HEVERT LYMPHADEN COMP.- arsenic trioxide, clematis recta flowering top, lachesis muta venom, mercuric cyanide, phytolacca americana root, toxicodendron pubescens shoot, scrophularia nodosa leaf with stem, sulfur, and thuja occidentalis leafy twig injection

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use Hevert® Lymphaden™ comp. safely and effectively.

See full prescribing information for Hevert® Lymphaden™ comp.

Hevert® Lymphaden™ comp. solution for injection, for intravenous, intramuscular, subcutaneous, and intracutaneous administration.

Rx Use Only
------------- INDICATIONS AND USAGE -------------
Hevert® Lymphaden™ comp. is a homeopathic drug indicated for the improvement of conditions such as swelling of the lymph nodes, and lymphatic edema. (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® Lymphaden™ 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® Lymphaden™ 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® Lymphaden™ 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® Lymphaden™ 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® Lymphaden™ comp. is a homeopathic drug indicated for the improvement of conditions such as swelling of the lymph nodes, and lymphatic edema.

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® Lymphaden™ 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® Lymphaden™ 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® Lymphaden™ 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® Lymphaden™ comp. or any of its ingredients. There are not adequate and well-controlled studies in pregnant women. Hevert® Lymphaden™ 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® Lymphaden™ comp. is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hevert® Lymphaden™ 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® Lymphaden™ 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® Lymphaden™ 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
Arsenicum album	6X	5 %	7.5X
Clematis erecta	4X	5 %	5.5X
Lachesis mutus	8X	5 %	9.5X
Mercurius cyanatus	8X	5 %	9.5X
Phytolacca decandra	6X	5 %	7.5X
Rhus toxicodendron	6X	5 %	7.5X
Scrophularia nodosa	4X	5 %	5.5X
Sulphur	6X	5 %	7.5X
Thuja occidentalis	4X	5 %	5.5X

Inactive ingredients:

Sodium chloride 0.015 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® Lymphaden™ comp. ampules are supplied as 1 ampule of 2 mL solution for injection in packs of 10 ampules
- NDC: 54532-0029-4
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 499/1812
PRINCIPAL DISPLAY PANEL - 2.0 mL Ampule Carton

NDC: 54532-0029-4

HEVERT®
LYMPHADEN™
COMP.

Homeopathic

Solution for Injection

Rx only

IV IM SC IC

10 sterile 2.0 mL ampules
hEVERT

INGREDIENTS AND APPEARANCE

HEVERT LYMPHADEN COMP.
arsenic trioxide, clematis recta flowering top, lachesis muta venom, mercuric cyanide, phytolacca americana root, toxicodendron pubescens shoot, scrophularia nodosa leaf with stem, sulfur, and thuja occidentalis leafy twig injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 54532-0029
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	6 [hp_X] in 2 mL
CLEMATIS RECTA FLOWERING TOP (UNII: 396421SP9F) (CLEMATIS RECTA FLOWERING TOP - UNII:396421SP9F)	CLEMATIS RECTA FLOWERING TOP	4 [hp_X] in 2 mL
LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I)	LACHESIS MUTA VENOM	8 [hp_X] in 2 mL
MERCURIC CYANIDE (UNII: RWG7BD1032) (MERCURIC CYANIDE - UNII:RWG7BD1032, MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CYANIDE	8 [hp_X] in 2 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	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
SCROPHULARIA NODOSA LEAF WITH STEM (UNII: K93UPA2CNQ) (SCROPHULARIA NODOSA LEAF WITH STEM - UNII:K93UPA2CNQ)	SCROPHULARIA NODOSA LEAF WITH STEM	4 [hp_X] in 2 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 [hp_X] in 2 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	4 [hp_X] in 2 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 54532-0029-4	10 in 1 CARTON	06/01/2016
1		2 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
UNAPPROVED HOMEOPATHIC		06/01/2016

Labeler - Hevert Pharmaceuticals LLC (078647622)

Registrant - Hevert Arzneimittel GmbH & Co. KG (318100617)

Name	Address	ID/FEI	Business Operations
Establishment
Hevert Arzneimittel GmbH & Co. KG		318100617	API MANUFACTURE(54532-0029)

Name	Address	ID/FEI	Business Operations
Establishment
Solupharm Pharmazeutische Erzeugnisse GmbH		316875129	MANUFACTURE(54532-0029)