FDA Label for Zeel
View Indications, Usage & Precautions
Zeel Product Label
The following document was submitted to the FDA by the labeler of this product Medinatura. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
Ingredient name Potency Quantity Final dilution
a-Lipoicum acidum 8X 2.0 μl 10.99X
Arnica montana, radix 4X 200.0 μl 5.00X
Cartilago suis 6X 2.0 μl 9.00X
Coenzyme A 8X 2.0 μl 10.99X
Dulcamara 3X 10.0 μl 5.30X
Embryo totalis suis 6X 2.0 μl 9.00X
Funiculus umbilicalis suis 6X 2.0 μl 9.00X
Nadidum 8X 2.0 μl 10.99X
Natrum oxalaceticum 8X 2.0 μl 10.99X
Placenta suis 6X 2.0 μl 9.00X
Rhus toxicodendron 2X 10.0 μl 4.30X
Sanguinaria canadensis 4X 3.0 μl 6.82X
Sulphur 6X 3.6 μl 8.74X
Symphytum officinale 6X 10.0 μl 8.30
Indications And Usage
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.
- 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.
Co-administration Therapy with Traumeel® Injection Solution for the treatment of inflammatory and degenerative conditions of the musculoskeletal system.
Dosage And Administration
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.
- 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.
• The interval between injections is left to the discretion of the HCP, but should not exceed 1 ampulein 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 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
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
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.
Contraindications
- Zeel® Injection Solution is contraindicated in patients with known hypersensitivity to Zeel® or any of its ingredients.
Warnings And Precautions
None
Adversere Reactions
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.
•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.
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
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 Zeel® Injection Solution is not fully understood.
Pharmacodynamics
Not applicable for homeopathic medicinal products.
Dosage
One ampule containing 2.0 ml each containing the active ingredients in the strengths listed under Description.
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