Label: HEVERT CALMVALERA COMP.- black cohosh, anamirta cocculus seed, cypripedium parvifolum root, strychnos ignatii seed, passiflora incarnata flowering top, platinum, valerian, and zinc valerate dihydrate injection

  • NDC Code(s): 54532-0036-4
  • 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

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  • SPL UNCLASSIFIED SECTION

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

    Hevert® Calmvalera™ comp. solution for injection, for intravenous, intramuscular and subcutaneous administration.
    Rx Use Only
    ------------- INDICATIONS AND USAGE -------------
    Hevert® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders such as restlessness and sleep disorders, mild depressive states, and mental exhaustion. (1)
    --------- DOSAGE AND ADMINISTRATION ---------
    • Standard Dosage:
      Adults and children 12 years and older:
      1 mL to 2 mL 1 to 3 times per 7 days.
    • Acute Dosage:
      Adults and children 12 years and older:
      1 mL to 2 mL up to 3 times daily.
    Hevert® Calmvalera™ comp. may be administered intravenously, intramuscularly or subcutaneously. (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® Calmvalera™ comp. is contraindicated in patients with known hypersensitivity to lady's slipper or orchids, 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® Calmvalera™ 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® Calmvalera™ comp. on pregnant or lactating women, in patients under 18 years of age, or elderly. (8)
    Revised: 04/2018
  • 1 Indications and Usage

    1.1 Hevert® Calmvalera™ comp. is a homeopathic drug indicated for the treatment of nervous disorders, such as restlessness and sleep disorders, mild depressive states, and mental exhaustion.

  • 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 and children 12 years and older:

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

    2.3 Acute Dosage

    Adults and children 12 years and older:
    1 mL to 2 mL up to 3 times daily.
    Hevert® Calmvalera™ comp. may be administered intravenously, intramuscularly or subcutaneously.
    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.
  • 3 Dosage Forms and Strengths

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

  • 4 Contraindications

    Hevert® Calmvalera™ comp. is contraindicated in patients with known hypersensitivity to lady's slipper or orchids, or to any of its ingredients.

  • 5 Warnings and Precautions

    Keep out of reach of children.

  • 6 Adverse Reactions

    6.1 Post-marketing Experience

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

  • 7 Drug Interactions

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

  • 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® Calmvalera™ comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Calmvalera™ 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® Calmvalera™ comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Calmvalera™ comp. is administered to a nursing woman.

    8.4 Pediatric Use

    Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Hevert® Calmvalera™ comp. has not identified differences in responses between adults and pediatric patients.

    8.5 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® Calmvalera™ comp. has not identified differences in responses between adults and geriatric patients.

  • 10 Overdosage

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

  • 11 Description

    11.1 Ingredients

    Each 2 mL solution for injection ampule contains:

    Active Ingredients:
    Ingredient namePotencyQuantityFinal dilution
    Cimicifuga racemosa  4X 5 %  5.5X
    Cocculus indicus  4X 5 %  5.5X
    Cypripedium pubescens  4X 5 %  5.5X
    Ignatia amara  6X 5 %  7.5X
    Passiflora incarnata  4X 5 %  5.5X
    Platinum metallicum10X 5 %11.5X
    Valeriana officinalis  4X 5 %  5.5X
    Zincum valerianicum  8X 5 %  9.5X

    Inactive ingredients:

    Sodium chloride 0.015 g

    11.2 Pharmaceutical Form

    Sterile solution for injection

    11.3 Route of Administration

    Parenteral: IV, IM, or SC

  • 15 References

    German Homeopathic Pharmacopeia, Clarke

  • 16 How Supplied/Storage and Handling

    16.1 Dosage Forms and Package Sizes

    • Hevert® Calmvalera™ comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
    • NDC 54532-0036-4

    16.2 Storage

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

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

    Made in Germany

    US 529/1812

  • PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton

    NDC 54532-0036-4

    HEVERT®
    CALMVALERA™
    COMP.
    Homeopathic

    Solution for Injection

    Rx only

    IV IM SC

    10 sterile 2.0 mL ampules

    hEVERT

    PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton
  • INGREDIENTS AND APPEARANCE
    HEVERT CALMVALERA COMP. 
    black cohosh, anamirta cocculus seed, cypripedium parvifolum root, strychnos ignatii seed, passiflora incarnata flowering top, platinum, valerian, and zinc valerate dihydrate injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54532-0036
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9) BLACK COHOSH4 [hp_X]  in 2 mL
    ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED4 [hp_X]  in 2 mL
    CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA) CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT4 [hp_X]  in 2 mL
    STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K) STRYCHNOS IGNATII SEED6 [hp_X]  in 2 mL
    PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O) PASSIFLORA INCARNATA FLOWERING TOP4 [hp_X]  in 2 mL
    PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY) PLATINUM10 [hp_X]  in 2 mL
    VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW) VALERIAN4 [hp_X]  in 2 mL
    ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B) ZINC VALERATE DIHYDRATE8 [hp_X]  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54532-0036-410 in 1 CARTON08/01/2016
    12 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC08/01/2016
    Labeler - Hevert Pharmaceuticals LLC (078647622)
    Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hevert Arzneimittel GmbH & Co. KG318100617API MANUFACTURE(54532-0036)
    Establishment
    NameAddressID/FEIBusiness Operations
    Solupharm Pharmazeutische Erzeugnisse GmbH316875129MANUFACTURE(54532-0036)