HEVERT HEPAR COMP.- milk thistle, chelidonium majus root, quassia amara wood, and taraxacum officinale injection

Hevert Hepar comp. by

Drug Labeling and Warnings

Hevert Hepar 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 informationneeded 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 --------- 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® Hepar comp. may be administered intravenously, intramuscularly, subcutaneously, or intracutaneously. (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® 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. (4)
  --------- WARNINGS AND PRECAUTIONS ---------
  • Keep out of reach of children. (5)
  ---------------- ADVERSE REACTIONS ----------------
  • No adverse events have been reported with causal relationship to Hevert® Hepar 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® Hepar comp. on pregnant or lactating women, in patients under 18 years of age, or elderly. (8)
  Revised: 4/2018

• 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® Hepar comp. is a homeopathic drug indicated for the treatment of liver and biliary system disorders.

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® Hepar comp. may be administered intravenously, intramuscularly, subcutaneously, or intracutaneously.

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® 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.

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® Hepar 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® 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.

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® 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.

8.4 Pediatric Use

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.

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® Hepar 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
Carduus marianus	4X	10 %	5X
Chelidonium majus, radix	6X	10 %	7X
Quassia	4X	10 %	5X
Taraxacum officinale	4X	10 %	5X

Inactive ingredients:

Sodium chloride 0.014 g

11.2 Pharmaceutical Form

Sterile solution for injection

11.3 Route of Administration

Parenteral: IV, IM, SC or IC

15 References

German Homeopathic
Pharmacopeia, Clarke

16 How Supplied/Storage and Handling

16.1 Dosage Forms and Package Sizes

• Hevert® Hepar comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
• NDC: 54532-0028-4

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 487/1812

PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton

NDC: 54532-0028-4

HEVERT®
HEPAR
COMP.

Homeopathic

Solution for Injection

Rx only

IV IM SC IC

10 sterile 2.0 mL ampules
hEVERT

INGREDIENTS AND APPEARANCE

HEVERT HEPAR COMP. 
milk thistle, chelidonium majus root, quassia amara wood, and taraxacum officinale injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54532-0028
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MILK THISTLE (UNII: U946SH95EE) (MILK THISTLE - UNII:U946SH95EE)	MILK THISTLE	4 [hp_X]  in 2 mL
CHELIDONIUM MAJUS ROOT (UNII: FLT36UCF0N) (CHELIDONIUM MAJUS ROOT - UNII:FLT36UCF0N)	CHELIDONIUM MAJUS ROOT	6 [hp_X]  in 2 mL
QUASSIA AMARA WOOD (UNII: S5249Q85HW) (QUASSIA AMARA WOOD - UNII:S5249Q85HW)	QUASSIA AMARA WOOD	4 [hp_X]  in 2 mL
TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375)	TARAXACUM OFFICINALE	4 [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: 54532-0028-4	10 in 1 CARTON	06/01/2016
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		06/01/2016

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(54532-0028)

Establishment
Name	Address	ID/FEI	Business Operations
Solupharm Pharmazeutische Erzeugnisse GmbH		316875129	MANUFACTURE(54532-0028)