of product characteristics has been updated (MM/YYYY)
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco)

Package leaflet: Information for the user

GlucaGen HypoKit 1 mg
Powder and solvent for injectable solution
glucagon
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Never give it to others, even if they have the same symptoms as yours, because it could be dangerous.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor. See section 4.

Contents of this leaflet:

1. What GlucaGen HypoKit is and what it is used for
2. What you need to know before using GlucaGen HypoKit
3. How to use GlucaGen HypoKit
4. Possible side effects
5. How to store GlucaGen HypoKit
6. Contents of the pack and other information
7. Additional information for healthcare professionals

1. What GlucaGen HypoKit is and what it is used for

GlucaGen contains the active substance "glucagon".
GlucaGen HypoKit is used for the immediate, emergency treatment of children and adults with diabetes who use insulin. It is used when they lose consciousness (are unconscious) due to very low blood sugar levels. This is called "severe hypoglycaemia". GlucaGen HypoKit is used when the person is no longer able to take sugar orally.
Glucagon is a natural hormone that has the opposite effect of insulin in the human body. It helps the liver convert glycogen into glucose (sugar). The glucose is then released into the bloodstream – resulting in an increase in blood sugar levels.
For medical personnel: see paragraph 7.

2. What you need to know before using GlucaGen HypoKit

Important information

• Make sure your family members, coworkers, and close friends are informed about GlucaGen HypoKit. Explain that if you faint (lose consciousness), they must use GlucaGen HypoKit immediately.
• Show your family and close contacts where you keep GlucaGen HypoKit and how to use it.
• They must act quickly – remaining unconscious for a period of time can be dangerous. It is important that they receive instructions and know how to use GlucaGen HypoKit before you need it.
  • The syringe does not contain GlucaGen. Before injection, always mix the GlucaGen powder with the solvent contained in the syringe. Inform your family and close contacts to follow the instructions provided in section 3: How to use GlucaGen HypoKit.
  • Any mixed GlucaGen that is not used must be discarded.
  • After using GlucaGen HypoKit, you or someone else must contact a doctor or healthcare provider. It is important to understand why your blood sugar became very low and how to prevent it from happening again.

Do not use GlucaGen HypoKit if:

• you are allergic (hypersensitive) to glucagon or to any of the other ingredients of this medicine (listed in section 6).
• you have a tumour of the adrenal gland.

Do not use GlucaGen HypoKit if any of these situations apply.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using GlucaGen HypoKit.
GlucaGen may not work properly if:

• you have been fasting for a long time
• you have low levels of adrenaline
• your low blood sugar is caused by excessive alcohol intake
• you have a tumour that releases glucagon or insulin.

If any of these apply, speak with your doctor or pharmacist.
Other medicines and GlucaGen
The following medicines may affect how GlucaGen HypoKit works:

• insulin – used to treat diabetes
• indomethacin – used to treat joint pain and rheumatism.

The following medicines may be affected by GlucaGen HypoKit:

• warfarin – used to prevent blood clots. GlucaGen may increase the anticoagulant effect of warfarin.
• beta-blockers – used to treat high blood pressure and irregular heartbeat. GlucaGen HypoKit may temporarily increase blood pressure and heart rate.

If any of the above situations apply (or if you are unsure), talk to your doctor or pharmacist before taking GlucaGen HypoKit.
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, GlucaGen HypoKit may be used if you experience very low blood sugar.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant.
Driving and using machines
Before driving or operating machinery, wait until the effects of low blood sugar have passed.
GlucaGen contains sodium
GlucaGen contains less than 1 mmol of sodium (23 mg) per maximum dose (2 ml), which is essentially “sodium-free”.

3. How to use GlucaGen HypoKit

Use this medicine exactly as described in this leaflet or as instructed by your
physician. If you have any doubts, consult your doctor or pharmacist.
Preparation and administration of the injection

1. Remove the plastic protective caps from the vials. Remove the needle cap from the syringe. Do not remove the plastic support from the syringe. Insert the needle into the rubber stopper (within the marked circle) of the vial containing GlucaGen and inject all the liquid from the syringe into the vial.

2. Without removing the needle from the vial, gently shake the vial until GlucaGen is completely dissolved and the solution appears clear.

3. Make sure the plunger of the syringe is fully pushed forward. Keeping the needle in the liquid, slowly draw all the solution into the syringe. Be careful not to let the plunger come out of the syringe. It is important to remove any air bubbles from the syringe:
   • With the needle pointing upwards, tap the syringe gently with your fingers.
   • Slightly press the plunger to expel the air collected at the top of the syringe.

Continue pushing the plunger until the correct dose for injection is reached. A small amount of liquid will come out.
See below Dosage.

4. Inject the dose under the skin or into the muscle.
5. Turn the unconscious person onto their side to prevent choking.
6. As soon as the person regains consciousness and if able to swallow, give them a high-sugar snack such as sweets, biscuits, or fruit juice. A high-sugar snack will help prevent another episode of low blood sugar.

