Traumeel
Arnica Montana Root, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Achillea Millefolium, Calcium Sulfide, Comfrey Root, Aconitum Napellus, Bellis Perennis, Mercurius Solubilis, Hypericum Perforatum, Echinacea, Unspecified, Echinacea Purpurea And Hamamelis Virginiana Root Bark/stem Bark
Medinatura
Human Prescription Drug
NDC 50114-7004Traumeel also known as Arnica Montana Root, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Achillea Millefolium, Calcium Sulfide, Comfrey Root, Aconitum Napellus, Bellis Perennis, Mercurius Solubilis, Hypericum Perforatum, Echinacea, Unspecified, Echinacea Purpurea And Hamamelis Virginiana Root Bark/stem Bark is a human prescription drug labeled by 'Medinatura'. National Drug Code (NDC) number for Traumeel is 50114-7004. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Traumeel drug includes Achillea Millefolium - 3 [hp_X]/2.2mL Aconitum Napellus - 2 [hp_X]/2.2mL Arnica Montana Root - 2 [hp_X]/2.2mL Atropa Belladonna - 2 [hp_X]/2.2mL Bellis Perennis - 2 [hp_X]/2.2mL Calcium Sulfide - 6 [hp_X]/2.2mL Calendula Officinalis Flowering Top - 2 [hp_X]/2.2mL Comfrey Root - 6 [hp_X]/2.2mL Echinacea Purpurea - 2 [hp_X]/2.2mL Echinacea, Unspecified - 2 [hp_X]/2.2mL and more. The currest status of Traumeel drug is Active.
Drug Information:
| Drug NDC: | 50114-7004 |
| 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: | Traumeel |
| 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: | Arnica Montana Root, Atropa Belladonna, Calendula Officinalis Flowering Top, Matricaria Recutita, Achillea Millefolium, Calcium Sulfide, Comfrey Root, Aconitum Napellus, Bellis Perennis, Mercurius Solubilis, Hypericum Perforatum, Echinacea, Unspecified, Echinacea Purpurea And Hamamelis Virginiana Root Bark/stem Bark |
| 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: | ACHILLEA MILLEFOLIUM - 3 [hp_X]/2.2mL
ACONITUM NAPELLUS - 2 [hp_X]/2.2mL
ARNICA MONTANA ROOT - 2 [hp_X]/2.2mL
ATROPA BELLADONNA - 2 [hp_X]/2.2mL
BELLIS PERENNIS - 2 [hp_X]/2.2mL
CALCIUM SULFIDE - 6 [hp_X]/2.2mL
CALENDULA OFFICINALIS FLOWERING TOP - 2 [hp_X]/2.2mL
COMFREY ROOT - 6 [hp_X]/2.2mL
ECHINACEA PURPUREA - 2 [hp_X]/2.2mL
ECHINACEA, UNSPECIFIED - 2 [hp_X]/2.2mL
Load more...HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 1 [hp_X]/2.2mL
HYPERICUM PERFORATUM - 2 [hp_X]/2.2mL
MATRICARIA RECUTITA - 3 [hp_X]/2.2mL
MERCURIUS SOLUBILIS - 6 [hp_X]/2.2mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | INTRA-ARTICULAR
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: | 09 May, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Dec, 2024 |
| 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: | 14 Jun, 2026 |
| 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: | 2FXJ6SW4PK
U0NQ8555JD
MUE8Y11327
WQZ3G9PF0H
2HU33I03UY
1MBW07J51Q
18E7415PXQ
M9VVZ08EKQ
QI7G114Y98
4N9P6CC1DX
Load more...T7S323PKJS
XK4IUX8MNB
G0R4UBI2ZZ
324Y4038G2
|
| 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50114-7004-1 | 10 AMPULE in 1 CARTON (50114-7004-1) / 2.2 mL in 1 AMPULE | 09 May, 2007 | 31 Dec, 2024 | No |
| 50114-7004-2 | 3 AMPULE in 1 CARTON (50114-7004-2) / 2.2 mL in 1 AMPULE | 09 May, 2007 | 31 Dec, 2024 | No |
| 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. |
Product Elements:
Traumeel arnica montana root, atropa belladonna, calendula officinalis flowering top, matricaria recutita, achillea millefolium, calcium sulfide, comfrey root, aconitum napellus, bellis perennis, mercurius solubilis, hypericum perforatum, echinacea, unspecified, echinacea purpurea and hamamelis virginiana root bark/stem bark arnica montana root arnica montana root atropa belladonna atropa belladonna calendula officinalis flowering top calendula officinalis flowering top matricaria recutita matricaria recutita achillea millefolium achillea millefolium calcium sulfide calcium sulfide comfrey root comfrey root aconitum napellus aconitum napellus bellis perennis bellis perennis mercurius solubilis mercurius solubilis hypericum perforatum hypericum perforatum echinacea, unspecified echinacea, unspecified echinacea purpurea echinacea purpurea hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark water sodium chloride
Indications and Usage:
Indication and usage treatment of injuries and various conditions of the musculoskeletal system. ⢠traumeel ® injection solution is a homeopathic drug product indicated for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain co-administration therapy with zeel ® injection solution for the treatment of inflammatory and degenerative conditions of the musculoskeletal system. ⢠traumeel ® injection solution is a homeopathic drug product indicated, in combination with zeel ® injection solution, for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness.
