GUNA-HANDFOOT   - anti-interleukin-1.alpha. immunoglobulin g rabbit, canakinumab, arnica montana, benzoic acid, metenkefalin, caulophyllum thalictroides root, black cohosh, ledum palustre twig, mercurius solubilis and viola odorata injection, solution 
Guna spa

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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use GUNA®-HANDFOOT safely and effectively. See full prescribing information for GUNA®-HANDFOOT GUNA®-HANDFOOT (Homeopathic complex preparation) INJECTION SC, ID, IM Initial U.S. Approval: n.a. Initial Drug listing registration: 2006 See full prescribing information for complete boxed warning. •    Diagnosis: Hand and or Foot pain requires differential diagnosis for primary nerve pain, post-traumatic pain, or pain due to bone fractures, or post fracture pain. •    Treatment: Skin disinfection is required before injection. (5) INDICATIONS AND USAGE GUNA®-HANDFOOT is a homeopathic medication indicated for: •    Osteoarthritis of fingers •    Rhizoarthrosis of the thumb (Forestier disease) •    Arthrosis pain due to hammer toe •    Carpal-tunnel syndrome (use with GUNA®-NEURAL) •    De Quervain disease (use with GUNA®-NEURAL) •    Metatarsal pain •    Morton disease (use with GUNA®-NEURAL) •    Rheumatoid arthritis of hand/foot (use with GUNA®-POLYARTHRITIS) •    Hand/Foot tendon pain due to prolonged immobilization (post cast tendon pain). Administration may vary according to individual needs. GUNA®-HANDFOOT may be used together with other homeopathic medications. (1) DOSAGE AND ADMINISTRATION Standard protocol for IM administration: 1 vial 1-3 times a week according to severity and clinical progress. Standard protocol utilizing mesotherapy technique using 1 vial per treatment: 2 treatments for the first 2 weeks, 1 treatment a week until 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, key nerve points, or “local pain points”. Method of administration: In case of subcutaneous administration, use a 13 mm, 30G or a 4 mm, 27G needle to apply the classic mesotherapy technique.( 2) DOSAGE FORMS AND STRENGTHS •    2 ml glass vials in package of 10 •    2 ml glass vials in package of 50 Strengths according to homeopathic labeling: Active ingredients: Arnica montana 4X, Viola odorata 10X, Anti interleukin 1 alpha 4C, Anti interleukin 1 beta 4C, Beta-Endorphin 4C, Caulophyllum thalictroides 12X; Benzoicum acidum 6X, Cimicifuga racemosa 10X, Ledum palustre 6X , Mercurius solubilis 8X. Inactive ingredient: Sterile isotonic sodium chloride solution.( 3) CONTRAINDICATIONS There is no history of hypersensitivity to GUNA®-HANDFOOT. However patients with a known hypersensitivity to any ingredients should be tested before use, making a spot injection into one arm and be kept under observation for 1 hour.( 4) WARNINGS AND PRECAUTIONS Diagnosis: Hand/Foot pain requires differential diagnosis for primary nerve pain, post-traumatic pain, secondary pain due to present or previous bone fracture. Treatment: Skin disinfection is required before and after injection. In rare cases patients may experience hypersalivation within one hour of treatment. Discontinue treatment. The hypersalivation resolves over several hours without further medical treatment. (5) ADVERSE REACTIONS The most common mild adverse reaction is slight reddening at the injection site due to mechanical effect of the needle or a superficial skin reaction of mild erythema. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact GUNA Inc.  at 1-888-GUNA-TEL (486-2835) or www.gunainc.com Or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch DRUG INTERACTIONS No occurrences of drug interactions have been noted during clinical studies. There have been no reports of drug interactions with GUNA®-HANDFOOT.( 7) USE IN SPECIFIC POPULATIONS No restriction. (8) See 17 for PATIENT COUNSELING INFORMATION                     Revised: 01/2010 See 17 for PATIENT COUNSELING INFORMATION Revised: 05/2010

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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
BOXED WARNING 1. INDICATIONS AND USAGE 2. DOSAGE AND ADMINISTRATION 3. DOSAGE FORMS AND STRENGTHS 4. CONTRAINDICATIONS 5. WARNINGS AND PRECAUTIONS 6. ADVERSE REACTIONS 7. DRUG INTERACTIONS 8. USE IN SPECIFIC POPULATIONS 9. DRUG ABUSE AND DEPENDENCE 10. OVERDOSAGE 11. DESCRIPTION 12. CLINICAL PHARMACOLOGY 13. NONCLINICAL TOXICOLOGY 14. CLINICAL STUDIES 15. REFERENCES 16. HOW SUPPLIED/STORAGE AND HANDLING 17. PATIENT COUNSELING INFORMATION PACKAGE LABEL - GUNA®-HANDFOOT