After using GlucaGen HypoKit, you or someone else must contact your doctor or a healthcare professional. It is important to understand why you had a very low blood sugar level and how to prevent it from happening again.
Dosage
The recommended dose is:

• Adults: inject the entire contents of the medicine (1 ml)
• Children under 8 years of age or over 8 years of age but weighing less than 25 kg: inject half the contents of the medicine (0.5 ml)
• Children over 8 years of age or under 8 years of age but weighing 25 kg or more: inject the entire contents of the medicine (1 ml) – marked as “1” on the syringe

If you use more GlucaGen than you should
Too much GlucaGen may cause nausea and prolonged vomiting. Usually, no specific treatment is required.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. The following side effects may occur with this medicine:
Consult your doctor immediately if you notice any of the following serious side effects:
Very rare: (may occur in up to 1 in 10,000 people)

• Allergic reaction – signs may include shortness of breath, sweating, rapid heartbeat, rash, facial swelling, and collapse. ► Speak to your doctor immediately if you notice any of the serious side effects listed above.

Other side effects
Common: (may occur in up to 1 in 10 people)

• Feeling unwell (nausea).

Uncommon: (may occur in up to 1 in 100 people)

• Feeling unwell (vomiting).

Rare: (may occur in up to 1 in 1,000 people)

• Stomach ache (abdominal pain).

Not known: frequency cannot be estimated from the available data

• reactions at the injection site. ► If any of the side effects listed above occur, including those not listed in this leaflet, consult your doctor.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, consult your doctor. You can also report side effects directly through the national adverse reaction reporting system. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store GlucaGen HypoKit

• Keep this medicine out of the sight and reach of children.
• Store either: in a refrigerator (2°C to 8°C), or outside the refrigerator below 25°C for up to 18 months within the expiry date.
• Keep in the original packaging to protect from light.
• Do not freeze, to prevent product damage.
• Use immediately after reconstitution – do not store for later use.
• Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month indicated.
• Do not use the reconstituted solution if it appears gelatinous or if any of the powder has not dissolved properly.
• Do not use if the plastic caps are loose or missing when you receive the product – return the product to the pharmacy.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What GlucaGen Contains

• The active substance is glucagon 1 mg as hydrochloride, produced in yeast by recombinant DNA technology.
• The other ingredients are monohydrate lactose, water for injections, hydrochloric acid and/or sodium hydroxide (for pH adjustment).

Description of the Appearance of GlucaGen and Package Contents
GlucaGen is supplied as a sterile white glucagon powder in a vial, accompanied by a solvent contained in a single-use syringe. The powder is compact. After mixing, the solution contains glucagon 1 mg/ml.
Marketing Authorization Holder and Manufacturer
Novo Nordisk A/S
Novo Allé
DK-2880 Bagsværd, Denmark
This medicine is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Portugal, Slovakia, Slovenia, Spain, United Kingdom (Northern Ireland): GlucaGen
Norway and Sweden: Glucagon Novo Nordisk

7. Additional Information for Healthcare Professionals

Healthcare professionals must review all previous sections before reading this additional information.
The medicine must be administered immediately after reconstitution due to the instability
of GlucaGen in solution and must not be administered by intravenous infusion.
Do not attempt to recap the needle of the used syringe. Place the used syringe into the
orange box and dispose of the used needle in a sharps container as soon as possible.
Treatment of severe hypoglycemia
Administer by subcutaneous or intramuscular injection. If the patient does not respond within 10 minutes,
intravenous glucose must be administered. When the patient has responded to treatment, oral carbohydrates
should be given to restore hepatic glycogen stores and prevent recurrence of hypoglycemia.
Diagnostic indications
After completion of the procedure, oral carbohydrates should be administered, if compatible with the
diagnostic procedure used. Remember that GlucaGen has an effect opposite to that of insulin. When performing
endoscopic or radiological investigations, particular caution should be exercised when GlucaGen is administered
to diabetic patients or to patients with cardiac disorders.
Note that a syringe with a thinner needle and finer graduations may be more suitable for use in diagnostic
indications.
Examination of the gastrointestinal tract:
Doses range between 0.2 – 2 mg depending on the diagnostic technique and route of administration.
The dose used in diagnostic procedures to inhibit motility of the stomach, duodenal bulb, duodenum, and
small intestine is 0.2 – 0.5 mg intravenously or 1 mg intramuscularly. The dose to inhibit colonic motility is
0.5 – 0.75 mg intravenously or 1–2 mg intramuscularly. Onset of effect after intravenous administration of
0.2 – 0.5 mg occurs within one minute, with a duration of effect of 5 – 20 minutes. Onset of effect after
intramuscular administration of 1 – 2 mg occurs after 5 – 15 minutes and lasts approximately 10 – 40 minutes.
Additional adverse reactions following use in diagnostic indications.
Blood pressure changes, tachycardia, hypoglycemia, and hypoglycemic coma.
This leaflet was last updated MM/YYYY
Other sources of information
More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia Italiana del Farmaco)