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 
Hevert Pharmaceuticals LLC

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.

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HEVERT® CALMVALERA™ COMP.

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
FULL PRESCRIBING INFORMATION: CONTENTS*
1 Indications and Usage
2 Dosage and Administration
   2.1 General Instructions
   2.2 Standard Dosage
   2.3 Acute Dosage
   2.4 Instruction for Opening Glass Ampule
3 Dosage Forms and Strength
4 Contraindications
5 Warnings and Precautions
6 Adverse Reactions
   6.1 Post-marketing Experience
7 Drug Interactions
8 Use in specific Populations
   8.1 Pregnancy

     8.2 Labor and Delivery
     8.3 Nursing Mothers
     8.4 Pediatric Use
     8.5 Geriatric Use
10 Overdosage
11 Description
     11.1 Ingredients
     11.2 Pharmaceutical Form
     11.3 Route of Administration
15 References
16 How Supplied / Storage and Handling
     16.1 Dosage Forms and Package Sizes
     16.2 Storage
* Sections or subsections omitted from the full prescribing information are not listed.

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

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
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)

Revised: 7/2018
Document Id: e26be564-e644-4dd9-865c-cc36f527f822
Set id: d8b13f26-ed02-4c88-b661-b028d2273b6f
Version: 3
Effective Time: 20180716
 
Hevert Pharmaceuticals LLC