NORMAST® 300 mg ΔΙΣΚΙΑ

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NORMAST® 300 mg ΔΙΣΚΙΑ

– PALMITOILETANOLAMIDE micronized 300 mg

  • O νευρικόs ιστόs, τόσο περιφερικός, όσο και της σπονδυλικής στήλης, υποβάλλεται  σε υποτροπιάζουσες και / ή χρόνιες νευροφλεγμονώδεις καταστάσεις διαφορετικής προέλευσης και  χάνει την ικανότητα  της ενδογενούς σύνθεσης παλμιτοϋλαιθανολαμίδης, αυξάνοντας έτσι τον κίνδυνο φλεγμονώδους πόνου και σε περιπτώσεις βλάβης και / ή δυσλειτουργίας του σωματοαισθητικού συστήματος, μπορεί να έχει ως αποτέλεσμα την σταδιακή μετατροπή του φλεγμονώδους πόνου σε νευροπαθητικό πόνο.
  • Σε τέτοιες περιπτώσεις είναι πολύ σημαντικό να αντισταθμιστεί η διαδικασία ενεργοποίησης των μη νευρωνικών κυττάρων (όχι μόνο των μαστοκυττάρων στο επίπεδο των αισθητήριων απολήξεων και / ή το ενδονεύριο  διαμέρισμα, αλλά και της Μικρογλοίας στο  νωτιαίο μυελό) που φυσιολογικά είναι υπεύθυνα για την εξασφάλιση  της ομοιοδυναμικής ισορροπίας του νευρικού ιστού και του σωστού τροφισμού του ίδιου.

Η Παλμιτοϋλαιθανολαμίδη (PEA), τόσο σε μικρονισμένη μορφή (διαστάσεις σωματιδίων μεταξύ 2.0 και 10.0 μικρά) όπως Normast® 300mg δισκία όσο και σε υπερμικρονισμένη μορφή (διαστάσεις σωματιδίων μεταξύ 0.8 και 6.0 μικρών) όπως Normast® 600mg δισκία και Normast® 600mg μικροκοκκία.  Ενεργεί στον οργανισμό ως βιολογικός ρυθμιστής που είναι σε θέσει να επαναφέρει, σε διαφορετικά επίπεδα (αισθητήριες απολήξεις, ενδονεύριο διαμέρισμα, σπονδυλική συναπτική σύνδεση μεταξύ 1ου και 2ου νευρώνα),  την φυσιολογική αντιδραστικότητα του νευρικού ιστού ελέγχοντας έτσι τον φλεγμονώδη  και / ή τον νευροπαθητικό πόνο.

Δοσολογία: Στην αρχή χορηγείται για ένα κύκλο 10 ημερών Normast 600mg φακελίσκοι(σε μικροκοκκία) και μετά 2 δισκία ημερησίως για 30-60 ημέρες ,με Normast 300mg. Πρέπει να χρησιμοποιείται υπό ιατρική παρακολούθηση.

Τρόφιμo για Ειδικούς Ιατρικούς Σκοπούς Xωρίς  Γλουτένη.

ΑΓΟΡΑΣΤΕ ΤΑ ΤΩΡΑ

normast®

MICRONIZED AND ULTRAMICRONIZED PALMITOYLETHANOLAMIDE

PAIN & NEUROINFLAMMATION

Understanding the role of non-neuronal cells (Mast cells and Microglia) in the modulation of the sensitization level of the CNS in its whole, opens new perspectives for the design of therapies targeting pathological conditions — e.g. Neuroinflammation and Chronic and Neuropathic Pain — considered so far almost as a result of the primary alteration of the nervous conduction, both peripherally. and centrally. Up to date, the pharmacological approaches adopted in the control of chronic pain mechanism, had the neuron as main target. The pharmacological attenuation of microglial activation and mast cell hyper-reaction is emerging as a promising target for pathologic conditions of Neuroinflammation & Pain (Neurogenic, Neuropathic or mixed pain).

The most advanced scientific research has identified surprisingly similar regulation mechanisms for Mast cell and Microglia, both based on the on-demand expression of specific receptor complexes and their ligands. Among these, the progenitor is a lipid compound, Palmitoylethanolamide (PEA), identified in the early 90s by the Research Group coordinated by Prof. Rita Levi Montalcini, Nobel Prize in Medicine, as the natural ligand able to regulate the Mast cell reactivity.

This natural compound results to fully meet the requirements of the pharmacological modulation of both the non-neuronal cell line involved in the overall regulation process of the neuronal sensitization.

