Label: HEVERT GELSEMIUM COMP- aconitum napellus, anamirta cocculus seed, citrullus colocynthis fruit, gelsemium sempervirens root, lachesis muta venom, daphne mezereum bark, strychnos nux-vomica seed, lead acetate anhydrous, and toxicodendron pubescens shoot injection

  • NDC Code(s): 54532-0027-4
  • Packager: Hevert Pharmaceuticals LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 16, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use Hevert® Gelsemium comp. safely and effectively.
    See full prescribing information for Hevert®
    Gelsemium comp.

    Hevert® Gelsemium comp. solution for injection, for intramuscular, subcutaneous, and intracutaneous administration.
    Rx Use Only
    ------------- INDICATIONS AND USAGE -------------
    Hevert® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain. (1)
    --------- DOSAGE AND ADMINISTRATION ---------
    • Standard Dosage:
      Adults:
      1 mL to 2 mL 1 to 3 times per 7 days.
    • Acute Dosage:
      Adults:
      1 mL to 2 mL up to 3 times daily.

    Hevert® Gelsemium comp. may be administered intramuscularly, subcutaneously, or intracutaneously. (2)

    -------- DOSAGE FORMS AND STRENGTHS --------
    • One ampule containing 2 mL solution for injection, containing the active ingredients in the strengths listed under Description. (3)

    ---------------- CONTRAINDICATIONS ----------------
    • Hevert® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, or to any of its ingredients. (4)

    --------- WARNINGS AND PRECAUTIONS ---------
    • Keep out of reach of children. (5)

    ---------------- ADVERSE REACTIONS ----------------
    • No adverse events have been reported with causal relationship to Hevert® Gelsemium comp. (6.1)
    • To report SUSPECTED ADVERSE REACTIONS, contact Hevert Pharmaceuticals at 1-855-387-6466 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    ---------------- DRUG INTERACTIONS ----------------
    • None known. (7)

    ---------- USE IN SPECIFIC POPULATIONS ----------
    • No studies have been conducted with Hevert® Gelsemium comp. on pregnant or lactating women, or elderly. (8)
    Revised: 4/2018
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  • 1 Indications and Usage

    1.1 Hevert® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain.

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  • 2 Dosage and Administration

    2.1 General Instructions

    • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
    • Draw up required dose into syringe.
    • Discard any unused ampule contents. Do not reuse ampule.

    2.2 Standard Dosage

    Adults

    1 mL to 2 mL 1 to 3 times per 7 days.

    2.3 Acute Dosage

    Adults:
    1 mL to 2 mL up to 3 times daily.

    Hevert® Gelsemium comp. may be administered intramuscularly, subcutaneously, or intracutaneously.
    Image

    2.4 Instruction for Opening Glass Ampule

    • Cutting open the glass ampule is not necessary. Hold the ampule head up at an angle, and tap/shake down the solution contained in the ampule head. Then break off the ampule head by applying pressure away from the color dot. Discard unused solution.
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  • 3 Dosage Forms and Strengths

    One ampule containing 2 mL solution for injection, containing the active ingredients in the strengths listed under Description.

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  • 4 Contraindications

    Hevert® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, or to any of its ingredients.

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  • 5 Warnings and Precautions

    Keep out of reach of children.

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  • 6 Adverse Reactions

    6.1 Post-marketing Experience

    No adverse reactions have been reported with a causal relationship to Hevert® Gelsemium comp.

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  • 7 Drug Interactions

    No interactions have been reported, and none are expected due to the homeopathic dilutions.

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  • 8 Use in specific Populations

    8.1 Pregnancy

    8.1.1 Teratogenic effects

    Pregnancy Category C

    Animal reproduction studies have not been performed with Hevert® Gelsemium comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Gelsemium comp. should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    8.1.2 Non-teratogenic effects

    No non-teratogenic effects are known.

    8.2 Labor and Delivery

    No recognized use in labor or delivery.

