1 mg of powder and solvent for injection, solution
Glucagon

Read all of this leaflet carefully before you may need to inject this medicine. It contains information that is important to you.

  • Save this information, 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 give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects , talk to your doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about:
1. What Glucagon Novo Nordisk is and what it is used for
2. What you need to know before you use Glucagon Novo Nordisk
3. How to use Glucagon Novo Nordisk
4. Possible side effects
5. How Glucagon Novo Nordisk to be stored
6. Contents of the packaging and other information

1. What Glucagon Novo Nordisk is and what it is used for

Glucagon Novo Nordisk contains the active substance glucagon.

Glucagon Novo Nordisk is intended for immediate use in acute cases in children and adults with diabetes using insulin. It is used for unconsciousness due to very low blood sugar. This is called “severe hypoglycaemia”. Glucagon Novo Nordisk is used when the person cannot ingest sugar by mouth.

Glucagon is a natural hormone, which has the opposite effect to insulin in the body. It helps the liver convert a substance called “glycogen” into glucose (sugar). Glucose is then released into the bloodstream – this raises blood sugar levels.

For doctors / nurses: See section 7.

2. What you need to know before using Glucagon Novo Nordisk

Important information

  • Make sure your family members, co-workers or close friends know about Glucagon Novo Nordisk. Tell them that if you become unconscious, they should use Glucagon Novo Nordisk immediately.
  • Show your family members and others where to store Glucagon Novo Nordisk and how to use it. They need to act fast – if you are unconscious for a while it can be harmful. It is important that they have received instructions and know how to use Glucagon Novo Nordisk before you need it.
  • Prepare a solution of Glucagon Novo Nordisk powder (compact powder cake) and diluent before injection . Tell your family members and others to follow the instructions in section 3: How to use Glucagon Novo Nordisk.
  • Any unused solution of Glucagon Novo Nordisk must be discarded.
  • After receiving Glucagon Novo Nordisk, you or someone else must contact your doctor or healthcare professional. You need to know the reason for your very low blood sugar and how you can prevent it from happening again.

Do not use Glucagon Novo Nordisk if:

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

If any of these apply to you, do not use Glucagon Novo Nordisk.

Warnings and cautions

Talk to your doctor, pharmacist, or nurse before using Glucagon Novo Nordisk.

Glucagon Novo Nordisk does not operate as intended if:

  • you have been fasting for a long time
  • you have low levels of adrenaline
  • Your low blood sugar is due to consuming too much alcohol
  • you have a tumor that secretes glucagon or insulin

If any of these apply to you, talk to your doctor or pharmacist.

Other medicines and Glucagon Novo Nordisk

The following medicines may affect the effect of Glucagon Novo Nordisk:

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

The effect of the following medicines may be affected by Glucagon Novo Nordisk:

  • warfarin – used to treat blood clots. Glucagon Novo Nordisk may increase the blood-thinning effect of warfarin .
  • beta-receptor blockers – used to treat high blood pressure and irregular heartbeat. Glucagon Novo Nordisk can increase blood pressure and heart rate , but this only lasts a short time.

If any of these apply to you (or you are not sure ), talk to your doctor or pharmacist before taking Glucagon Novo Nordisk.

Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription.

Pregnancy and breastfeeding

If you experience very low blood sugar when you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, you can use Glucagon Novo Nordisk.

If you are pregnant, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

If you still feel the effects of severe hypoglycaemia , do not drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and / or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Glucagon Novo Nordisk contains sodium

Glucagon Novo Nordisk contains less than 1 mmol sodium (23 mg) per maximum dose (2 ml), ie essentially ‘sodium-free. is next to “sodium-free”.

3. How to use Glucagon Novo Nordisk

Always use this medicine exactly as your doctor has told you. If you are not sure, ask your doctor or pharmacist.

Preparation of solution and injection

Draw up all the water in a disposable syringe.  Insert the injection needle through the rubber membrane (within the marked circle) into the glucagon vial and inject all the water from the syringe into the vial.

1. Remove both plastic caps from the vials. Draw up all the water in a disposable syringe. Insert the injection needle through the rubber membrane (within the marked circle) into the glucagon vial and inject all the water from the syringe into the vial.

Leave the injection needle in place and shake the vial gently until all the glucagon powder has dissolved and a clear solution has been obtained.

2. Leave the injection needle in place and shake the vial gently until all the glucagon powder has dissolved and a clear solution has been obtained.

