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These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

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Pain Relief Without the Risks of Steroids,Opioids or NSAIDs


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Traditional Pain Medicines Are Effective And Safe When Used Under Professional Supervision … But They May Not Be Right For You:

• Opioids such as oxycodone can be addictive.• Steroid Injections are effective but too-frequent use can cause joint

degeneration.• Viscosupplement Injections don’t work for everybody and are

expensive.• NSAIDS like ibuprofen and naproxen sodium should not be

used for more than 10 consecutive days.

Ask your doctor about Traumeel®, the unusually safe and effi cacious German anti-infl ammatory pain reliever that is

backed by clinical studies.

This brochure summarizes 5 clinical studies showing Traumeel®’s efficacy and safety, and provides information on where the full clinical

results can be read.

PAIN RELIEFWITHOUT THE RISK OF STEROIDS, OPIOIDS OR NSAIDS


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Traumeel® Ointment Is Clinically Proven In Patients With Infl ammation, Body Pain And Sports Injuries.

The latest study published in the International Journal of Clinical Practice demonstrated that Traumeel® ointment is as eff ective as the topical NSAID Diclofenac (1% gel) in reducing pain and returning patients with acute ankle sprain to normal function.1

Traumeel® reduced pain as eff ectively as Diclofenac 1% gel on days 7 and 14.




Clinical: Pain Relief Ointment


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Clinical Results

Traumeel® Injections, when combined with Zeel® Injections have been shown to provide meaningful pain relief for moderate to severe osteoarthritis of the knee. The graph below shows superior relief versus placebo, which lasted the full 99 days of the study.2

Significant + Relevant Pain Relief: WOMAC Scores

Figure: Mean WOMAC A (Pain) changes from baseline. Solutions did not discriminate for WOMAC A pain as expected after only 1 of 3 injections on day 8 (p = 0.3715), but were subsequently significantly different (p = 0.05) on days 15, 43, 57, 71, 85 and 99 (primary end point day), and approached significance on day 29 (p = 0.0686).




Clinical: Pain Relief Injections


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What Is Traumeel®?Traumeel® is imported from Germany, where it is has been used by doctors for years. It is a combination of 12 plant medicines and two mineral extracts (see pages 11, 13, 16). All 14 of these medicines are micro-dosed and are intended to stimulate your body to resolve its own pain.

How Does Traumeel® Therapy Work For You?The mechanism of action of Traumeel® is still under investigation, but studies suggest that these highly diluted natural medicines regulate inflammation and reduce pain.

How Safe Is The Treatment With Traumeel® Products? Can I Keep Taking My Other Medications?Yes, you can! With Traumeel®, you don’t have to worry about drug-to-drug interactions with other medications. Traumeel® therapy is considered very safe, and adverse events are exceptionally low.

What Are The Conditions Commonly Treated With Traumeel®?Traumeel® is effective in a broad range of indications:• Sprains, strains and bruises of ankle, knee, shoulder, neck or wrist3

• Low back pain• Tendinopathies4

• Osteoarthritis • Epicondylitis (“tennis elbow”)5

• Acute and chronic musculoskeletal conditions6

Who Should NOT Have This Therapy?• People who are allergic to any of the ingredients in Traumeel® ointment,

tablets or injection solution.

What Side Effects Have Been Associated With Traumeel®?Reports of adverse events are exceptionally low. Allergic (hypersensitivity) re-actions (e.g., skin allergies, redness/swelling and pruritus) can occur in rare cases, in which case use of the product should be discontinued. The safety and effectiveness of the therapy has not been established in pregnant or lactating women.

You are encouraged to report negative side effects of prescrip-tion drugs to the FDA. Visit MedWatch or call 1-800-FDA-1088.

Frequently Asked Questions


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6These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

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Traumeel® has helped millions of people all over the world manage their acute and chronic pain for more

than 60 years!

