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Neuralgo-Rheum

Package insert / prescribing information
Generic name: pseudognaphalium obtusifolium, causticum, colchicum autumnale bulb, citrullus colocynthis fruit pulp, iron, lithium benzoate, toxicodendron pubescens leaf and filipendula ulmaria
Dosage form: injection

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Neuralgo-Rheum Description

Each 1.1 ml solution for injection ampule contains:
Active Ingredients:
Ingredient name Potency Quantity Final dilution
Causticum 10X 1.1 µl 12.99
Causticum 30X 1.1 µl 32.99
Causticum 200X 1.1 µl 203.00
Colchicum autumnale 10X 1.1 µl 12.99
Colchicum autumnale 30X 1.1 µl 32.99
Colchicum autumnale 200X 1.1 µl 203.00
Colocynthis 10X 1.1 µl 12.99
Colocynthis 30X 1.1 µl 32.99
Ferrum metallicum 10X 1.1 µl 12.99
Ferrum metallicum 30X 1.1 µl 32.99
Gnaphalium polycephalum 6X 3.3 µl 8.52
Gnaphalium polycephalum 10X 3.3 µl 12.52
Gnaphalium polycephalum 30X 3.3 µl 32.52
Lithium benzoicum 10X 1.1 µl 12.99
Lithium benzoicum 30X 1.1 µl 32.99
Rhus toxicodendron 10X 1.1 µl 12.99
Rhus toxicodendron 30X 1.1 µl 32.99
Spiraea ulmaria 10X 1.1 µl 12.99
Spiraea ulmaria 30X 1.1 µl 32.99

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

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

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

NEURALGO RHEUM
pseudognaphalium obtusifolium, causticum, colchicum autumnale bulb, citrullus colocynthis fruit pulp, iron, lithium benzoate, toxicodendron pubescens leaf and filipendula ulmaria root injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50114-7070
Route of Administration INTRADERMAL, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 6 [hp_X] in 1.1 mL
CAUSTICUM (CAUSTICUM) CAUSTICUM 10 [hp_X] in 1.1 mL
COLCHICUM AUTUMNALE BULB (COLCHICUM AUTUMNALE BULB) COLCHICUM AUTUMNALE BULB 10 [hp_X] in 1.1 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 10 [hp_X] in 1.1 mL
IRON (IRON) IRON 10 [hp_X] in 1.1 mL
LITHIUM BENZOATE (LITHIUM CATION) LITHIUM BENZOATE 10 [hp_X] in 1.1 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 1.1 mL
FILIPENDULA ULMARIA ROOT (FILIPENDULA ULMARIA ROOT) FILIPENDULA ULMARIA ROOT 10 [hp_X] in 1.1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description
1 NDC:50114-7070-1 10 AMPULE in 1 CARTON
1 1.1 mL in 1 AMPULE
2 NDC:50114-7070-2 3 AMPULE in 1 CARTON
2 1.1 mL in 1 AMPULE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/08/2014 08/31/2023
Labeler - MediNatura Inc (102783016)
Establishment
Name Address ID/FEI Operations
Biologische Heilmittel Heel 315635359 manufacture(50114-7070)
Establishment
Name Address ID/FEI Operations
Siegfried Hameln GmbH 315869123 manufacture(50114-7070)
MediNatura Inc