Omeoformula 5 Vein

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®5-VEIN (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Superficial Venous insufficiency
1.2.    Varicose veins
1.3.    Water retention
1.4.    Swollen legs or Lower Extremity Edema.

2. DOSAGE AND ADMINISTRATION

1.1.    Treatment for IM application: 1 vial 1-3 times a week according to severity and clinical evolution.
1.2.    Treatment using mesotherapy technique: Apply 0.3 ml to each point. Using a 13 mm 30G or a 4 mm 27G needle, make the classic intradermal injection utilizing mesotherapy technique. Sites of application: Tissue area around the blood vessels of the affected region of the body. 
1.3.    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.
1.4.    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:  Aesculus 4X, Apis 8X, Arnica 4X, Collagen 6X, Crotalus 8X, Crotalus 12X, Hamamelis 4X, Hypericum 6X,  Lachesis 8X, Myosotis 4X, Solidago 8X, Tabacum 8X, Urtica 8X, Vein 8X, Vein 12X, Vipera 6X.
Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to OMEOFORMULA®5-VEIN. 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®5-VEIN.  OMEOFORMULA®5-VEIN should  not  be  administered  to  a pregnant woman. 
8.2    Nursing mothers:    It is not known whether any of the ingredients in OMEOFORMULA®5-VEIN  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when OMEOFORMULA®5-VEIN 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® 5-VEIN 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 suis-organ ingredients. These effects are enhanced by the activity of additional 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® 5-VEIN  are due to  the effects of the ingredients according to their description as listed in the Homeopathic Materia Medica.
12.3.    Pharmacokinetics
Homeopathic attenuation  provides complete bioavability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    OMEOFORMULA® 5-VEIN has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    OMEOFORMULA® 5-VEIN formulation is based  on classical Homeopathy and  each ingredient has been selected according to the homeopathic description as referred to in Materia Medica.

15. REFERENCES

15.1.    E.Italia, M. De Bellis: Manuale di Omeo-mesoterapia – Guna Ed. 1995
15.2.    L. Milani: Weihe e altri Punti tra Agopuntura e Omeopatia. Guna Editore
15.3.    H.H.Reckeweg: Homeopathic Materia Medica omeopatica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC 17089-457-31  10 glass vials packed in carton box
16.2.    NDC 17089-457-32  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®5-VEIN.

PACKAGE LABEL

OMEOFORMULA 5-VEIN 
apis mellifera - arnica montana - crotalus horridus horridus venom - horse chestnut - hypericum perforatum - lachesis muta venom - myosotis arvensis - solidago virgaurea flowering top - sus scrofa collagen - sus scrofa vein - tobacco leaf - urtica urens - vipera berus venom - aesculus hippocastanum flower - injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-457
Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AESCULUS HIPPOCASTANUM FLOWER (AESCULUS HIPPOCASTANUM FLOWER) AESCULUS HIPPOCASTANUM FLOWER 4 [hp_X]  in 2 mL
APIS MELLIFERA (APIS MELLIFERA) APIS MELLIFERA 8 [hp_X]  in 2 mL
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 4 [hp_X]  in 2 mL
SUS SCROFA COLLAGEN (SUS SCROFA COLLAGEN) SUS SCROFA COLLAGEN 6 [hp_X]  in 2 mL
CROTALUS HORRIDUS HORRIDUS VENOM (CROTALUS HORRIDUS HORRIDUS VENOM) CROTALUS HORRIDUS HORRIDUS VENOM 8 [hp_X]  in 2 mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 4 [hp_X]  in 2 mL
HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 6 [hp_X]  in 2 mL
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 8 [hp_X]  in 2 mL
MYOSOTIS ARVENSIS (MYOSOTIS ARVENSIS) MYOSOTIS ARVENSIS 4 [hp_X]  in 2 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (SOLIDAGO VIRGAUREA FLOWERING TOP) SOLIDAGO VIRGAUREA FLOWERING TOP 8 [hp_X]  in 2 mL
TOBACCO LEAF (TOBACCO LEAF) TOBACCO LEAF 8 [hp_X]  in 2 mL
URTICA URENS (URTICA URENS) URTICA URENS 8 [hp_X]  in 2 mL
SUS SCROFA VEIN (SUS SCROFA VEIN) SUS SCROFA VEIN 8 [hp_X]  in 2 mL
VIPERA BERUS VENOM (VIPERA BERUS VENOM) VIPERA BERUS VENOM 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:17089-457-31 10 VIAL, GLASS (VIAL) in 1 BOX
1 2 mL in 1 VIAL, GLASS
2 NDC:17089-457-32 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 06/03/2010
Labeler - Guna spa (430538264)
Establishment
Name Address ID/FEI Operations
Guna spa 430538264 manufacture
Revised: 06/2010
 
Guna spa



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