Lymphomyosot X

Heel Inc

Lymphomyosot X 1.1ml Injection

FULL PRESCRIBING INFORMATION: CONTENTS*

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

FULL PRESCRIBING INFORMATION

LYMPHOMYOSOT X DESCRIPTION

Inactive Ingredients:

Water for injections 1,089.0 μl

Sodium Chloride 10.3 μl

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 Considerations

• The dosage schedules listed below can be used as a general guide for the administration of Lymphomyosot® 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 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 X CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

OVERDOSAGE

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

LYMPHOMYOSOT X 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 Heel Inc. at 1.800.920.9203info@heelusa.comor FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE

CLINICAL PHARMACOLOGY SECTION

Mechanism of Action

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

Pharmacodynamics

Not applicable for homeopathic medicinal products.