GLUCAGEN- glucagon hydrochloride kit GLUCAGEN- glucagon hydrochloride injection, powder, for solution

GlucaGen by

Drug Labeling and Warnings

GlucaGen by is a Prescription medication manufactured, distributed, or labeled by Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk, Novo Nordisk A/S, Catalent Belgium SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    1.1 Treatment of severe hypoglycemia

    GlucaGen is used to treat severe hypoglycemic (low blood sugar) reactions which may occur in patients with diabetes mellitus treated with insulin. Because GlucaGen depletes glycogen stores, the patient should be given supplemental carbohydrates as soon as he/she awakens and is able to swallow, especially children or adolescents. Medical evaluation is recommended for all patients who experience severe hypoglycemia.

    1.2 Use as a diagnostic aid

    GlucaGen is indicated for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract. GlucaGen is not recommended in combination with anticholinergic agents due to the possibility of increased side effects. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied.

  • 2 DOSAGE AND ADMINISTRATION

    For GlucaGen HypoKit:

    2.1 Treatment of severe hypoglycemia

    1. Using the supplied prefilled syringe, carefully insert the needle through the rubber stopper of the vial containing

    GlucaGen powder and inject all the liquid from the syringe into the vial.

    2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted

    fluid should be clear and of water-like consistency.

    3. The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon.

    4. The reconstituted GlucaGen should be used immediately after reconstitution.

    5. Inject 1 mL (adults and children, weighing more than 55 lbs (25 kg)) or 0.5 mL (children weighing less than 55 lbs (25

    kg)) subcutaneously, intramuscularly, or intravenously. Common injection sites for GlucaGen are upper arms, thighs,

    or buttocks. If the weight is not known: children younger than 6 years should be given a 0.5 mL and children 6 years

    and older should be given 1 mL.

    6. Discard any unused portion.

    7. Emergency assistance should be sought immediately after subcutaneous or intramuscular injection of glucagon.

    8. The glucagon injection may be repeated using a new kit while waiting for emergency assistance.

    9. Intravenous glucose MUST be administered if the patient fails to respond to glucagon.

    10. When the patient has responded to the treatment, give fast-acting and long-acting oral carbohydrates to restore the

    liver glycogen and prevent recurrence of hypoglycemia.

    For GlucaGen Diagnostic Kit and the GlucaGen 10-pack:

    2.2 Use as a diagnostic aid

    • 1. GlucaGen should be reconstituted with 1 mL of Sterile Water for Reconstitution (if supplied) or 1 mL of Sterile Water for Injection, USP. Using a syringe, withdraw all of the Sterile Water for Reconstitution (if supplied) or 1 mL Sterile Water for Injection, USP and inject into the GlucaGen vial.
    • 2. Shake the vial gently until the powder is completely dissolved and no particles remain in the fluid. The reconstituted fluid should be clear and of water-like consistency.
    • 3. The reconstituted GlucaGen gives a concentration of approximately 1 mg/mL glucagon.
    • 4. The reconstituted GlucaGen should be used immediately after reconstitution.
    • 5. GlucaGen must be administered by medical personnel.
    • 6. Discard any unused portion.
    • 7. Onset of action after an injection will depend on the organ under examination and route of administration [see Pharmacodynamics (12.2)].
    • 8. The usual diagnostic dose for relaxation of the stomach, duodenal bulb, duodenum, and small bowel is 0.2 mg to 0.5 mg given intravenously or 1 mg given intramuscularly; the usual dose to relax the colon is 0.5 mg to 0.75 mg intravenously and 1 mg to 2 mg intramuscularly [see Pharmacodynamics (12.2)].
    • 9. After the end of the diagnostic procedure, give oral carbohydrates to patients who have been fasting, if this is compatible with the diagnostic procedure applied.

    The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are intended only for use by healthcare providers as a diagnostic aid. The GlucaGen Diagnostic Kit and the GlucaGen 10-pack presentations are not intended for use by patients to treat severe hypoglycemia because they are not packaged with a syringe and diluent necessary for rapid preparation and administration during an emergency outside of a healthcare facility.

