Lymphomyosot X Prescribing Information

Lymphomyosot X Description

Indications and Usage for Lymphomyosot X

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/Side Effects

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 Strengths

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

Lymphomyosot X - Clinical Pharmacology

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