ENGYSTOL- cynanchum vincetoxicum root and sulfur injection

Engystol by

Drug Labeling and Warnings

Engystol by is a Homeopathic medication manufactured, distributed, or labeled by MediNatura, Hameln Pharma GmbH, Biologische Heilmittel Heel. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Ingredient name	Potency	Quantity	Final dilution
Asclepias vincetoxicum	6X	6.6 μl	8.22X
Asclepias vincetoxicum	10X	6.6 μl	12.22X
Asclepias vincetoxicum	30X	6.6 μl	32.22X
Sulphur	4X	3.3 μl	6.52X
Sulphur	10X	3.3 μl	12.52X

INDICATIONS AND USAGE

Engystol® Injection Solution is a homeopathic drug product indicated for the support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.

DOSAGE AND ADMINISTRATION

General Considerations

The dosage schedules listed below can be used as a general guide for the administration of Engystol® Injection Solution.

Engystol® Injection Solution may be administered s.c., i.d., i.m., or i.v.

The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard any unused ampule contents.

Draw up required dose into syringe.

Discard any unused ampule contents. Do not reuse ampule.

• Only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product.

Standard Dosage:

Adults and children 12 years and older: 1 ml 1 to 3 times per 7 days.

Children 6 to 11 years: 0.7 ml 1 to 3 times per 7 days.

Children 2 to 5 years: 0.5 ml 1 to 3 times per 7 days.

Acute Dosage:

Adults and children 12 years and older: 1 ml daily, and then continue with standard dosage.

Children 6 to 11 years: 0.7 ml daily, and then continue with standard dosage.

Children 2 to 5 years: 0.5 ml daily, and then continue with standard dosage.

CONTRAINDICATIONS

Engystol® Injection Solution is contraindicated in patients with known hypersensitivity to Engystol® or any of its ingredients.

WARNINGS AND PRECAUTIONS

None

ADVERSE REACTIONS

Post-marketing Experience

The following adverse events have been identified during post-marketing use of Engystol® Injection Solution. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Allergic (hypersensitivity) skin reactions may occur in isolated cases.

To report SUSPECTED ADVERSE REACTIONS, contact MediNatura. at 1.844.633.4628 or info@medinatura.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

OVERDOSAGE

No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.

CLINICAL PHARMACOLOGY

Mechanism of Action

The exact mechanism of Engystol® Injection Solution is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

1 ampule containing 1.1 ml solution for injection each containing the active ingredients in the strengths listed under Description.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ENGYSTOL 
cynanchum vincetoxicum root and sulfur injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 50114-7015
Route of Administration	INTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CYNANCHUM VINCETOXICUM ROOT (UNII: 9R858U917W) (CYNANCHUM VINCETOXICUM ROOT - UNII:9R858U917W)	CYNANCHUM VINCETOXICUM ROOT	6 [hp_X]  in 1.1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	4 [hp_X]  in 1.1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50114-7015-1	10 in 1 CARTON	05/31/2014
1		1.1 mL in 1 AMPULE; Type 0: Not a Combination Product
2	NDC: 50114-7015-2	3 in 1 CARTON	05/31/2014
2		1.1 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		05/31/2014

Labeler - MediNatura (102783016)

Establishment
Name	Address	ID/FEI	Business Operations
Hameln Pharma GmbH		315869123	manufacture(50114-7015)

Establishment
Name	Address	ID/FEI	Business Operations
Biologische Heilmittel Heel		315635359	manufacture(50114-7015)