Engystol Prescribing Information

Engystol Description

Indications and Usage for Engystol

Engystol® Injection Solution is a homeopathic drug product indicated for the support of the immune system to reduce severity and duration of symptoms in viral infections, particularly in the early stages of colds and influenza-like illnesses.

Engystol Dosage and Administration

General Considerations

• The dosage schedules listed below can be used as a general guide for the administration of Engystol® Injection Solution.

• Engystol® 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. Discard any unused ampule contents.

• 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

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

Warnings and Precautions

None

Adverse Reactions/Side Effects

Post-marketing Experience

• The following adverse events have been identified during post-marketing use of Engystol® 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

Overdosage

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

Engystol - Clinical Pharmacology

Mechanism of Action

The exact mechanism of Engystol® 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.