Injection Solution Ingredient Information: Each 2.0 ml ampule contains: Arnica Montana, radix 4X 200 mcl, Rhus toxicodendron 2X 10 mcl, Dulcamara 3X 10 mcl, Symphytum officinale 6X 10 mcl, Sulphur 6X 3.6 mcl, Sanguinaria Canadensis 4X 3 mcl, Cartilago suis 6X 2 mcl, Embryo suis 6X 2 mcl, Funiculus umbillicalis suis 6X 2 mcl, Placenta suis 6X 2 mcl, α-Lipoicum acidum 8X 2 mcl, Coenzyme A 8X 2 mcl, Nadidum 8X 2 mcl, Natrum oxalaceticum 8X 2 mcl. Inactive ingredient: Sterile isotonic sodium chloride solution.
Indications and Usage for Zeel
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Zeel® Injection Solution is indicated for the temporary relief of mild to moderate arthritic pain, osteoarthritis and joint stiffness.
Zeel Dosage and Administration
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The dosage schedule listed below can be used as a general guide for the administration of Zeel® Injection Solution. Zeel® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response to therapy.
Adults and children 7 years and older: 1 ampule daily for acute disorders, or 1 ampule 1 to 3 times per week. Children ages 2 to 6 receive: ½ the adult dosage.
Discard unused solution.
Zeel® Injection Solution may be administered intravenously, intramuscularly, subcutaneously, or intradermally. The required dose of Zeel® Injection Solution is first withdrawn from the ampule into the syringe, and the syringe is then shaken briefly. Zeel® Injection Solution should be administered using a narrow gauge needle (e.g. 22 to 30 gauge). Note: Parental drug products like Zeel® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Zeel® Injection Solution is a clear, colorless solution.
Discolored solutions should be discarded.
Warnings and Precautions
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Zeel® Injection Solution should not be administered for pain for more than 10 days for adults or five days for children. If new symptoms occur, or if redness, pain or swelling at the puncture site persists, the patient should be carefully re-evaluated because these could be signs of a more serious condition. Zeel® Injection Solution should not be administered to children for the pain of arthritis unless directed by a physician.
Pregnancy Category C. Animal reproduction studies have not been conducted with this drug. It is also not known whether this drug can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This drug should be given to a pregnant woman only if clearly needed.
To report SUSPECTED ADVERSE REACTIONS, contact Heel Inc. at 1.800.920.9203 or info@heelusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Overdosage
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Due to the low concentration of active ingredients in homeopathic preparations such as Zeel® Injection Solution, adverse reactions following overdosage are extremely unlikely. However care must be taken not to exceed the recommended dosage.
Zeel - Clinical Pharmacology
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The exact mechanism of action of Zeel® Injection Solution is not fully understood. In-vitro data indicates that the ingredients in Zeel® Injection Solution may reduce pain, stiffness and inflammation in arthritic joints via immunomodulation. Hence, it has been shown that Zeel® Injection Solution inhibits activity of the leukocyte elastase. This enzyme is released during inflammatory reactions and attacks the articular cartilage which is rich in proteoglycans. A study of human whole blood cultures demonstrated that certain plant extracts contained in Zeel® Injection Solution (e.g. Rhus toxicodendron, Arnica montana) stimulates lymphocytes to release the transforming growth factor β. The protective effect of Zeel® Injection Solution upon cartilage has also been demonstrated by in-vitro and in-vivo studies. The clinical effectiveness and tolerance of Zeel® Injection Solution has also been demonstrated in a drug monitoring study.
PRINCIPAL DISPLAY PANEL
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| Zeel arnica montana and toxicodendron pubescens leaf and solanum dulcamara stem and symphytum tuberosum root and sulfur and sanguinaria canadensis root and sus scrofa cartilage and sus scrofa embryo and sus scrofa umbilical cord and sus scrofa placenta and alpha lipoic acid and coenzyme a and nadide and sodium diethyl oxalacetate injection | ||||||||||||||||||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved homeopathic | 01/24/2011 | ||
| Labeler - Hameln Pharma GmbH (315869123) |
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