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 
MediNatura

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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Zeel 2.0 ml Injection

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

INDICATIONS AND USAGE

Treatment of arthrosis/osteoarthritis, and/or rheumatic joint diseases

Co-administration Therapy with Traumeel® Injection Solution for the treatment of inflammatory and degenerative conditions of the musculoskeletal system.

DOSAGE AND ADMINISTRATION

General Considerations

•  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.

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

None

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

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

CLINICAL PHARMACOLOGY

Mechanism of Action

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

Pharmacodynamics

Not applicable for homeopathic medicinal products.

DOSAGE

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

Zeel 2.0 ml Injection.jpg

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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:50114-7030
Route of AdministrationINTRADERMAL, INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRA-ARTICULAR
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT4 [hp_X]  in 2.0 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF2 [hp_X]  in 2.0 mL
SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP3 [hp_X]  in 2.0 mL
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT6 [hp_X]  in 2.0 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_X]  in 2.0 mL
SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT4 [hp_X]  in 2.0 mL
SUS SCROFA CARTILAGE (UNII: 73ECW5WG2F) (SUS SCROFA CARTILAGE - UNII:73ECW5WG2F) SUS SCROFA CARTILAGE6 [hp_X]  in 2.0 mL
SUS SCROFA EMBRYO (UNII: 9928MC12VO) (SUS SCROFA EMBRYO - UNII:9928MC12VO) SUS SCROFA EMBRYO6 [hp_X]  in 2.0 mL
SUS SCROFA UMBILICAL CORD (UNII: 118OYG6W3H) (SUS SCROFA UMBILICAL CORD - UNII:118OYG6W3H) SUS SCROFA UMBILICAL CORD6 [hp_X]  in 2.0 mL
SUS SCROFA PLACENTA (UNII: C8CV8867O8) (SUS SCROFA PLACENTA - UNII:C8CV8867O8) SUS SCROFA PLACENTA6 [hp_X]  in 2.0 mL
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) .ALPHA.-LIPOIC ACID8 [hp_X]  in 2.0 mL
COENZYME A (UNII: SAA04E81UX) (COENZYME A - UNII:SAA04E81UX) COENZYME A8 [hp_X]  in 2.0 mL
NADIDE (UNII: 0U46U6E8UK) (NADIDE - UNII:0U46U6E8UK) NADIDE8 [hp_X]  in 2.0 mL
SODIUM DIETHYL OXALACETATE (UNII: 6CA025Y4FG) (DIETHYL OXALACETATE - UNII:15S56468G7) SODIUM DIETHYL OXALACETATE8 [hp_X]  in 2.0 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50114-7030-110 in 1 CARTON07/31/2014
12.0 mL in 1 AMPULE; Type 0: Not a Combination Product
2NDC:50114-7030-23 in 1 CARTON07/31/2014
22.0 mL in 1 AMPULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic07/31/2014
Labeler - MediNatura (102783016)
Establishment
NameAddressID/FEIBusiness Operations
Hameln Pharma GmbH315869123manufacture(50114-7030)
Establishment
NameAddressID/FEIBusiness Operations
Biologische Heilmittel Heel315635359manufacture(50114-7030)

Revised: 10/2019
Document Id: 5d101f9d-c986-4d2f-9530-94712def2338
Set id: 8e4a234c-785f-4be0-9a11-50bd82e2311e
Version: 13
Effective Time: 20191016
 
MediNatura