Who May Benefi t From Traumeel® Ointment, Tablets And Injection?• Someone who is taking several medications and wants to reduce the risk

of drug-to-drug interactions when adding another pain medication.• Someone who suff ers from diabetes, heart disease, or other risk factors

that complicate treatment with standard medications.

Is Traumeel® Suitable For Professional Athletes?Yes. Traumeel® is not a performance-enhancing drug. Traumeel® is explicitly listed as a permitted remedy for elite athletes by the German National Anti-Doping Agency (NADA). See www.NADA.de

Where To Find Traumeel® Products:Many healthcare practitioners incorporate the Traumeel® product line into their patients’ treatment options. Ask your doctor which form of Traumeel® is best for you. Since Traumeel® is an Rx product you will need a prescription from your doctor.

Use Traumeel® Injection Therapy During Your Doctor’s Offi ce Visit And Continue With Traumeel® Topical And/Or Oral Dosage Forms At Home.Traumeel® injections were clinically shown in Germany to provide non-inferior pain relief to diclofenac (a European NSAID) on “tennis elbow” while also off ering superior tolerability and superior improvement in joint mobility. Read the full study at: www.medinatura.com


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9 These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

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PRESCRIBING INFORMATIONThe following pages outline the complete prescribing

information for Traumeel® Tablets, Traumeel® Ointment, and Traumeel® Injection Solution

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HIGHLIGHTS OF PRESCRIBING INFORMATION: Traumeel® Tablets, Oral, Rx OnlyThese highlights do not include all the information needed to use Traumeel tablets safely and effectively. See full prescribing infor-mation for Traumeel® Tablets.

FULL PRESCRIBING INFORMATION: CONTENTS*

1. Indications and Usage2. Dosage and Administration

(2.1) General Considerations(2.2) Standard Dosage

3. Dosage Form and Strength4. Contraindications5. Warnings and Precautions6. Adverse Reactions

(6.1) Post-marketing Experience7. Drug Interactions8. Use in Specific Populations

(8.1) Pregnancy(8.2) Labor and Delivery(8.3) Nursing Mothers

(8.4) Pediatric Use(8.5) Geriatric Use

11. Description(11.1) Ingredients(11.2) Pharmaceutical Form(11.3) Route of Administration

12. Clinical Pharmacology(12.1) Mechanism of Action(12.2) Pharmacodynamics

15. References16. How Supplied / Storage and Handling

*Sections or subsections omitted from the full prescribing informa-tion are not listed.

FULL PRESCRIBING INFORMATION

1. Indications and Usage(1.1) Traumeel® Tablets are an analgesic / anti-inflammatory homeopathic drug product indicated for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.

2. Dosage and Administration(2.1) General Considerations

• The dosage schedule below can be used as a general guide for the administration of Traumeel® Tablets.(2.2) Standard Dosage:

• Adults and children 12 years and older: 2 tablets every 4 hours. Do not exceed 12 tablets per 24 hours.• Children under 12 years: 1 tablet every 4 hours. Do not exceed 6 tablets per 24 hours.

3. Dosage Forms and Strength(3.1) 300 mg tablets each containing the active ingredients in the strengths listed under Description. (11)

4. Contraindications(4.1) Traumeel® Tablets are contraindicated in patients with known hypersensitivity to Traumeel® or any of its ingredients.

5. Warnings and Precautions(5.1) Do not use if known sensitivity to Traumeel® or any of its ingredients exists.

6. Adverse Reactions(6.1) No adverse events with a causal relationship to Traumeel have been reported.

7. Drug Interactions(7.1) Due to the homeopathic dilutions, no interactions have been reported, and none are expected.

8. Use in Specific Populations(8.1) Pregnancy

INDICATIONS AND USAGETraumeel® Tablets is an analgesic anti-inflammatory homeopathic drug indicated for the treatment of injuries, inflammation and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain. (1)

