DESCRIPTION

List of Excipients:

Water for injection 1,072.5 μl

Sodium Chloride 10.3 μl

INDICATIONS AND USAGE

Neuralgo-Rheum® Injection Solution is a homeopathic drug product indicated for the treatment of nerve pain, soft tissue rheumatism and symptoms of disc protrusion.

DOSAGE AND ADMINISTRATION

General Considerations

The dosage schedules listed below can be used as a general guide for the administration of Neuralgo-Rheum Injection Solution.

• Neuralgo-Rheum Injection Solution may be administered s.c., i.d., i.m., or i.v..

• If co-administration with a local anesthetic is desired, Neuralgo-Rheum Injection Solution may be mixed with lidocaine or similar agents at the  discretion of the physician.

• 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.

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

Neuralgo-Rheum Injection Solution is contraindicated in patients with known hypersensitivity to Neuralgo-Rheum or any of its ingredients.

WARNINGS AND PRECAUTIONS

None

ADVERSE REACTIONS

Post-marketing Experience

 No adverse events have been reported with a causal relationship to Neuralgo-Rheum Injection Solution.

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.

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 Neuralgo-Rheum 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.