{"adverse_reactions":["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. 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"],"boxed_warning":["BOXED WARNING 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. 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 )"],"clinical_pharmacology":["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."],"clinical_studies":["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."],"contraindications":["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. 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 )"],"description":["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."],"dosage_and_administration":["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 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":["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 • 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 )"],"drug_abuse_and_dependence":["9. DRUG ABUSE AND DEPENDENCE 9.1. No Known"],"drug_interactions":["7. DRUG INTERACTIONS 7.1. None known No occurrences of drug interactions have been noted during clinical studies. There have been no reports of drug interactions with GUNA®-HANDFOOT.( 7 )"],"effective_time":"20110622","id":"c27a418c-c9f9-405c-aa3c-bf6e7aebfd1b","indications_and_usage":["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) 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 )"],"information_for_patients":["17. PATIENT COUNSELING INFORMATION 17.1. Patients should be informed about Homeopathy and Acupuncture and the main differences with conventional clinical approaches."],"nonclinical_toxicology":["13. NONCLINICAL TOXICOLOGY 13.1. GUNA®-HANDFOOT has no level of toxicity due to the attenuation of the ingredients."],"openfda":{},"overdosage":["10. OVERDOSAGE 10.1. No Known"],"package_label_principal_display_panel":["PACKAGE LABEL - GUNA®-HANDFOOT NDC 17089-286-31 10 vials NDC 17089-286-32 50 vials Rx only www.gunainc.com image of box label"],"references":["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."],"set_id":"26db80da-7046-4fba-adf9-4da46069cbdd","spl_product_data_elements":["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 - ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT CANAKINUMAB CANAKINUMAB ARNICA MONTANA ARNICA MONTANA BENZOIC ACID BENZOIC ACID METENKEFALIN METENKEFALIN CAULOPHYLLUM THALICTROIDES ROOT CAULOPHYLLUM THALICTROIDES ROOT BLACK COHOSH BLACK COHOSH LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG MERCURIUS SOLUBILIS MERCURIUS SOLUBILIS VIOLA ODORATA VIOLA ODORATA SODIUM CHLORIDE WATER"],"storage_and_handling":["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"],"use_in_specific_populations":["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. No restriction. ( 8 ) See 17 for PATIENT COUNSELING INFORMATION Revised: 01/2010"],"version":"3","warnings_and_cautions":["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. 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 )"]}