  • 3 DOSAGE FORMS AND STRENGTHS

    GlucaGen is supplied in a vial, alone, or accompanied by Sterile Water for Reconstitution (1 mL) also in a vial (10 pack or diagnostic kit). It is also supplied as GlucaGen HypoKit®, a presentation with a disposable prefilled syringe containing 1 mL Sterile Water for Reconstitution. When the glucagon powder is reconstituted with Sterile Water for Reconstitution (if supplied) or with Sterile Water for Injection, USP, it forms a solution of 1 mg/mL glucagon for subcutaneous, intramuscular, or intravenous injection (appearance of the powder may vary, and occasionally the powder may appear compacted).

  • 4 CONTRAINDICATIONS

    GlucaGen is contraindicated in patients with:

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Pheochromocytoma

    GlucaGen is contraindicated in patients with pheochromocytoma because GlucaGen may stimulate the release of catecholamines from the tumor. If the patient develops a dramatic increase in blood pressure, 5 to 10 mg of phentolamine mesylate has been shown to be effective in lowering blood pressure for the short time that control would be needed.

    5.2 Insulinoma and Glucagonoma

    GlucaGen should not be administered to patients suspected of having insulinoma. In patients with insulinoma, intravenous 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. A patient developing symptoms of hypoglycemia after a dose of GlucaGen should be given glucose orally or intravenously, whichever is most appropriate. Caution should be observed in administering GlucaGen to patients with glucagonoma.

    5.3 Hypersensitivity and Allergic Reactions

    Allergic reactions may occur and include generalized rash, and in some cases anaphylactic shock with breathing difficulties, and hypotension. The anaphylactic reactions have generally occurred in association with endoscopic examination during which patients often received other agents including contrast media and local anesthetics. The patients should be given standard treatment for anaphylaxis including an injection of epinephrine if they encounter respiratory difficulties after GlucaGen injection.

    5.4 Glycogen Stores and Hypoglycemia

    In order for GlucaGen treatment to reverse hypoglycemia, adequate amounts of glucose must be stored in the liver (as glycogen). Therefore, GlucaGen should be used with caution in patients with conditions such as prolonged fasting, starvation, adrenal insufficiency, or chronic hypoglycemia because these conditions result in low levels of releasable glucose in the liver and an inadequate reversal of hypoglycemia by GlucaGen treatment.

    5.5 Necrolytic Migratory Erythema

    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.

    5.6 Cardiac Disease

    Caution should be observed when GlucaGen is used as an adjunct in endoscopic or radiographic procedures to inhibit gastrointestinal motility in patients with known cardiac disease.

    5.7 Laboratory Tests

    Blood glucose measurements may be considered to monitor the patient’s response.

  • 6 ADVERSE REACTIONS

    The following important adverse reactions are described below and elsewhere in the labeling:

    Side effects may include nausea and vomiting at doses above 1 mg or with rapid injection. Hypotension has been reported up to 2 hours after administration in patients receiving GlucaGen as premedication for upper GI endoscopy procedures. GlucaGen exerts positive inotropic and chronotropic effects and may, therefore, cause tachycardia and hypertension. Adverse reactions indicating toxicity of GlucaGen have not been reported. A temporary increase in both blood pressure and pulse rate may occur following the administration of GlucaGen. Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of GlucaGen’s short half-life [see Drug Interactions (7.1)]. The increase in blood pressure and pulse rate may require therapy in patients with pheochromocytoma or coronary artery disease [see Warnings and Precautions (5.1)]. Anaphylactic reactions may occur in some cases.

    The following adverse reactions have been identified during postapproval use of GlucaGen. 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 Frequency of Adverse Reactions

    Treatment of severe hypoglycemia

    Frequency (%)

    Adverse Reaction

    < 10

    Nausea

    < 1

    Vomiting

    Use as a diagnostic aid

    < 10

    Nausea

    < 1

    Vomiting

    < 1

    Hypoglycemia

    <1

    Hypoglycemic coma

    Necrolytic migratory erythema (NME) cases have been reported postmarketing in patients receiving continuous infusion of glucagon.

