OMEOFORMULA2-CELLULITE
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adenosine cyclic 3',5'-phosphate,
.alpha.-ketoglutaric acid,
araneus diadematus,
barium oxalosuccinate,
calcium phosphate,
calcium sulfate anhydrous,
aconitic acid, cis-,
citric acid monohydrate,
malic acid,
echinacea angustifolia,
fumaric acid,
graphite,
hamamelis virginiana root bark/stem bark,
juglans regia leaf,
sus scrofa small intestine mucosa lymph follicle,
magnesium gluconate,
manganese phosphate, dibasic,
myosotis arvensis,
sodium pyruvate,
sodium sulfate,
niacinamide,
scrophularia nodosa,
succinic acid and
sus scrofa vein injection, solution
Guna spa
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OMEOFORMULA®2-CELLULITE (Homeopathic complex preparation) INJECTION SC, ID, IM1.1. Treatment total body adiposity
1.2. Treatment of localized adiposity
It is helpful to combine the treatment with appropriate dietary modifications.
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 procedures stated in the Homeopathic Pharmacopeia of United States.
Active ingredients: a-Ketoglutaricum acidum 6X; Adenosinum cyclophosphoricum 6X; Aranea diadema 10X; Barium oxalosuccinate 6X; Calcarea phosphorica 6X; Calcarea phosphorica 30X; Calcarea phosphorica 200X; Calcarea sulphurica 6X; Calcarea sulphurica 30X; Calcarea sulphurica 200X; Cis-Aconitic acid 6X; Citricum acidum 6X; Dl malic acid 6X; Echinacea angustifolia 10X; Fumaricum acidum 6X; Graphites 10X; Hamamelis virginiana 10X; Juglans regia 6X; Lymphatic vessel 6X; Magnesium gluconate 6X; Manganum phosphoricum 6X; Myosotis arvensis 6X; Natrum pyruvicum 6X; Natrum sulphuricum 6X; Nicotinamidum 6X; Scrophularia nodosa 6X; Succinicum acidum 6X; Vein 10X.
Inactive ingredient: Sterile isotonic sodium chloride solution.
4.1. There is no history of hypersensitivity to OMEOFORMULA®2-CELLULITE. 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.
5.1. 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.
5.2. Skin disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.
7.1. None Known.
8.1 Pregnancy: Pregnancy category C. Animal reproduction studies have not been conducted with OMEOFORMULA®2-CELLULITE. OMEOFORMULA®2-CELLULITE should not be administered to a pregnant woman.
8.2 Nursing mothers: It is not known whether any of the ingredients in OMEOFORMULA®2-CELLULITE are secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when OMEOFORMULA®2-CELLULITE is administered to a nursing woman.
8.3 Pediatric use: Effectiveness in pediatric patients has not been established.
8.4 Geriatric use: No restrictions.
9.1. No Known.
10.1. No Known.
OMEOFORMULA®2- CELLULITE 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 proving as refer in Materia Medica. Aranea diadema and Natrum sulfuricum promote reduction in edema limiting water retention. Myosotis arvensis, Lymphatic vessels, Scrophularia nodosa, and Juglans regia promote edema reduction by facilitating lymphatic drainage. Vein and Hamamelis improve venous return. Calcium sulphuricum and Graphites reduce cellulite accumulation on the lateral thighs, while Calcium phosphoricum reduces cellulite accumulation at the root of the thigh. Krebs cycle intermediates support cell metabolism. Echinacea angustifolia protects the epithelial cells against stretch marks.
12.1. Mechanism of Action
The medication acts through a low-dose enzymatic mechanism.
12.2. Pharmacodynamics
The physiological effects of OMEOFORMULA®2- CELLULITE are due to the effects of the ingredients, according to their description in the Homeopathic Materia Medica.
12.3. Pharmacokinetics
Homeopathic attenuation provides complete bioavability of the active ingredients.
13.1. OMEOFORMULA®2- CELLULITE has no level of toxicity due to the attenuation of the ingredients.
14.1. OMEOFORMULA®2-CELLULITE formulation is based on classical Homeopathy and each ingredient has been selected according to the homeopathic proving as refer 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. Aurelia Verlag.
17.1. Patients should be informed of the homeopathic approach and OMEOFORMULA®2- CELLULITE therapeutic goals.
OMEOFORMULA2-CELLULITE
.alpha.-ketoglutaric acid - aconitic acid, cis - araneus diadematus - barium cation - calcium phosphate - citric acid monohydrate - cyclic amp - echinacea angustifolia - fumaric acid - graphite - juglans regia leaf - magnesium gluconate - malic acid - manganese phosphate, dibasic - myosotis arvensis - natrum sulphuricum - niacinamide - scrophularia nodosa - sodium pyruvate - succinic acid - sus scrofa small intestine mucosa lymph follicle - sus scrofa vein - injection, solution |
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
unapproved homeopathic | 09/29/2006 |
Labeler - Guna spa (430538264) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Guna spa | 430538264 | manufacture |