HEVERT GELSEMIUM COMP- aconitum napellus, anamirta cocculus seed, citrullus colocynthis fruit, gelsemium sempervirens root, lachesis muta venom, daphne mezereum bark, strychnos nux-vomica seed, lead acetate anhydrous, and toxicodendron pubescens shoot injection

Hevert Gelsemium comp by

Drug Labeling and Warnings

Hevert Gelsemium 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 INFORMATIONThese highlights do not include all the information needed to use Hevert® Gelsemium comp. safely and effectively.See full prescribing information for Hevert® Gelsemium comp. Hevert® Gelsemium comp. solution for injection, for intramuscular, subcutaneous, and intracutaneous administration.Rx Use Only ------------- INDICATIONS AND USAGE ------------- Hevert® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain. (1) --------- DOSAGE AND ADMINISTRATION --------- Standard Dosage: Adults: 1 mL to 2 mL 1 to 3 times per 7 days. Acute Dosage: Adults: 1 mL to 2 mL up to 3 times daily. Hevert® Gelsemium comp. may be administered 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® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, 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® Gelsemium 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® Gelsemium comp. on pregnant or lactating women, 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 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® Gelsemium comp. is a homeopathic drug indicated for the improvement of painful nerve conditions, such as postherpetic neuralgia, trigeminal neuralgia, or sciatic nerve pain.

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

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® Gelsemium comp. is contraindicated in patients with known hypersensitivity to Rhus toxicodendron or other plants from the cashew family, 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® Gelsemium 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® Gelsemium comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Gelsemium 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® Gelsemium comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Gelsemium comp. is administered to a nursing woman.

8.4 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® Gelsemium 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
Aconitum napellus	4X	5 %	5.5X
Cocculus indicus	4X	5 %	5.5X
Colocynthis	4X	5 %	5.5X
Gelsemium sempervirens	4X	5 %	5.5X
Lachesis mutus	12X	5 %	13.5X
Mezereum	6X	5 %	7.5X
Nux vomica	6X	5 %	7.5X
Plumbum aceticum	6X	5 %	7.5X
Rhus toxicodendron	6X	5 %	7.5X

Inactive ingredients:
Sodium chloride 0.014 g

11.2 Pharmaceutical Form

Sterile solution for injection

11.3 Route of Administration

Parenteral: IM, SC or IC

15 References

German Homeopathic Pharmacopeia, Clarke

16 How Supplied/Storage and Handling

16.1 Dosage Forms and Package Sizes

• Hevert® Gelsemium comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
• NDC: 54532-0027-4

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 530/1812

PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton

NDC: 54532-0027-4

HEVERT®
GELSEMIUM
COMP.
Homeopathic

Solution for Injection
Rx only

IM SC IC

10 sterile 2.0 mL ampules
hEVERT

INGREDIENTS AND APPEARANCE

HEVERT GELSEMIUM COMP 
aconitum napellus, anamirta cocculus seed, citrullus colocynthis fruit, gelsemium sempervirens root, lachesis muta venom, daphne mezereum bark, strychnos nux-vomica seed, lead acetate anhydrous, and toxicodendron pubescens shoot injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54532-0027
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	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
CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6)	CITRULLUS COLOCYNTHIS FRUIT	4 [hp_X]  in 2 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	4 [hp_X]  in 2 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	12 [hp_X]  in 2 mL
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV)	DAPHNE MEZEREUM BARK	6 [hp_X]  in 2 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	6 [hp_X]  in 2 mL
LEAD ACETATE ANHYDROUS (UNII: KL498O6790) (LEAD Cation PB4+ - UNII:7Y62STE4M2)	LEAD ACETATE ANHYDROUS	6 [hp_X]  in 2 mL
TOXICODENDRON PUBESCENS SHOOT (UNII: 46PYZ1F82M) (TOXICODENDRON PUBESCENS SHOOT - UNII:46PYZ1F82M)	TOXICODENDRON PUBESCENS SHOOT	6 [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: 54532-0027-4	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(54532-0027)

Establishment
Name	Address	ID/FEI	Business Operations
Solupharm Pharmazeutische Erzeugnisse GmbH		316875129	MANUFACTURE(54532-0027)