GLUCAGEN HYPOKIT- glucagon hydrochloride
Novo Nordisk
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use GlucaGen safely and effectively. See full prescribing information for GlucaGen.
GlucaGen® (glucagon) for injection, for subcutaneous, intramuscular or intravenous use Initial U.S. Approval: 1960 RECENT MAJOR CHANGESINDICATIONS AND USAGEGlucaGen is an antihypoglycemic agent and a gastrointestinal motility inhibitor indicated: DOSAGE AND ADMINISTRATIONDosage in adults and pediatric patients using the GlucaGen HypoKit to treat severe hypoglycemia (2.2)
Important Administration Instructions for Using the GlucaGen HypoKit to Treat Severe Hypoglycemia (2.1)
Dosage in Adults for Using GlucaGen Diagnostic Kit and GlucaGen 10-pack as a Diagnostic Aid (2.4)
DOSAGE FORMS AND STRENGTHSFor Injection (3): Treatment of Severe Hypoglycemia: 1 mg single-dose vial of GlucaGen with a 1 mL single-dose syringe of Sterile Water for Injection, USP (GlucaGen HypoKit®) Use as a Diagnostic Aid: 1 mg single-dose vial of GlucaGen 1 mg single-dose vial of GlucaGen with a 1 mL single-dose vial of Sterile Water for Injection, USP (Diagnostic Kit) CONTRAINDICATIONSWARNINGS AND PRECAUTIONSSubstantial Increase in Blood Pressure in Patients with Pheochromocytoma: Contraindicated in patients with pheochromocytoma because GlucaGen may stimulate the release of catecholamines from the tumor. (4, 5.1) Hypoglycemia in Patients with Insulinoma: In patients with insulinoma, administration may produce an initial increase in blood glucose; however, GlucaGen may stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. If a patient develops symptoms of hypoglycemia after a dose of GlucaGen, give glucose orally or intravenously. (4, 5.2) Hypersensitivity and Allergic Reactions: Allergic reactions have been reported and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. (4, 5.3) Lack of Efficacy in Patients with Decreased Hepatic Glycogen: GlucaGen is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for GlucaGen to be effective. Patients with these conditions should be treated with glucose. (5.4) Necrolytic Migratory Erythema (NME): a skin rash, has been reported postmarketing following continuous glucagon infusion and resolved with discontinuation of the glucagon. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks. (5.5) Hyperglycemia in Patients with Diabetes Mellitus when Used as a Diagnostic Aid: Treatment with GlucaGen in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment and treat if indicated. (5.6) Blood Pressure and Heart Rate Increase in Patients with Cardiac Disease when Used as a Diagnostic Aid: GlucaGen may increase myocardial oxygen demand, blood pressure, and pulse rate. Cardiac monitoring is recommended in patients with cardiac disease during use of GlucaGen as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy. (5.7) Hypoglycemia in Patients with Glucagonoma: Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to treatment. (5.8) ADVERSE REACTIONSGlucagon adverse reactions identified during post approval use are: injection site reactions, nausea, vomiting, headache, dizziness, asthenia, pallor, diarrhea, somnolence, and decreased blood pressure. (6) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-800-727-6500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. DRUG INTERACTIONSBeta-blockers: Patients taking beta-blockers may have a transient increase in pulse and blood pressure. (7.1) Indomethacin: In patients taking indomethacin GlucaGen may lose its ability to raise glucose or may produce hypoglycemia. (7.2) Anticholinergic drugs: Concomitant use of anticholinergic drugs with GlucaGen for use as a diagnostic aid is not recommended. (7.3) Warfarin: GlucaGen may increase the anticoagulant effect of warfarin. (7.4) Insulin: Monitor blood glucose when GlucaGen is used as a diagnostic aid in patients receiving insulin. (7.5) See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling. Revised: 3/2021 |
GlucaGen is for subcutaneous, intramuscular, or intravenous injection. Administer intravenously ONLY under medical supervision.
Instruct patients and their caregivers on the signs and symptoms of severe hypoglycemia. Because severe hypoglycemia requires the help of others to recover, instruct the patient to inform those around them about GlucaGen and its Instructions for Use. Administer GlucaGen as soon as possible when severe hypoglycemia is recognized.