DOSAGE AND ADMINISTRATIONStandard Dosage:Adults and children 12 years and older:

• 2 tablets every 4 hours. Do not exceed 12 tablets per 24 hours. (2.2)

Children under 12 years:• 1 tablet every 4 hours. Do not exceed 6 tablets per

24 hours. (2.2)

DOSAGE FORM AND STRENGTH• 300 mg tablets, each containing the active ingredients in

the strengths listed under Description. (3, 11)

CONTRAINDICATIONS• Traumeel® Tablets are contraindicated for patients

with known hypersensitivity to Traumeel® or any of its ingredients. (4)

WARNINGS AND PRECAUTIONS• Do not use if known sensitivity to Traumeel® or any of its

ingredients exists. (5)

ADVERSE REACTIONS• No adverse events with a causal relationship to Traumeel®

have been reported(6)• To report SUSPECTED ADVERSE REACTIONS,

contact MediNatura at 1.844.633.4628 or [email protected], or contact the FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS• None known (7)

USE IN SPECIFIC POPULATIONS• No studies have been conducted with Traumeel®

Tablets on pregnant or lactating women, children, or the elderly. (8)

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(8.1.1) Teratogenic Effects• Some ingredients in Traumeel tablets have been shown to be teratogenic in various animal species when given

in doses several thousand times the human dose. There are no adequate and well-controlled studies in pregnant women. Traumeel® tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

(8.1.2) Non-teratogenic Effects• No known non-teratogenic effects.

(8.2) Labor and Delivery• Not recognized for use in labor or delivery.

(8.3) Nursing Mothers• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution

should be exercised when Traumeel tablets are administered to a nursing woman.(8.4) Pediatric Use

• Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Traumeel® tablets has not identified differences in responses between adults and pediatric patients.

(8.5) Geriatric Use• Safety and effectiveness in geriatric patients have not been established. However, traditional homeopathic use of the

ingredients in Traumeel® tablets has not identified differences in responses between adults and geriatric patients.11. Description

(11.1) Ingredients - Each 300 mg tablet contains:

Active Ingredients:

Ingredient Name Potency Quantity Final Dilution

Aconitum napellus 3X 30 mg 4X

Arnica montana, radix 2X 15 mg 3.3X

Belladonna 4X 75 mg 4.6X

Bellis perennis 2X 6 mg 3.7X

Calendula officinalis 2X 15 mg 3.3X

Chamomilla 3X 24 mg 4.1X

Echinacea 2X 6 mg 3.7X

Echinacea purpurea 2X 6 mg 3.7X

Hamamelis virginiana 2X 15 mg 3.3X

Hepar sulphuris calcareum 8X 30 mg 9X

Hypericum perforatum 2X 3 mg 4X

Mercurius solubilis 8X 30 mg 9X

Millefolium 3X 15 mg 4.3X

Symphytum officinale 8X 24 mg 9.1X

Inactive Ingredients:

Lactose 6 mg

Magnesium sterate 1.5 mg

(11.2) Pharmaceutical Form• Tablet

(11.3) Route of Administration• Oral

12. Clinical Pharmacology(12.1) Mechanism of Action

• The exact mechanism of Traumeel® Tablets is not fully understood.(12.2) Pharmacodynamics

• Not applicable for homeopathic medicinal products.15. References

• Homeopathic Pharmacopeia of the United States Revision Service16. How Supplied / Storage and Handling

(16.1) Dosage forms and package sizes• Bottle with 90 tablets • NDC 50114-9483-2

(16.2) Storage and handling• Store at room temperature. Protect from light.• Keep this and all medicines out of the reach of children

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HIGHLIGHTS OF PRESCRIBING INFORMATION: Traumeel® Ointment, Topical, Rx OnlyThese highlights do not include all the information needed to use Traumeel® Ointment safely and effectively. See full prescribing information for Traumeel® Ointment.

