Label: ZEEL - arnica montana root, toxicodendron pubescens leaf, solanum dulcamara top, comfrey root, sulfur, sanguinaria canadensis root, sus scrofa cartilage, sus scrofa embryo, sus scrofa umbilical cord, sus scrofa placenta, .alpha.-lipoic acid, coenzyme a, nadide and sodium diethyl oxalacetate injection

  • NDC Code(s): 50114-7030-1, 50114-7030-2
  • Packager: MediNatura
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

Drug Label Information

Updated 01/15

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  • 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

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  • 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.

    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.

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  • 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.

    •  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.

    • 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.
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  • CONTRAINDICATIONS

    • Zeel® Injection Solution is contraindicated in patients with known hypersensitivity to Zeel® or any of its ingredients.
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  • WARNINGS AND PRECAUTIONS

    None

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

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  • OVERDOSAGE

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

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  • CLINICAL PHARMACOLOGY

    Mechanism of Action

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

    Pharmacodynamics

    Not applicable for homeopathic medicinal products.

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  • DOSAGE

    One ampule containing 2.0 ml each containing the active ingredients in the strengths listed under Description.

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  • INGREDIENTS AND APPEARANCE
    ZEEL 
    arnica montana root, toxicodendron pubescens leaf, solanum dulcamara top, comfrey root, sulfur, sanguinaria canadensis root, sus scrofa cartilage, sus scrofa embryo, sus scrofa umbilical cord, sus scrofa placenta, .alpha.-lipoic acid, coenzyme a, nadide and sodium diethyl oxalacetate injection
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50114-7030
    Route of Administration INTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRA-ARTICULAR DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ARNICA MONTANA ROOT (ARNICA MONTANA ROOT) ARNICA MONTANA ROOT 4 [hp_X]  in 2.0 mL
    TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 2 [hp_X]  in 2.0 mL
    SOLANUM DULCAMARA TOP (SOLANUM DULCAMARA TOP) SOLANUM DULCAMARA TOP 3 [hp_X]  in 2.0 mL
    COMFREY ROOT (COMFREY ROOT) COMFREY ROOT 6 [hp_X]  in 2.0 mL
    SULFUR (SULFUR) SULFUR 6 [hp_X]  in 2.0 mL
    SANGUINARIA CANADENSIS ROOT (SANGUINARIA CANADENSIS ROOT) SANGUINARIA CANADENSIS ROOT 4 [hp_X]  in 2.0 mL
    SUS SCROFA CARTILAGE (SUS SCROFA CARTILAGE) SUS SCROFA CARTILAGE 6 [hp_X]  in 2.0 mL
    SUS SCROFA EMBRYO (SUS SCROFA EMBRYO) SUS SCROFA EMBRYO 6 [hp_X]  in 2.0 mL
    SUS SCROFA UMBILICAL CORD (SUS SCROFA UMBILICAL CORD) SUS SCROFA UMBILICAL CORD 6 [hp_X]  in 2.0 mL
    SUS SCROFA PLACENTA (SUS SCROFA PLACENTA) SUS SCROFA PLACENTA 6 [hp_X]  in 2.0 mL
    .ALPHA.-LIPOIC ACID (.ALPHA.-LIPOIC ACID) .ALPHA.-LIPOIC ACID 8 [hp_X]  in 2.0 mL
    COENZYME A (COENZYME A) COENZYME A 8 [hp_X]  in 2.0 mL
    NADIDE (NADIDE) NADIDE 8 [hp_X]  in 2.0 mL
    SODIUM DIETHYL OXALACETATE (DIETHYL OXALACETATE) SODIUM DIETHYL OXALACETATE 8 [hp_X]  in 2.0 mL
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM CHLORIDE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50114-7030-1 10 in 1 CARTON
    1 2.0 mL in 1 AMPULE
    2 NDC:50114-7030-2 3 in 1 CARTON
    2 2.0 mL in 1 AMPULE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved homeopathic 01/31/2004
    Labeler - MediNatura (102783016)
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