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Guna-Neural

Generic Name: onitum napellus, metenkefalin, citrullus colocynthis fruit pulp, ferric phosphate, formica rufa, pseudognaphalium obtusifolium, iris versicolor root, kalmia latifolia leaf, neurotrophin-4 and paris quadrifolia
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.

GUNA®-NEURAL (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Non-specific brachial pain
1.2.    Brachial nerve pain due to cervical entrapment (use with GUNA®-NECK)
1.3.    Intercostal nerve pain due to thoracic entrapment (use with GUNA®-THORACIC)
1.4.    Postherpetic neuralgia
1.5.    Atypical facial neuralgia(Sluder syndrome, Charlin syndrome)
1.6.    Trigeminal neuralgia
1.7.    TMJ Dysfunction Pain
1.8.    Arnold syndrome (use with GUNA®-NECK)
1.9.    Cervical, Thoracic, Lumbar, Iliolumbar, and Sacroiliac nerve root pain (use with GUNA®-NECK, GUNA®-THORACIC, GUNA®-LUMBAR, GUNA®-ISCHIAL, respectively).


2. DOSAGE AND ADMINISTRATION

2.1.    Standard protocol for IM administration: 1 vial 1-3 times a week according to severity and clinical progress.
2.2.    Standard protocol according to mesotherapy technique: 1 vial per treatment; 2 treatments for the first 2 weeks, 1 treatment a week till pain relief (average 8-10 sessions). For chronic pathologies: continue 1 treatment a week for 1 month until pain relief, then 1 treatment a month. Select application site according to trigger points, tender points, referred pain zones, acupuncture points, nerve key points, Head zones or “local pain points”. Using a 13 mm, 30G or a 4 mm, 27G needle, make the classic intradermal injection according to mesotherapyic technique. 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.

3. DOSAGE FORMS AND STRENGTHS

3.1.    2 ml glass vials
Each ingredient is attenuated according to the Homeopathic Pharmacopeia of the United States.
Active ingredients: Aconitum napellus 8X, Beta-Endorphin 4C, Colocynthis 4X, Ferrum phosphoricum 2X, Formica rufa 8X, Gnaphalium polycephalum 6X, Iris versicolor 8X, Kalmia latifolia 3X, Neurotrophin 4 4C, Paris quadrifolia 6X.
Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-NEURAL. However patients with a known hypersensitivity to any ingredient should be tested before  use, making a spot injection into one arm and be kept under observation for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1.    Nerve pain requires differential diagnosis for visceral pain, and primary or metastatic cancer pain.
5.2.    Skin cleansing/disinfection is required before application. Saprophytic bacteria may produce injection site abscesses with improper skin preparation.
5.3.    Patients with known hypersensitivity to formic acid should be kept under observation during the therapy.

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  GUNA®-NEURAL.  GUNA®-NEURAL should  not  be  given  to  a pregnant woman. 
8.2    Nursing mothers:    It is not known whether any of the ingredients in GUNA®-NEURAL are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when GUNA®-NEURAL is administered to a nursing woman.
8.3    Pediatric use: No restrictions.
8.4    Geriatric use: No restrictions.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known.

10. OVERDOSAGE

10.1.    No Known.

11. DESCRIPTION

GUNA®-NEURAL is a sterile solution made with isotonic sodium chloride solution.
It is a homeopathic complex medicine, whose active ingredients have been selected in order to promote 2 main activities:
•    Detoxification of the connective tissue matrix
•    Pain modulation through stimulation of the physiological mechanism of pain control.
Attenuation of the biological substrates acts to target the area of activity of the product.



