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Omeoformula 4 Breast

Generic Name: adenosine triphosphate, aconitic acid, cis-, sus scrofa embryo, sus scrofa pituitary gland, magnesium phosphate, sus scrofa mamma, nadide, senecio vulgaris, pulsatilla vulgaris, sus scrofa skin and sus scrofa uterus
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®4-BREAST (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Breast tissue revitalisation
1.2.    Breast Firming.

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.
Sites of application: Tissue area around the breast, without injecting the mammal gland. 
- From the clavicle, go down along the pectoral muscle with 3 parallel injection lines.
- From the areola, proceed with 4 injection lines, in a sunburst shape.
- In the space below the breast, along its insertion on the thorax.
Standard protocol consists of one treatment a week for 5-7 weeks. For prolonged treatments, 2 treatments for the first week, 1 treatment 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:  Adenosintriphosphate 10X; Cis-Aconitic acid 10X; Embryo 6X; Hypophysis 6X; Hypophysis 30X; Magnesia phosphorica 10X; Mamma 6X; Mamma 30X; Nadidum 10X; Old man in the spring 4X; Pulsatilla 4X; Skin tissue 6X; Uterus 6X.
Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to OMEOFORMULA®4-BREAST. 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 the infection at the site of administration due to 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®4-BREAST.  OMEOFORMULA®4-BREAST should  not  be  administered  to  a pregnant woman. 
8.2    Nursing mothers:    OMEOFORMULA®4-BREAST  is not indicated for use in a nursing woman.
8.3    Pediatric use: OMEOFORMULA®4-BREAST  is not indicated for pediatric use.
8.4    Geriatric use: No restrictions.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

OMEOFORMULA® 4-BREAST  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 in Materia Medica.
The firming and toning activity is due to  the suis-organ ingredients that are supported with the ingredients that stimulate the collagen pathway.


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® 4-BREAST is  due to  the effects of the ingredients, as they are listed in the Homeopathic Materia Medica.
12.3.    Pharmacokinetics
The homeopathic attenuation  provides complete bioavability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    OMEOFORMULA® 4-BREAST has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

OMEOFORMULA®4-BREAST formulation is based  on classical Homeopathy and each ingredient has been selected according to the homeopathic description as referred in Materia Medica.

15. REFERENCES

15.1.    E.Italia, M. De Bellis: Manuale di Omeo-mesoterapia – Guna Ed. 1995
15.2.    H.H.Reckeweg: Materia Medica omeopatica. Ed. 1 Guna Editore.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC 17089-275-31  10 glass vials packed in carton box
16.2.    NDC 17089-275-32  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 the therapeutic goals of OMEOFORMULA® 4-BREAST.

PACKAGE LABEL

OMEOFORMULA4-BREAST  
aconitic acid, cis - adenosine triphosphate - magnesium phosphate - nadide - pulsatilla vulgaris - senecio vulgaris - sus scrofa mamma - sus scrofa pituitary gland - sus scrofa skin - sus scrofa uterus - sus scrofa embryo - injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-275
Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ADENOSINE TRIPHOSPHATE (ADENOSINE TRIPHOSPHATE) ADENOSINE TRIPHOSPHATE 10 [hp_X]  in 2 mL
ACONITIC ACID, CIS- (ACONITIC ACID, CIS-) ACONITIC ACID, CIS- 10 [hp_X]  in 2 mL
SUS SCROFA EMBRYO (SUS SCROFA EMBRYO) SUS SCROFA EMBRYO 6 [hp_X]  in 2 mL
SUS SCROFA PITUITARY GLAND (SUS SCROFA PITUITARY GLAND) SUS SCROFA PITUITARY GLAND 6 [hp_X]  in 2 mL
MAGNESIUM PHOSPHATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE 10 [hp_X]  in 2 mL
SUS SCROFA MAMMA (SUS SCROFA MAMMA) SUS SCROFA MAMMA 6 [hp_X]  in 2 mL
NADIDE (NADIDE) NADIDE 10 [hp_X]  in 2 mL
SENECIO VULGARIS (SENECIO VULGARIS) SENECIO VULGARIS 4 [hp_X]  in 2 mL
PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 4 [hp_X]  in 2 mL
SUS SCROFA SKIN (SUS SCROFA SKIN) SUS SCROFA SKIN 6 [hp_X]  in 2 mL
SUS SCROFA UTERUS (SUS SCROFA UTERUS) SUS SCROFA UTERUS 6 [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:17089-275-31 10 VIAL, GLASS (VIAL) in 1 BOX
1 2 mL in 1 VIAL, GLASS
2 NDC:17089-275-32 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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