Instruct the patient or caregiver to read the Instructions for Use at the time they receive a prescription for GlucaGen. Emphasize the following instructions to the patient or caregiver:
Adults and Pediatric Patients Weighing 25 kg or More or for Pediatric Patients with Unknown Weight 6 Years and Older
Pediatric Patients Weighing Less Than 25 kg or for Pediatric Patients with Unknown Weight Less Than 6 Years of Age
For GlucaGen Diagnostic Kit and the GlucaGen 10-pack:
GlucaGen for injection is a white lyophilized powder supplied as follows:
Treatment of Severe Hypoglycemia
Use as a Diagnostic Aid
GlucaGen is contraindicated in patients with:
GlucaGen is contraindicated in patients with pheochromocytoma because GlucaGen may stimulate the release of catecholamines from the tumor [see Contraindications (4)]. If the patient develops a substantial increase in blood pressure and a previously undiagnosed pheochromocytoma is suspected, 5 to 10 mg of phentolamine mesylate, administered intravenously, has been shown to be effective in lowering blood pressure for the short time that control would be needed.
In patients with insulinoma, administration of glucagon may produce an initial increase in blood glucose; however, GlucaGen administration may directly or indirectly (through an initial rise in blood glucose) stimulate exaggerated insulin release from an insulinoma and cause hypoglycemia. GlucaGen is contraindicated in patients with insulinoma [see Contraindications (4)]. If a patient develops symptoms of hypoglycemia after a dose of GlucaGen, give glucose orally or intravenously.
Allergic reactions have been reported with glucagon, these include generalized rash, and in some cases anaphylactic shock with breathing difficulties and hypotension. GlucaGen is contraindicated in patients with a prior hypersensitivity reaction [see Contraindications (4)].
GlucaGen is effective in treating hypoglycemia only if sufficient hepatic glycogen is present. Patients in states of starvation, with adrenal insufficiency or chronic hypoglycemia may not have adequate levels of hepatic glycogen for GlucaGen administration to be effective. Patients with these conditions should be treated with glucose.
Necrolytic migratory erythema (NME), a skin rash commonly associated with glucagonomas (glucagon-producing tumors) and characterized by scaly, pruritic erythematous plaques, bullae, and erosions, has been reported postmarketing following continuous glucagon infusion. NME lesions may affect the face, groin, perineum and legs or be more widespread. In the reported cases NME resolved with discontinuation of the glucagon, and treatment with corticosteroids was not effective. Should NME occur, consider whether the benefits of continuous glucagon infusion outweigh the risks.
Treatment with GlucaGen in patients with diabetes mellitus may cause hyperglycemia. Monitor diabetic patients for changes in blood glucose levels during treatment and treat if indicated.
GlucaGen may increase myocardial oxygen demand, blood pressure, and pulse rate which may be life-threatening in patients with cardiac disease. Cardiac monitoring is recommended in patients with cardiac disease during use of GlucaGen as a diagnostic aid, and an increase in blood pressure and pulse rate may require therapy.
Glucagon administered to patients with glucagonoma may cause secondary hypoglycemia. Test patients suspected of having glucagonoma for blood levels of glucagon prior to use as a diagnostic aid as GlucaGen is contraindicated in this setting [see Contraindications (4)].
The following important adverse reactions are described below and elsewhere in the labeling:
The following adverse reactions have been identified during post-approval use of glucagon. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Table 1: Clinically Significant Drug Interactions with GlucaGen
Beta-Blockers |
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Clinical Impact: |
Patients taking beta-blockers may have a transient increase in pulse and blood pressure when given GlucaGen. |
Intervention: |
The increase in blood pressure and heart rate may require therapy in patients with coronary artery disease. |
Indomethacin |
|
Clinical Impact: |
In patients taking indomethacin, GlucaGen may lose its ability to raise blood glucose or may even produce hypoglycemia. |
Intervention: |
Monitor blood glucose levels during GlucaGen treatment of patients taking indomethacin. |
Anticholinergic Drugs |
|
Clinical Impact: |
The concomitant use of anticholinergic drugs and GlucaGen increase the risk of gastrointestinal adverse reactions due to additive effects on inhibition of gastrointestinal motility. |
Intervention: |
Concomintant use of anticholinergic drugs with GlucaGen for use as a diagnostic aid is not recommended. |
Warfarin |
|
Clinical Impact: |
GlucaGen may increase the anticoagulant effect of warfarin. |
Intervention: |
Monitor patients for unusual bruising or bleeding, as adjustments in warfarin dosage may be required. |
Insulin |
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Clinical Impact: |
Insulin acts antagonistically to glucagon. |
Intervention: |
Monitor blood glucose when GlucaGen is used as a diagnostic aid in patients receiving insulin. |
Risk Summary
Available data from case reports and a small number of observational studies with glucagon use in pregnant women over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Multiple small studies have demonstrated a lack of transfer of pancreatic glucagon across the human placental barrier during early gestation. In rat and rabbit reproduction studies, no embryofetal toxicity was observed with glucagon administered by injection during the period of organogenesis at doses representing up to 100 and 200 times the human dose, respectively, based on body surface area (mg/m2) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively.
