Traumeel

Hameln Pharma GmbH

Traumeel 2.2ml Injection

FULL PRESCRIBING INFORMATION: CONTENTS*

• TRAUMEEL DESCRIPTION
• INDICATION AND USAGE
• TRAUMEEL DOSAGE AND ADMINISTRATION
• TRAUMEEL CONTRAINDICATIONS
• WARNINGS AND PRECAUTIONS
• TRAUMEEL ADVERSE REACTIONS
• OVERDOSAGE
• CLINICAL PHARMACOLOGY
• DOSAGE
• PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

TRAUMEEL DESCRIPTION

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 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 CONTRAINDICATIONS

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.

TRAUMEEL 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

Traumeel_09.jpg