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Description
MANNOCIST-D
D-Mannosio 1,5 g
Trattamento e prevenzione delle CISTITI
Dispositivo Medico CE 0373
INDICAZIONI: Mannocist-D bustine, a base di D-Mannosio, è un dispositivo medico in grado di inibire l'adesione dei batteri responsabili delle infezioni delle vie urinarie a livello dell'epitelio uretrale e vescicale, di favorirne l'eliminazione tramite le urine e di limitare quindi l'insorgenza di infezioni. Il D-Mannosio può essere utilizzato sia nelle infezioni acute delle vie urinarie, sia nelle loro recidive. L'uso concomitante di Mannocist-D con antibiotici e antimicrobici può favorire la funzionalità di questi ultimi aumentando l'aderenza del paziente alla terapia.
COMPOSIZIONE: D-Mannosio 1,5 g, sodio bicarbonato, sorbitolo, biossido di silicio.
MODALITA' D'USO: fase acuta: per i primi 3 giorni, 1 bustina al mattino e 1 a metà pomeriggio, a stomaco e vescica vuoti; fase di mantenimento: 1 bustina tutte le mattine, a stomaco e vescica vuoti, fino a totale scomparsa dei sintomi. Se il rapporto sessuale è il fattore scatenante delle cistiti, assumere 1 bustina dopo ogni rapporto e 2 bustine nelle 24 ore successive, secondo le modalità sopra descritte. Assumere il prodotto sciogliendo il contenuto della bustina in mezzo bicchiere d'acqua, successivamente non bere e non mangiare per circa 40 minuti. Durante il resto della giornata è importante bere acqua in abbondanza per favorire l'eliminazione dei batteri con la minzione.
CONTROINDICAZIONI: gli studi di citotossicità, sensibilizzazione e di irritazione della mucosa orale non hanno riscontrato controindicazioni.
EFFETTI INDESIDERATI: possono verificarsi fenomeni di meteorismo, che in genere scompaiono dopo pochi giorni.
CONFEZIONE: 20 bustine monodose da 2 g.
• Principali caratteristiche
- STRATEGIA DI CONTRASTO DELLE UTI (Urinary Tract Infection) ALTERNATIVA E/O SUPPORTO ALLE TERAPIE ANTIBIOTICHE E ANTIMICROBICHE
- DISPOSITIVO MEDICO CLASSE IIa CERTIFICATO DA ISTITUTO SUPERIORE DI SANITÀ
- D-MANNOSIO 1,5 g PER MONODOSE
- NESSUNA CONTROINDICAZIONE D’USO SECONDO I TEST DI BIOCOMPATIBILITÀ ESEGUITI -Citotossicità -Sensibilizzazione allergica -Irritazione della mucosa orale.
- PRIVO DI GLUTINE E LATTOSIO
- NICKEL TESTED Valore riscontrato <0,1 ppm
• D-Mannosio Il D-Mannosio è uno zucchero semplice, un monosaccaride esoso estratto dal legno di larice o betulla dall'elevato profilo di sicurezza d'uso. Viene rapidamente assorbito dall'intestino e nell'arco di poco tempo (30 min) distribuito nel sangue e a tutti gli organi(1). Non può essere trasformato in glicogeno e pertanto non viene accumulato nel fegato o in altri organi, nè viene utilizzato dall'organismo(2). Il mannosio in eccesso raggiunge il rene e la vescica e viene eliminato con le urine. La somministrazione di mannosio a lungo termine, in concentrazioni fino al 20%, non ha prodotto effetti sul metabolismo nè segni di tossicità, il che supporta il buon profilo tossicologico generale(3).
