Traumeel injection solution

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 of action of TRAUMEEL Injection Solution does not appear to be the result of cyclooxygenase or lipoxygenase enzyme inhibition, as is the case with nonsteroidal 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 neuropeptides (2).

In vitro studies show that the ingredients in TRAUMEEL Injection Solution are noncytotoxic to granulocytes, lymphocytes, platelets, and endothelia, which indicates that the defensive functions of these cells are preserved during treatment with TRAUMEEL Injection Solution (3).

The anti-inflammatory, anti-edematous, and anti-exudative effects of TRAUMEEL Injection Solution have been demonstrated in clinical trials as well as in in vivo experimental models including the carrageenin-induced edema test and the adjuvant arthritis test (3).

TRAUMEEL Injection Solution is indicated for the treatment of symptoms associated with inflammatory, exudative, and degenerative processes due to acute trauma (such as contusions, lacerations, 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 pains associated with backache, muscular aches, and the minor pain from rheumatoid arthritis, osteoarthritis, gouty arthritis, and ankylosing spondylitis.

TRAUMEEL Injection Solution is contraindicated in patients with a known hypersensitivity to TRAUMEEL Injection Solution or any of its ingredients (see ADVERSE REACTIONS ).

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.

General:

Adverse effects with TRAUMEEL Injection Solution are extremely rare. TRAUMEEL Injection Solution exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system effects.

Information for Patients:

No harmful or potentially hazardous side effects such as central nervous system depression are known. TRAUMEEL Injection Solution is generally well-tolerated. However, if symptoms persist or worsen, a physician should be consulted (see WARNINGS ).

TRAUMEEL Injection Solution is not known to interact with other medications. Furthermore, the administration of TRAUMEEL Injection Solution can be safely augmented by the application of a topical dosage form of TRAUMEEL.

Drug/Laboratory Test Interactions:

TRAUMEEL Injection Solution is not known to interact with any laboratory tests.

Carcinogenesis:

No studies have been performed to evaluate the carcinogenicity of TRAUMEEL Injection Solution. In world-wide post-marketing surveillance studies no evidence of carcinogenicity has been found (2).

Pregnancy:

Pregnancy Category C. In general, medications such as TRAUMEEL Injection Solution that are classified as homeopathic are not known to cause direct or indirect harm to the fetus. However, animal reproduction studies have not been performed and there are no well-controlled studies in pregnant women. In cases of pregnancy or suspected pregnancy, TRAUMEEL Injection Solution should be used only if potential benefits justify potential risks to the fetus.

Nursing Mothers:

It is not known whether any of the ingredients in TRAUMEEL Injection Solution are excreted in human milk. However, because many drugs are excreted in human milk, TRAUMEEL Injection Solution should be administered with caution to nursing mothers.

Pediatric Use:

TRAUMEEL Injection Solution can be safely administered to children as young as 2 years (see DOSAGE AND ADMINISTRATION ).