Guna-Ischial

Generic Name: aconitum napellus, anti-interleukin-1.alpha. immunoglobulin g rabbit, canakinumab, arsenic trioxide, metenkefalin, black cohosh, pseudognaphalium obtusifolium, lachesis muta venom, rhododendron aureum leaf and toxicodendron pubescens leaf
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®-ISCHIAL (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Sciatica pain
1.2.    Lumbar-sciatic pain (use with GUNA®-LUMBAR)
1.3.    Nerve pain in the lower lumbar spine
1.4.    Leg nerve pain due to post-surgery treatment of disc herniation L4-L5, L5-S1
1.5.    Mortons neuroma. The simultaneous administration of GUNA®- NEURAL gives wider therapeutic coverage


2. DOSAGE AND ADMINISTRATION

2.1.    Standard protocol for IM administration: 1 vial 1-3 times a week according to severity and clinical response.
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 till pain relief, then 1 treatment a month.
Select application site according to trigger points, tender points, referred pain zones, acupuncture points, key nerve points 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 procedures stated in the Homeopathic Pharmacopeia of the United States.
Active ingredients: Aconitum napellus 8X, Anti interleukin 1 alpha 4C, Anti interleukin 1 beta 4C, Arsenicum album 6X, Beta-Endorphin 4C, Cimicifuga racemosa 4X, Gnaphalium  polycephalum 4X, Lachesis mutus 8X, Rhododendron chrysanthum 6X, Rhus toxicodendron 4X.
Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-ISCHIAL. 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.    Sciatic pain requires differential diagnosis for disc injuries, herniated disk, primary or secondary cancer pain; classification according to simple spinal pain, projected and referred pain from internal organs.
5.2.    Skin cleansing/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  GUNA®-ISCHIAL.  GUNA®- ISCHIAL should  not  be  given  to  a pregnant woman. 
8.2    Nursing mothers:    It is not known whether any of the ingredients in GUNA®- ISCHIAL  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when GUNA®- ISCHIAL 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

11.1.    GUNA®-ISCHIAL 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. Anti IL-1 induces a download regulation of IL-1 inflammatory activity.
12.2.    Pharmacodynamics
The physiological effects of GUNA®-ISCHIAL 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®-ISCHIAL the attenuation of each ingredient has been selected according to the Arndt-Schulz Principle (inverted effect law). Attenuation of the physiological ingredients promotes 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
Homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

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

14. CLINICAL STUDIES

14.1.    GUNA®-ISCHIAL 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:
Anti interleukin 1 alpha 4C / Anti interleukin 1 beta 4C:
•    Biological classification: Interleukin 1 receptor antagonist (IL-1ra) belongs to the IL-1 family. Endogenous IL-1ra is produced in human autoimmune and chronic inflammatory diseases.
•    Etiopathogenesis: It binds to IL-1 receptors in competition with IL-1, but does not elicit intracellular response from this binding. Its key role  is counteracting the proinflammatory effects of IL-1.
•    Space-time localization: next to Arnica.  Reference group: Arnica-Mercurius.
•    Clinical: Immunological based diseases, autoimmune and chronic inflammatory diseases, acute and chronic pain, osteoarthritis, chronic arthritis, inflammatory psoriasis, wet eczema, localized inflammatory swelling.  Appropriate for local application.
•    Modalities: Worsens with cold and   movement. Improves with rest and warmth.
•    Association with other cell mediators: TNF 15C / IL8 4C /
NT4 4C / GCSF 4C.
 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.
14.2.    Modalities: It worsens with fatigue and intensive exercise.
•    Association with other cell mediators: Sepia / Arnica / Aconitum / Bromum / Aurum / Iodium / IL-6 4C / Melatonin 15C, 30C, 12LM, 18LM, 30LM / NT4 4C / BDNF 4C.

15. REFERENCES

15.1.    I. Bianchi: Citochine e Interferoni. Farmacologia e Clinica. Nuova IPSA Editore.
15.2.    L. Milani: Weihe e altri Punti tra Agopuntura e Omeopatia. Guna Editore.
15.3.    J. Malzac: Materia Medica Immunologia. IPSA Editore.
15.4.    H.H.Reckeweg: Homeopathic Materia Medica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-277-31  10 glass vials packed in carton box
16.2.    NDC  17089-277-32   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 about Homeopathy and Acupuncture and the main differences with conventional clinical approaches.

PACKAGE LABEL

Guna-Ischial 
aconitum napellus - arsenic trioxide - black cohosh - canakinumab - lachesis muta venom - metenkefalin - pseudognaphalium obtusifolium - rhododendron aureum leaf - toxicodendron pubescens leaf - anti-interleukin-1.alpha. immunoglobulin g rabbit - injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-277
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
ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT) ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT 4 [hp_C]  in 2 mL
CANAKINUMAB (CANAKINUMAB) CANAKINUMAB 4 [hp_C]  in 2 mL
ARSENIC TRIOXIDE (ARSENIC TRIOXIDE) ARSENIC TRIOXIDE 6 [hp_X]  in 2 mL
METENKEFALIN (METENKEFALIN) METENKEFALIN 4 [hp_C]  in 2 mL
BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 4 [hp_X]  in 2 mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM (PSEUDOGNAPHALIUM OBTUSIFOLIUM) PSEUDOGNAPHALIUM OBTUSIFOLIUM 4 [hp_X]  in 2 mL
LACHESIS MUTA VENOM (LACHESIS MUTA VENOM) LACHESIS MUTA VENOM 8 [hp_X]  in 2 mL
RHODODENDRON AUREUM LEAF (RHODODENDRON AUREUM LEAF) RHODODENDRON AUREUM LEAF 6 [hp_X]  in 2 mL
TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 4 [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:17089-277-31 10 VIAL, GLASS (VIAL) in 1 BOX
1 2 mL in 1 VIAL, GLASS
2 NDC:17089-277-32 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



Hide
(web3)