Traumeel

Heel Inc

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

FULL PRESCRIBING INFORMATION

TRAUMEEL DESCRIPTION

Each 2.2 ml ampule contains:

Inactive Ingredients

Water for injection 2,179.10 μl

Sodium Chloride 19.40 μl

INDICATION AND USAGE

Treatment of injuries and various conditions of the musculoskeletal system.

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

Co-administration Therapy with Zeel® Injection Solution for the treatmnet 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.

TRAUMEEL DOSAGE AND ADMINISTRATION

General Considerations

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

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

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

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.

TRAUMEEL 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 Contraindication section of the respective Zeel® Injection Solution labeling.

WARNINGS AND PRECAUTIONS

Keep out of reach of children.

TRAUMEEL ADVERSE REACTIONS

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 frquency 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.

To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203

info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

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

CLINICAL PHARMACOLOGY

Mechanism of Action

The exact mechanism of Traumeel® Injection Solution is not fully understood.

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

One ampule containing 2.2 ml each containing the active ingredients in the strengths listed under Description.