  • 7 DRUG INTERACTIONS

    7.1 Beta-blockers

    Patients taking beta-blockers might be expected to have a greater increase in both pulse and blood pressure, an increase of which will be temporary because of glucagon’s short half-life. The increase in blood pressure and pulse rate may require therapy in patients with pheochromocytoma or coronary artery disease.

    7.2 Indomethacin

    When used with indomethacin, glucagon may lose its ability to raise blood glucose or may even produce hypoglycemia. Therefore, caution should be exercised for patients taking indomethacin when glucagon will be administered.

    7.3 Anticholinergic Drugs

    Coadministration with an anticholinergic drug is not recommended due to increased gastrointestinal side effects.

    7.4 Warfarin

    Glucagon may increase the anticoagulant effect of warfarin. Therefore, caution should be exercised for patients taking warfarin when glucagon will be administered.

    7.5 Insulin

    Insulin reacts antagonistically towards glucagon. Therefore, caution should be exercised when glucagon is used as a diagnostic aid in diabetes patients.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Reproduction studies were performed in rats and rabbits at GlucaGen doses of 0.4, 2.0, and 10 mg/kg. These doses represent exposures of up to 100 and 200 times the human dose based on mg/m2 for rats and rabbits, respectively, and revealed no evidence of harm to the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Glucagon does not cross the human placenta barrier.

    8.3 Nursing Mothers

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GlucaGen is administered to a nursing woman. No clinical studies have been performed in nursing mothers, however, GlucaGen is a peptide and intact glucagon is not absorbed from the GI tract. Therefore, even if the infant ingested glucagon it would be unlikely to have any effect on the infant. Additionally, GlucaGen has a short plasma half-life thus limiting amounts available to the child.

    8.4 Pediatric Use

    For the treatment of severe hypoglycemia: The use of glucagon in pediatric patients has been reported to be safe and effective.

    For use as a diagnostic aid: Safety and effectiveness in pediatric patients have not been established.

  • 10 OVERDOSAGE

    No reports of overdosage with GlucaGen have been reported. If overdosage occurs, the patient may experience nausea, vomiting, inhibition of GI 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.

  • 11 DESCRIPTION

    GlucaGen (glucagon) for injection is an antihypoglycemic agent and a gastrointestinal motility inhibitor for subcutaneous, intramuscular or intravenous use. It is produced by expression of recombinant DNA in a Saccharomyces cerevisiae vector with subsequent purification. The chemical structure of the glucagon in GlucaGen is identical to human glucagon and to glucagon extracted from beef and pork pancreas. 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:

    Structural formula of GlucaGen.

    GlucaGen is a sterile, lyophilized white powder in a 2 mL vial (appearance of the powder may vary, and occasionally the powder may appear compacted). The reconstituted solution contains glucagon as hydrochloride 1 mg/mL and lactose monohydrate (107 mg). GlucaGen is supplied at pH 2.5-3.5 and is soluble in water.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Antihypoglycemic Action: Glucagon induces liver glycogen breakdown, releasing glucose from the liver. Hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect.

    Gastrointestinal Motility Inhibition: Extra hepatic effects of glucagon include relaxation of the smooth muscle of the stomach, duodenum, small bowel, and colon.

    12.2 Pharmacodynamics

    For the 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.

