Omeoformula 3 Tissue Tone
Dosage Form: injection, solution
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.
OMEOFORMULA®3-TISSUE TONE (Homeopathic complex preparation) INJECTION SC, ID, IM
1. INDICATIONS AND USAGE
1.1. Skin slackening
1.2. Tissue revitalization
1.3. Gluteal muscle tone.
2. DOSAGE AND ADMINISTRATION
2.1. Treatment for IM application: 1 vial 1-3 times a week according to severity and clinic evolution.
2.2. Treatment using mesotherapy technique: Apply 0.3 ml for each point. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injections utilizing mesotherapy technique.
Application points: Apply to the affected area (abdomen, upper and lower extremities, gluteus muscles). Gluteus muscles: from the center of the gluteus muscle proceed along 4 injection lines, in a sunburst shape; apply along the subgluteal furrow.
Standard protocol consists of one session a week for 5-7 weeks. For prolonged treatments, 2 sessions for the first week, 1 session a week for 1 month and then 1 session a month are recommended.
Discard unused solution.
2.3. Opening of Vials: Use sterile needles and sterile syringe. Do not reuse. Do not use if foreign particles are present. Draw 1 cc of air into syringe, insert needle into vial inject air and withdraw the solution into the syringe
3. DOSAGE FORMS AND STRENGTHS
3.1. Injectable solution for subcutaneneous, intradermal, or intramuscular administration.
Pharmaceutical forms: 2 ml glass vials.
3.2. Each ingredient is attenuated according to the Homeopathic Pharmacopea of United States.
Active ingredients: a-Ketoglutaricum acidum 6X; Barium oxalosuccinate 6X; Calcarea carbonica 6X; Calcarea carbonica 30X; Calcarea carbonica 200X; Cis-Aconitic acid 6X; Citricum acidum 6X; Cyclamen europaeum 6X; DL malic acid 6X; Embryo 6X; Fumaricum acidum 6X; Funiculus umbilicalis 6X; Isoleucine 6X; Leucine 6X; Lysine 6X; Magnesium gluconate 6X; Manganum phosphoricum 6X; Methionine 6X; Natrum pyruvicum 6X; Natrum sulphuricum 6X; Nicotinamidum 6X; Phenylalanine 6X; Placenta 10X; Pulsatilla 6X; Succinicum acidum 6X; Threonine 6X; Thuja occidentalis 6X; Tryptophan 6X; Valine 6X.
Inactive ingredient: Sterile isotonic sodium chloride solution.
4.1. There is no history of hypersensitivity to OMEOFORMULA®3-TISSUE TONE. However patients with a known hypersensitivity to any ingredient should be tested before use. Make a spot injection (0.1ml) into the forearm and observe for any reactions for 1 hour.
5. WARNINGS AND PRECAUTIONS
5.1. Be sure to disinfect the area before application. Skin disinfection helps avoid infection at the site of administration that can result from saprophytic bacteria (i.e. atypical mycobacteria, staphylococcus genus) that may be present on the skin.
6. ADVERSE REACTIONS
6.1. The most common mild adverse reaction is slight reddening at the injection site due to the mechanical effect of the needle or a superficial skin reaction of mild erythema.
7. DRUG INTERACTIONS
7.1. None Known.
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy: Pregnancy category C. Animal reproduction studies have not been conducted with OMEOFORMULA®3-TISSUE TONE. OMEOFORMULA®3-TISSUE TONE should not be administered to a pregnant woman.
8.2 Nursing mothers: It is not known whether any of the ingredients in OMEOFORMULA®3-TISSUE TONE are secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when OMEOFORMULA®3-TISSUE TONE is administered to a nursing woman.
8.3 Pediatric use: Effectiveness in pediatric patients has not been established.
8.4 Geriatric use: No restrictions.
9. DRUG ABUSE AND DEPENDENCE
9.1. No Known.
10.1. No Known.
OMEOFORMULA®3- TISSUE TONE is a sterile solution made with isotonic sodium chloride solution. Its formulation is based on classical Homeopathy and each ingredient has been selected according to the homeopathic description as referred to in Materia Medica.
The firming and toning activity is due to the activity of the suis-organ ingredients. The amino acid ingredients promote protein synthesis.
12. CLINICAL PHARMACOLOGY
12.1. Mechanism of Action
The medication acts through a low-dose enzymatic mechanism.
The physiological effects of OMEOFORMULA®3- TISSUE TONE are due to the effects of the ingredients, according to their description in the Homeopathic Materia Medica.
Homeopathic attenuation provides complete bioavability of the active ingredients.
13. NONCLINICAL TOXICOLOGY
13.1. OMEOFORMULA®3- TISSUE TONE has no level of toxicity due to the attenuation of the ingredients.
14. CLINICAL STUDIES
14.1. OMEOFORMULA®3- TISSUE TONE formulation is based on classical Homeopathy and each ingredient has been selected according to the homeopathic description as referred in Materia Medica.
15.1. E.Italia, M. De Bellis: Manuale di Omeo-mesoterapia – Guna Ed. 1995
15.2. H.H. Reckeweg: Homeopathic Materia medica omeopatica. Aurelia Verlag.
16. HOW SUPPLIED/STORAGE AND HANDLING16.1. NDC 17089-274-31 10 glass vial packed in carton box
16.2. NDC 17089-274-32 50 glass vial packed in carton box
16.3. Store at room temperature, 20-25°C (68-77° F). Avoid freezing and excessive heat.
17. PATIENT COUNSELING INFORMATION
17.1. Patients should be informed of the homeopathic approach and the therapeutic goals of OMEOFORMULA®3- TISSUE TONE.
|OMEOFORMULA 3-TISSUE TONE |
.alpha.-ketoglutaric acid - aconitic acid, cis - barium cation - calcium carbonate - citric acid monohydrate - cyclamen purpurascens tuber - fumaric acid - isoleucine - leucine - lysine - magnesium gluconate - malic acid - manganese phosphate, dibasic - methionine - natrum sulphuricum - niacinamide - phenylalanine - pulsatilla vulgaris - sodium pyruvate - succinic acid - sus scrofa placenta - sus scrofa umbilical cord - threonine - thuja occidentalis twig - tryptophan - valine - sus scrofa embryo - injection, solution
|Labeler - Guna spa (430538264)|