Neuralgo-Rheum: Package Insert / Prescribing Info

Neuralgo-Rheum Description

List of Excipients:

Water for injection 1,072.5 μl

Sodium Chloride 10.3 μl

Indications and Usage for Neuralgo-Rheum

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

Neuralgo-Rheum 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/Side Effects

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.

Neuralgo-Rheum - 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 Forms and Strengths

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