Data from FDA - Curated by EPG Health - Last updated 05 July 2018

Indication(s)

INDICATION AND USAGE 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 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.

Learning Zones

An epgonline.org Learning Zone (LZ) is an area of the site dedicated to providing detailed self-directed medical education about a disease, condition or procedure.

Acute and Advanced Heart Failure

Acute and Advanced Heart Failure

What are the most effective treatments for acute heart failure? Can you define advanced heart failure? Discover here...

+ 3 more

Allergic Rhinitis

Allergic Rhinitis

Allergic rhinitis causes great strain on the workforce. Help to reduce sick days and improve productivity with appropriate treatment options.

+ 4 more

Anticoagulation Therapy for Stroke Prevention

Anticoagulation Therapy for Stroke Prevention

Anticoagulation therapy for Stroke Prevention Learning Zone offers a deep-dive into atrial fibrillation causes, consequences, diagnosis and management to help you deliver optimal care and prevent strokes in patients living with this common arrhythmia.

Load more

Related Content

Advisory information

contraindications
CONTRAINDICATIONS Traumeel® Injection Solution is contraindicated in patients with known hypersensitivity to Traumeel® or any of its ingredients.
Adverse reactions
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 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. •To report SUSPECTED ADVERSE REACTIONS, contact MediNatura at 1.844.633.4628 or [email protected] or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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. 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.

More information

Category Value
Agency product number U0NQ8555JD
Orphan designation No
Product NDC 50114-7004
Date Last Revised 20-06-2018
Type HUMAN PRESCRIPTION DRUG
Marketing authorisation holder Medinatura