INDICATIONS AND USAGETraumeel® Ointment is an analgesic anti-inflammatory homeopathic drug indicated for the treatment of injuries, inflammation and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain. (1)

DOSAGE AND ADMINISTRATIONStandard Dosage:Adults, children, and infants:

• Apply generously to affected areas 2 to 3 times daily, or as needed. Massage thoroughly into the skin. Traumeel® may be applied using mild compression bandaging and/or occlusive bandaging. (2.2)

DOSAGE FORM AND STRENGTH• Topical ointment containing the active ingredients in the

strengths listed under Description. (3, 11)

CONTRAINDICATIONS• Traumeel® Ointment is contraindicated patients with

known hypersensitivity to Traumeel® or any of its ingredients. (4)

WARNINGS AND PRECAUTIONS• For external use only. Cetylstearyl alcohol may cause local

skin reactions, i.e. contact dermatitis. Do not apply over large areas of the body. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a physician should be consulted. (5)

ADVERSE REACTIONS• In rare cases, allergic skin reactions may develop. Do

not use if known sensitivity to Traumeel® or any of its ingredients exists. (6)

• To report SUSPECTED ADVERSE REACTIONS, contact MediNatura at 1.844.633.4628 or [email protected], or contact the FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.


USE IN SPECIFIC POPULATIONS• No studies have been conducted with Traumeel ointment

on pregnant or lactating women, children, or the elderly. (8)

Revised 04/2016













1. Indications and Usage(1.1) Traumeel® Ointment is an analgesic / anti-inflammatory homeopathic drug product indicated for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.


• The dosage schedule below can be used as a general guide for the administration of Traumeel® Ointment. (2.2) Standard Dosage:

• Adults, children, and infants: Apply generously to affected areas 2 to 3 times daily, or as needed. Massage thoroughly into the skin. Traumeel® may be applied using mild compression bandaging and/or occlusive bandaging.

3. Dosage Forms and Strength(3.1) One tube containing 100 g containing the active ingredients in the strengths listed under Description. (11)

4. Contraindications(4.1) Traumeel® Ointment is contraindicated in patients with known hypersensitivity to Traumeel® or any of its ingredients.

5. Warnings and PrecautionsFor external use only. Do not apply over large areas of the body. Do not apply over open wounds or broken skin. If symptoms persist or worsen, or if a rash develops, a physician should be consulted.

6. Adverse ReactionsHypersensitivity reactions or local allergic reactions (cutaneous inflammation, redness, swelling and pruritis) can occur in very rare cases, in which case use of the product should be discontinued. Do not use if known sensitivity to Traumeel® ointment or any of its ingredients exists.

7. Drug Interactions(7.1) Due to the homeopathic dilutions, no interactions have been reported, and none are expected.

8. Use in Specific Populations

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(8.1) Pregnancy(8.1.1) Teratogenic Effects

• Some ingredients in Traumeel® Ointment have been shown to be teratogenic in various animal species when given in doses several thousand times the human dose. There are no adequate and well-controlled studies in pregnant women. Traumeel® Ointment should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

(8.1.2) Non-teratogenic Effects• No known non-teratogenic effects.

(8.2) Labor and Delivery• Not recognized for use in labor or delivery.

(8.3) Nursing Mothers• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution

should be exercised when Traumeel is administered to a nursing woman.(8.4) Pediatric Use

• Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Traumeel® Ointment has not identified differences in responses between adults and pediatric patients.


ingredients in Traumeel® Ointment has not identified differences in responses between adults and geriatric patients.11. Description

(11.1) Ingredients - Each 100 g ointment contains:

Active Ingredients:


