LYMPHOMYOSOT X (ARANEUS DIADEMATUS, TRIBASIC CALCIUM PHOSPHATE, EQUISETUM HYEMALE, FERROUS IODIDE,FUMARIA OFFICINALIS FLOWERING TOP, GENTIANA LUTEA ROOT, GERANIUM ROBERTIANUM, MYOSOTIS ARVENS

LYMPHOMYOSOT X (ARANEUS DIADEMATUS, TRIBASIC CALCIUM PHOSPHATE, EQUISETUM HYEMALE, FERROUS IODIDE,FUMARIA OFFICINALIS FLOWERING TOP, GENTIANA LUTEA ROOT, GERANIUM ROBERTIANUM, MYOSOTIS ARVENS
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NDC 50114-8200-1, 50114-8200-3
Set ID 8080de86-492c-4fd0-9b52-f4262bae0b29
Category HUMAN PRESCRIPTION DRUG LABEL
Packager MediNatura
Generic Name
Product Class
Product Number
Application Number
  • 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

  • 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.

  • 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 administer 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.

  • WARNINGS AND PRECAUTIONS

    Keep out of reach of children.

  • CONTRAINDICATIONS

    Lymphomyosot® X Injection Solution is contraindicationed in patients with known hypersensiticety to Lymphomyost® X or any of its ingredients.

  • OVERDOSAGE

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

  • 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.

  • DOSAGE FORMS AND STRENGTH

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

  • MECHANISM OF ACTION

    The exact mechanism of Lymphomyosot® X injection Solution is not fully understood.

  • PRINCIPAL DISPLAY PANEL

    Lymphomyosot X 1.1ml Injection.jpg

  • INGREDIENTS AND APPEARANCE
    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 injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50114-8200
    Route of AdministrationINTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS6 [hp_X]  in 1.1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION12 [hp_X]  in 1.1 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE12 [hp_X]  in 1.1 mL
    FERROUS IODIDE (UNII: F5452U54PN) (FERROUS IODIDE - UNII:F5452U54PN) FERROUS IODIDE3 [hp_X]  in 1.1 mL
    FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL) FUMARIA OFFICINALIS FLOWERING TOP4 [hp_X]  in 1.1 mL
    GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT5 [hp_X]  in 1.1 mL
    GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL) (GERANIUM ROBERTIANUM - UNII:R5I1HK0UBL) GERANIUM ROBERTIANUM4 [hp_X]  in 1.1 mL
    MYOSOTIS ARVENSIS (UNII: C73BK97H5J) (MYOSOTIS ARVENSIS - UNII:C73BK97H5J) MYOSOTIS ARVENSIS3 [hp_X]  in 1.1 mL
    NASTURTIUM OFFICINALE (UNII: YH89GMV676) (NASTURTIUM OFFICINALE - UNII:YH89GMV676) NASTURTIUM OFFICINALE4 [hp_X]  in 1.1 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE4 [hp_X]  in 1.1 mL
    PINUS SYLVESTRIS LEAFY TWIG (UNII: Q1RGP4UB73) (PINUS SYLVESTRIS LEAFY TWIG - UNII:Q1RGP4UB73) PINUS SYLVESTRIS LEAFY TWIG4 [hp_X]  in 1.1 mL
    SMILAX ORNATA ROOT (UNII: 2H1576D5WG) (SMILAX ORNATA ROOT - UNII:2H1576D5WG) SMILAX ORNATA ROOT6 [hp_X]  in 1.1 mL
    SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA3 [hp_X]  in 1.1 mL
    TEUCRIUM SCORODONIA FLOWERING TOP (UNII: LOK3I16O7G) (TEUCRIUM SCORODONIA FLOWERING TOP - UNII:LOK3I16O7G) TEUCRIUM SCORODONIA FLOWERING TOP3 [hp_X]  in 1.1 mL
    THYROID, UNSPECIFIED (UNII: 0B4FDL9I6P) (THYROID, UNSPECIFIED - UNII:0B4FDL9I6P) THYROID, UNSPECIFIED12 [hp_X]  in 1.1 mL
    VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J) (VERONICA OFFICINALIS FLOWERING TOP - UNII:9IH82J936J) VERONICA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50114-8200-33 in 1 CARTON07/31/2014
    11.1 mL in 1 AMPULE; Type 0: Not a Combination Product
    2NDC:50114-8200-110 in 1 CARTON07/31/2014
    21.1 mL in 1 AMPULE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/31/2014
    Labeler - MediNatura (102783016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hameln Pharma GmbH315869123manufacture(50114-8200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biologische Heilmittel Heel315635359manufacture(50114-8200)

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