HEVERT HEPAR COMP.- milk thistle, chelidonium majus root, quassia amara wood, and taraxacum officinale 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® Hepar comp. safely and effectively.
See full prescribing information for Hevert® Hepar comp.
Hevert® Hepar comp. solution for injection, for intravenous, intramuscular, subcutaneous, and intracutaneous administration.
Rx Use Only
------------- INDICATIONS AND USAGE -------------
Hevert® Hepar comp. is a homeopathic drug indicated for the improvement of liver and biliary system disorders. (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® Hepar comp. is a homeopathic drug indicated for the treatment of liver and biliary system disorders.
|Adults and children 12 years and older:
1 mL to 2 mL up to 3 times daily.
|Hevert® Hepar comp. may be administered intravenously, intramuscularly, subcutaneously, or intracutaneously.|
One ampule containing 2 mL solution for injection, containing the active ingredients in the strengths listed under Description.
Hevert® Hepar comp. is contraindicated in patients with known hypersensitivity to Carduus marianus, Taraxacum officinale or other plants from the daisy family (Compositae), 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® Hepar comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Hepar comp. should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether Hevert® Hepar comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Hepar 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® Hepar 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|
|Carduus marianus||4X||10 %||5X|
|Chelidonium majus, radix||6X||10 %||7X|
|Taraxacum officinale||4X||10 %||5X|
Sodium chloride 0.014 g
Hevert Pharmaceuticals, LLC, Boulder, CO 80303, www.hevertusa.com
Made in Germany
|HEVERT HEPAR COMP.
milk thistle, chelidonium majus root, quassia amara wood, and taraxacum officinale injection
|Labeler - Hevert Pharmaceuticals LLC (078647622)|
|Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)|
|Hevert Arzneimittel GmbH & Co. KG||318100617||API MANUFACTURE(54532-0028)|
|Solupharm Pharmazeutische Erzeugnisse GmbH||316875129||MANUFACTURE(54532-0028)|