When steroids aren’t right, what do you do?

What if your patient:• Had a steroid injection a month ago,

and requests another injection?• Has arthritis pain in small joints?• Requests an alternative to steroids?• Is diabetic, yet requests a steroid injection?• Can’t afford viscosupplements?

*Conventional steroid alternatives studied included hyaluronate, NSAID, acetaminophen, opioid-containing medication, glucosamine and chondroitin.

OAK pain relief from non-steroid alternatives

Inadequate pain relief and large functional loss among patients(n=1109) with knee osteoarthritis:

evidence from a prospective multinational longitudinal study of osteoarthritis real-world therapies.1

Source:1. Rheumatology 2105;54:270-277

100

80

60

40

20

0

46%

54%

21%

79%

Adequate AdequateInadequate Inadequate

Perc

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ge o

f pat

ient

s

• Provides similar relief to steroids on moderate to severe OA pain• Is safe enough to use weekly – none of the side effects of steroids• Is suitable even for small joints • Is perfect for patients who dislike steroids• Is safe for diabetics• Is highly cost-effective

Conventional steroid alternatives* are inadequate. 54% of patients receiving them report inadequate relief.1

Of these, 79% of patients with moderate to severe osteoarthritis pain (WOMAC ≥4) report inadequate pain relief.1

Traumeel® & Zeel® present an OA treatment that:

All Pain Moderate-Severe Pain

1 2

Zeel® Mechanism of ActionProtects and strengthens cartilage to improve

joint function and reduce stiffness.Zeel inhibits activity of the leukocyte elastase - the enzyme released during inflammatory reactions that attacks the articular cartilage which is

rich in proteoglycans.1 Zeel also stimulates lymphocytes to release TGF-ß the transforming growth factor-(beta) crucial for tissue remodeling.2

The protective effect of Zeel upon cartilage has also been demonstrated by in vitro.3 Additionally, Zeel modulates the production of the leukotriene

LTB4 and PGE2, while improving cartilage quality and decreasing cartilage damage.4,5

Traumeel® Mechanism of ActionReduces inflamation to ease pain.

In-vitro studies show that Traumeel® Injection Solution inhibits IL-1ß, TNF-ß, and IL-8.

Inhibiting these physiological messengers modulates the inflammatory response, which helps relieve pain.1

Traumeel® and Zeel® Injection Solutions were developed by physicians in Europe and have been available globally

for more than sixty years.

Using very low doses of plant, mineral and tissue extracts, they manage the pain, inflammation and joint degradation of arthritis

and osteoarthritis while exhibiting an excellent safety profile.

Source:1. Porozov, S., Cahalan, L., Weiser, M., Branski, D., Lider, O., & Oberbaum, M. Inhibition of IL-1 Band TN F-a secretion from resting and activated human immunocytes by the homeopathic medication Traumeel S. Clin Dev lmmunol. 2004; 11(2):143-149

References:1. Stancikova M. Inhibition of leucyte elastasis in vitro with Zeel and its various potentized

components – a preliminary report. Biologische Medizin. Vol 28 (2) 1999, 83-84.2. Heine H. The working mechanisms of Antihomotoxic Potentized Preparations. Biomedical

Therapy. XVII (4) 1999. 117-120.3. Weh L, Froeschle G. Incubation in Preparations as a Means of Influencing cartilage mechanics:

A mechanical study. Biologicai Therapy. VIII (4) 1990, 91-93. 4. Orlandini A, Rossi M, Setti M. The Effectiveness of Zeel and new Research Methods in

Rheumatology. Biologische Medizin. Vol 26 (4) 1997, 164-165. 5. Gottwald R. Weiser M. Treatment of Osteoarthritis of the Knee with Zeel® Injection Solution T.

Medicina Biologica 2000; Vol. 13 No. 4: 109-113.

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Traumeel® & Zeel® provide pain relief that is statistically significant and clinically relevant for patients with moderate

to severe osteoarthritis pain.

Conclusion:Tr14 & Ze14 provided statistically significant and clinically relevant pain relief on days 15 to 99 in comparison to placebo.

In this double-blind, randomized, controlled trial, a biological/mineral multi-extract combination was shown to be a safe and effective treatment for pain in moderate-to-severe knee OA.

