Zeel Solution (Heel)

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DESCRIPTION

ZEEL® Injection Solution is a combination formulation consisting of five botanical substances, five mineral substances and four animal-derived substances. ZEEL® Injection Solution is officially classified as a homeopathic combination remedy. ¹

1. Botanical ingredients
   Arnica montana, radix (mountain arnica)
   Dulcamara (bittersweet)
   Rhus toxicodendron (poison oak)
   Sanguinaria canadensis (blood root)
   Symphytum officinale (comfrey)
2. Mineral ingredients:
   Sulphur (sulphur)
   (alpha)-Lipoicum acid (thioctic acid)
   Coenzyme A (coenzyme A)
   Nadidum (nicotinamide adenine dinucleotide)
   Natrum oxalaceticum (sodium oxalacetate)
3. Animal-derived ingredients
   Cartilago suis (porcine cartilage)
   Embryo totalis suis (porcine embryo)
   Funiculus umbilicalis suis (porcine umbilical cord)
   Placenta suis (porcine placenta)

Injection Solution:    Each 2.0 ml ampule contains as active ingredients: Arnica montana, radix 4 × 200 µl, Rhus toxicodendron 2 × 10 µl, Dulcamara 3 × 10 µl, Symphytum officinale 6 × 10 µl, Sulphur 6 × 3.6 µl, Sanguinaria canadensis 4 × 3 µl, Cartilago suis 6 × 2 µl, Embryo totalis suis 6 × 2 µl, Funiculus umbilicalis suis 6 × 2 µl, Placenta suis 6 × 2 µl, Coenzyme A 8 × 2 µl, (alpha)-Lipoicum acidum 8 × 2 µl, Nadidum 8 × 2 µl, Natrum oxalaceticum 8 × 2 µl. Each 2.0 ml ampule contains as an inactive ingredient sterile isotonic sodium chloride solution.

CLINICAL PHARMACOLOGY

While the exact mechanism of action of ZEEL® is not fully understood, in vitro data indicates that the ingredients in ZEEL® may reduce pain, stiffness and inflammation in arthritic joints via immuno-modulation. Hence, it has been shown that ZEEL® inhibits activity of the leukocyte elastase. This enzyme is released during inflammatory reactions and attacks the articular cartilage which is rich in proteoglycans. ² A study of human whole blood cultures demonstrated that certain plant extracts contained in ZEEL® (e.g. Rhus toxicodendron, Arnica montana) stimulate lymphocytes to release the transforming growth factor-(beta). ³ The protective effect of ZEEL® upon cartilage has also been demonstrated by in vitro and in vivo studies. ^4,5,6 The clinical effectiveness and tolerance of ZEEL® has been demonstrated in randomized, blind, multi-center, controlled clinical trials as well as uncontrolled post-marketing physician surveys.

INDICATIONS AND USAGE

ZEEL® Injection Solution is indicated for the temporary relief of symptoms of osteoarthritis including mild to moderate pain, articular stiffness and inflammation.

CONTRAINDICATIONS

Administration should be avoided in cases of known hypersensitivity to Rhus toxicodendron.

WARNINGS

ZEEL® Injection Solution should not be administered for pain for more than 10 days for adults or five days for children. If pain persists or worsens, if new symptoms occur, or if redness or swelling is present the patient should be carefully evaluated because these could be signs of a serious condition. ZEEL® Injection Solution should not be administered to children for the pain of arthritis unless directed by a physician.

PRECAUTIONS

General:

Adverse reactions with ZEEL® Injection Solution are extremely rare. ZEEL® Injection Solution exhibits no known adverse renal, hepatic, cardiovascular, gastrointestinal or central nervous system effects.

Information for Patients:

No harmful or potentially hazardous side effects such as central nervous system depression are known. ZEEL® Injection Solution is generally well tolerated.

Drug interactions:

ZEEL® Injection Solution is not known to interact with other medications. Furthermore the administration of ZEEL® Injection Solution can be safely augmented by the application of the topical dosage form of ZEEL®.

Drug/Laboratory Test Interactions:

ZEEL® Injection Solution is not known to interact with any laboratory tests.

Carcinogenesis:

No studies have been performed to evaluate the carcinogenicity of ZEEL® Injection Solution. In worldwide post-marketing surveillance no evidence of carcinogenicity has been found. ⁷

Pregnancy Category C:

In general, medications such as ZEEL® Injection Solution that are classified as homeopathic are not known to cause direct or indirect harm to the fetus. However, animal reproduction studies have not been performed and there are no well-controlled studies in pregnant women. In cases of pregnancy or suspected pregnancy, ZEEL® Injection Solution should be used only if potential benefits justify potential risks to the fetus.

