Lymphomyosot

Heel Inc

Lymphomyosot 1.1ml Injection

FULL PRESCRIBING INFORMATION: CONTENTS*

• LYMPHOMYOSOT DESCRIPTION
• INDICATION AND USAGE
• LYMPHOMYOSOT DOSAGE AND ADMINISTRATION
• LYMPHOMYOSOT CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• LYMPHOMYOSOT ADVERSE REACTIONS
• OVERDOSAGE
• CLINICAL PHARMACOLOGY
• DOSAGE

FULL PRESCRIBING INFORMATION

LYMPHOMYOSOT DESCRIPTION

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.

LYMPHOMYOSOT 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.

LYMPHOMYOSOT 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.

LYMPHOMYOSOT 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.