Label: LYMPHOMYOSOT- geranium robertianum and rorippa nasturtium-aquaticum and tribasic calcium phosphate and levothyroxine and injection

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 1, 2010

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  • DESCRIPTION

    Injection Solution Ingredient Information: Each 1.1ml ampule contains: Geranium robertianum 4X 1.1 mcl, Nasturtium aquaticum 4X 1.1 mcl, Ferrum iodatum 12X 1.1 mcl, Juglans regia 3X 0.55 mcl, Myosotis arvensis 3X 0.55 mcl, Scrophularia nodosa 3X 0.55 mcl, Teucrium scorodonia 3X 0.55 mcl, Veronica officinalis 3X 0.55 mcl, Equistetum hyemale 4X 0.55 mcl, Fumaria officinalis 4X 0.55 mcl, Natrum sulphuricum 4X 0.55 mcl, Pinus sylvestris 4X 0.55 mcl, Gentiana lutea 5X 0.55 mcl, Aranea diadema 6X 0.55 mcl, Sarsaparilla 6X 0.55 mcl, Calcarea phosphorica 12X 0.55 mcl, Levothyroxine 12X 0.55 mcl. Inactive Ingredients: Sterile Isotonic sodium chloride solution.

  • INDICATION AND USAGE

    Lymphomyosot® Injection Solution is classified as a homeopathic combination drug.


    Botanical Ingredients:
    Equisetum hyemale (Horsetail), Fumaria officinalis (Common fumitory), Gentiana lutea (Yellow gentian), Geranium robertianum (Herb Robert), Juglans regia (Walnut), Myosotis arvensis (Forget-me-not), Nasturtium aquaticum (Watercress), Pinus sylvestris (Scotch Pine), Sarsaparilla (Wild liquorice), Scrophularia nodosa (Figwort), Teucrium scorodonia (Wood-germander), Veronica officinalis (Common speedwell).


    Mineral Ingredients:
    Calcarea phosphorica (Tribasic calcium phosphate), Ferrum iodatum (Ferrous iodide), Natrum sulphuricum (Disodium sulfate).


    Animal-derived ingredients:
    Aranea diadema (Papal-cross spider), Levothyroxine (L-thyroxine).


    Lymphomyosot® Injection Solution is indicated for the temporary relief of swelling due to poor circulation, minor injury and environmental toxins.




     
  • DOSAGE AND ADMINISTRATION

    The dosage schedules listed can be used as a general guide for the administration of Lymphomyosot® Injection Solution. Lymphomyosot® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response therapy.


    Adults and children 7 years and older: in acute disorders, 1 ampule per day, otherwise 1 ampule, 1 to 3 times per week IM/SC/IV/ID. Children ages 2 to 6: receive 1/2 the adult dosage. Discard unused solution.


    Lymphomyosot® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Lymphomyosot® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefly. Lymphomyosot® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Lymphomyosot® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Lymphomyosot® Injection Solution is a clear, colorless solution. Discolored solutions should be discarded.
  • WARNINGS AND PRECAUTIONS

    If new syptoms occur, or if redness, pain or swelling at the puncture site persists, the patient should be carefully re-evaluated because these could be signs of a more serious condition.


    Lymphomyosot® Injection Solution exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system side effects.


    No harmful or potentially harmful side effects such as central nervous system depression are known. Lymphomyosot® Injection Solution is generally well-tolerated, however, if symptoms persist or worsen discontinue use.


    Teratogenic effects: In general, homeopathic drugs are not known to cause direct or indirect harm to the fetus Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

    Drug Interactions: None known

    Drug/Laboratory Test Interaction: None known

    Carcinogenesis, mutagenesis, impairment of fertility: Not applicable
  • OVERDOSAGE

    Due to the low concentration of active ingredients in homeopathic preparations such as Lymphomyosot® Injection Solution. adverse reactions following over dosage are extremely unlikely. However, care must be taken not to exceed the recommended dosage.





  • CLINICAL PHARMACOLOGY

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

  • DOSAGE

    Injections: 1.1 ml ampule

  • STORAGE CONDITIONS

    Avoid freezing and excessive heat. Store at room temperature. Protect from light.

  • PRINCIPAL DISPLAY PANEL


    Lymphomyosot_injectable box.jpg

    Lymphomyosot_injectable box.jpg

  • INGREDIENTS AND APPEARANCE
    LYMPHOMYOSOT 
    geranium robertianum and rorippa nasturtium-aquaticum and tribasic calcium phosphate and levothyroxine and injection
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52919-123
    Route of AdministrationINTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL) (GERANIUM ROBERTIANUM - UNII:R5I1HK0UBL) GERANIUM ROBERTIANUM4 [hp_X]  in 1.1 mL
    RORIPPA NASTURTIUM-AQUATICUM (UNII: YH89GMV676) (RORIPPA NASTURTIUM-AQUATICUM - UNII:YH89GMV676) RORIPPA NASTURTIUM-AQUATICUM4 [hp_X]  in 1.1 mL
    FERROUS IODIDE (UNII: F5452U54PN) (FERROUS IODIDE - UNII:F5452U54PN) FERROUS IODIDE12 [hp_X]  in 1.1 mL
    JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG) JUGLANS REGIA FLOWERING TOP3 [hp_X]  in 1.1 mL
    MYOSOTIS ARVENSIS (UNII: C73BK97H5J) (MYOSOTIS ARVENSIS - UNII:C73BK97H5J) MYOSOTIS ARVENSIS3 [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
    VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J) (VERONICA OFFICINALIS FLOWERING TOP - UNII:9IH82J936J) VERONICA OFFICINALIS FLOWERING TOP3 [hp_X]  in 1.1 mL
    EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE4 [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
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SULFATE4 [hp_X]  in 1.1 mL
    PINUS SYLVESTRIS TOP (UNII: Q1RGP4UB73) (PINUS SYLVESTRIS TOP - UNII:Q1RGP4UB73) PINUS SYLVESTRIS 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
    ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS6 [hp_X]  in 1.1 mL
    SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SARSAPARILLA6 [hp_X]  in 1.1 mL
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE12 [hp_X]  in 1.1 mL
    LEVOTHYROXINE (UNII: Q51BO43MG4) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE12 [hp_X]  in 1.1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52919-123-101.1 mL in 1 AMPULE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2010
    Labeler - Hameln Pharma GmbH (315869123)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hameln Pharma GmbH315869123manufacture