Medication Guide App

Guna-Polyarthritis

Generic Name: aconitum napellus, anti-interleukin-1.alpha. immunoglobulin g rabbit, canakinumab, metenkefalin, colchicum autumnale bulb, drosera rotundifolia, guaiacum officinale resin, ledum palustre twig, salicylic acid and viscum album fruit
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®-POLYARTHRITIS (Homeopathic complex preparation) INJECTION SC, ID, IM

1. INDICATIONS AND USAGE

1.1.    Nonspecific diffuse brachial nerve pain
1.2.    Small joints rheumatoid arthritis of hand and foot (use with GUNA®-HAND FOOT)
1.3.    Costochondritis (Tietze’s syndrome, use with GUNA®-NEURAL)
1.4.    Chronic polyarthritis due to autoimmune disease (e.g. Systemic Lupus Erythematosus.
1.5.    Break-Bone fever (Dengue  Fever) (when nerve pain is dominant use with GUNA®-NEURAL; when muscle pain is dominant use with GUNA®-MUSCLE)
1.6.    Joint pain due to viral or protozoal infection
1.7.    Joint pain due to cancer (chronic leukemia, monoclonal blood diseases).

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 using  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 mesotherapy 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: Salicylicum acidum 3X, Aconitum napellus 8X, Anti interleukin 1 alpha 4C, Anti interleukin 1 beta 4C, Beta-Endorphin 4C, Drosera 8X, Ledum palustre 8X, Viscum album 10X, Colchicum autumnale 10X, Guaiacum 10X.
Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity or allergy to GUNA®-POLYARTHRITIS. However patients with a known hypersensitivity or allergy 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.    Joint pain requires differential diagnosis for acute or subacute viral diseases, bacterial infection, pain due to overweight (leg joints) hyperuricemia syndrome, gout, and referred pain.
5.2.    Patients with known sensitivity to salycilates should be monitored closely during the therapy, and should only be treated after successful application of a test dose without adverse effects.
5.3.    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®- POLYARTHRITIS.  GUNA®- POLYARTHRITIS should  not  be  given  to  a pregnant woman. 
8.2    Nursing mothers:    It is not known whether any of the ingredients in GUNA®- POLYARTHRITIS  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when GUNA®- POLYARTHRITIS 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®-POLYARTHRITIS 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 down regulation of IL-1 inflammatory activity.
12.2.    Pharmacodynamics
The physiological effects of GUNA®-POLYARTHRITIS 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 a balancing effect on biochemical pathways.
In GUNA®-POLYARTHRITIS 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
The  Homeopathic attenuation provides complete bioavailability of the active ingredients.

13. NONCLINICAL TOXICOLOGY

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

14. CLINICAL STUDIES

14.1.    GUNA®-POLYARTHRITIS 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.
•    Clinic: Immunological based diseases, autoimmune and chronic inflammatory diseases, acute and chronic pain, osteoarthritis, chronic arthritis, inflammatory psoriasis, wet eczema, localised inflammatory swelling. Appropriate for local application.
•    Modalities: Worsens with cold and movement. Improves with rest and warm.
•    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.
•    Modalities: Worsens with 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.    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  17089-283- 31   10 glass vials packaged in carton box
16.2.    NDC  17089-283- 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-Polyarthritis 
aconitum napellus - canakinumab - colchicum autumnale bulb - drosera rotundifolia - guaiacum officinale resin - ledum palustre twig - metenkefalin - salicylic acid - viscum album fruit - anti-interleukin-1.alpha. immunoglobulin g rabbit - injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17089-283
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
METENKEFALIN (METENKEFALIN) METENKEFALIN 4 [hp_C]  in 2 mL
COLCHICUM AUTUMNALE BULB (COLCHICUM AUTUMNALE BULB) COLCHICUM AUTUMNALE BULB 10 [hp_X]  in 2 mL
DROSERA ROTUNDIFOLIA (DROSERA ROTUNDIFOLIA) DROSERA ROTUNDIFOLIA 8 [hp_X]  in 2 mL
GUAIACUM OFFICINALE RESIN (GUAIACUM OFFICINALE RESIN) GUAIACUM OFFICINALE RESIN 10 [hp_X]  in 2 mL
LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 8 [hp_X]  in 2 mL
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 3 [hp_X]  in 2 mL
VISCUM ALBUM FRUIT (VISCUM ALBUM FRUIT) VISCUM ALBUM FRUIT 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:17089-283-31 10 VIAL, GLASS (VIAL) in 1 BOX
1 2 mL in 1 VIAL, GLASS
2 NDC:17089-283-32 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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