{"adverse_reactions":["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"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY Mechanism of Action The exact mechanism of Zeel ® Injection Solution is not fully understood. Pharmacodynamics Not applicable for homeopathic medicinal products."],"contraindications":["CONTRAINDICATIONS Zeel® Injection Solution is contraindicated in patients with known hypersensitivity to Zeel® or any of its ingredients."],"description":["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"],"dosage_and_administration":["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."],"dosage_forms_and_strengths":["DOSAGE One ampule containing 2.0 ml each containing the active ingredients in the strengths listed under Description."],"effective_time":"20211014","id":"481ac8c7-8ec2-40e1-b29a-e846a24ad4a2","indications_and_usage":["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."],"openfda":{},"overdosage":["OVERDOSAGE No negative effects of an overdose have been reported and none are expected due to the homeopathic dilutions."],"package_label_principal_display_panel":["Zeel 2.0 ml Injection.jpg"],"set_id":"8e4a234c-785f-4be0-9a11-50bd82e2311e","spl_product_data_elements":["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 ARNICA MONTANA ROOT ARNICA MONTANA ROOT TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF SOLANUM DULCAMARA TOP SOLANUM DULCAMARA TOP COMFREY ROOT COMFREY ROOT SULFUR SULFUR SANGUINARIA CANADENSIS ROOT SANGUINARIA CANADENSIS ROOT SUS SCROFA CARTILAGE SUS SCROFA CARTILAGE SUS SCROFA EMBRYO SUS SCROFA EMBRYO SUS SCROFA UMBILICAL CORD SUS SCROFA UMBILICAL CORD SUS SCROFA PLACENTA SUS SCROFA PLACENTA .ALPHA.-LIPOIC ACID .ALPHA.-LIPOIC ACID COENZYME A COENZYME A NADIDE NADIDE SODIUM DIETHYL OXALACETATE DIETHYL OXALACETATE SODIUM CHLORIDE WATER"],"version":"15","warnings_and_cautions":["WARNINGS AND PRECAUTIONS None"]}