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  4. Engystol

Engystol

Cynanchum Vincetoxicum Root And Sulfur


Medinatura
Human Prescription Drug
NDC 50114-7015
Engystol also known as Cynanchum Vincetoxicum Root And Sulfur is a human prescription drug labeled by 'Medinatura'. National Drug Code (NDC) number for Engystol is 50114-7015. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Engystol drug includes Cynanchum Vincetoxicum Root - 6 [hp_X]/1.1mL Sulfur - 4 [hp_X]/1.1mL . The currest status of Engystol drug is Active.

Drug Information:

Drug NDC: 50114-7015
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Engystol
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Cynanchum Vincetoxicum Root And Sulfur
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Medinatura
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:CYNANCHUM VINCETOXICUM ROOT - 6 [hp_X]/1.1mL
SULFUR - 4 [hp_X]/1.1mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRADERMAL
INTRAMUSCULAR
INTRAVENOUS
SUBCUTANEOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 31 May, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 28 Feb, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 17 Dec, 2025
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:MediNatura
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UNII:9R858U917W
70FD1KFU70
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
50114-7015-110 AMPULE in 1 CARTON (50114-7015-1) / 1.1 mL in 1 AMPULE31 May, 201428 Feb, 2025No
50114-7015-23 AMPULE in 1 CARTON (50114-7015-2) / 1.1 mL in 1 AMPULE31 May, 201428 Feb, 2025No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.
Other medicines with the same generic name

Engystol


Cynanchum Vincetoxicum Root And Sulfur

Injection
MediNatura
NDC: 50114-7015

Product Elements:

Engystol cynanchum vincetoxicum root and sulfur cynanchum vincetoxicum root cynanchum vincetoxicum root sulfur sulfur sodium chloride water

Indications and Usage:

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.

Warnings and Cautions:

Warnings and precautions none

Dosage and Administration:

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. chil
dren 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.

Dosage Forms and Strength:

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

Contraindications:

Contraindications engystol ® injection solution is contraindicated in patients with known hypersensitivity to engystol ® or any of its ingredients.

Adverse Reactions:

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:

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

Description:

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

Clinical Pharmacology:

Clinical pharmacology mechanism of action the exact mechanism of engystol ® injection solution is not fully understood. pharmacodynamics not applicable for homeopathic medicinal products.

Package Label Principal Display Panel:

Engystol 1.1ml injection.jpg


Comments/ Reviews:

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