Lymphomyosot X
Araneus Diadematus, Tribasic Calcium Phosphate, Equisetum Hyemale, Ferrous Iodide,fumaria Officinalis Flowering Top, Gentiana Lutea Root, Geranium Robertianum, Myosotis Arvensis, Nasturtium Officinale, Sodium Sulfate, Pinus Sylvestris Leafy Twig,smilax Regelii Root, Scrophularia Nodosa, Teucrium Scorodonia Flowering Top, Thyroid, Unspecified Andveronica Officinalis Flowering Top
Medinatura
Human Prescription Drug
NDC 50114-8200Lymphomyosot X also known as Araneus Diadematus, Tribasic Calcium Phosphate, Equisetum Hyemale, Ferrous Iodide,fumaria Officinalis Flowering Top, Gentiana Lutea Root, Geranium Robertianum, Myosotis Arvensis, Nasturtium Officinale, Sodium Sulfate, Pinus Sylvestris Leafy Twig,smilax Regelii Root, Scrophularia Nodosa, Teucrium Scorodonia Flowering Top, Thyroid, Unspecified Andveronica Officinalis Flowering Top is a human prescription drug labeled by 'Medinatura'. National Drug Code (NDC) number for Lymphomyosot X is 50114-8200. This drug is available in dosage form of Injection. The names of the active, medicinal ingredients in Lymphomyosot X drug includes Araneus Diadematus - 6 [hp_X]/1.1mL Equisetum Hyemale - 12 [hp_X]/1.1mL Ferrous Iodide - 3 [hp_X]/1.1mL Fumaria Officinalis Flowering Top - 4 [hp_X]/1.1mL Gentiana Lutea Root - 5 [hp_X]/1.1mL Geranium Robertianum - 4 [hp_X]/1.1mL Myosotis Arvensis - 3 [hp_X]/1.1mL Nasturtium Officinale - 4 [hp_X]/1.1mL Pinus Sylvestris Leafy Twig - 4 [hp_X]/1.1mL Scrophularia Nodosa - 3 [hp_X]/1.1mL and more. The currest status of Lymphomyosot X drug is Active.
Drug Information:
| Drug NDC: | 50114-8200 |
| 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: | Lymphomyosot X |
| 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: | Araneus Diadematus, Tribasic Calcium Phosphate, Equisetum Hyemale, Ferrous Iodide,fumaria Officinalis Flowering Top, Gentiana Lutea Root, Geranium Robertianum, Myosotis Arvensis, Nasturtium Officinale, Sodium Sulfate, Pinus Sylvestris Leafy Twig,smilax Regelii Root, Scrophularia Nodosa, Teucrium Scorodonia Flowering Top, Thyroid, Unspecified Andveronica Officinalis Flowering Top |
| 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: | ARANEUS DIADEMATUS - 6 [hp_X]/1.1mL
EQUISETUM HYEMALE - 12 [hp_X]/1.1mL
FERROUS IODIDE - 3 [hp_X]/1.1mL
FUMARIA OFFICINALIS FLOWERING TOP - 4 [hp_X]/1.1mL
GENTIANA LUTEA ROOT - 5 [hp_X]/1.1mL
GERANIUM ROBERTIANUM - 4 [hp_X]/1.1mL
MYOSOTIS ARVENSIS - 3 [hp_X]/1.1mL
NASTURTIUM OFFICINALE - 4 [hp_X]/1.1mL
PINUS SYLVESTRIS LEAFY TWIG - 4 [hp_X]/1.1mL
SCROPHULARIA NODOSA - 3 [hp_X]/1.1mL
Load more...SMILAX ORNATA ROOT - 6 [hp_X]/1.1mL
SODIUM SULFATE - 4 [hp_X]/1.1mL
TEUCRIUM SCORODONIA FLOWERING TOP - 3 [hp_X]/1.1mL
THYROID, UNSPECIFIED - 12 [hp_X]/1.1mL
TRIBASIC CALCIUM PHOSPHATE - 12 [hp_X]/1.1mL
VERONICA OFFICINALIS FLOWERING TOP - 3 [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 Jul, 2014 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Aug, 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: | 27 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: | 6T6CO7R3Z5
59677RXH25
F5452U54PN
VH659J61ZL
S72O3284MS
R5I1HK0UBL
C73BK97H5J
YH89GMV676
Q1RGP4UB73
7H443NUB2T
Load more...2H1576D5WG
0YPR65R21J
LOK3I16O7G
0B4FDL9I6P
91D9GV0Z28
9IH82J936J
|
| 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. |
| Pharmacologic Class: | Blood Coagulation Factor [EPC]
Calcium [CS]
Cations
Divalent [CS]
Increased Coagulation Factor Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 50114-8200-1 | 10 AMPULE in 1 CARTON (50114-8200-1) / 1.1 mL in 1 AMPULE | 31 Jul, 2014 | 31 Aug, 2024 | No |