    8.3 Nursing Mothers

    It is not known whether Hevert® Gelsemium comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Gelsemium comp. is administered to a nursing woman.

    8.4 Geriatric Use

    Safety and effectiveness in elderly patients (≥65 years of age) have not been established. However, traditional homeopathic use of the ingredients in Hevert® Gelsemium comp. has not identified differences in responses between adults and geriatric patients.

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  • 10 Overdosage

    No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.

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  • 11 Description

    11.1 Ingredients

    Each 2 mL solution for injection ampule contains:

    Active Ingredients:
    Ingredient name Potency Quantity Final dilution
    Aconitum napellus 4X 5 % 5.5X
    Cocculus indicus 4X 5 % 5.5X
    Colocynthis 4X 5 % 5.5X
    Gelsemium sempervirens 4X 5 % 5.5X
    Lachesis mutus 12X 5 % 13.5X
    Mezereum 6X 5 % 7.5X
    Nux vomica 6X 5 % 7.5X
    Plumbum aceticum 6X 5 % 7.5X
    Rhus toxicodendron 6X 5 % 7.5X

    Inactive ingredients:
    Sodium chloride 0.014 g

    11.2 Pharmaceutical Form

    Sterile solution for injection

    11.3 Route of Administration

    Parenteral: IM, SC or IC

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  • 15 References

    German Homeopathic Pharmacopeia, Clarke

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  • 16 How Supplied/Storage and Handling

    16.1 Dosage Forms and Package Sizes

    • Hevert® Gelsemium comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
    • NDC 54532-0027-4

    16.2 Storage

    • Store at 68 to 77 °F. Protect from light.
    • Keep out of reach of children
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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Hevert Pharmaceuticals, LLC, Boulder, CO 80303 www.hevertusa.com

    Made in Germany

    US 530/1812

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  • PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton

    NDC 54532-0027-4

    HEVERT®
    GELSEMIUM
    COMP.
    Homeopathic

    Solution for Injection
    Rx only

    IM SC IC

    10 sterile 2.0 mL ampules
    hEVERT

    PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton
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  • INGREDIENTS AND APPEARANCE
    HEVERT GELSEMIUM COMP 
    aconitum napellus, anamirta cocculus seed, citrullus colocynthis fruit, gelsemium sempervirens root, lachesis muta venom, daphne mezereum bark, strychnos nux-vomica seed, lead acetate anhydrous, and toxicodendron pubescens shoot injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54532-0027
    Route of Administration INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD) ACONITUM NAPELLUS 4 [hp_X]  in 2 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED 4 [hp_X]  in 2 mL
    CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6) CITRULLUS COLOCYNTHIS FRUIT 4 [hp_X]  in 2 mL
    GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT 4 [hp_X]  in 2 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM 12 [hp_X]  in 2 mL
    DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK 6 [hp_X]  in 2 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED 6 [hp_X]  in 2 mL
    LEAD ACETATE ANHYDROUS (UNII: KL498O6790) (LEAD Cation PB4+ - UNII:7Y62STE4M2) LEAD ACETATE ANHYDROUS 6 [hp_X]  in 2 mL
    TOXICODENDRON PUBESCENS SHOOT (UNII: 46PYZ1F82M) (TOXICODENDRON PUBESCENS SHOOT - UNII:46PYZ1F82M) TOXICODENDRON PUBESCENS SHOOT 6 [hp_X]  in 2 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54532-0027-4 10 in 1 CARTON 06/01/2016
    1 2 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED HOMEOPATHIC 06/01/2016
    Labeler - Hevert Pharmaceuticals LLC (078647622)
    Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)
    Establishment
    Name Address ID/FEI Business Operations
    Hevert Arzneimittel GmbH & Co. KG 318100617 API MANUFACTURE(54532-0027)
    Establishment
    Name Address ID/FEI Business Operations
    Solupharm Pharmazeutische Erzeugnisse GmbH 316875129 MANUFACTURE(54532-0027)
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