Disclosure:C. Lozada, Rio Pharmaceutical Services. 5, Heel USA, 5; E. del Rio, Biologische Heilmittel Heel GmbH, 5;

D. Reitberg, Rio Pharmaceutical Services, LLC, 5; R. Smith, Rio Pharmaceutical Services, LLC, 5; C. Kahn, Biologische Heilmittel Heel GmbH, 5; R. W. Moskowitz, Rio Pharmaceutical Services, LLC, 5, Heel USA, 5

WOMAC A (Pain): Clinical Relevance Proportions of Patients Meeting Validated Criterion for Response on WOMAC Subscale A:

ITT population with LOCF; Minimally Important Difference (MID) from Baseline = -32.6 mm

Resp

onse

Rat

es

1 15 29 43 57 71 85 99

Study Day

LOCF = Last Observation Carried Forward

Traumeel/Zeel Placebo p < 0.05 p = 0.0599

60%

50%

40%

30%

20%

10%

0%

✳

✳

✳✳ ✳ ✳ ✳

22/111 29/111

34/111 33/11136/111

20/117

44/117

49/117

58/117

63/117 62/11764/117 64/117

38/111

44/111 46/111

5 6

Traumeel® & Zeel® Provide Similar Pain Relief To Steroids

Traumeel® & Zeel® relieve pain without the risks of opioid addiction, steroid joint degeneration, or NSAID GI damage.

32%

The Mozart study was published in Annals of Rheumatic Diseases (6/2015, Vol. 74)

along with a comparison to alternative pain relief therapies, based on meta-analyses

of competitive clinical studies.

The conclusion was that Traumeel® & Zeel® show persistent efficacy over time consistent with those observed for Steroids, Diclofenac, Ibuprofen, and Naproxen, as shown below:

Abstract available at MediNatura.com.

*Using IA placebo injections as the comparator, a peer-reviewed meta-analysis of 129 trials (Ann. Intern. Med. 2015; 162:46-54)

reported that the Hedges’ g* effect size at 3 months was 0.32 for IA injections of corticosteroids.

Effect sizes for commonly used oral NSAIDS were 0.23 for diclofenac, 0.15 for ibuprofen, and 0.09 for naproxen.

In the Mozart study, the reported Hedges’ g* value for TZ on Days 44 through 72 post initial dose was 0.3. Sources: A. https://www.drugs.com/drp/traumeel-injection-solution.html B. http://www.drugs.com/pro/celestone-soluspan.html C. http://www.drugs.com/pro/naproxen-tablets.html D. http://www.clevelandclinicmeded.com/medicalpubs/diseasemanagement/nephrology/diabetic-nephropathy/

Repo

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Corticosteroids Traumeel & Zeel

Diclofenac Ibuprofen Naproxen

Medical Issue Traumeel®Injection SolutionA

Corticosteroid Injection(Betamethasone)B NSAID Oral (Naproxen)C

Increased cardiovascular risk No known related AEs ordisease interactions

Use with caution in patients with congestive heart failure, hypertension, or renal insufficiency

May cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death

Diabetes No known related AEs ordisease interactions

May increase blood glucose concentrations; administer cautiously in patients with diabetes mellitus, glucose intolerance, or a predisposition to hyperglycemia

No known direct effects on blood glucose levels; patients with diabetic nephropathy may experience a significant drop in GFR, particularly when used with angiotensin-blocking agentsD

Polypharmacy No known drug-to-druginteractions

694 drugs (3032 brand and generic names) are known to interact

437 drugs (1685 brand and generic names) are known to interact

Disease interactions No known disease interactions 22 known disease interactions 20 known disease interactions

Toxicity to joint tissue No known detrimental effects on joint tissue

Intra-articular injection may result in damage to joint tissues Not applicable

Injections near to tendons and tendon structures

No known detrimental effects on tendons or tendon structures Potential risk of tendon ruptures Not applicable

Hypersensitivity to anycomponents of the product Contraindicated Contraindicated Contraindicated

7 8

Traumeel® and Zeel® are so safe they can be used

in large or small joints and for patients

with comorbidities.

Effective Pain Relief:1. Osteoarthritis of the Knee2. Arthritis in Small Joints3. Carpal Tunnel4. Rotator Cuff Syndrome5. Epicondylitis6. Fibromyalgia7. Facet Pain8. Trigger Point Injections

(used for multiple reasons including back pain)

9. Sprains10. Archilles Tenton Injuries11. Plantar Fasciitis

Safe For:• Diabetes• Hypertensives• Multi Rx users• Patients with heart problems• Patients who need multiple

injections that are safe for use with or between corticosteroid injections

• Patients when viscosupplementation fails

• First-line therapy instead of corticosteroid or NSAIDS

• Chronic pain sufferers• Use with PRP and stem cell

therapy• Injuries near tendons, and

ligaments

1

2

9

10 11

3

4

5

6

78

9 10

1. Achilles Tendon InjuriesProduct(s) & Dosage: 2.2cc Traumeel mixed with 1cc lidocaine.Application: Inject achilles s.c. in a retrograde fashion right along the tendon.Duration: Apply mixture 1 twice a week for two weeks; and a third week if pain persists. Beneficial adjunctive therapy: Traumeel ointment or ointment & tablets.

