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
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.
Drug Label Information
Updated October 14, 2021
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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.
- CONTRAINDICATIONS
- WARNINGS AND PRECAUTIONS
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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
- OVERDOSAGE
- CLINICAL PHARMACOLOGY
- DOSAGE
- PRINCIPAL DISPLAY PANEL
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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 injectionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50114-7030 Route of Administration INTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRA-ARTICULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 4 [hp_X] in 2.0 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 2 [hp_X] in 2.0 mL SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP 3 [hp_X] in 2.0 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 6 [hp_X] in 2.0 mL SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR 6 [hp_X] in 2.0 mL SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT 4 [hp_X] in 2.0 mL SUS SCROFA CARTILAGE (UNII: 73ECW5WG2F) (SUS SCROFA CARTILAGE - UNII:73ECW5WG2F) SUS SCROFA CARTILAGE 6 [hp_X] in 2.0 mL SUS SCROFA EMBRYO (UNII: 9928MC12VO) (SUS SCROFA EMBRYO - UNII:9928MC12VO) SUS SCROFA EMBRYO 6 [hp_X] in 2.0 mL SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H) SUS SCROFA UMBILICAL CORD 6 [hp_X] in 2.0 mL SUS SCROFA PLACENTA (UNII: C8CV8867O8) (SUS SCROFA PLACENTA - UNII:C8CV8867O8) SUS SCROFA PLACENTA 6 [hp_X] in 2.0 mL .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) .ALPHA.-LIPOIC ACID 8 [hp_X] in 2.0 mL COENZYME A (UNII: SAA04E81UX) (COENZYME A - UNII:SAA04E81UX) COENZYME A 8 [hp_X] in 2.0 mL NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK) NADIDE 8 [hp_X] in 2.0 mL SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7) SODIUM DIETHYL OXALACETATE 8 [hp_X] in 2.0 mL Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50114-7030-1 10 in 1 CARTON 07/31/2014 12/31/2024 1 2.0 mL in 1 AMPULE; Type 0: Not a Combination Product 2 NDC:50114-7030-2 3 in 1 CARTON 07/31/2014 12/31/2024 2 2.0 mL in 1 AMPULE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/31/2014 12/31/2024 Labeler - MediNatura (102783016) Establishment Name Address ID/FEI Business Operations Hameln Pharma GmbH 315869123 manufacture(50114-7030) Establishment Name Address ID/FEI Business Operations Biologische Heilmittel Heel 315635359 manufacture(50114-7030)