Nursing Mothers:

It is not known whether any of the ingredients of ZEEL® Injection Solution are excreted in human milk. However, because many drugs are excreted in human milk, ZEEL® Injection Solution should be administered with caution to nursing mothers.

Pediatric use:

ZEEL® Injection Solution can be administered to children as young as 2 years. (see DOSAGE AND ADMINISTRATION .) A physician should be consulted before administering ZEEL® Injection Solution to children below the age of 2 years.

ADVERSE REACTIONS

In rare cases patients with hypersensitivity to botanicals of the Compositae family or the genus Rhus of the Anacardiaceae family may experience an allergic reaction to ZEEL® Injection Solution including anaphylactic reaction.

The sole ZEEL® Injection Solution ingredient of the Compositae family is Arnica montana, radix (mountain arnica).

The sole ZEEL® Injection Solution ingredient of the genus Rhus of the Anacardiaceae family is Rhus toxicodendron (poison oak).

OVERDOSAGE

Due to the low concentration of active ingredients in homeopathic preparations such as ZEEL® Injection Solution adverse reactions following overdosage are extremely unlikely. However, care must be taken not to exceed the recommended dosage.

DOSAGE AND ADMINISTRATION

The dosage schedules listed below can be used as a general guide for the administration of ZEEL® Injection Solution. ZEEL® Injection Solution shows individual differences in clinical response. Therefore, the dosage for each patient should be individualized according to the patient's response to therapy. For best results, treatment with ZEEL® Injection Solution should be initiated when the diagnosis of arthritis or arthropy is first considered. ZEEL® Injection Solution may be administered until symptoms disappear. However if symptoms persist or worsen a physician should be consulted. (See WARNINGS .)

Adults and children above 6 years:    1 ampule daily for acute disorders or 1 or 2 ampules 1 to 3 times weekly.

Children 2-6 years:    Half the adult dosage. Discard unused solution.

ZEEL® Injection Solution may be administered either intravenously, intramuscularly, subcutaneously or intradermally. ZEEL® Injection Solution is indicated for peri-articular administration. Intra-articular injection may be administered under aseptic conditions. If coadministration with a local anesthetic is desired, ZEEL® Injection Solution may be mixed in a 1:1 ratio with 1% or 2% lidocaine hydrochloride. Similar anesthetics may also be used. The local anesthetic is first withdrawn into the syringe. The required dose of ZEEL® Injection Solution is then withdrawn from the ampule into the syringe and the syringe is then shaken briefly. Normally about 0.5 to 1.0 ml milliliters of each drug is withdrawn into the syringe. ZEEL® Injection Solution should be administered using a narrow gauge needle (e.g., 22 to 30 gauge). Note: Parenteral drug products like ZEEL® Injection Solution should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Discolored solutions should be discarded.

HOW SUPPLIED

ZEEL® Injection Solution in 2.0 ml ampules. Packs of 10. NDC 50114-7030-1.

Avoid freezing and excessive heat. Store at room temperature between 15°C and 30°C (59° and 86° F.) Protect from light.

CAUTION:   Rx only.

REFERENCES

1. The Homeopathic Pharmacopoeia of the United States (HPUS), 8 ^th Edition. Falls Church, Virginia, 1979 and the Homeopathic Pharmacopoeia of the United States Revision Service (HPRS), 1988.
2. Stancikova M. Inhibition of leucyte elastasis in vitro with Zeel and its various potentized components - a preliminary report. Biologische Medizin . Vol 28 (2) 1999, 83-84.
3. Heine H. The working mechanisms of Antihomotoxic Potentized Preparations. Biomedical Therapy . XVII (4) 1999, 117-120.
4. Weh L, Froeschle G. Incubation in Preparations as a Means of Influencing cartilage mechanics: A mechanical study. Biological Therapy . VIII (4) 1990, 91-93.
5. Stancikova M et al. Effects of Zeel on Experimental Osteoarthritis in Rabbit Knee. Research Institute of Rheumatic Diseases. Slovakia, 1999. Data pending publication.
6. Orlandini A, Rossi M, Setti M. The Effectiveness of Zeel and new Research Methods in Rheumatology. Biologische Medizin . Vol 26 (4) 1997, 164-165.
7. Data on file. Heel GmbH, Baden-Baden, Germany

This full prescribing information has been compiled in accordance with the Code of Federal Regulations (CFR), 21, sections 201.56 and 201.57.

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