NDC | 52919-123-10 |
Set ID | 8b9820bb-d592-46bf-b1db-f91947bf49aa |
Category | HUMAN PRESCRIPTION DRUG LABEL |
Packager | Hameln Pharma GmbH |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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.
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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).
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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.
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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.
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
- CLINICAL PHARMACOLOGY
- DOSAGE
- STORAGE CONDITIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LYMPHOMYOSOT
geranium robertianum and rorippa nasturtium-aquaticum and tribasic calcium phosphate and levothyroxine and injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:52919-123 Route of Administration INTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GERANIUM ROBERTIANUM (UNII: R5I1HK0UBL) (GERANIUM ROBERTIANUM - UNII:R5I1HK0UBL) GERANIUM ROBERTIANUM 4 [hp_X] in 1.1 mL RORIPPA NASTURTIUM-AQUATICUM (UNII: YH89GMV676) (RORIPPA NASTURTIUM-AQUATICUM - UNII:YH89GMV676) RORIPPA NASTURTIUM-AQUATICUM 4 [hp_X] in 1.1 mL FERROUS IODIDE (UNII: F5452U54PN) (FERROUS IODIDE - UNII:F5452U54PN) FERROUS IODIDE 12 [hp_X] in 1.1 mL JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG) JUGLANS REGIA FLOWERING TOP 3 [hp_X] in 1.1 mL MYOSOTIS ARVENSIS (UNII: C73BK97H5J) (MYOSOTIS ARVENSIS - UNII:C73BK97H5J) MYOSOTIS ARVENSIS 3 [hp_X] in 1.1 mL SCROPHULARIA NODOSA (UNII: 7H443NUB2T) (SCROPHULARIA NODOSA - UNII:7H443NUB2T) SCROPHULARIA NODOSA 3 [hp_X] in 1.1 mL TEUCRIUM SCORODONIA FLOWERING TOP (UNII: LOK3I16O7G) (TEUCRIUM SCORODONIA FLOWERING TOP - UNII:LOK3I16O7G) TEUCRIUM SCORODONIA FLOWERING TOP 3 [hp_X] in 1.1 mL VERONICA OFFICINALIS FLOWERING TOP (UNII: 9IH82J936J) (VERONICA OFFICINALIS FLOWERING TOP - UNII:9IH82J936J) VERONICA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1.1 mL EQUISETUM HYEMALE (UNII: 59677RXH25) (EQUISETUM HYEMALE - UNII:59677RXH25) EQUISETUM HYEMALE 4 [hp_X] in 1.1 mL FUMARIA OFFICINALIS FLOWERING TOP (UNII: VH659J61ZL) (FUMARIA OFFICINALIS FLOWERING TOP - UNII:VH659J61ZL) FUMARIA OFFICINALIS FLOWERING TOP 4 [hp_X] in 1.1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM SULFATE 4 [hp_X] in 1.1 mL PINUS SYLVESTRIS TOP (UNII: Q1RGP4UB73) (PINUS SYLVESTRIS TOP - UNII:Q1RGP4UB73) PINUS SYLVESTRIS TOP 4 [hp_X] in 1.1 mL GENTIANA LUTEA ROOT (UNII: S72O3284MS) (GENTIANA LUTEA ROOT - UNII:S72O3284MS) GENTIANA LUTEA ROOT 5 [hp_X] in 1.1 mL ARANEUS DIADEMATUS (UNII: 6T6CO7R3Z5) (ARANEUS DIADEMATUS - UNII:6T6CO7R3Z5) ARANEUS DIADEMATUS 6 [hp_X] in 1.1 mL SARSAPARILLA (UNII: 2H1576D5WG) (SARSAPARILLA - UNII:2H1576D5WG) SARSAPARILLA 6 [hp_X] in 1.1 mL TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) TRIBASIC CALCIUM PHOSPHATE 12 [hp_X] in 1.1 mL LEVOTHYROXINE (UNII: Q51BO43MG4) (LEVOTHYROXINE - UNII:Q51BO43MG4) LEVOTHYROXINE 12 [hp_X] in 1.1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52919-123-10 1.1 mL in 1 AMPULE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/01/2010 Labeler - Hameln Pharma GmbH (315869123) Establishment Name Address ID/FEI Business Operations Hameln Pharma GmbH 315869123 manufacture