Omeoformula 2 Cellulite

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®2-CELLULITE (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Treatment total body adiposity
1.2.    Treatment of localized adiposity
It is helpful to combine the treatment with appropriate dietary modifications.


2. DOSAGE AND ADMINISTRATION

2.1.    Treatment of total body adiposity for IM application: 1 vial 1-3 times a week according to severity and clinic evolution.
2.2.    Treatment of localized adiposity 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 Affected area (saddlebags, root of the thigh, knees, and arms) and/or at acupuncture points.
Standard  protocol consists of one treatment a week for 5-7 weeks. For prolonged treatments, 2 treatments for the first week, 1 session a week for 1 month and then 1 treatment 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 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. CONTRAINDICATIONS

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. 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.
5.2.    Skin disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.

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®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. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

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. CLINICAL PHARMACOLOGY

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. NONCLINICAL TOXICOLOGY

13.1.    OMEOFORMULA®2- CELLULITE  has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

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. REFERENCES

15.1.    E.Italia, M. De Bellis: Manuale di Omeo-mesoterapia – Guna Ed. 1995.
15.2.    H.H. Reckeweg: Homeopathic Materia medica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC 17089-273-31  10 glass vials packed in carton box
16.2.    NDC 17089-273-32   50 glass vials 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 OMEOFORMULA®2- CELLULITE  therapeutic goals.

PACKAGE LABEL

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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-273
Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENOSINE CYCLIC 3',5'-PHOSPHATE (ADENOSINE CYCLIC 3',5'-PHOSPHATE) ADENOSINE CYCLIC 3',5'-PHOSPHATE 6 [hp_X]  in 2 mL
.ALPHA.-KETOGLUTARIC ACID (.ALPHA.-KETOGLUTARIC ACID) .ALPHA.-KETOGLUTARIC ACID 6 [hp_X]  in 2 mL
ARANEUS DIADEMATUS (ARANEUS DIADEMATUS) ARANEUS DIADEMATUS 10 [hp_X]  in 2 mL
BARIUM OXALOSUCCINATE (BARIUM OXALOSUCCINATE) BARIUM OXALOSUCCINATE 6 [hp_X]  in 2 mL
CALCIUM PHOSPHATE (CALCIUM CATION) CALCIUM PHOSPHATE 30 [hp_X]  in 2 mL
CALCIUM SULFATE ANHYDROUS (CALCIUM CATION) CALCIUM SULFATE ANHYDROUS 30 [hp_X]  in 2 mL
ACONITIC ACID, CIS- (ACONITIC ACID, CIS-) ACONITIC ACID, CIS- 6 [hp_X]  in 2 mL
CITRIC ACID MONOHYDRATE (ANHYDROUS CITRIC ACID) CITRIC ACID MONOHYDRATE 6 [hp_X]  in 2 mL
MALIC ACID (MALIC ACID) MALIC ACID 6 [hp_X]  in 2 mL
ECHINACEA ANGUSTIFOLIA (ECHINACEA ANGUSTIFOLIA) ECHINACEA ANGUSTIFOLIA 10 [hp_X]  in 2 mL
FUMARIC ACID (FUMARIC ACID) FUMARIC ACID 6 [hp_X]  in 2 mL
GRAPHITE (GRAPHITE) GRAPHITE 10 [hp_X]  in 2 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 10 [hp_X]  in 2 mL
JUGLANS REGIA LEAF (JUGLANS REGIA LEAF) JUGLANS REGIA LEAF 6 [hp_X]  in 2 mL
SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE (SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE) SUS SCROFA SMALL INTESTINE MUCOSA LYMPH FOLLICLE 6 [hp_X]  in 2 mL
MAGNESIUM GLUCONATE (MAGNESIUM CATION) MAGNESIUM GLUCONATE 6 [hp_X]  in 2 mL
MANGANESE PHOSPHATE, DIBASIC (MANGANESE PHOSPHATE, DIBASIC) MANGANESE PHOSPHATE, DIBASIC 6 [hp_X]  in 2 mL
MYOSOTIS ARVENSIS (MYOSOTIS ARVENSIS) MYOSOTIS ARVENSIS 6 [hp_X]  in 2 mL
SODIUM PYRUVATE (PYRUVIC ACID) SODIUM PYRUVATE 6 [hp_X]  in 2 mL
SODIUM SULFATE (SODIUM CATION) SODIUM SULFATE 6 [hp_X]  in 2 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 6 [hp_X]  in 2 mL
SCROPHULARIA NODOSA (SCROPHULARIA NODOSA) SCROPHULARIA NODOSA 6 [hp_X]  in 2 mL
SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 6 [hp_X]  in 2 mL
SUS SCROFA VEIN (SUS SCROFA VEIN) SUS SCROFA VEIN 10 [hp_X]  in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 0.018 mL  in 2 mL
WATER  
Packaging
# Item Code Package Description
1 NDC:17089-273-31 10 VIAL, GLASS (VIAL) in 1 BOX
1 2 mL in 1 VIAL, GLASS
2 NDC:17089-273-32 50 VIAL, GLASS (VIAL) in 1 BOX
2 2 mL in 1 VIAL, GLASS
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
Revised: 06/2010
 
Guna spa



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