DESCRIPTION

Injection Solution Ingredient Information: Each 1.1 ml ampule contains: Asclepias vincetoxicum 6X, 10X, 30X 6.6 mcl each; Sulphur 4X, 10X 3.3 mcl each. Inactive ingredient: sterile isotonic sodium chloride solution.

INDICATIONS AND USAGE

Engystol® Injection Solution is indicated for stimulation of the nonspecific defense system in viral infections such as influenza, cold sores and feverish conditions.

DOSAGE AND ADMINISTRATION

The dosage schedules listed below can be used as a general guide for the administration of Engystol® Injection Solution . Engystol® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response to therapy.

Adults and children 7 years and older: in acute disorders, 1 ampule per day, otherwise1 ampule, 1 to 3 times per week IM/SC/IV/ID. Children ages 2 to 6 receive ½ the adult dosage.

Discard unused solution.

Engystol® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Engystol® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefly. Engystol® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Engystol® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Engystol® Injection Solution is a clear, colorless solution.

Discolored solutions should be discarded.

WARNINGS AND PRECAUTIONS

If pain persists or worsens, if new symptoms occur, or if redness or swelling is present, the patient should be carefully re-evaluated because these could be signs of a serious condition.

Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

OVERDOSAGE

Due to the low concentration of active ingredients in homeopathic preparations such as Engystol® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.

CLINICAL PHARMACOLOGY

The exact mechanism of action of Engystol® Injection Solution is not fully understood.

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