    Graph

    Figure 1. Recovery from Insulin Induced Hypoglycemia (mean blood glucose) after Intramuscular Injection of

    1 mg GlucaGen in Type I Diabetic Men

    For use as a diagnostic aid:

    Table 2 Pharmacodynamic Properties of Glucagon

    Route of Administration

    Dose*

    Time of Maximal Glucose Concentration

    Time of Onset of Action for GI Smooth Muscle Relaxation

    Duration of Smooth Muscle Relaxation1

    IV

    0.25-0.5 mg

    5-20 minutes

    45 seconds

    9-17 minutes

    2 mg

    5-20 minutes

    45 seconds

    22-25 minutes

    IM

    1 mg

    30 minutes

    8-10 minutes

    12-27 minutes

    2 mg

    30 minutes

    4-7 minutes

    21-32 minutes

    •   *The usual 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 usual dose to relax the colon is 0.5 – 0.75 mg intravenously and 1 – 2 mg intramuscularly.
    •   1Note: The time of maximal glucose concentration for GlucaGen administered subcutaneously is 30-45 minutes.

    12.3 Pharmacokinetics

    Intramuscular injection of 1 mg GlucaGen resulted in a mean Cmax (CV%) of 1686 pg/mL (43%) and median Tmax of 12.5 minutes. The mean apparent half-life of 45 minutes after intramuscular injection probably reflects prolonged absorption from the injection site. Glucagon is degraded in the liver, kidney, and plasma. 

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long term studies in animals to evaluate carcinogenic potential have not been performed. Several studies have been conducted to evaluate the mutagenic potential of glucagon. 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. In vivo, very high doses (100 and 200 mg/kg) of glucagon (both origins) gave a slightly higher incidence of micronucleus formation in male mice but there was no effect in females. The weight of evidence indicates that GlucaGen is not different from glucagon pancreatic origin and does not pose a genotoxic risk to humans. GlucaGen was not tested in animal fertility studies. Studies in rats have shown that pancreatic glucagon does not cause impaired fertility. 

  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    16.1 How Supplied

    GlucaGen (glucagon) for injection is supplied as a sterile, lyophilized white powder.

    GlucaGen HypoKit (NDC: 0169-7065-15)includes:

    • 1 single-dose vial containing 1 mg GlucaGen (glucagon) for injection
    •   (NDC: 0169-7065-15)
    • 1 disposable syringe containing 1 mL Sterile Water for Reconstitution

    GlucaGen Diagnostic Kit (NDC: 0597-0260-10) includes:

    • 1 single-dose vial containing 1 mg GlucaGen (glucagon) for injection
    •   (NDC: 0597-0053-01)
    • 1 vial containing 1 mL Sterile Water for Reconstitution (NDC: 0597-0265-94)

    GlucaGen 10-pack (NDC: 0597-0053-45)includes:

    • 10 single-dose vials, each containing 1 mg GlucaGen (glucagon) for injection

    16.2 Recommended Storage

    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. GlucaGen should not be used after the expiry date on the vials.

    After Reconstitution:

    Reconstituted GlucaGen should be used immediately. Discard any unused portion. If the solution shows any sign of gel formation or particles, it should be discarded.

  • 17 PATIENT COUNSELING INFORMATION

     [See FDA-Approved Patient Information and Instructions for Use.]

    17.1 Physician Instructions

    Refer patients and family members to the FDA-approved patient labeling for instructions describing the method of preparing and injecting GlucaGen. Advise the patient and family members to become familiar with the technique of preparing GlucaGen before an emergency arises. Instruct patients to use 1 mg for adults or ½ the adult dose (0.5 mg) for children weighing less than 55 lb (25 kg). To prevent severe hypoglycemia, patients and family members should be informed of the symptoms of mild hypoglycemia and how to treat it appropriately. Family members should be informed to arouse the patient as quickly as possible because prolonged hypoglycemia may result in damage to the central nervous system. Patients should be advised to inform their physician each time a hypoglycemic reaction occurs so that the treatment regimen may be adjusted if necessary.

    No studies on the effects on the ability to drive and use machines have been performed. After diagnostic procedures, hypoglycemia has been reported infrequently. The patient’s ability to concentrate and react may be impaired as a result of hypoglycemia. This may present a risk in situations where these abilities are especially important, such as driving or operating machinery. Therefore, these activities should be avoided until the patient has had intake of oral carbohydrates.

