Omeoformula 1 Adiposity

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®1-ADIPOSITY (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Treatment  of total body adiposity
1.2.    Treatment of localized adiposity
It is helpful to combine the treatment with oral detoxification therapy, in order to facilitate the elimination of the toxic load, activated by the injection therapy. Patients should also incorporate dietary modifications to facilitate weight loss.


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 the affected area (abdomen, lower and upper limbs, gluteus muscles)or at acupuncture points.
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 form: 2 ml glass vials.
3.2.    Each ingredient is attenuated according to the Homeopathic Pharmacopeia of United States.
Active ingredients: a-Ketoglutaricum acidum 6X; Adeps suillus 10X; Artery 6X; Barium oxalosuccinate 6X; Calcarea fluorica 10X; Calcarea fluorica 30X; Calcarea fluorica 200X; Carduus marianus 6X; Cis-Aconitic acid 6X; Citricum acidum 6X; DL malic acid 6X; Fucus vesiculosus 10X; Fucus vesiculosus 30X; Fucus vesiculosus 200X; Fumaricum acidum 6X; Hypophysis 10X; Hypophysis 30X; Hypophysis 200X; Magnesium gluconate 6X; Manganum phosphoricum 6X; Natrum oxalaceticum 6X; Natrum pyruvicum 6X;  Nicotinamidum 6X; Sarsaparilla 6X; Succinicum acidum 6X; Sulphur 12X; Thyroidinum 10X.
Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to OMEOFORMULA®1-ADIPOSITY. 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®1-ADIPOSITY.  OMEOFORMULA®1-ADIPOSITY should  not  be  administered  to  a pregnant woman. 
8.2    Nursing mothers:    It is not known whether any of the ingredients in OMEOFORMULA®1-ADIPOSITY  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when OMEOFORMULA®1-ADIPOSITY is administered to a nursing woman.
8.3    Pediatric use: OMEOFORMULA®1-ADIPOSITY is  safe  to use  in adults 14 years and older.
8.4    Geriatric use: No restrictions.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

OMEOFORMULA®1- ADIPOSITY is a sterile solution made with isotonic sodium chloride solution.
OMEOFORMULA®1-ADIPOSITY formulation is based  on classical Homeopathy and  each ingredient has been selected according to the homeopathic description as referred to in Materia Medica
•    Fucus vesiculosus and Thyroidinum improve oxidative metabolic processes. Hypophysis and Adeps suillus enhance immune response against adiposities.  Sulfur, Carduus marianus, and Sarsaparilla permits the centrifugation of the connective tissue toxins,  the hepatic catabolism of fats, and activation of renal activity; 
•    Artery, and Calcarea fluorica act on tissue tonification  by stimulating increased vascularisation, combating exhaustion of the matrix. The Krebs cycle intermediates provide general stimulation of the cell emphasizing triglyceride hydrolysis (Fumaric acid), drainage (Malic acid) and support of connective tissue structure (alpa Keto- glutaric acid).



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®1- ADIPOSITY is    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®1-ADIPOSITY has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    OMEOFORMULA®1-ADIPOSITY formulation is based on classical Homeopathy and each ingredient has been selected according to the homeopathic description 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 omeopatica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-272-31  10 glass vials packed in carton box
16.2.    NDC  17089-272-32  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®1-ADIPOSITY therapeutic goals.

PACKAGE LABEL

OMEOFORMULA1-ADIPOSITY 
.alpha.-ketoglutaric acid - aconitic acid, cis - barium cation - calcium fluoride - citric acid monohydrate - fucus vesiculosus - fumaric acid - lard - magnesium gluconate - malic acid - manganese phosphate, dibasic - niacinamide - sarsaparilla - silybum marianum seed - sodium diethyl oxalacetate - sodium pyruvate - succinic acid - sulfur - sus scrofa artery - sus scrofa pituitary gland - thyroid - injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-272
Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LARD (LARD) LARD 10 [hp_X]  in 2 mL
.ALPHA.-KETOGLUTARIC ACID (.ALPHA.-KETOGLUTARIC ACID) .ALPHA.-KETOGLUTARIC ACID 6 [hp_X]  in 2 mL
SUS SCROFA ARTERY (SUS SCROFA ARTERY) SUS SCROFA ARTERY 6 [hp_X]  in 2 mL
BARIUM OXALOSUCCINATE (BARIUM OXALOSUCCINATE) BARIUM OXALOSUCCINATE 6 [hp_X]  in 2 mL
CALCIUM FLUORIDE (CALCIUM FLUORIDE) CALCIUM FLUORIDE 30 [hp_X]  in 2 mL
SILYBUM MARIANUM SEED (SILYBUM MARIANUM SEED) SILYBUM MARIANUM SEED 6 [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
FUCUS VESICULOSUS (FUCUS VESICULOSUS) FUCUS VESICULOSUS 30 [hp_X]  in 2 mL
FUMARIC ACID (FUMARIC ACID) FUMARIC ACID 6 [hp_X]  in 2 mL
SUS SCROFA PITUITARY GLAND (SUS SCROFA PITUITARY GLAND) SUS SCROFA PITUITARY GLAND 30 [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
SODIUM DIETHYL OXALACETATE (DIETHYL OXALACETATE) SODIUM DIETHYL OXALACETATE 6 [hp_X]  in 2 mL
SODIUM PYRUVATE (PYRUVIC ACID) SODIUM PYRUVATE 6 [hp_X]  in 2 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 6 [hp_X]  in 2 mL
SARSAPARILLA (SARSAPARILLA) SARSAPARILLA 6 [hp_X]  in 2 mL
SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 6 [hp_X]  in 2 mL
SULFUR (SULFUR) SULFUR 12 [hp_X]  in 2 mL
THYROID (THYROID) THYROID 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:17089-272-31 10 VIAL, GLASS (VIAL) in 1 BOX
1 2 mL in 1 VIAL, GLASS
2 NDC:17089-272-32 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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