12. CLINICAL PHARMACOLOGY

12.1.    Mechanism of Action
Due to the homeopathic nature of the active ingredients, receptors may be activated by feedback regulation. Beta-endorphins  at the 4C dose activate the membrane receptors for endogenous endorphins that play a key role in pain relief.
12.2.    Pharmacodynamics
The physiological effects of GUNA®-NEURAL are due to the action of the ingredients, as described in the Homeopathic Materia Medica.
In Homeopathy there is no direct relationship between dose and effect, but rather there is a relationship between attenuation and balancing effect on biochemical pathways.
In GUNA®-NEURAL the attenuation of each ingredient has been selected according to  the Arndt-Schulz Principle (inverted effect law). membrane receptor feedback in order to normalize altered biological pathways. In Addition the attenuation technique activates the low dilutions and stabilizes clinical activity of the compound.
12.3.    Pharmacokinetics
The homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

13.1.    GUNA®-NEURAL  has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

GUNA®-NEURAL formulation is based on classical Homeopathy and each ingredient has been selected according to its description in the Homeopathic Materia Medica. The product is intended for application to target points such as acupuncture points, Weihe points, and key neurological points.
Clinical indications of the key ingredients:
Beta-Endorphin 4C:
•    Biological classification: Neuropeptide  and neurotransmitter. It is produced by the  anterior lobe of the hypophysis  and by the hypothalamus.
•    Etiopathogenesis: It acts on the mechanism that enhances pain. It suppresses the memory of painful events and negative experiences.
•    Space-time localization: Next to Arnica.
Reference group: Mercurius.
•    Clinical: Pain management by enhancing the immune response. It acts on modulating pain, cardiac, gastric and vascular function as well as panic syndrome and satiation. Organic and functional pain. Remedy for somatization disorders. It enhances acupuncture sessions. Antidepressive activity. It may improve individual positive attitudes.
•    Modalities: Worsens due to fatigue and intensive exercise.
•    Association with other cell mediators: Sepia / Arnica / Aconitum / Bromum / Aurum / Iodium / IL6 4C / Melatonin 15C, 30C, 12LM, 18LM, 30LM / NT4 4C / BDNF 4C.

15. REFERENCES

15.1.    L. Milani: Weihe e altri Punti tra Agopuntura e Omeopatia. Guna Editore,
15.2.    J. Malzac: Materia Medica Immunologia. IPSA Editore,
15.3.    H.H. Reckeweg: Homeopathic Materia medica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-276-31  10 glass vials packaged in carton box.
16.2.    NDC  17089-276-32  50 glass vials packaged 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 about Homeopathy and Acupuncture and the main differences with conventional clinical approaches.

PACKAGE LABEL

Guna-Neural 
aconitum napellus - ferric phosphate - formica rufa - iris versicolor root - kalmia latifolia leaf - metenkefalin - neurotrophin-4 - paris quadrifolia - pseudognaphalium obtusifolium - citrullus colocynthis fruit pulp - injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-276
Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACONITUM NAPELLUS (ACONITUM NAPELLUS) ACONITUM NAPELLUS 8 [hp_X]  in 2 mL
METENKEFALIN (METENKEFALIN) METENKEFALIN 4 [hp_C]  in 2 mL
CITRULLUS COLOCYNTHIS FRUIT PULP (CITRULLUS COLOCYNTHIS FRUIT PULP) CITRULLUS COLOCYNTHIS FRUIT PULP 4 [hp_X]  in 2 mL
FERRIC PHOSPHATE (FERRIC CATION) FERRIC PHOSPHATE 2 [hp_X]  in 2 mL
FORMICA RUFA (FORMICA RUFA) FORMICA RUFA 8 [hp_X]  in 2 mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 6 [hp_X]  in 2 mL
IRIS VERSICOLOR ROOT (IRIS VERSICOLOR ROOT) IRIS VERSICOLOR ROOT 8 [hp_X]  in 2 mL
KALMIA LATIFOLIA LEAF (KALMIA LATIFOLIA LEAF) KALMIA LATIFOLIA LEAF 3 [hp_X]  in 2 mL
NEUROTROPHIN-4 (NEUROTROPHIN-4) NEUROTROPHIN-4 4 [hp_C]  in 2 mL
PARIS QUADRIFOLIA (PARIS QUADRIFOLIA) PARIS QUADRIFOLIA 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:17089-276-31 10 VIAL, GLASS (VIAL) in 1 BOX
1 2 mL in 1 VIAL, GLASS
2 NDC:17089-276-32 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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