Aconitum napellus 1X 0.050 g 4.3X

Arnica montana, radix 3X 1.500 g 4.82X

Belladonna 1X 0.050 g 4.3X

Bellis perennis MT 0.100 g 3X

Calendula officinalis MT 0.450 g 2.34X

Chamomilla MT 0.150 g 2.82X

Echinacea MT 0.150 g 2.82X

Echinacea purpurea MT 0.150 g 2.82X

Hamamelis virginiana MT 0.450 g 2.34X

Hepar sulphuris calcareum 6X 0.025 g 9.6X

Hypericum perforatum 6X 0.090 g 9.04X

Mercurius solubilis 6X 0.040 g 9.39X

Millefolium MT 0.090 g 3.04X

Symphytum officinale 4X 0.100 g 7X


Paraffin, liquid 9.342 g

Cetostearyl alcohol (type A), emulsifying 8.007 g

Paraffin, white soft 9.342 g

Water, purified 60.579 g

Ethanol (96%) 9.335 g

(11.2) Pharmaceutical Form• Ointment

(11.3) Route of Administration• Topical, Occlusive Dressing Technique


• The exact mechanism of Traumeel® Ointment is not fully understood.(12.2) Pharmacodynamics



(16.1) Dosage forms and package sizes• Tube of 100g ointment • NDC 50114-9482-8

(16.2) Storage and handling• Store at room temperature. Protect from light.• Keep this and all medicines out of the reach of children

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HIGHLIGHTS OF PRESCRIBING INFORMATION: Injection Solution, Parenteral Use Rx OnlyThese highlights do not include all the information needed to use Traumeel® Injection Solution safely and effectively. See full prescribing information for Traumeel® Injection Solution.

INDICATIONS AND USAGETraumeel® Injection Solution is a homeopathic drug indicated:

• As a mono-therapy, for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain. (1.1)

• In combination with Zeel® Injection Solution, for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis /osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness. (1.2)

DOSAGE AND ADMINISTRATIONStandard Dosage:

Adults and children 12 years and older:• 1 ampule 1 to 3 times per 7 daysChildren 6 to 11 years: • ⅔ of an ampule 1 to 3 times per 7 days Children 2 to 5 years: • ½ ampule 1 to 3 times per 7 days (2.2)

Acute Dosage:Adults and children 12 years and older:• 1 ampule daily, and then continue with standard

dosage.Children 6 to 11 years: • ⅔ of an ampule daily, and then continue with

standard dosage. Children 2 to 5 years: • ½ ampule daily, and then continue with standard

dosage. (2.3)• When co-administered with Zeel® Injection Solution,

the two products may be mixed 1:1.

DOSAGE FORM AND STRENGTH• 1 ampule containing 2.2 ml solution, containing the active

ingredients in the strengths listed under Description. (3, 11)

CONTRAINDICATIONS• Traumeel® Injection Solution is contraindicated in

patients with known hypersensitivity to Traumeel® or any of its ingredients. (4)

WARNINGS AND PRECAUTIONS• Keep out of reach of children. (5)

ADVERSE REACTIONS• Allergic (hypersensitivity) reactions, (e.g. skin allergies,

redness/swelling at the injection site, even up to anaphylaxis) may occur in isolated cases. (6)

• To report SUSPECTED ADVERSE REACTIONS, contact MediNatura at 1.844.633.4628 or [email protected], or contact the FDA at 1.800.FDA.1088 or www.fda.gov/medwatch.


USE IN SPECIFIC POPULATIONS• No studies have been conducted with Traumeel® Injection

Solution on pregnant or lactating women, children, or the elderly. (8)

Revised 12/2014













1. Indications and Usage(1.1) Treatment of injuries and various conditions of the musculoskeletal system.

• Traumeel® Injection Solution is a homeopathic drug product indicated for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.

(1.2) Co-administration Therapy with Zeel® Injection Solution for the treatment of inflammatory and degenerative conditions of the musculoskeletal system.

• Traumeel® Injection Solution is a homeopathic drug product indicated, in combination with Zeel® Injection Solution, for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness.


• The dosage schedules listed below can be used as a general guide for the administration of Traumeel® Injection Solution.

