HEVERT ARNICA- arnica montana root injection

Hevert Arnica by

Drug Labeling and Warnings

Hevert Arnica 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]

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HIGHLIGHTS OF PRESCRIBING INFORMATION; These highlights do not include all the information needed to use Hevert® Arnica safely and effectively.; See full prescribing information for Hevert® Arnica.; Hevert® Arnica solution for injection, for intravenous, intramuscular, subcutaneous, and intracutaneous administration.; Rx Use Only; ----------- INDICATIONS AND USAGE -----------; Hevert® Arnica is a homeopathic drug indicated for the treatment of muscle pain and stiffness, bruising and swelling due to injuries and overexertion. (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® Arnica 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® Arnica is contraindicated in patients with known hypersensitivity to Arnica montana or other plants from the daisy family (Compositae). (4) ------ WARNINGS AND PRECAUTIONS ------- Keep out of reach of children. (5) -------------- ADVERSE REACTIONS -------------- No adverse events have been reported with causal relationship to Hevert® Arnica (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® Arnica 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 Strengths 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.

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FULL PRESCRIBING INFORMATION

1 Indications and Usage

1.1 Hevert® Arnica is a homeopathic drug indicated for the treatment of muscle pain and stiffness, bruising and swelling due to injuries and overexertion.

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® Arnica 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® Arnica is contraindicated in patients with known hypersensitivity to Arnica montana or other plants from the daisy family (Compositae).

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® Arnica

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® Arnica or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Arnica 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® Arnica is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Arnica 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® Arnica 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® Arnica 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
Arnica montana, radix	4×	50 %	4.5×

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® Arnica ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
• NDC: 54532-0025-4

16.2 Storage

• Store at 68 to 77 °F. Protect from light.
• Keep out of reach of children

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Distributed by:
Hevert Pharmaceuticals, LLC, Boulder, CO 80303, www.hevertusa.com

Made in Germany

US 000/1601

PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton

NDC: 54532-0025-4

HEVERT®
ARNICA
Homeopathic

Solution for Injection
Rx only

IV IM SC IC

10 sterile 2.0 mL ampules
hEVERT

INGREDIENTS AND APPEARANCE

HEVERT ARNICA 
arnica montana root injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54532-0025
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327)	ARNICA MONTANA ROOT	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: 54532-0025-4	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(54532-0025)

Establishment
Name	Address	ID/FEI	Business Operations
Solupharm Pharmazeutische Erzeugnisse GmbH		316875129	MANUFACTURE(54532-0025)