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Traumeel ,

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Traumeel by Heel, Germany

2.2 ml amps

Used by elite athletes and in race horses as a pre-race performance enhancer due to its circulation-stimulating properties.

“a bridge between classical homeopathy and conventional pharmacology”

Traumeel is a homeopathic medication containing 12 botanical substances and 1 mineral substance. It has been sold in the in Germany since 1937 and it is available worldwide.

For best results, treatment with Traumeel injections should be initiated immediately following injury or at the first sign of symptoms.

Traumeel injections can be administered intramuscularly, intravenously, subcutaneously or intradermally. Traumeel can also be administed with a local anaesthetic if desired.

Traumeel is a homeopathic combination drug which reduces inflammation, swelling and oozing. The pharmacology involved is not yet understood; studies suggest that the drug modifies the action of neutrophils and the release of inflammatory mediators(2). Injected locally, its analgesic effect is compa- rable to steroids but without the risks of tendon rupture or skin depigmentation. A relatively old drug (available for 80 years), Traumeel is licensed for frequent use, with the only contraindication being adverse allergic reaction. Among elite athletes its use is common and anecdotally it attracts very favourable reports. There is data to suggest comparable efficacy of both topical and injected Traumeel when compared with NSAID therapy, with fewer side effects and greater patient satisfaction(3,4).

Description: Injection Solution Ingredient Information:

Each 2.2 ml 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; Echinacea 2X, Echinacea purpurea 2X 0.55 mcl each; Hamamelis virginiana 1X 0.22 mcl. Inactive ingredient: Sterile isotonic sodium chloride solution

Indications and Usage:

TraumeelTM Injection Solution is indicated for the temporary relief of muscular pain, inflammation, sports injuries and bruising.(1.1)

Dosage and Administration:

Adults 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 ½ the adult dosage. (2.1)

Dosage Form and Strength:

Injections: 2.2 ml ampule

Contraindications:

TraumeelTM Injection Solution is contraindicated in patients with known hypersensitivity to TraumeelTM Injection Solution or any of its ingredients (see Adverse Reactions).

Warnings and Precautions:

If pain persists or worsens, if new symptoms occur, or if redness or swelling is present, the patient should be care fully 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 TraumeelTM Injection Solution. TraumeelTM Injection Solution ingredients of the Compositae familiar are: Arnica montana, radix (mountain arnica), Calendula officinalis (marigold), Millefolium (milfoil), Chamomilla (chamomile), Bellis perennis (daisy), Echinacea angustifolia (narrow-lead cone flower), Echinacea purpurea (purple cone flower). (3.1)

FULL PRESCRIBING INFORMATION

1. Indications and Usage

1.1 TraumeelTM Injection Solution is an anti-inflammatory, analgesic, anti-edematous, anti-exudative combination formulation of 12 botanical substances and 2 mineral substances. TraumeelTM Injection Solution is officially classified as a homeopathic combination drug.

1.2 Botanical ingredients: Arnica montana, radix (mountain arnica) Calendula officinalis (marigold) Hamamelis virginiana (witch hazel) Millefolium (milfoil) Belladonna (deadly nightshade) Aconitum napellus (monkshood) Chamomilla (chamomile) Symphytum officinale (comfrey) Bellis perennis (daisy) Echinacea angustifolia (narrow-leafed cone flower) Echinacea purpurea (purple cone flower) Hypericum perforatum (St. John’s wort)

1.3 Mineral ingredients: Hepar sulphuris calcareum (calcium sulfide) Mercurius solubilis (Hahnemann’s soluble mercury)  

1.4 TraumeelTM 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, epicondy litis, etc.) and for minor aches and pains associated with such conditions. TraumeelTM is also indicated for the treatment of minor aches and the minor pain from rheumatoid arthritis, osteoarthritis, gouty arthritis, and ankylosing spondylitis.

2. Dosage and Administration

2.1 The dosage schedules listed below can be used as a general guide for the administration of TraumeelTM Injection Solution. TraumeelTM 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 TraumeelTM Injection Solution should be initiated immediately following injury or at the first sign of symptoms. TraumeelTM Injection Solution may be administered until symptoms disappear.
Adults: 1 ampule daily for acute disorders, or 1 to 2 ampules 1 to 3 times weekly.
Children (2 to 6 years): ½ the adult dosage.
Discard unused solution. TraumeelTM Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. TraumeelTM Injection Solution is indicated for intra-articular use under sterile conditions. If coadminstration with local anesthetic is desired, TraumeelTM 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 TraumeelTM 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. TraumeelTM Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like TraumeelTM Injection Solution should be inspected visually for particulate matter and discoloration prior to administration when ever solution and container permit. TraumeelTM Injection Solution is a clear, colorless solution. Discolored solutions should be discarded. 3. Warnings and Precautions

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

3.2 No harmful or potentially harmful side effects such as central nervous system depression are known. TraumeelTM Injection Solution is generally well- tolerated, however, if symptoms persist or worsen, a physician should be consulted.

3.3 Teratogenic effects: In general, homeopathic drugs are not known to direct or indirect harm to the fetus.

3.4 Drug Interactions: None known

3.5 Drug / Laboratory Test Interaction: None known

3.6 Carcinogenesis, mutagenesis, impairment of fertility: Not applicable

4. Use in Specific Populations

4.1 Pediatric Use: TraumeelTM Injection Solution can safely be administered to children as young as 2 years (see Dosage and Administration).

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

4.3 Geriatric use: TraumeelTM Injection Solution is safe to use in adults 12 years and older (see Dosage and Administration).

5. Clinical Pharmacology

5.1 The exact mechanism of action of TraumeelTM Injection Solution is not fully understood. Various cellular and biochemical pathways appear to be modulated by the product ingredients. The mechanism or action of TraumeelTM 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). TraumeelTM Injection Solution does not inhibit the arachidonic acid pathway of prostaglandin synthesis. Instead, the mechanism of action of TraumeelTM 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.

5.2 In-vitro studies show that the ingredients of TraumeelTM Injection Solution are noncytotoxic to granulocytes, lymphocytes, platelets, and endothelia, which indicates that the defensive functions of these cells are preserved during treatment with TraumeelTM Injection Solution.

5.3 The anti-inflammatory, analgesic, anti-edematous, and anti-exudative effects of TraumeelTM 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.

6. Drug Abuse and Dependence

6.1 Not applicable for homeopathic drugs

7. Overdosage

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

8. How Supplied

8.1 TraumeelTM Injection Solution 2.2 ml ampules: Packs of 10 ampules: NDC 50114-7004-1

9. Storage Conditions

9.1 Avoid freezing and excessive heat. Store at room temperature. Protect from light.

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