• If co-administration with a local anesthetic is desired, Traumeel® Injection Solution may be mixed with lidocaine or similar agents at the discretion of the physician.

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• Traumeel® Injection solution may be administered s.c., i.d., i.m., i.a. or i.v.• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampule in 24 hours.• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration,

whenever solution and container permit. Draw up the contents of the ampule into the syringe. Discard half or one third of the contents, depending on the required dosage, before administering.

• Only licensed practitioners with sufficient expertise in injecting drugs, including the respective route of administration, should administer the product.

(2.2) Standard Dosage: for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.

Adults and children 12 years and older: • 1 ampule 1 to 3 times per 7 days Children 6 to 11 years: • ⅔ of an ampule 1 to 3 times per 7 days Children 2 to 5 years: • ½ ampule 1 to 3 times per 7 days

(2.3) Acute Dosage: for the treatment of injuries, inflammatory and degenerative conditions of the musculoskeletal system and for the relief of associated symptoms such as pain.

Adults and children 12 years and older: • 1 ampule daily, and then continue with standard dosage. Children 6 to 11 years: • ⅔ of an ampule daily, and then continue with standard dosage. Children 2 to 5 years: • ½ ampule daily, and then continue with standard dosage.

(2.4) Co-administration therapy with Zeel® Injection Solution: for the treatment of inflammatory and degenerative conditions of the musculoskeletal system, such as arthrosis/osteoarthritis and/or rheumatic joint diseases, and for the relief of symptoms including pain, swelling, and joint stiffness.

• In the treatment of musculoskeletal conditions, if co-administration with another homeopathic medicinal product is desired, Traumeel® Injection Solution may be mixed in a ratio of 1:1 with Zeel® Injection Solution.

• For convenience, the daily dose of Traumeel® Injection Solution may be administered at the same time as a Zeel® Injection Solution, according to the dosing recommendations for each medication.

(2.5) Instructions for Opening Glass Ampule

• • Cutting open the glass ampule is not necessary. Hold the ampule head up at an angle, and tap/shake down the solution

contained in the ampule head. Then break off the ampule head by applying pressure away from the color dot. Discard unused solution.

3. Dosage Forms and StrengthOne ampule containing 2.2 ml of solution containing the active ingredients in the strengths listed under Description. (11)

4. Contraindications• Traumeel® Injection Solution is contraindicated in patients with known hypersensitivity to Traumeel® or any of its

ingredients.• When Traumeel® Injection Solution is co-administered with Zeel® Injection Solution, refer to the Contraindications

section of the respective Zeel® Injection Solution labeling.5. Warnings and Precautions

None6. Adverse Reactions

(6.1) Post-marketing Experience• The following adverse events have been identified during post-marketing use of Traumeel® Injection Solution. Because

these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

• Adverse event rates observed in Monotherapy use of Traumeel® Injection Solution: Allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) may occur in isolated cases.

• Adverse event rates observed in the Monotherapy use of Zeel® Injection Solution: Allergic (hypersensitivity) skin reactions may occur in isolated cases.

7. Drug InteractionsNo interactions have been reported, and none are expected due to the homeopathic dilutions.

8. Use in Specific Populations(8.1) Pregnancy

(8.1.1) Teratogenic Effects• Pregnancy Category C. Some ingredients in Traumeel® Injection Solution have been shown to be teratogenic in

various animal species when given in doses several thousand times the human dose.• There are no adequate and well-controlled studies in pregnant women. Traumeel® Injection solution should be

used during pregnancy only if the potential benefit justifies the potential risk to the fetus.• When Traumeel® Injection Solution is administered with Zeel® Injection Solution in a woman of childbearing age,

refer to the pregnancy category and product labelling for Zeel® Injection Solution.(8.1.2) Non-teratogenic Effects

• No known non-teratogenic effects.

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(8.2) Labor and Delivery• No recognized use in labor or delivery.

