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.
|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 ---------
|-------- DOSAGE FORMS AND STRENGTHS --------
|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
5 Warnings and Precautions
6 Adverse Reactions
6.1 Post-marketing Experience
7 Drug Interactions
8 Use in specific Populations
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
11.2 Pharmaceutical Form
11.3 Route of Administration
16 How Supplied / Storage and Handling
16.1 Dosage Forms and Package Sizes
* Sections or subsections omitted from the full prescribing information are not listed.
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.
|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.
One ampule containing 2 mL solution for injection, containing the active ingredients in the strengths listed under Description.
Hevert® Calmvalera™ comp. is contraindicated in patients with known hypersensitivity to lady's slipper or orchids, or to any of its ingredients.
No interactions have been reported, and none are expected due to the homeopathic dilutions.
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.
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.
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.
No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.
Each 2 mL solution for injection ampule contains:
|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|
Sodium chloride 0.015 g
Hevert Pharmaceuticals, LLC, Boulder, CO 80303
Made in Germany
|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
|Labeler - Hevert Pharmaceuticals LLC (078647622)|
|Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)|
|Hevert Arzneimittel GmbH & Co. KG||318100617||API MANUFACTURE(54532-0036)|
|Solupharm Pharmazeutische Erzeugnisse GmbH||316875129||MANUFACTURE(54532-0036)|