Dosage Form: injection, solution
GUNA®-THORACIC (Homeopathic complex preparation) INJECTION SC, ID, IM
1. INDICATIONS AND USAGE
1.1. Thoracic pain due to degenerative thoracic spine disorders (thoracic osteoarthrosis).
1.2. Thoracic pain due to scoliosis.
1.3. Thoracic pain due to thoracic long muscle trigger points. The simultaneous administration of GUNA®-MUSCLE provides broader therapeutic coverage.
1.4. Thoracic pain due to veterbral body osteophytes.
1.5. Simple posterior thoracic pain (thoracic syndrome).
1.6. Mechanical imbalance (costo-vertebral facet joint syndrome).
1.7. Thoracic spinal malalignment syndrome.
1.8. Thoracic spinal nerve root pain. The simultaneous administration of GUNA®-NEURAL provides broader therapeutic coverage.
1.9. Thoracic pain due to osteoporosis.
1.10. Spinal Enthesopathy/Ligament Laxity.
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: Chininum sulphuricum 8X; Anti interleukin 1 alpha 4C, Anti interleukin 1 beta 4C, Beta-Endorphin 4C, Calcarea phosphorica 6X, Cimicifuga racemosa 4X, Intervertebral disk 4X, Spongia tosta 10X, Chelidonium majus 4X, Conium maculatum 6X.
Inactive ingredient: Sterile isotonic sodium chloride solution
4. CONTRAINDICATIONS
4.1. There is no history of hypersensitivity to GUNA®-THORACIC. 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. Spinal pain requires differential diagnosis for musculoskeletal, neurological, and soft tissue pathologies including but not limited to: disc injuries, herniated disc, and referred pain from organ pathologies and primary or secondary cancer pain. Classification according to muscular pain, radicular nerve pain, skeletal pain, and osteoarticular pain should be made.
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®-THORACIC. GUNA®-THORACIC should not be given to a pregnant woman.
8.2 Nursing mothers: It is not known whether any of the ingredients in GUNA®-THORACIC are secreted in human milk. However, since many drugs are secreted in human milk, caution should be exercised when GUNA®-THORACIC 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®-THORACIC 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 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®-THORACIC 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®-THORACIC 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
Homeopathic attenuation provides complete bioavailability of the active ingredients.
13. NONCLINICAL TOXICOLOGY
13.1. GUNA®-THORACIC has no level of toxicity due to the attenuation of the ingredients.
14. CLINICAL STUDIES
14.1 GUNA®-THORACIC 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: 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, localised 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; supporting cardiac, gastric and vascular function; and functions in panic disorders and satiation. Organic and functional pain. Remedy for somatization disorders. It enhances acupuncture sessions. Antidepressive activity. It may improve individual positive attitudes.
• Modalities: It worsens with 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
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 omeopatica. Aurelia Verlag.
16. HOW SUPPLIED/STORAGE AND HANDLING
16.1. NDC 17089-282-31 10 glass vials packaged in carton box.
16.2. NDC 17089-282-32 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-Thoracic black cohosh - calcium phosphate - canakinumab - chelidonium majus - conium maculatum flowering top - metenkefalin - quinine sulfate - spongia officinalis skeleton, roasted - sus scrofa intervertebral disk - anti-interleukin-1.alpha. immunoglobulin g rabbit - injection, solution | ||||||||||||||||||||||||||||||||||||
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| 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 | |
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