2. Arthritis in the small jointsProduct(s) & Dosage: 2.2 cc Traumeel combined with 2.0 cc Neuralgo-Rheum and 2 cc lidocaine.Application: Inject mixture into the joint (IA) about 1cc per each small joint.Duration: Once a week for 3 consecutive weeks.

3. Back PainApproach A (Inspecific Back Pain with Muscle Spasms).Product(s) & Dosage: 2.2 cc Traumeel combined with 1.0 cc Spascupreel. Application: Inject Traumeel combined with Spascupreel into the relevant trigger points or pain zone. Both agents can be mixed in the same syringe prior to injection. This mixture is administered as multiple injections of smaller volume (around 1 cc per trigger point). Traumeel has also been successfully utilized in cervical and lumbar spine facet i.a. injections.Duration: Once per week for 3 to 4 consecutive weeks.

Approach B (moderate to sevre low back pain).Product(s) & Dosage: 4.4 cc Traumeel combined with 5-6 cc lidocaine.Application: Injection epidurally.Duration: Two injections between steroid injections to elongate the time between steroid shots or on its own depending on the patient’s co-morbidities.

4. Carpal TunnelProduct(s) & Dosage: 2.2 cc Traumeel. Application: When performing a “real” carpal tunnel injection with Traumeel, the needle is inserted 1 cm proximal to the distal wrist flexion crease, just ulnar to the palmaris longus tendon at a 30 degree angle directly distally and slightly radially (if the palmaris longus is absent, the needle should be directed in line with the ring finger).Duration: One session per week over 2 – 3 consecutive weeks. Beneficial adjunctive therapy: Traumeel ointment or ointment & tablets.

5. EpicondylitisProduct(s) & Dosage: 2.2cc Traumeel mixed with 1cc lidocaine or marcaine.Application: Joints.Duration: Once per week for 2 weeks, 3 weeks if pain persists. Beneficial adjunctive therapy: Traumeel ointment or ointment & tablets.

6. Facet PainProduct(s) & Dosage: 2.2 cc Traumeel + 1.1 cc Neuralgo-Rheum injected into facet.Application: Inject into facet.Duration: Once a week for three weeks.

Protocols More protocols available at MediNatura.com.

7. FibromyalgiaProduct(s) & Dosage: 2.2 cc Traumeel mixed with 2.0 cc Spascupreel and 2 cc lidocaine per injection sessionApplication: Inject 1 cc of this mixture into the 6 most painful trigger points, using a 27G or 30G needle.Trigger point (TP) injections, though designed to relieve myofascial pain syndrome, can provide great benefits to those with fibromyalgia. Because so many fibromyalgia patients also have myofascial pain syndrome, trigger point injections are becoming increasingly attractive for treating fibromyalgia pain.Duration: One session per week over 2 – 3 consecutive weeks.

8. Osteoarthritis of the kneeProduct(s) & Dosage: 2.2 cc Traumeel mixed with 2.0 cc Zeel per injection and 1-2 cc lidocaine.Application: Inject intra-articularly. In most cases arthrocentesis will be performed prior to the i.a. knee injection. Usually a 25G or 22G 1.5” needle is used for this procedure. Ultrasound guided injections may lead to a higher accuracy. Injection has to be done under aseptic conditions.Duration: Once per week for 3 consecutive weeks. Pain relief of 3 to 6 months has bee reported. Procedure can be repeated as needed.

9. Osteoarthritis of the HipProduct(s) & Dosage: 2.2cc Traumeel mixed with 4.0cc Zeel plus 2cc lidocaine.Application: Peri- or intra-articular injection of the affected hip.Duration: Once per week ever 3 to 4 consecutive weeks under aseptic conditions.

10. Plantar FasciitisProduct(s) & Dosage: In chronic, intermittent plantar fascial pain, a combination of 2.2 cc Traumeeel mixed with 1cc lidocaine.Application: The mixture is given as an injection at the trigger point area of tenderness, around the plantar medial calcaneal tuberosity area of the foot, optimally along with the following acupuncture points: KI 3, KI 4 and KI 5.Duration: Injections may be repeated once a week for up to 3 weeks.

