Mannocist-d 20 sachets

MANNOCYST-D

D-Mannose 1.5 g

Treatment and prevention
of CYSTITIS

Medical Device CE 0373

INDICATIONS: Mannocist-D sachets, based on D-Mannose, is a medical device capable of inhibiting the adhesion of bacteria responsible for urinary tract infections at the level of the urethral and bladder epithelium, of promoting their elimination through urine and therefore of limiting the onset of infections. D-Mannose can be used both in acute urinary tract infections and in their recurrences. The concomitant use of Mannocist-D with antibiotics and antimicrobials can promote the functionality of the latter, increasing the patient's adherence to therapy.

COMPOSITION: D-Mannose 1.5 g, sodium bicarbonate, sorbitol, silicon dioxide.

HOW TO USE: acute phase: for the first 3 days, 1 sachet in the morning and 1 in the mid-afternoon, on an empty stomach and bladder; maintenance phase: 1 sachet every morning, on an empty stomach and bladder, until the symptoms have completely disappeared. If sexual intercourse is the trigger for cystitis, take 1 sachet after each intercourse and 2 sachets in the following 24 hours, according to the methods described above. Take the product by dissolving the contents of the sachet in half a glass of water, then do not drink or eat for about 40 minutes. During the rest of the day it is important to drink plenty of water to help eliminate bacteria through urination.

CONTRAINDICATIONS: Cytotoxicity, sensitization and oral mucosa irritation studies have not found any contraindications.

SIDE EFFECTS: meteorism may occur, which generally disappear after a few days.

PACKAGING: 20 single-dose sachets of 2 g.

• Main features

- STRATEGY TO CONTRAST UTI (Urinary Tract Infection) ALTERNATIVE AND/OR SUPPORT TO ANTIBIOTIC AND ANTIMICROBIAL THERAPIES

- CLASS IIa MEDICAL DEVICE CERTIFIED BY THE HIGHER INSTITUTE OF HEALTH

- D-MANNOSE 1.5 g PER SINGLE DOSE

- NO CONTRAINDICATIONS FOR USE ACCORDING TO THE BIOCOMPATIBILITY TESTS PERFORMED
-Cytotoxicity
-Allergic sensitization
-Irritation of the oral mucosa.

- GLUTEN AND LACTOSE FREE

- NICKEL TESTED Value found < 0.1 ppm

• D-Mannose
D-Mannose is a simple sugar, a hexose monosaccharide extracted from larch or birch wood with a high safety profile of use. It is rapidly absorbed from the intestine and distributed in the blood and to all organs within a short time (30 min) ⁽¹⁾ . It cannot be transformed into glycogen and therefore is not accumulated in the liver or other organs, nor is it used by the body ⁽²⁾ . Excess mannose reaches the kidney and bladder and is eliminated in the urine. Long-term administration of mannose, in concentrations up to 20%, has not produced effects on metabolism or signs of toxicity, which supports the good general toxicological profile ⁽³⁾ .

• D-Mannose activity on bacteria
Adhesion of bacteria to the surface of animal cells is a crucial factor for virulence and the establishment of infections. Often this recognition-adhesion is mediated by sugar residues such as D-Mannose and L-fucose that bind to specific lectins on the bacterial surface. Several virulence factors are known and described that are mostly and abundantly represented on pathogenic serotypes for example of E.coli (known as UPEC Uropathogenic Escherichia coli), Salmonella spp and other bacteria involved in urinary tract infections such as Proteus mirabilis ⁽⁴⁾⁽⁵⁾ .

• D-Mannose in the treatment of UTIs
The bladder wall is coated with various mannosylated proteins, including Tamm-Horsfall proteins (THP), which interfere with bacterial adhesion to the epithelium. THP binds to E. coli with a highly specific and saturable bond, which is inhibited by D-Mannose ^(6), suggesting an important role of the mannosyllated groups of THP in specific binding, in particular with pathogenic E. coli with the virulence factor FimH, which are more abundant in patients with UTI than in the healthy population. D-Mannose mimics the functionality of the urothelial barrier, inhibiting bacterial adhesion to the urethral and bladder epithelium. Bacteria, binding to free D-Mannose molecules in the urine, instead of nesting in the mucosal walls, remain trapped in the urine flow and eliminated with it. In vitro and vivo studies have highlighted the ability of mannosides to reduce bacterial load by 2 orders of magnitude in urine and 4 in the bladder ⁽⁷⁾ .

• Conclusions
There is a strong and consolidated scientific rationale for the efficacy of D-Mannose in inhibiting the adhesion of bacteria responsible for UTIs, in promoting bacterial clearance through urine and therefore in reducing the onset of infections ^(8-10) . The nature of the monosaccharide and long-term studies support the fact that it is devoid of toxicity even if ingested at doses much higher than those ordinarily present in the diet ⁽³⁾ .

BIBLIOGRAPHY
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10.Han Z, Pinkner JS, Ford B, Obermann R, Nolan W, Wildman SA, Hobbs D, Ellenberger T, Cusumano CK, Hyltgren SJ, Jaetka JW. Structure-based drug design and optimization of mannoside bacterial FimH antagonists. J Med Chem. 2010 Jun 24;53(12):4779-92