1. INDICATIONS AND USAGE

1.1    Lumbar pain due to degenerative lumbar spine disorders (lumbar and lumbar-sacral arthrosis)
1.2    Lumbar vertebral osteophytes
1.3    Low back pain due to muscular and tendinous trigger points. The simultaneous administration of GUNA®-MUSCLE gives wider therapeutic coverage.
1.4    Simple lumbar pain (low back syndrome)
1.5    Weak low back syndrome
1.6    Postural low back ache
1.7    Lumbar and lumbo-sacral mechanical imbalance
1.8    Lumbar and lumbo-sacral spinal malalignment syndrome
1.9    Sacro-iliac syndrome
1.10    Spinal Enthesopathy/Ligament Laxity
1.11    Spinal lumbar and lumbo-sacral nerve root pain. 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 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, 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 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:  Alumina 8X;  Anti interleukin 1 alpha 4C, Beta-Endorphin 4C, Bryonia alba 4X, Hamamelis virginiana 6X, Natrum sulphuricum 8X, Phosphoricum acidum 6X, Sepia 4X; Anti interleukin 1 beta 4C,  Intervertebral disk 4X.
Inactive ingredient: Sterile isotonic sodium chloride solution.

4. CONTRAINDICATIONS

4.1.    There is no history of hypersensitivity to GUNA®-LUMBAR. However patients with a known hypersensitivity to any ingredient should be tested before use, making a spot injection into one arm and be kept under observation for 1 hour.

5. WARNINGS AND PRECAUTIONS

5.1.    Spinal pain requires differential diagnosis for for musculoskeletal, neurological, and soft tissue pathologies including but not limited to: disck 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®-LUMBAR.  GUNA®- LUMBAR should  not  be  given  to  a pregnant woman. 
8.2    Nursing mothers:    It is not known whether any of the ingredients in GUNA®- LUMBAR  are  secreted  in  human milk.  However, since many drugs are secreted in human milk, caution should be exercised when GUNA®- LUMBAR 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®-LUMBAR 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®-LUMBAR 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®-LUMBAR the attenuation of each ingredient has been selected according to the 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®-LUMBAR has no level of toxicity due to the attenuation of the ingredients.

14. CLINICAL STUDIES

14.1.    GUNA®-LUMBAR 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 near 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: It worsens with cold and movement. It 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 omeopatica. Aurelia Verlag.

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1.    NDC  17089-287-31    10 glass vials packaged in carton box
16.2.    NDC  17089-287-32    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.

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