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FULL PRESCRIBING INFORMATION

1. INDICATIONS AND USAGE

1.1    Osteoarthritis of fingers
1.2    Rhizoarthrosis of the thumb (Forestier disease)
1.3    Arthrosis pain due to hammer toe
1.4    Carpal-tunnel syndrome (use with GUNA®-NEURAL)
1.5    De Quervain disease (use with GUNA®-NEURAL)
1.6    Metatarsal pain
1.7    Morton disease (use with GUNA®-NEURAL)
1.8    Rheumatoid arthritis of hand/foot (use with GUNA®-POLYARTHRITIS)
1.9    Hand/Foot tendon pain due to prolonged immobilization ( post cast tendon pain)

2. DOSAGE AND ADMINISTRATION

2.1.    Standard protocol for IM administration:
1 vial 1-3 times a week according to severity and clinical progress evolution.
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, 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 mesotherapic technique.
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: Arnica montana 4X, Viola odorata 10X, Anti interleukin 1 alpha 4C, Anti interleukin 1 beta 4C, Beta-Endorphin 4C, Caulophyllum thalictroides 12X; Benzoicum acidum 6X, Cimicifuga racemosa 10X , Ledum palustre 6X , Mercurius solubilis 8X.
Inactive ingredient: Sterile isotonic sodium chloride solution

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-HANDFOOT. However patients with a known hypersensitivity to any ingredients 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.    Hand/Foot pain requires differential diagnosis for primary nerve pain, post-traumatic pain, pain due to bone fractures, or post fracture pain.
5.2.    In rare cases patients may experience hypersalivation within one hour of treatment. Discontinue treatment. The hypersalivation resolves over several hours without further medical treatment.
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.    No restrictions, although indications target the use of GUNA®-HANDFOOT to adults, with the aim of pain management of the hand/foot area.

9. DRUG ABUSE AND DEPENDENCE

9.1.    No Known

10. OVERDOSAGE

10.1.    No Known

11. DESCRIPTION

 11.1    GUNA®-HANDFOOT 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 the pain control.
Furthermore, the 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 strength activate the membrane receptor for endogen 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®-HANDFOOT 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®-HANDFOOT the attenuation of each ingredient has been selected according to Arndt-Schulz Principle (inverted effect law). The 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®-HANDFOOT has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1    GUNA®-HANDFOOT 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: It is 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 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 due to fatigue and intensive exercise.
•    Association with other cell mediators: Sepia / Arnica / Aconitum / Bromum / Aurum / Iodium / IL6 4CH / Melatonin 15C, 30C, 12LM, 18LM, 30LM / NT4 4C / BDNF 4C.

15. REFERENCES

(1)    L. Milani: Weihe e altri Punti tra Agopuntura e Omeopatia. Guna Editore
(2)    J. Malzac: Materia Medica Immunologia. IPSA Editore
(3)    H.H. Reckeweg: Homeopathic  Materia Medica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC   17089- 286-31  10 glass vials in carton box
16.2.    NDC   17089- 286-32  50 glass vials in carton box

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®-HANDFOOT

NDC 17089-286-31    10 vials
NDC 17089-286-32    50 vials

Rx only

www.gunainc.com

GUNA-HANDFOOT   arnica montana - benzoic acid - black cohosh - canakinumab - caulophyllum thalictroides root - ledum palustre twig - mercury - metenkefalin - viola odorata - anti-interleukin-1.alpha. immunoglobulin g rabbit -   injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 17089-286 Route of Administration INTRADERMAL, SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 4 [hp_X]  in 2 mL BENZOIC ACID (BENZOIC ACID) BENZOIC ACID 6 [hp_X]  in 2 mL METENKEFALIN (METENKEFALIN) METENKEFALIN 4 [hp_C]  in 2 mL CAULOPHYLLUM THALICTROIDES ROOT (CAULOPHYLLUM THALICTROIDES ROOT) CAULOPHYLLUM THALICTROIDES ROOT 12 [hp_X]  in 2 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 10 [hp_X]  in 2 mL LEDUM PALUSTRE TWIG (LEDUM PALUSTRE TWIG) LEDUM PALUSTRE TWIG 6 [hp_X]  in 2 mL MERCURIUS SOLUBILIS (MERCURIUS SOLUBILIS) MERCURIUS SOLUBILIS 8 [hp_X]  in 2 mL VIOLA ODORATA (VIOLA ODORATA) VIOLA ODORATA 10 [hp_X]  in 2 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.018 mL  in 2 mL WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 17089-286-31 10 VIAL In 1 BOX contains a VIAL, GLASS 1 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-286-31) 2 17089-286-32 50 VIAL In 1 BOX contains a VIAL, GLASS 2 2 mL In 1 VIAL, GLASS This package is contained within the BOX (17089-286-32)

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: 05/2010Guna spa