Hold the injection needle in the liquid and slowly withdraw all the solution to the syringe.

3. Check that the rubber piston is fully depressed. Hold the injection needle in the liquid and slowly withdraw all the solution to the syringe. Do not pull the rubber plunger out of the syringe. It is important to remove any air bubbles in the syringe by:

  • with the injection needle pointing upwards, tap the syringe with one finger
  • gently push in the plunger to spray the air collected at the top of the syringe.

Continue to push the plunger in until you have set the correct dose for injection. A small amount of liquid will drain out when you do this.

See How much should I use below.

Inject the dose under the skin (subcutaneously) or into muscle.

Inject dose one under the skin ( subcutaneously ) or into muscle.

5. Turn the unconscious person on their side to prevent suffocation.

Give the person something high in sugar such as sweets, biscuits, or fruit juices as soon as he or she regains consciousness and can eat. Snacks with a high sugar content prevent the blood sugar from falling again.

After receiving Glucagon Novo Nordisk, you or someone else must contact your doctor or healthcare provider. You need to know the reason for your very low blood sugar and how you can prevent it from happening again.

How much should I use?

The recommended dose is:

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

If you take more Glucagon Novo Nordisk than you should

If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, always contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. If you take too high a dose of Glucagon Novo Nordisk, it may cause severe vomiting. No special treatment is 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 occur with this medicine:

Contact a doctor immediately if you notice any of the following side effects:

Very rare: may affect up to 1 in 10,000 users

  • allergic reaction – signs of this may include wheezing, sweating, palpitations, rash, swelling of the face and collapse.
  • Contact a doctor immediately if you notice any of the side effects listed above.

Other side effects are

Common: may affect up to 1 in 10 users

  • Nausea.

Uncommon: may affect up to 1 in 100 people

  • Vomiting.

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

  • Abdominal pain.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glucagon Novo Nordisk

  • Keep this medicine out of the sight and reach of children.
  • Store in a refrigerator (2 ° C – 8 ° C).
  • Store in the original package. Sensitive to light.
  • Do not freeze to avoid damage to the product.
  • Used immediately after preparation – not saved for later use.
  • Do not use this medicine after the expiry date which is stated on the label after “EXP”. Expiration date is the last day of the specified month.
  • Do not use the reconstituted solution if it has become jelly-like or if the powder is not completely dissolved.
  • Do not use the package if the plastic caps have come loose or are missing when you receive them – return the package to the pharmacy.
  • Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

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

What the medicine looks like and contents of the pack

Glucagon Novo Nordisk consists of a sterile, white glucagon powder in a vial and diluent in a vial. The powder is in the form of a compact powder cake. The reconstituted solution contains glucagon 1 mg/ml.

Pack sizes: 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

7. Additional information for healthcare professionals

Medical personnel is referred to all previous sections before reading the additional information below.

Due to the unstable solution of Glucagon Novo Nordisk, it should be given immediately after reconstitution and should not be given as an intravenous infusion .

Treatment of severe hypoglycaemia

Administered as a subcutaneous or intramuscular injection. If the patient does not respond to treatment within 10 minutes, glucose is given intravenously. When the patient responds to the treatment, carbohydrates are given orally, to restore liver glycogen and prevent recurrence of hypoglycemia .

Use in diagnostics

When the examination is completed, carbohydrates should be given orally, if this is consistent with the current diagnostic examination. Remember that Glucagon Novo Nordisk has the opposite effect to insulin. Caution should be exercised when using Glucagon Novo Nordisk as an aid in endoscopy or radiological examination of patients with diabetes or elderly patients with heart disease.

Examination of the gastrointestinal tract:

Dosage one varies between 0.2–2 mg depending on the examination technique and route of administration. The diagnostic dose for ventricular, duodenal bulbus, duodenum and small bowel relaxation is 0.2–0.5 mg intravenously or 1 mg intramuscularly . The dose for colon relaxation is 0.5-0.75 mg intravenously or 1-2 mg intramuscularly. After an intravenous injection of 0.2-0.5 mg, the effect sets in within one minute and lasts 5-20 minutes. After an intramuscular injection of 1-2 mg, the effect sets in after 5–15 minutes and lasts approximately 10–40 minutes.

Additional side effects are when used in diagnostics

Changes in blood pressure, tachycardia, hypoglycaemia, and hypoglycaemic coma.

Muhammad Nadeem

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