(8.3) Nursing Mothers• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk,

caution should be exercised when Traumeel® Injection Solution is administered to a nursing woman.(8.4) Pediatric Use

• Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Traumeel® Injection Solution has not identified differences in responses between adults and pediatric patients.


of the ingredients in Traumeel® Injection Solution has not identified differences in responses between adults and geriatric patients.

10. Overdosage• No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions.

11. Description(11.1) Ingredients - Each 2.2 ml ampule contains:

Active Ingredients:


Aconitum napellus 2X 1.32 µl 5.22X

Arnica montana, radix 2X 2.20 µl 5.00X

Belladonna 2X 2.20 µl 5.00X

Bellis perennis 2X 1.10 µl 5.30X

Calendula officinalis 2X 2.20 µl 5.00X

Chamomilla 3X 2.20 µl 6.00X

Echinacea 2X 0.55 µl 5.60X

Echinacea purpurea 2X 0.55 µl 5.60X

Hamamelis virginiana 1X 0.22 µl 5.00X

Hepar sulphuris calcareum 6X 2.20 µl 9.00X

Hypericum perforatum 2X 0.66 µl 5.52X

Mercurius solubilis 6X 1.10 µl 9.30X

Millefolium 3X 2.20 µl 6.00X

Symphytum officinale 6X 2.20 µl 9.00X


Water for injection 2,179.10 µl

Sodium Chloride 19.40 µl

(11.2) Pharmaceutical Form• Injection Solution

(11.3) Route of Administration• Parenteral: s.c., i.d., i.m., i.a. or i.v


• The exact mechanism of Traumeel® Injection Solution is not fully understood.(12.2) Pharmacodynamics



(16.1) Dosage forms and package sizes• 1 ampule of 2.2 ml in packs of 10 ampules • NDC 50114-7004-1

(16.2) Storage and handling• Store at room temperature. Protect from light.

1. González de Vega, C., Speed, C., Wolfarth, B., & González, J. Traumeel® vs. diclofenac for reducing pain and improving ankle mobility after acute ankle sprain: a multicentre, randomised, blinded, controlled and non-in-feriority trial. Int J Clin Pract. October 2013;67(10):979–989.

2. Lozada C et al. A Multi-Center Double-Blind, Randomized, Controlled Tri-al (db-RCT) to Evaluate the Eff ectiveness and Safety of Co-Administered Traumeel® (Tr14) and Zeel® (Ze14) Intra articular (IA) Injections Versus IA Placebo in Patients with Moderate-to-Severe Pain Associated with OA of the Knee. 2014 ACR Annual Meeting, Abstract Number: 2896.

3. Zell, J., Connert, W.D., Mau, J., & Feuerstake, G. Behandlung von akuten Sprunggelenksdistorsionen: Doppelblindstudie zum Wirksamkeitsnach-weis eines homöopathischen Salbenpräparats [Treatment of acute sprains of the ankle: a controlled double-blind trial to test the eff ective-ness of a homeopathic preparation]. Fortschr Med. 1988;106(5):96-100. English translation available in: Biol Ther. 1989; VII(1):1-6.

4. Schneider, C., Klein, P., Stolt, P., & Oberbaum, M. A homeopathic oint-ment preparation compared with 1% diclofenac gel for acute symptom-atic treatment of tendinopathy. Explore. 2005;1(6):446-452.

5. Birnesser, H., Oberbaum, M., Klein, P., & Weiser, M. The homeopathic preparation Traumeel® S compared with NSAIDs for symptomatic treat-ment of epicondylitis. J Musculoskeletal Research. 2004;8(2-3):119-128.

6. Zenner, S. & Weiser, M. Oral treatment of traumatic, infl ammatory and degenerative conditions with a homeopathic remedy. Biomed Ther. 1997;XV(1):22-26.

17 These statements have not been reviewed by the Food and Drug Administration. They are supported by traditional homeopathic principles.

References

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