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GlucaGen HypoKit Instructions For Use Manual

GlucaGen HypoKit Instructions For Use Manual

(glucagon) for injection 1 mg/ml

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Summary of

Instructions for Use

This is only a summary of the Instructions for Use. Please see the full Instructions for Use on the following pages.
––––––––––––––– Preparing the GlucaGen
Step 1. Check that the orange plastic cap
on your vial of GlucaGen
®
is firmly attached.
Do not use if the cap is loose or missing.
With your thumb, flip the cap off the
GlucaGen
®
vial.
Pull Straight Off
Step 2. Pick up the prefilled syringe
containing sterile water. Do not use any
other liquid to mix the medicine. Hold the
syringe with 1 hand. With your other hand,
pull the needle cover off the syringe. Do not
remove the plastic backstop from the syringe.
Step 3. Pick up the GlucaGen
®
powder. Hold the vial with 1 hand. With your
other hand, push the needle of the prefilled
syringe through the center of the rubber
stopper.
Indications and Usage
What is GlucaGen
(glucagon) for
®
injection 1mg/mL?
GlucaGen
®
is a prescription medicine
used to treat very low blood sugar (severe
hypoglycemia) in people with diabetes who
use insulin.
Important Safety Information
Who should not use GlucaGen
Do not use GlucaGen
if:
®
you are allergic to glucagon or lactose or any
of the ingredients in GlucaGen
you have a tumor in the gland on top
of your kidneys (adrenal gland) called a
pheochromocytoma
Step 4. Hold the vial and syringe together,
with the needle still inserted into the vial.
Carefully turn the vial and syringe together
right side up. Slowly push the plunger down
until the syringe is empty. Do not take the
syringe out of the vial.
Step 5. Firmly hold both the vial and syringe
together in one hand, and gently shake until
the powder is completely dissolved. Do not
use if a gel has formed, or if you see particles
in the solution. Do not take the syringe out
of the vial.
vial of dry
Step 6. With the needle still inserted into
the vial, carefully turn the vial and syringe
together upside down. Gently pull down on
the plunger and slowly withdraw all of the
liquid into the syringe. Do not pull the plunger
out of the syringe.
See instructions for giving the injection on the next page u
you have a tumor in your pancreas called an
insulinoma
What should I tell my doctor before using
GlucaGen
?
®
Before using GlucaGen
about all of your medical conditions,
including if you:
have kidney problems
have pancreas problems. Tumors in your
pancreas called glucagonomas
?
®
have not had food or water for a long time
(prolonged fasting or starvation)
have low blood sugar that does not go away
®
(chronic hypoglycemia)
have heart problems
are pregnant or plan to become pregnant
dose
––––––––––––––––
®
Step 7. Keep the needle inside the vial.
Check the syringe for air bubbles. If you see
bubbles, tap the syringe until the bubbles rise
to the top of the syringe. Gently push on the
plunger to move only the air bubbles back
into the vial.
Step 8. Hold the vial and syringe as shown.
The usual dose for adults and children who
weigh more than 55 pounds (25 kg) is 1 mg
(1 mL). Use the content of the full syringe
(1 mL).
The usual dose for children who weigh less
than 55 pounds (25 kg) is 0.5 mg (0.5 mL).
Gently push the plunger until it is at the
0.5 mL mark on the syringe to ensure there
is 0.5 mL liquid left in the syringe.
Take the syringe and needle out of the vial
when the correct dose of GlucaGen
syringe.
If you do not know how much the child
weighs:
Give a child under 6 years of age 0.5 mg
(0.5 mL).
Give a child 6 years of age and older 1 mg
(1 mL).
are breastfeeding or plan to breastfeed. It
is not known if GlucaGen
breast milk
Tell your doctor about all the medicines
you take, including prescription and over
, tell your doctor
®
the counter medicines, vitamins and herbal
supplements. GlucaGen
other medicines work, and other medicines
may affect how GlucaGen
Please see additional Important
Safety Information on next page, and
Prescribing Information on following
pages.
1 mL
0.5 mL
is in the
®
passes into your
®
may affect the way
®
®
works.

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Summary of Contents for GlucaGen HypoKit

  • Page 1: Instructions For Use

    Gently push the plunger until it is at the 0.5 mL mark on the syringe to ensure there is 0.5 mL liquid left in the syringe. Take the syringe and needle out of the vial when the correct dose of GlucaGen is in the ® syringe.
  • Page 2 (hypoglycemia reaction) happens. The person’s dose of following pages. diabetes medicine may need to be changed. Hypoglycemia may happen again after receiving GlucaGen treatment. ® Early symptoms of hypoglycemia may include: sweating, drowsiness, dizziness, sleep disturbances, irregular heartbeat (palpitation), anxiety, tremor, blurred vision, hunger, slurred speech, depressed mood, tingling in the hands, feet, lips, or tongue, irritability, abnormal behavior, lightheadedness, unsteady movement, inability to concentrate, personality changes, headache, and restlessness.
  • Page 3 (glucagon) for injection 1 mg/mL HIGHLIGHTS OF PRESCRIBING INFORMATION ——— WARNINGS AND PRECAUTIONS ——— These highlights do not include all the information needed to use GlucaGen safely ® • Administer cautiously to patients suspected of having glucagonoma due to risk of secondary and effectively.
  • Page 4 GlucaGen is supplied in a vial, alone, or accompanied by Sterile Water for Reconstitution (1 mL) also ® DRUG INTERACTIONS in a vial (10 pack or diagnostic kit). It is also supplied as GlucaGen HypoKit , a presentation with ®...
  • Page 5 (both origins) gave a slightly higher incidence of micronucleus formation in male mice and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine but there was no effect in females. The weight of evidence indicates that GlucaGen is not different ®...
  • Page 6 GlucaGen (glucagon) for injection ® Date of issue: July 6, 2018 Version: 9 GlucaGen and HypoKit are registered trademarks of Novo Nordisk A/S ® ® Manufactured by: Novo Nordisk A/S 2880 Bagsvaerd, Denmark For information contact: Novo Nordisk Inc. 800 Scudders Mill Road...
  • Page 7: Patient Information

    • vomiting • temporary fast heartbeat or pounding in your chest (tachycardia). Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GlucaGen ®...
  • Page 8 ® General information about the safe and effective use of GlucaGen ® Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use GlucaGen for a condition for which ® it was not prescribed. Do not give GlucaGen ®...
  • Page 9 Preparing the GlucaGen dose: ® Take the syringe and needle out of the vial when the correct dose of GlucaGen ® is in the syringe. • The GlucaGen medicine comes as a dry powder. Before you use GlucaGen , you must mix the dry ®...
  • Page 10 Step 11. Pull the needle out of the skin and press on the injection site (See Figure L). Figure L Throw away your used syringe with the needle attached and any GlucaGen you did not use. See ® “How should I dispose of (throw away) used GlucaGen prefilled syringes”...