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Lymphomyosot

Heel Inc

Lymphomyosot 1.1ml Injection


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

DESCRIPTION

 Each 1.1 ml ampule contains:
 Active Ingredients:
 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
 Juglans regia  3X  0.55 µl  6.30X
 Levothyroxine  12X  0.55 µl  15.30X
 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
 Veronica officinalis  3X  0.55 µl  6.30X

Inactive Ingredients:

Water for injections 1,089.0 μl

Sodium Chloride 10.3 μl

INDICATION AND USAGE

Lymphomyosot® 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 Considerations

  • The dosage schedules listed below can be used as a general guide for the administration of Lymphomyosot® Injection Solution.
  • Lymphomyosotl® 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 the contents of the ampule into the syringe.
  • Discard any unused ampule contents. Do not reuse ampule.

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

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.

CONTRAINDICATIONS

Lymphomyosot® Injection Solution is contraindicated in patients with known hypersensitivity to Lymphomyosot® or any of its ingredients.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

ADVERSE REACTIONS

Post-marketing Experience

  • The following adverse events have been identified during post-marketing use of Lymphomyosot® 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 Heel Inc. at 1.800.920.9203

info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

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


CLINICAL PHARMACOLOGY

Mechanism of Action

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

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

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

Lymphomyosot

GERANIUM ROBERTIANUM, NASTURTIUM OFFICINALE, FERROUS IODIDE, JUGLANS REGIA LEAF, JUGLANS REGIA FRUIT RIND, IMMATURE, MYOSOTIS ARVENSIS, SCROPHULARIA NODOSA, TEUCRIUM SCORODONIA FLOWERING TOP, VERONICA OFFICINALIS FLOWERING TOP, EQUISETUM HYEMALE, FUMARIA OFFICINALIS FLOWERING TOP, SODIUM SULFATE, PINUS SYLVESTRIS FLOWERING TOP,GENTIANA LUTEA ROOT, ARANEUS DIADEMATUS, SMILAX REGELII ROOT, TRIBASIC CALCIUM PHOSPHATE and LEVOTHYROXINE INJECTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:50114-7026
Route of Administration INTRADERMAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
GERANIUM ROBERTIANUM GERANIUM ROBERTIANUM 4 [hp_X]
NASTURTIUM OFFICINALE NASTURTIUM OFFICINALE 4 [hp_X]
FERROUS IODIDE FERROUS IODIDE 12 [hp_X]
JUGLANS REGIA LEAF JUGLANS REGIA LEAF 3 [hp_X]
JUGLANS REGIA FRUIT RIND, IMMATURE JUGLANS REGIA FRUIT RIND, IMMATURE 3 [hp_X]
MYOSOTIS ARVENSIS MYOSOTIS ARVENSIS 3 [hp_X]
SCROPHULARIA NODOSA SCROPHULARIA NODOSA 3 [hp_X]
TEUCRIUM SCORODONIA FLOWERING TOP TEUCRIUM SCORODONIA FLOWERING TOP 3 [hp_X]
VERONICA OFFICINALIS FLOWERING TOP VERONICA OFFICINALIS FLOWERING TOP 3 [hp_X]
EQUISETUM HYEMALE EQUISETUM HYEMALE 4 [hp_X]
FUMARIA OFFICINALIS FLOWERING TOP FUMARIA OFFICINALIS FLOWERING TOP 4 [hp_X]
SODIUM SULFATE SODIUM CATION 4 [hp_X]
PINUS SYLVESTRIS FLOWERING TOP PINUS SYLVESTRIS FLOWERING TOP 4 [hp_X]
GENTIANA LUTEA ROOT GENTIANA LUTEA ROOT 5 [hp_X]
ARANEUS DIADEMATUS ARANEUS DIADEMATUS 6 [hp_X]
SMILAX REGELII ROOT Smilax Regelii Root 6 [hp_X]
TRIBASIC CALCIUM PHOSPHATE CALCIUM CATION 12 [hp_X]
LEVOTHYROXINE LEVOTHYROXINE 12 [hp_X]

Inactive Ingredients

Ingredient Name Strength
SODIUM CHLORIDE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 1.1 in 1 AMPULE
2 1.1 in 1 AMPULE
3 NDC:50114-7026-2 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2010-04-01


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