| 50114-8200-3 | 3 AMPULE in 1 CARTON (50114-8200-3) / 1.1 mL in 1 AMPULE | 31 Jul, 2014 | 31 Aug, 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:
Lymphomyosot x araneus diadematus, tribasic calcium phosphate, equisetum hyemale, ferrous iodide,fumaria officinalis flowering top, gentiana lutea root, geranium robertianum, myosotis arvensis, nasturtium officinale, sodium sulfate, pinus sylvestris leafy twig,smilax regelii root, scrophularia nodosa, teucrium scorodonia flowering top, thyroid, unspecified andveronica officinalis flowering top araneus diadematus araneus diadematus tribasic calcium phosphate calcium cation equisetum hyemale equisetum hyemale ferrous iodide ferrous iodide fumaria officinalis flowering top fumaria officinalis flowering top gentiana lutea root gentiana lutea root geranium robertianum geranium robertianum myosotis arvensis myosotis arvensis nasturtium officinale nasturtium officinale sodium sulfate sodium sulfate anhydrous pinus sylvestris leafy twig pinus sylvestris leafy twig smilax ornata root smilax ornata root scrophularia nodosa scrophularia nodosa teucrium scorodonia flowering top teucrium scorodonia flowering top thyroid, unspecified thyroid, unspecified veronica officinalis flowering top veronica officinalis flowering top sodium chloride water
Indications and Usage:
Indication and usage lymphomyosot x ® injection solution is a homeopathic drug product indicated for the improvement of lymphatic drainage, the non-specific immune defense, and conditions such as benign hypertrophy of lymphnodes, chronic tonsillitis, tonsillar hypertrophy and lymphatic edema.
Warnings and Cautions:
Warnings and precautions keep out of reach of children.
Dosage and Administration:
Dosage and administration general consideration ⢠if co-administration with a local anesthetic is desired, lymphomyosot® x injection solution may be mixed with lidocaine or similar agents at the discretion of the physician. ⢠the dosage schedules listed below can be used as a general guide for the administration of lymphomyosot® x injection solution. ⢠lymphomyosot® x 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. ⢠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 adminis
Read more...ter the product. 2.2 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. 2.3 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 forms and strength one ampule containing 1.1 ml solution for injection each containing the active ingredients in the strengths listed under description.
Contraindications:
Contraindications lymphomyosot ® x injection solution is contraindicationed in patients with known hypersensiticety to lymphomyost ® x or any of its ingredients.
Adverse Reactions:
Adverse reactions post-marketing experience the following adverse events have been identified during post-marketing use of lymphomyosot ® x 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 aranea diadema 6x 0.55 μl 9.30x calcarea phosphorica 12x 0.55 μl 15.30x equisetum hyemale 4x 0.55 μl 7.30x ferrum iodatum 12x 1.1 μl 15.00x fumaria officinalis 4x 0.55 μl 7.30x gentiana lutea 5x 0.55 μl 8.30x geranium robertianum 4x 1.1 μl 7.00x myosotis arvensis 3x 0.55 μl 6.30x nasturtium aquaticum 4x 1.1 μl 7.00x natrum sulphuricum 4x 0.55 μl 7.30x pinus sylvestris 4x 0.55 μl 7.30x sarsaparilla 6x 0.55 μl 9.30x scrophularia nodosa 3x 0.55 μl 6.30x teucrium scorodonia 3x 0.55 μl 6.30x thyroidinum 12x 0.55 μl 15.30x veronica officinalis 3x 0.55 μl 6.30x
Clinical Pharmacology:
Mechanism of action the exact mechanism of lymphomyosot ® x injection solution is not fully understood.
Package Label Principal Display Panel:
Lymphomyosot x 1.1ml injection.jpg