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Lymphomyosot X Prescribing Information

Package insert / product label
Dosage form: injection

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.

Lymphomyosot X 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.

Lymphomyosot X 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.

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 Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50114-8200
Route of Administration INTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARANEUS DIADEMATUS (ARANEUS DIADEMATUS) ARANEUS DIADEMATUS 6 [hp_X] in 1.1 mL
TRIBASIC CALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM CATION 12 [hp_X] in 1.1 mL
EQUISETUM HYEMALE (EQUISETUM HYEMALE) EQUISETUM HYEMALE 12 [hp_X] in 1.1 mL
FERROUS IODIDE (FERROUS IODIDE) FERROUS IODIDE 3 [hp_X] in 1.1 mL
FUMARIA OFFICINALIS FLOWERING TOP (FUMARIA OFFICINALIS FLOWERING TOP) FUMARIA OFFICINALIS FLOWERING TOP 4 [hp_X] in 1.1 mL
GENTIANA LUTEA ROOT (GENTIANA LUTEA ROOT) GENTIANA LUTEA ROOT 5 [hp_X] in 1.1 mL
GERANIUM ROBERTIANUM (GERANIUM ROBERTIANUM) GERANIUM ROBERTIANUM 4 [hp_X] in 1.1 mL
MYOSOTIS ARVENSIS (MYOSOTIS ARVENSIS) MYOSOTIS ARVENSIS 3 [hp_X] in 1.1 mL
NASTURTIUM OFFICINALE (NASTURTIUM OFFICINALE) NASTURTIUM OFFICINALE 4 [hp_X] in 1.1 mL
SODIUM SULFATE (SODIUM SULFATE ANHYDROUS) SODIUM SULFATE 4 [hp_X] in 1.1 mL
PINUS SYLVESTRIS LEAFY TWIG (PINUS SYLVESTRIS LEAFY TWIG) PINUS SYLVESTRIS LEAFY TWIG 4 [hp_X] in 1.1 mL
SMILAX ORNATA ROOT (SMILAX ORNATA ROOT) SMILAX ORNATA ROOT 6 [hp_X] in 1.1 mL
SCROPHULARIA NODOSA (SCROPHULARIA NODOSA) SCROPHULARIA NODOSA 3 [hp_X] in 1.1 mL
TEUCRIUM SCORODONIA FLOWERING TOP (TEUCRIUM SCORODONIA FLOWERING TOP) TEUCRIUM SCORODONIA FLOWERING TOP 3 [hp_X] in 1.1 mL
THYROID, UNSPECIFIED (THYROID, UNSPECIFIED) THYROID, UNSPECIFIED 12 [hp_X] in 1.1 mL
VERONICA OFFICINALIS FLOWERING TOP (VERONICA OFFICINALIS FLOWERING TOP) VERONICA OFFICINALIS FLOWERING TOP 3 [hp_X] in 1.1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description
1 NDC:50114-8200-3 3 AMPULE in 1 CARTON
1 1.1 mL in 1 AMPULE
2 NDC:50114-8200-1 10 AMPULE in 1 CARTON
2 1.1 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/31/2014 08/31/2024
Labeler - MediNatura (102783016)
Establishment
Name Address ID/FEI Operations
Hameln Pharma GmbH 315869123 manufacture(50114-8200)
Establishment
Name Address ID/FEI Operations
Biologische Heilmittel Heel 315635359 manufacture(50114-8200)
MediNatura