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 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.

----------

HEVERT® GELSEMIUM COMP.

HIGHLIGHTS OF PRESCRIBING INFORMATION
These 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

Adults:
1 mL to 2 mL up to 3 times daily.

Hevert® Gelsemium comp. may be administered intramuscularly, subcutaneously, or intracutaneously.		Image

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 namePotencyQuantityFinal dilution
Aconitum napellus4X5 %5.5X
Cocculus indicus4X5 %5.5X
Colocynthis4X5 %5.5X
Gelsemium sempervirens4X5 %5.5X
Lachesis mutus12X5 %13.5X
Mezereum6X5 %7.5X
Nux vomica6X5 %7.5X
Plumbum aceticum6X5 %7.5X
Rhus toxicodendron6X5 %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

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

PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54532-0027
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACONITUM NAPELLUS WHOLE (UNII: U0NQ8555JD) (ACONITUM NAPELLUS WHOLE - UNII:U0NQ8555JD) ACONITUM NAPELLUS WHOLE4 [hp_X]  in 2 mL
ANAMIRTA COCCULUS SEED (UNII: 810258W28U) (ANAMIRTA COCCULUS SEED - UNII:810258W28U) ANAMIRTA COCCULUS SEED4 [hp_X]  in 2 mL
CITRULLUS COLOCYNTHIS FRUIT (UNII: 0E49E3V9U6) (CITRULLUS COLOCYNTHIS FRUIT - UNII:0E49E3V9U6) CITRULLUS COLOCYNTHIS FRUIT4 [hp_X]  in 2 mL
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q) GELSEMIUM SEMPERVIRENS ROOT4 [hp_X]  in 2 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 2 mL
DAPHNE MEZEREUM BARK (UNII: X2N6E405GV) (DAPHNE MEZEREUM BARK - UNII:X2N6E405GV) DAPHNE MEZEREUM BARK6 [hp_X]  in 2 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_X]  in 2 mL
LEAD ACETATE ANHYDROUS (UNII: KL498O6790) (LEAD Cation PB4+ - UNII:7Y62STE4M2) LEAD ACETATE ANHYDROUS6 [hp_X]  in 2 mL
TOXICODENDRON PUBESCENS SHOOT (UNII: 46PYZ1F82M) (TOXICODENDRON PUBESCENS SHOOT - UNII:46PYZ1F82M) TOXICODENDRON PUBESCENS SHOOT6 [hp_X]  in 2 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54532-0027-410 in 1 CARTON06/01/201612/31/2021
12 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED HOMEOPATHIC06/01/201612/31/2021
Labeler - Hevert Pharmaceuticals LLC (078647622)
Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)
Establishment
NameAddressID/FEIBusiness Operations
Hevert Arzneimittel GmbH & Co. KG318100617API MANUFACTURE(54532-0027)
Establishment
NameAddressID/FEIBusiness Operations
Solupharm Pharmazeutische Erzeugnisse GmbH316875129MANUFACTURE(54532-0027)

Revised: 10/2021
Document Id: ddd6316e-3775-4858-9e7f-fbb4b0a6f261
Set id: 5856840b-9012-4613-8de4-3ad0f4ed110e
Version: 5
Effective Time: 20211021
 
Hevert Pharmaceuticals LLC