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 traumeel ® injection solution. if co-administration with a local anesthetic is desired, traumeel ® injection solution may be mixed with lidocaine or similar agents at the discretion of the physician. traumeel ® injection solution may be administered s.c., i.d., i.m., i.a. 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. draw up the contents of the ampule into the syringe. discard half or one third of the contents, depending on the required dosage, before administering. only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer th
Read more...e product. standard dosage - for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain. adults and children 12 years and older: 1 ampule 1 to 3 times per 7 days children 6 to 11 years: 2/3 of an ampule 1 to 3 times per 7 days children 2 to 5 years: 1/2 ampule 1 to 3 times per 7 days acute dosage - for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain. adults and children 12 years and older: 1 ampule daily, and then continue with standard dosage children 6 to 11 years: 2/3 of an ampule daily, and then continue with standard dosage children 2 to 5 years: 1/2 ampule daily, and then continue with standard dosage co-administration therapy with zeel ® injection solution - for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness. in the treatment of musculoskeletal conditions, if co-administration with another homeopathic medicinal product is desired, traumeel ® injection solution may be mixed in a ratio of 1:1 with zeel ® injection solution. for convenience, the daily dose of traumeel ® injection solution may be administered at the same time as a zeel ® injection solution, according to the dosing recommendations for each medication.
Dosage Forms and Strength:
Dosage one ampule containing 2.2 ml each containing the active ingredients in the strengths listed under description.
Contraindications:
Contraindications traumeel ® injection solution is contraindicated in patients with known hypersensitivity to traumeel ® or any of its ingredients.
Adverse Reactions:
Adverse reactions post-marketing experience ⢠the following adverse events have been identified during post-marketing use of traumeel ® 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. ⢠adverse event rates observed in monotherapy use of traumeel ® injection solution: allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) may occur in isolated cases. ⢠adverse event rates observed in the monotherapy use of zeel ® injection solution: allergic (hypersensitivity) skin reactions may occur in isolated cases. â¢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 active ingredients: ingredient name potency quantity final dilution aconitum napellus 2x 1.32 μl 5.22x arnica montana, radix 2x 2.20 μl 5.00x bellis perennis 2x 1.10 μl 5.30x belladonna 2x 2.20 μl 5.00x calendula officinalis 2x 2.20 μl 5.00x chamomilla 3x 2.20 μl 6.00x echinacea 2x 0.55 μl 5.60x echinacea purpurea 2x 0.55 μl 5.60x hamamelis virginiana 1x 0.22 μl 5.00x hepar sulphuris calcareum 6x 2.20 μl 9.00x hypericum perforatum 2x 0.66 μl 5.52x mercurius solubilis 6x 1.10 μl 9.30x millefolium 3x 2.20 μl 6.00x symphytum officinale 6x 2.20 μl 9.00x
Clinical Pharmacology:
Clinical pharmacology mechanism of action the exact mechanism of traumeel ® injection solution is not fully understood. pharmacodynamics not applicable for homeopathic medicinal products.
Package Label Principal Display Panel:
Traumeel 2.2ml injection.jpg