Data
Animal Data
In rats and rabbits given glucagon by injection at doses of 0.4, 2, and 10 mg/kg (up to 100 and 200 times the human dose based on mg/m2 for rats and rabbits, respectively) there was no evidence of increased malformations or embryofetal lethality.
Risk Summary
There is no information available on the presence of glucagon in human or animal milk, the effects of glucagon on the breastfed child or the effects of glucagon on milk production. However, glucagon is a peptide and would be expected to be broken down to its constituent amino acids in the infant's digestive tract and is therefore, unlikely to cause harm to an exposed infant.
The safety and effectiveness of GlucaGen for the treatment of severe hypoglycemia in pediatric patients with diabetes have been established.
Safety and effectiveness for use as a diagnostic aid during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in pediatric patients have not been established.
If overdosage occurs, the patient may experience nausea, vomiting, inhibition of gastrointestinal tract motility, increase in blood pressure and pulse rate. In case of suspected overdosing, the serum potassium may decrease and should be monitored and corrected if needed. If the patient develops a dramatic increase in blood pressure, phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.
Glucagon is an antihypoglycemic agent and a gastrointestinal motility inhibitor. It is produced by expression of recombinant DNA in a Saccharomyces cerevisiae vector with subsequent purification. The chemical structure of the glucagon is identical to human glucagon. Glucagon with the empirical formula of C153H225N43O49S, and a molecular weight of 3483, is a single-chain polypeptide containing 29 amino acid residues. The structure of glucagon is:
GlucaGen is a sterile, lyophilized white powder for reconstitution for subcutaneous, intramuscular or intravenous use, supplied in a 2 mL vial (appearance of the powder may vary, and occasionally the powder may appear compacted). Each vial for reconstitution contains 1 mg of glucagon, 107 mg of lactose monohydrate, hydrochloric acid and sodium hydroxide. Hydrochloric acid and/or sodium hydroxide may be used to adjust the pH before lyophilization. The reconstituted solution of GlucaGen contains glucagon 1 mg/mL at pH 2.5-3.5, and is soluble in water.
Glucagon increases blood glucose concentration by activating hepatic glucagon receptors, thereby stimulating glycogen breakdown and release of glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect. Extrahepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.
Treatment of Severe Hypoglycemia:
Blood glucose concentration rises within 10 minutes of injection and maximal concentrations are attained at approximately 30 minutes after injection (see Figure 1). The duration of hyperglycemic action after intravenous or intramuscular injection is 60 – 90 minutes.
Figure 1. Recovery from Insulin Induced Hypoglycemia (mean blood glucose) after Intramuscular Injection of 1 mg GlucaGen in Type 1 Diabetic Men
Diagnostic Aid:
Table 2: Pharmacodynamic Properties of Glucagon for Intravenous Route
Route of Administration |
Dosea |
Time of Maximal Glucose Concentration |
Time of Onset of Action for GI Smooth Muscle Relaxation |
Duration of Smooth Muscle Relaxation |
Intravenous |
0.25 to 0.5 mg |
5 to 20 minutes |
45 seconds |
9 to 17 minutes |
aDose is determined based on the length of the procedure.
Table 3: Pharmacodynamic Properties of GlucaGen for Intramuscular Route
Route of Administration |
Dosea |
Time of Maximal Glucose Concentration |
Time of Onset of Action for GI Smooth Muscle Relaxation |
Duration of Smooth Muscle Relaxation |
Intramuscular |
1 mg |
30 minutes |
8 to 10 minutes |
12 to 27 minutes |
2 mg |
30 minutes |
4 to 7 minutes |
21 to 32 minutes |
aDose is determined based on the length of the procedure.
