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DILUENT FOR GLUCAGEN 1MG (WATER FOR INJECTIONS 1ML)

Active substance(s): WATER FOR INJECTIONS

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Regulatory Operations
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Package leaflet: Information for the user

GlucaGen® HypoKit 1 mg
Powder and solvent for solution for injection
Glucagon
Read all of this leaflet carefully before you are given this injection because it
contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor. This includes any possible side effects not
listed in this leaflet. See section 4.
What is in this leaflet
1. What GlucaGen® HypoKit is and what it is used for
2. What you need to know before you use 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 medical professionals

1. What GlucaGen® HypoKit is and what it is used 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 use 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.
• 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.

4. Inject the dose under the skin or into a muscle.

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.

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.

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.

4

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.

Driving and using machines
Wait until the effects of very low blood sugar have worn off, before driving or using any tools
or machines.

4. Possible side effects

GlucaGen® HypoKit contains latex
The cap of the syringe contains latex rubber. This may cause severe allergic reactions in people
who are allergic to latex.

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.

3. How to use 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.

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.
►If you get any side effects above, talk to your doctor. This includes any possible side
effects not listed in this leaflet.

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. Without taking the needle out of the vial, gently shake the vial until
GlucaGen® has completely dissolved, and the solution is clear.

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may happen with this medicine:

1

2

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.
United Kingdom
Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

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.

3

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
- 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

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GlucaGen® HypoKit 1 mg
Powder and solvent for solution for injection
Glucagon

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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.
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 elderly 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 03/2015

GlucaGen® is a trademark owned by
Novo Nordisk A/S, Denmark
© 2015
Novo Nordisk A/S

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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