DESCRIPTION

Injection Solution Ingredient Information: Each 2.2ml ampule contains: Arnica montana, radix 2X, Belladonna 2X, Calendula officinalis 2X, Chamomilla 3X, Millefolium 3X, Hepar sulphuris calcareum 6X, Symphytum officinale 6X 2.2 mcl each; Aconitum napellus 2X 1.32 mcl; Bellis perennis 2X, Mercurius solubilis 6X, 1.1 mcl each; Hypericum perforatum 2X, 0.66 mcl each; Echinacea 2X, Echinacea purpurea 2X 0.55 mcl each; Hamamelis virginiana 1X 0.22 mcl. Inactive ingredient: sterile isotonic sodium chloride solution.

INDICATION AND USAGE

Traumeel® Injection Solution is an anti-inflammatory, analgesic, anti-edematous, anti-exudative combination formulation of 12 botanical ingredients, 1 mineral substance and 1 animal derived substance. Traumeel® Injection Solution is officially classified as a homeopathic combination drug

Botanical ingredients:

Arnica montana. radix (Mountain arnica), Calendula officinalis (Marigold), Hamamelis virginina (Witch hazel), Millefolium (Milfoil), Belladonna (Deadly nightshade), Aconitum napellus (Monkshood), Chamomilla (Chamomile), Symphytum officinale (Comfrey), Bellis perennis (Daisy), Echinacea (Narrow-leaf coneflower), Echinacea purpurea (Purple coneflower), Hypericum perforatum (St. John's Wort)

Mineral Ingredients:

Mercurius solubilis (Hahnemann's soluble mercury)

Animal derived ingredient:

Hepar sulphuris calcareum (calcium sulfide-made from oyster shells)

Traumeel® Injection Solution is indicated for the treatment of symptoms associated with inflammatory, exudative, and degenerative processes due to acute trauma (such as contusions, leacerations, fractures, sprains, post-operative wounds, etc.), repetitive or overuse injuries (such as tendonitis, bursitis, epicondylitis, etc.) and for minor aches and pains associated with such conditions. Traumeel® Injection Solution is also indicated for the treatment of minor aches and the minor pain from rheumatoid arthritis, osteoarthritis, gouty arthritis, and ankylosing spondylitits.

DOSAGE AND ADMINISTRATION

The dosage schedule listed below can be used as a general guide for the administration of Traumeel® Injection Solution. Traumeel® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response therapy. For best results, treatment with Traumeel® Injection Solution should be initiated immediately following injury or at the first signs of symptoms. Traumeel® Injection Solution may be administered until symptoms disappear.

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 or periarticular. Children ages 2 to 6 receive 1/2 the adult dosage. Discard unused solution.

Traumeel® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. Traumeel® Injection Solution is indicated for intra-articular use under sterile conditions. If coadministration with local anesthetic is desired, Traumeel® Injection Solution may be mixed in a 1:1 ratio with 1% or 2% lidocaine hydrochloride. Similar local anesthetics may also be used. the required dose of Traumeel® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefly. Normally about 0.5 to 1.0 milliliters of each drug is withdrawn into the syringe. Traumeel® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Traumeel® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration when ever solution and container permit. Traumeel® Injection Solution is a clear, colorless solution. Discolored solutions should be discarded.

WARNINGS AND PRECAUTIONS

If new syptoms occur, or if redness, pain or swelling at the puncture site persists, 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.

ADVERSE REACTIONS

In rare cases, patients with hypersensitivity to botanicals of the Compositae family may experience an allergic reaction after the administration of Traumeel® Injection Solution.  Traumeel® Injection Solution ingredients of the Compositae family are: Arnica montana, radix (mountain arnica), Calendula officinalis (marigold), Milefolium (milfoil), Chamomilla (chamomile), Bellis perennis (daisy), Echinacea (narrow-leaf coneflower), Echinacea purpurea (purple coneflower).

OVERDOSAGE

Due to the low concentration of active ingredients in homeopathic preparations such as Traumeel® 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 Traumeel® Injection Solution is not fully understood. Various cellular and biochemical pathways appear to be modulated by the product ingredients. The mechanism or action of Traumeel® Injection Solution does not appear to be the result of cyclooxygenase or lipoxygenase enzyme inhibition, as is the case with non-steroidal anti-inflammatory drugs (NSAIDS). Traumeel® Injection Solution does not inhibit the arachidonic acid pathway of prostaglandin synthesis. Instead, the mechanism of action of Traumeel® Injection Solution appears to be the result of modulation of the release of oxygen radicals from activated neutrophils, and inhibition of the release of inflammatory mediators (possibly interleukin-1 from activated macrophages) and neuropepetides.

n-vitro studies show that the ingredients of Traumeel® Injection Solution are non-cytotoxic to granulocytes, lymphocytes, platelets, and endothelia, which indicates that the defensive functions of these cells are preserved during treatment with Traumeel® Injection Solution.

The anti-inflammatory, analgesic, anti-edematous, and anti exudative effects of Traumeel® Injection Solution have been demonstrated in clinical trials as well as in-vivo experimental models including the carrageenin-induced edema test and the adjuvant arthritis test.

DOSAGE

Injections: 2.2ml ampule

PRINCIPAL DISPLAY PANEL

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