The time of maximal glucose concentration for GlucaGen administered subcutaneously is 30-45 minutes.
Absorption
Intramuscular injection of 1 mg GlucaGen resulted in a mean Cmax (CV%) of 1686 pg/mL (43%) and median Tmax of 12.5 minutes.
Elimination
The mean apparent half-life of 45 minutes after intramuscular injection probably reflects prolonged absorption from the injection site.
Metabolism
Glucagon is degraded in the liver, kidney, and plasma.
Carcinogenesis
Long term studies in animals to evaluate carcinogenic potential have not been performed.
Mutagenesis
The mutagenic potential tested in the Ames and human lymphocyte assays, was borderline positive under certain conditions for both glucagon (pancreatic) and glucagon (rDNA) origin. Doses of 100 and 200 mg/kg of glucagon of both pancreatic and recombinant origins gave slightly higher incidences of micronucleus formation in male mice but there was no effect in females. The weight of evidence indicates that synthetic and recombinant glucagon are not different and do not pose a genotoxic risk to humans.
Impairment of Fertility
Glucagon was not tested in animal fertility studies. Studies in rats have shown that pancreatic glucagon does not cause impaired fertility.
GlucaGen for injection is supplied as a lyophilized white powder available as follows:
Presentation |
NDC |
Strength |
Description |
Treatment of Severe Hypoglycemia |
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GlucaGen HypoKit |
0169-7065-15 |
1 mg per vial |
1 mL single-dose vial of GlucaGen with 1 mL single-dose syringe of Sterile Water for Injection, USP for reconstitution |
Use as a Diagnostic Aid |
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GlucaGen 10-pack: 10 Single-dose vials |
0597-0053-45 |
1 mg per vial |
1 mL single-dose vial of GlucaGen |
GlucaGen Diagnostic Kit |
0597-0260-10 |
1 mg per vial |
1 mL single-dose vial of GlucaGen with 1 mL single-dose vial of Sterile Water for Injection, USP for reconstitution |
Before Reconstitution:
The GlucaGen package may be stored up to 24 months at controlled room temperature 20o to 25oC (68o to 77oF) prior to reconstitution. Do not freeze. Keep in the original package to protect from light.
After Reconstitution:
Use the reconstituted GlucaGen solution immediately. Discard any unused portion [see Dosage and Administration (2)].
Advise the patient to read the FDA-approved (Patient Information and Instructions for Use).
Recognition of Severe Hypoglycemia
Inform patient and family members or caregivers on how to recognize the signs and symptoms of severe hypoglycemia and the risks of prolonged hypoglycemia.
Administration
Review the Patient Information and Instructions for Use with the patient and family members or caregivers.
Serious Hypersensitivity
Inform patients that allergic reactions can occur with GlucaGen. Advise patients to seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions (5.3)].
Manufactured by:
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S
© 1998-2021 Novo Nordisk
For information contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536, USA
1-800-727-6500
www.novonordisk-us.com
PATIENT INFORMATION GlucaGen® (Glū-ka-Gen) (glucagon) injection, for subcutaneous, intramuscular, or intravenous use |
What is GlucaGen? GlucaGen is a prescription medicine used:
It is not known if GlucaGen is safe and effective for use in children, to temporarily stop stomach movement during radiologic tests. |
Who should not use GlucaGen? Do not use GlucaGen if:
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What should I tell my doctor before using GlucaGen? Before using GlucaGen, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. GlucaGen may affect the way other medicines work, and other medicines may affect how GlucaGen works. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. |
How should I use GlucaGen?
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What are the possible side effects of GlucaGen? GlucaGen may cause serious side effects, including:
Very low blood sugar can cause passing out (loss of consciousness), confusion, seizures, and death. Talk to your doctor about how to tell if you have low blood sugar and what to do if this happens while using GlucaGen for injection. Know your symptoms of low blood sugar. Follow your doctor’s instructions to treat low blood sugar.
The most common side effects of GlucaGen may include:
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. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
How should I store GlucaGen? Before you mix the GlucaGen powder and liquid:
After you mix the GlucaGen powder and liquid:
Keep GlucaGen and all medicines out of the reach of children. |
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 to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about GlucaGen that is written for health professionals. |
What are the ingredients in GlucaGen? Active Ingredient: glucagon. Inactive ingredients: lactose monohydrate, hydrochloric acid, sodium hydroxide, and sterile water for reconstitution. Manufactured by: Novo Nordisk A/S, 2880 Bagsvaerd, Denmark. GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S; © 1998-2021 Novo Nordisk. For more information, go to www.novonordisk-us.com or call 1-800-727-6500. |
This Patient Information has been approved by the U.S. Food and Drug Administration.