1 – Peripheral sensitization and Neurogenic inflammation

The interaction between nerve terminals and tissue Mast cells influences the peripheral pain threshold. An altered control of the Mast cell determines an abnormal release of growth factors (neoinnervations, angiogenesis, fibroblast activation), vasoactive amines (microvasal permeation, edema, inflammatory cell recall), pro-inflammatory and cytolesive cytokines. The hyper-reactive Mast cell induces Peripheral Sensitization (lowering of the algogen threshold) and Neurogenic Inflammation (distrectual neuroinflammation).

An endogenous synthesis of Palmytoilethanolamide (PEA) and a contextual expression of specific receptor complexes for the latter, represent the regulatory response of Mast cell. Intense and/or persisting noxae can exceed the endogenous synthesis capacity of PEA; the administration of micronized PEA (normast® 300 mg tablets) has shown to be efficacious for the control of Peripheral Sensitization and Neurogenic Inflammation.

Diseases sustained by Peripheral Sensitization and Neurogenic Inflammation

  • Dismethabolic Neuropathies (diabetic, elderly patients)
  • latrogenic Neuropathies (Chemotherapies induced)
  • Toxic Neuropathies (Alchoholic, uremic)
  • Infectious Neuropathies (Postherpetic)
  • Distrectual Neuropathies (Arthritis/Arthrosis)

normast® 300 tablets induces remarkable painful symptoms attenuation in diabetic neuropathy

normast® 300 tablets potentiates the effect of Pregabalin pain reduction in diabetic neuropathy, improving daily activities

normast® 300 tablets induces a significant increase of LEPs (Laser -evoked Potential) in patients suffering from painful neuropathy of different origin

normast® 300 tablets induces an intensity reduction of pain in iatrogenic neuropathy associated to a significant increase of LEPs (Laser -evoked Potential)

normast® 300 tablets induces a marked decrease in ostheoarticular pain intensity significantly more high in I respect of Ibuprofen

2 – Neurogenic Endoneurial Edema

Mast cell maintains the delicate homeodynamic balance of the miniature endoneurial compartment containing, along with the myelinated and non myelinated axons , the vasa nervorum and the connectival cell lineage (fibroblasts).

Compressive, dismetabolic, infective and toxic noxae induce endoneurial Mast cell hyper reactivity as a consequence of an insufficient regulation, resulting in pathological condition,. in particular axonal sensitization, endoneurial edema with vasa nervorum collapse and, progressively, a myelinic and/or axonal lesion of wallerian type, due to an abnormal release of mast cell proteases. This lesion is the start signal of neuropathic pain. The staging is that one of the Miniature Compartment Syndrome (MCS).

The administration of micronized PEA (normast® 300 mg tablets) has shown to be efficacious for the control of the endoneurial Neurogenic edema, generally associated with several peripheral neuropathies, troncular and radicular.

Diseases sustained by Miniature Compartment Syndrome

  • Troncular Neuropathies (Compressive, Traumatic, Toxic/latrogenic)
  • Canalicular Syndromes (Carpal, Cubital, Tarsal Tunnel)
  • Vertebro-radicular Syndromes (Discopathies, Herniations, Lornbasciatalgies)
  • Algo-dystrophic Syndromes

normast® 300 tablets decreases lumbosciatalgy pain intensity in with dose-dependent effect

normast® 300 tablets effect on lumbosciatalgy pain intensity reduction at the end of treatment, occurs regardless of the simultaneous FANs administration

normast® 300 tablets decreases in a highly significant and dose-dependent way the Motor Distal Latency in the compression suffering from Carpal Tunnel Syndrome

normast® 300 tablets significantly reduces pain intensity in Carpal Tunnel Syndrome in diabetic patients

3 – Periphery and spinal station interaction: the bi-directional cross-talk between Mast cell and Microglia

Microglia controls the nervous signal between the first and the second neuron and it is in turn controlled by Palmitoylethanolamide (PEA). The abnormal release of mast cell mediators (cytokines and growth factors) associated with prolonged peripheral stimuli exposure, can prime the spinal microglia that activates and proliferates, releasing in turn cytokine signals received by Mast cell. Therefore, between Mast Cell and Microglia there is a dense bidirectional cross-talk having amplifying loop features.

It comes out the need of a pharmacological intervention, in sub-acute and chronic conditions, on the modulation of both cell targets at the same time.

The administration of micronized PEA (normast® 300 mg tablets) has shown to be efficacious to counteract the onset and duration of Neuropathic Pain sustained by the cross-talk between non-neuronal cells, through the simultaneous modulation of Mast cell and Microglia and preventing their activation, thanks to the progressive down-regulation of both the cell lines.

