FDA Label for Thyreoidea Compositum
View Indications, Usage & Precautions
Thyreoidea Compositum Product Label
The following document was submitted to the FDA by the labeler of this product Heel Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Injection Solution Ingredient Information: Each 2.2ml ampule contains: Sarcolacticum acidum 3X, Viscum album 3X, Colchicum autumnale 4X, Conium maculatum 4X, Galium aparine 4X, Fucus vesiculosus 6X, Sedum acre 6X, Sempervivum tectorum 6X, ATP Adenosine triphosphate 8X, Fumaricum acidum 8X, α-Ketoglutaricum acidum 8X, Malicum acidum 8X, Natrum oxalaceticum 8X, Pulsatilla 8X, Spongia tosta 8X, Thyreoidea suis 8X, Calcarea fuorica 10X, Funiculus umbilicalis suis 10X, Hepar suis 10X, Medulla ossis suis 10X, Splen suis 10X, Sulphur 10X, Thymus suis 10X, Cortisone aceticum 28X 22mcl each. Inactive ingredient: Sterile isotonic sodium chloride solution.
Indications And Usage
Thyreoidea compositum® Injection Solution is indicated for stimulation of the defense system in thyroid dysfunction, connective tissue dysfunction and glandular dysfunction.
Dosage And Administration
The dosage schedules listed below can be used as a general guide for the administration of Thyreoidea compositum® Injection Solution. Thyreoidea compositum® 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, otherwise 1 ampule, 1 to 3 times per week IM/SC/IV/ID.Children ages 2 to 6 receive ½ the adult dosage. Discard unused solution.Thyreoidea compositum® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Thyreoidea compositum® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefy. Thyreoidea compositum® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Thyreoidea compositum® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Thyreoidea compositum® 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 [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Overdoasge
Due to the low concentration of active ingredients in homeopathic preparations such as Thyreoidea compositum® 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 Thyreoidea compositum®Injection Solution is not fully understood.
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