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  • Zeel® Injection Solution, Parenteral Use Rx Only

    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 
    Heel

    Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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    HIGHLIGHTS OF PRESCRIBING INFORMATION

    Zeel® Injection Solution, Parenteral Use Rx Only

    These highlights do not include all the information needed to use Zeel® Injection Solution safely and effectively. See full prescribing information for Zeel®. (1)

    INDICATIONS AND USAGE

    Zeel® Injection Solution is a homeopathic drug indicated:

    • As a mono-therapy, for the treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases and for the relief of symptoms such as pain and joint stiffness. (1.1)
    • 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. (1.2)

    DOSAGE AND ADMINISTRATION

    • Standard Dosage:
      Adults and children 12 years and older:
      1 ampule 1 to 3 times per 7 days
      Children 6 to 11 years:
      ⅔ of an ampule 1 to 3 times per 7 days (2)
    • Acute Dosage:
      Adults and children 12 years and older:
      1 ampule daily, and then continue with standard dosage.
      Children 6 to 11 years:
      ⅔ of an ampule daily, and then continue with standard dosage. (2)
    • When co-administered with Traumeel® Injection Solution, the two products may be mixed 1:1.

    DOSAGE FORMS AND STRENGTHS

    • 1 ampule containing 2.0 ml each containing the active ingredients in the strengths listed under Description. (10)

    CONTRAINDICATIONS

    • Zeel® Injection Solution is contraindicated in patients with known hypersensitivity to Zeel® or any of its ingredients. (4)

    WARNINGS AND PRECAUTIONS

    • Keep out of reach of children. (5)

    ADVERSE REACTIONS

    • Allergic (hypersensitivity) skin reactions may occur in isolated cases. (6)
    • 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 .

    DRUG INTERACTIONS

    • None known (7)

    USE IN SPECIFIC POPULATIONS

    • No studies have been conducted with Zeel® Injection Solution on pregnant or lactating women, children, or elderly. (8)

    Revised: 1/2014

    FULL PRESCRIBING INFORMATION

    1 Indications and Usage

    1.1 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.

    1.2 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.

    2 Dosage and Administration

    2.1 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 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.

    2.2 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:

    ⅔ of an ampule 1 to 3 times per 7 days

    2.3 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:

    ⅔ of an ampule daily, and then continue with standard dosage.

    2.4 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.

    2.5 Instructions for Opening Glass Ampule

    Figure
    • Cutting open the glass ampule is not necessary. Hold the ampule head up at an angle, and tap/shake down the solution contained in the ampule head. Then break off the ampule head by applying pressure away from the color dot. Discard unused solution.

    3 Dosage Forms and Strength

    One ampule containing 2.0 ml each containing the active ingredients in the strengths listed under Description. (10)

    4 Contraindications

    • Zeel® Injection Solution is contraindicated in patients with known hypersensitivity to Zeel® or any of its ingredients.
    • When Zeel® Injection Solution is co-administered with Traumeel® Injection Solution, refer to the Contraindications section of the respective Traumeel® Injection Solution labeling.

    5 Warnings and Precautions

    Keep out of reach of children.

    6 Adverse Reactions

    6.1 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.

    7 Drug Interactions

    No interactions have been reported, and none are expected due to the homeopathic dilutions.

    8 Use in Specific Populations

    8.1 Pregnancy

    8.1.1 Teratogenic effects

    Pregnancy Category C. Some ingredients in Zeel® Injection Solution have been shown to be teratogenic in various animal species when given in doses several thousand times the human dose. There are no adequate and well-controlled studies in pregnant women. Zeel® Injection solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    When Zeel® Injection Solution is administered with Traumeel® Injection Solution in a woman of childbearing age, refer to the pregnancy category and product labelling for Traumeel® Injection Solution.

    8.1.2 Non-teratogenic effects

    No known non-teratogenic effects.

    8.2 Labor and delivery

    No recognized use in labor or delivery.

    8.3 Nursing Mothers:

    It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Zeel® Injection Solution is administered to a nursing woman.

    8.4 Pediatric use

    Safety and effectiveness in pediatric patients have not been established. However, traditional homeopathic use of the ingredients in Zeel® Injection Solution has not identified differences in responses between adults and pediatric patients.

    8.5 Geriatric use

    Safety and effectiveness in geriatric patients have not been established. However, traditional homeopathic use of the ingredients in Zeel® Injection Solution has not identified differences in responses between adults and geriatric patients.

    9 Overdosage

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

    10 Description

    10.1 Ingredients

    • Each 2.0 ml ampule contains:
    Table

    Inactive Ingredients:

    Water for injection 1,747.4 μl
    Sodium Chloride 17.6 μl

    10.2 Pharmaceutical Form

    • Injection solution

    10.3 Route of Administration

    • Parenteral:  s.c., i.d., i.m., i.a. or i.v

    11 Clinical Pharmacology

    11.1 Mechanism of Action

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

    11.2 Pharmacodynamics

    Not applicable for homeopathic medicinal products.

    12 References

    • Homeopathic Pharmacopeia of the United States Revision Service

    13 How Supplied / Storage and handling

    13.1 Dosage forms and package sizes

    • 1 ampule of 2.0 ml in packs of 10 ampules
    • NDC 50114-7030-1

    13.2 Storage and handling

    • Store at room temperature. Protect from light.

    PRODUCT PHOTO

    NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

    The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected over dosage, the drug's identity should be verified by chemical analysis.

    Image from Drug Label Content