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 Calmvalera comp. by

Drug Labeling and Warnings

Hevert Calmvalera comp. by is a Homeopathic medication manufactured, distributed, or labeled by Hevert Pharmaceuticals LLC, Hevert Arzneimittel GmbH & Co. KG, Solupharm Pharmazeutische Erzeugnisse GmbH. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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

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 name	Potency	Quantity	Final 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 metallicum	10X	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

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 Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54532-0036
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	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
CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT (UNII: 21Y9GZ1LZA) (CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT - UNII:21Y9GZ1LZA)	CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT	4 [hp_X]  in 2 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	6 [hp_X]  in 2 mL
PASSIFLORA INCARNATA FLOWERING TOP (UNII: CLF5YFS11O) (PASSIFLORA INCARNATA FLOWERING TOP - UNII:CLF5YFS11O)	PASSIFLORA INCARNATA FLOWERING TOP	4 [hp_X]  in 2 mL
PLATINUM (UNII: 49DFR088MY) (PLATINUM - UNII:49DFR088MY)	PLATINUM	10 [hp_X]  in 2 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	4 [hp_X]  in 2 mL
ZINC VALERATE DIHYDRATE (UNII: MN0RX54EQA) (VALERIC ACID - UNII:GZK92PJM7B)	ZINC VALERATE DIHYDRATE	8 [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: 54532-0036-4	10 in 1 CARTON	08/01/2016
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		08/01/2016

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(54532-0036)

Establishment
Name	Address	ID/FEI	Business Operations
Solupharm Pharmazeutische Erzeugnisse GmbH		316875129	MANUFACTURE(54532-0036)