Diseases sustained by the cross-talk between Mast cells and Microglia

  • Central Pain Syndromes (due to Multiple Sclerosis, Post-Stroke, Phantom limb, Fibromyalgia)
  • Spinal Cord diseases ( Vertebral canal stenosis, Spine flexion and extension injuries)
  • Peripheral Neuropathies in sub-acute and chronic stage.

normast® 600 tablets potentiates the effect of standard analgesic therapy for the reduction of neuropathic pain due to low back pain

normast® 600 tablets has shown marked efficacy on the post-ictus spasticity

normast® 600 tablets induces a remarkable reduction of Chronic Pain caused by different etiopathogenesis

normast® 600 tablets induces a remarkable reduction of Chronic Pain caused by different etiopathogenesis, regardless to other concomitantly administer antalgic therapies

4 – Neuropathic Pain and Spinal Neuroinflammation

When abnormal signals of injuries or dysfunctions of the Nervous System — peripheral, spinal, sovraspinal — propagate from periphery, or from centre, to the synaptic junction between the first and the second neuron, Microglia activates and proliferates, triggering Spinal Neuroinflammation processes and simultaneously inducing, for neuronal plasticity, a deep modification of the synaptic transmission in an amplified way. This amplification of the signal towards the encephalic centers sustains and maintains Neuropathic Pain. Hence the need for an efficacious and rapid intervention on the microglial target.
The exogenous supply of ultra-micronized PEA for sublingual route (normast® 600 mg microgranules for sublingual use) has shown to be effective and adequately rapid for the control of Neuropathic Pain and Spinal Neuroinflammation.

normast® 600 mg sublingual micro granules induces a significant chronic pain reduction caused by different etiopathogenesis, both in monotherapy and in multitherapy with other antalgic treatments

normast® – Combination Drug Therapy (CDT)

Met analysis on clinical effects of Norrnast in more than 2.099 patients (16 clinical trials)
normast® 600 mg sublingual micro granules has been shown to reduce, in just 5 days, 40% of pain perception as a consequence of the specific activity on the spinal Microglia. In this way, the subsequent administration of normast® tablets (300 and 600mg) it has reduced 80% of pain perception just within 30 days. A therapy with the same duration only with normast® 300 mg tablets reduces 60% of pain perception.

The performed met analysis leads to the conclusion that the Combination Drug Therapy with normast° 600mg sublingual and normast® tablets (300 and 600mg) results to be a relevant therapeutical option for the rapid control of Neuropathic or mixed Pain (Neuropathic and Inflammatory)

ALIA mechanism and PEA activity

The endogenous regulation of Mast cells and Microglia takes place via a local pleiotropic biological mechanism which is in common to this two cell lines, and discovered by the Research Laboratories of Epitech Group in cooperation with the Nobel Prize Rita Levi-Montalcini: ALIA mechanism (Autacoid Local Injury Antagonism).

This mechanism is based on the on-demand production of the molecule of Palmitoylethanolamide (PEA) and on the simultaneous expression of a receptorial complex specific for this molecule (CBs, PPARs, etc.). Through these receptors, PEA normalizes the mast cell degranulation and the microglial activation, restoring the tissue homeodynamic control. Due to a progressive depletion of endogenous PEA, Mast cells and Microglia lose their regulation capacity, amplifying and maintaining Pain & Neuroinflammation.

normast® efficacy and tolerability

The analysis of the results obtained in over 2.000 patients in published clinical trials has sown optimal efficacy and high safety of this treatment

NNT (Number Needed to Treat) = 1,8 in low back pain (MEC 50%)

NNH (Number Needed to Harm)> 250

normast® formulations and specific indications for use

normast® 600 mg sublingual micro granules –  ultra-micronized PEA

in attack phase or in case of acute exacerbation of Neuropathic or mixed Pain, guarantees a rapid and concentrated effect on the spinal microglia and counteracting Central Sensitization and Spinal Neuroinflammation

Dosage: 1 x 2 sachets/day for 5-10 days, according to the Physician’s judgment

normast® 600 mg tablets –  ultra-micronized PEA

in the maintenance phase for painful chronic states of peripheral or spinal origin or central pain, guarantees the simultaneous effect on the cross-talk mechanism between peripheral mast cells and spinal microglia

Dosage: 1 x 2 tablets/day for repeated cycles of 30-60 days, according to the Physician’s judgment

normast® 300 mg tablets –  micronized PEA

in the maintenance phase for painful chronic states of peripheral origin guarantees a higher and concentrated effect on mast cell, counteracting Peripheral Sensitization and Neurogenic Inflammation, peripheral and endoneurial

Dosage: 1 x 2 tablets/day for repeated cycles of 30-60 days, according to the Physician’s judgment

ΒΙΒΛΙΟΓΡΑΦΙΑ

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