    Date of issue: July 6, 2018
    Version: 9

    GlucaGen® and HypoKit® are registered trademarks of Novo Nordisk A/S

    © 1998-2018 Novo Nordisk

    For information contact:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Ridgefield, CT 06877
    1-800-243-0127

    Manufactured for:
    Boehringer Ingelheim Pharmaceuticals, Inc.
    Ridgefield, CT 06877

    By:
    Novo Nordisk A/S
    2880 Bagsvaerd, Denmark

  • PRINCIPAL DISPLAY PANEL - GlucaGen diagnostic kit

    NDC: 0597-0260-10

    GlucaGen®

    (glucagon) for injection

    1 mg per vial

    For intramuscular or intravenous injection

    GlucaGen® should be reconstituted
    with Sterile Water for Reconstitution
    immediately before use

    Single use only. Discard unused portion.
    Protect from Light.

    See package insert for complete product
    information.

    FOR DIAGNOSTIC USE ONLY - NOT INTENDED FOR
    USE BY PATIENTS TO TREAT SEVERE
    HYPOGLYCEMIA

    Rx ONLY

    Boehringer
    Ingelheim

    1 Vial Carton
  • PRINCIPAL DISPLAY PANEL - GlucaGen diagnostic kit - (10 Pack)

    NDC: 0597-0053-45

    10 vials each containing 1 mg per vial

    GlucaGen®

    (glucagon) for injection

    1 mg per vial

    For intramuscular or intravenous injection

    Protect from Light

    FOR DIAGNOSTIC USE ONLY - NOT INTENDED FOR
    USE BY PATIENTS TO TREAT SEVERE HYPOGLYCEMIA

    Rx ONLY

    Boehringer
    Ingelheim

    Carton - 10 Vials
  • INGREDIENTS AND APPEARANCE
    GLUCAGEN 
    glucagon hydrochloride kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0597-0260
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0597-0260-101 in 1 KIT; Type 0: Not a Combination Product06/22/2005
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 VIAL, GLASS 1 mL
    Part 21 VIAL, GLASS 1 mL
    Part 1 of 2
    GLUCAGEN 
    glucagon hydrochloride injection, powder, for solution
    Product Information
    Item Code (Source)NDC: 0597-0053
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLUCAGON HYDROCHLORIDE (UNII: 1H87NVF4DB) (glucagon - UNII:76LA80IG2G) glucagon1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 107 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0597-0053-011 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02091806/22/2005
    Part 2 of 2
    WATER 
    water liquid
    Product Information
    Item Code (Source)NDC: 0597-0265
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 1 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0597-0265-941 mL in 1 VIAL, GLASS; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02091806/22/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02091806/22/2005
    GLUCAGEN 
    glucagon hydrochloride injection, powder, for solution
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 0597-0053
    Route of AdministrationSUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLUCAGON HYDROCHLORIDE (UNII: 1H87NVF4DB) (GLUCAGON - UNII:76LA80IG2G) GLUCAGON1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) 107 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 0597-0053-4510 in 1 CARTON06/22/2005
    11 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02091806/22/2005
    Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
    Registrant - Novo Nordisk (622920320)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novo Nordisk A/S306711800MANUFACTURE(0597-0260, 0597-0053, 0597-0053, 0597-0265) , API MANUFACTURE(0597-0260, 0597-0053, 0597-0053, 0597-0265)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalent Belgium SA370696762ANALYSIS(0597-0260, 0597-0053, 0597-0265, 0597-0053) , MANUFACTURE(0597-0260, 0597-0053, 0597-0265, 0597-0053)

    • Trademark Results [GlucaGen]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    GLUCAGEN
    GLUCAGEN
    77009824 3254580 Live/Registered
    Novo Nordisk A/S
    2006-09-28
    GLUCAGEN
    GLUCAGEN
    74145009 1841542 Dead/Cancelled
    NOVO NORDISK A/S
    1991-03-06
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