Revised: 03/2021
Instructions for Use
GlucaGen® (Glū-ka-Gen)
(glucagon) for injection
HypoKit®
Read this Instructions for Use before you start using GlucaGen and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor or pharmacist if you have any questions about how to use GlucaGen.
Important:
How should I store GlucaGen?
Before you mix the GlucaGen powder and liquid:
After you mix the GlucaGen powder and liquid:
Supplies you will need for your GlucaGen injection (See Figure A):
Preparing the GlucaGen dose:
Step 1. Using your thumb, flip the orange plastic cap off the GlucaGen vial (See Figure B).
Step 2. Pick up the prefilled syringe containing sterile water. Hold the syringe with 1 hand and with your other hand, pull the needle cover off the syringe (See Figure C).
Step 3. Pick up the GlucaGen vial. Hold the vial of dry powder with 1 hand and with your other hand, push the needle of the prefilled syringe through the center of the rubber stopper (See Figure D).
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 (See Figure E).
Step 5. Hold the entire unit (the vial and syringe) in one hand and gently shake the vial until the powder is completely dissolved (See Figure F).
Step 6. Firmly hold the vial and syringe together, 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 (See Figure G).
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 (See Figure H). Gently push on the plunger to move only the air bubbles back into the vial.
Step 8. Hold the vial and syringe as shown (See Figure I).
Take the syringe and needle out of the vial when the correct dose of GlucaGen is in the syringe. |
If you do not know how much the child weighs:
Giving the GlucaGen injection:
Step 9. Choose the injection site (See Figure J).
Common injection sites for GlucaGen are upper arms, thighs, or buttocks.
Step 10. With one hand gently pinch the skin at the injection site. With your other hand insert the needle into the skin and push the syringe plunger down until the syringe is empty (See Figure K).
After Giving the GlucaGen injection:
Step 11. Pull the needle out of the skin and press on the injection site (See 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” at the end of these instructions.
Step 12. Turn the person on their side. When an unconscious person awakens, they may vomit. Turning the person on their side will lessen the chance of choking.
Step 13. Call for emergency medical help right away.
Step 14. Feed the person as soon as they are awake and able to swallow.
Give the person a fast-acting source of sugar (such as a regular soft drink or fruit juice) and a long-acting source of sugar (such as crackers and cheese or a meat sandwich).
Step 15. If the patient does not awaken within 15 minutes, give another dose of GlucaGen. Call your doctor and get emergency help right away.
Step 16. Even if the GlucaGen treatment wakes the person, tell their doctor right away. The doctor should be told whenever a severe drop in blood sugar (hypoglycemia reaction) happens. The person’s dose of diabetes medicine may need to be changed.
Hypoglycemia may happen again after receiving GlucaGen treatment.
Early symptoms of hypoglycemia may include:
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If not treated early, hypoglycemia may worsen and the person may have severe hypoglycemia. Signs of severe hypoglycemia include:
How should I dispose of (throw away) GlucaGen pre-filled syringes?
Keep GlucaGen and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S
© 1998-2021 Novo Nordisk
For information contact:
Novo Nordisk Inc.
800 Scudders Mill Road
Plainsboro, NJ 08536
1-800-727-6500
Revised: 03/2021
NDC 0169-7065-15
GlucaGen® HypoKit
(glucagon) for injection
Emergency Use for Low Blood Sugar
1 mg per vial
Single use only. Discard unused portion.
Protect from light
Rx only
Novo Nordisk Inc.
Plainsboro, NJ 08536
www.novonordisk-us.com
1-800-727-6500
Manufactured by:
Novo Nordisk A/S
2880 Bagsvaerd, Denmark
GLUCAGEN HYPOKIT
glucagon hydrochloride kit |
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Labeler - Novo Nordisk (622920320) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Novo Nordisk A/S - Hax | 306711800 | MANUFACTURE(0169-7065) , API MANUFACTURE(0169-7065) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Catalent Belgium SA | 370696762 | ANALYSIS(0169-7065) , MANUFACTURE(0169-7065) |