11. Rotator Cuff SyndromeProduct(s) & Dosage: 2.2 cc Traumeel alone or mixed with an anesthetic (e.g. 1-2 cc lidocaine).Application: A lateral approach is generally used, though other approaches have been described. A 20-25G, 1.5” needle is suitable for this approach. Traumeel can be intermixed with lidocaine in the same syringe. Image guided injections are more accurate, but also require a skilled clinician who is familiar with the technique and equipment.Duration: Once a week for three consecutive weeks. Beneficial adjunctive therapy: Traumeel ointment or ointment & tablets.

12. SprainsProduct(s) & Dosage: 2.2 to 4.4 cc Traumeel ; if muscle is very tender add 1 cc of Spascupreel ; for immediate pain relief add 1 cc procaine or lidocaine to mixture. Application: Multiple i.m. injections to pain zone or trigger points. Depending on affected size 1 to 5 injections in regional muscles each session. Duration: 1 weekly session for 2 to 4 consecutive weeks. Beneficial adjunctive therapy: Traumeel ointment or ointment & tablets.

11 12

Injection Solution Injection SolutionFull PI (with complete component list) available at MediNatura.com1. 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.

2. Dosage and Administration 2.1 General Considerations • 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.

• 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: 2⁄3 of an ampule 1 to 3 times per 7 days Children 2 to 5 years: 1⁄2 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: 2⁄3 of an ampule daily, and then continue with standard dosage. Children 2 to 5 years: 1⁄2 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.

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 Strength One ampule containing 2.2 ml each 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® Injection Solution 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 None.

6. Adverse Reactions 6.1 Post-marketing Experience • The following adverse events have been identified during postmarketing

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 Injection Solution: Allergic (hypersensitivity) reactions (e.g. skin allergies, redness/swelling at the injection site, even up to anaphylaxis) may occur in isolated cases.

7. Drug Interactions No 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.

Full PI (with complete component list) available at MediNatura.com1. Indications and Usage 1.1 Treatment of arthrosis/osteoarthritis, and/or rheumatic joint

diseases. • Zeel® Injection Solution is a homeopathic drug product indicated for the

treatment of arthrosis/ osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

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

• Zeel® Injection Solution is a homeopathic drug product indicated, in combination with Traumeel® 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.

2. Dosage and Administration 2.1 General Considerations • The dosage schedules listed below can be used as a general guide for the

administration of Zeel® Injection Solution. • If co-administration with a local anesthetic is desired, Zeel® Injection

Solution may be mixed with lidocaine or similar agents at the discretion of the physician.

• Zeel® 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 arthrosis/osteoarthritis, and/ or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

Adults and children 12 years and older: 1 ampule 1 to 3 times per 7 days Children 6 to 11 years: 2⁄3 of an ampule 1 to 3 times per 7 days 2.3 Acute Dosage – for the treatment of arthrosis/osteoarthritis, and/or

rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness.

Adults and children 12 years and older: 1 ampule daily, and then continue with standard dosage. Children 6 to 11 years: 2⁄3 of an ampule daily, and then continue with standard dosage. 2.4 Co-administration therapy with Traumeel® 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, Zeel® Injection Solution may be mixed in a ratio of 1:1 with Traumeel® Injection Solution.

• For convenience, the daily dose of Zeel® Injection Solution may be administered at the same time as a Traumeel® 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 Strength One ampule containing 2.0 ml each containing the active ingredients in the

strengths listed under Description. (11)

4. Contraindications • Zeel® Injection Solution is contraindicated in patients with known

hypersensitivity to Zeel® Injection Solution or any of its ingredients. • When Zeel® Injection Solution is co-administered with Traumeel®

Injection Solution, refer to the Contraindications section of the respective Traumeel® Injection Solution labeling.

5. Warnings and Precautions None.

6. Adverse Reactions 6.1 Post-marketing Experience • The following adverse events have been identified during post-marketing

use of Zeel® 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 Zeel® Injection Solution: Allergic (hypersensitivity) skin reactions may occur in isolated cases

7. Drug Interactions No 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 Zeel® 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. Zeel® Injection solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

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When Steroids aren’t right, choose Traumeel® & Zeel®

10421 Research Rd, Albuquerque, NM 87123 | 1-844-633-4628 | info@MediNatura.com

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