• D-Mannosio attività sui batteri L'adesione dei batteri alla superficie delle cellule animali è un fattore cruciale per la virulenza e l'instaurarsi di infezioni. Spesso questo riconoscimento-adesione è mediato da residui di zuccheri quali D-Mannosio e L-Fucosio che si legano alle lecitine specifiche della superficie batterica. Sono noti e descritti diversi fattori di virulenza che sono maggiormente e abbondantemente rappresentati sui sierotipi patogeni per esempio di E.coli (noti come UPEC Uropathogenic Escherichia coli), di Salmonella spp e altri batteri coinvolti nelle infezioni delle vie urinarie come Proteus mirabilis(4)(5).
• D-Mannosio nel trattamento delle UTI La parete della vescica è rivestita con varie proteine mannosilate, tra le quali le proteine di Tamm-Horsfall (THP), che interferiscono con l'adesione dei batteri all'epitelio. La THP si lega a E.coli con un legame altamente specifico e saturabile, che è inibito dal D-Mannosio(6) suggerendo un ruolo importante dei gruppi mannosilati di THP nel legame specifico, in particolare con i coli patogeni dotati del fattore di virulenza FimH, che più abbondanti si riscontrano nei pazienti affetti da UTI rispetto alla popolazione sana. Il D-Mannosio mima la funzionalità della barriera uroteliale, inibendo l’adesione dei batteri a livello dell’epitelio uretrale e vescicale. I batteri, legandosi con le molecole di D-Mannosio libere nell'urina, anzichè annidarsi nelle pareti della mucosa, rimangono intrappolati nel flusso dell'urina e con essa eliminati. Studi in vitro e vivo hanno evidenziato la capacità dei mannosidi di ridurre la carica batterica di 2 ordini di grandezza nelle urine e di 4 nella vescica(7).
• Conclusioni Esiste un forte e consolidato razionale scientifico in merito all'efficacia del D-Mannosio nell’inibire l’adesione dei batteri responsabili delle UTI, nel favorire la clearance batterica tramite le urine e nel ridurre quindi l’insorgenza delle infezioni(8-10). La natura del monosaccaride e gli studi effettuati a lungo termine supportano il fatto che esso sia privo di tossicità anche se ingerito a dosi molto più elevate di quelle ordinarie nella dieta(3).
BIBLIOGRAFIA 1. Alton G, Hasilik M, Nieheus R, Fana F and Freeze HH.Direct manipulation of mannose for mammalian glycoprotein biosynthesis. Glycobiology. 1998;8:285-295 2. Sharon N. Carboydrates as future anti-adhesion drugs for infectious diseases Biochim Biophys Acta. 2006 Apr;1760(4);527-37. Epub 2006 Jan 18 3. Davis JA, Freeze HH: Studies of mannose metabolism and effects of long-term mannose ingestion in the mouse. Biochim Biophys Acta,. 2001 Oct 3;1528(2-3):116-26 4. Rosen DA. Pinkener JS, Walker JN, Elam JS, Jones JM, Hultgren SJ.Molecular variations in Klebsiella pneumonia and Escherichia coli FimH affect function and pathogenesis in the urinary tract. Infect Immun. 2008 Jul;76(7):3346-56. Epub 2008 May 12 5. Zunino P., Sosa V, Schalapp G, Allen AG, Preston A, Maskell DJ. Mannose-resistant Proteuslike and P.mirailis fimbriae have specific and additive roles in P.mirabilis urinary tract infections. FEMS Immunol Med Microbiol. 2007 Oct-,51(1):125-33 6. Pak J, Pu Y, Zhang ZT, Hasty DL, Wu XR. Tamm-Horsfall protein binds to type 1 fimbriated Escherichia coli and prevents E.coli form binding to uroplakin Ia and Ib receptors. J Biol Chem. 2001 Mar 30; 276(13):9924-30. Epub 2000 Dec 27. 7. Klein t, Abgottspon D, Wittwer M, Rabbani S, Herold J, Jiang X, Kleeb S, Luthi C, Scharenberg M, Bezencon J, Gulber E, Pang L, Smiesko M, Cutting B, Schwardt O, Ernst B. FimH antagonists for the oral treatment of urinary tract infections: from design and synthesis to in vitro and in vivo evaluation. J Med Chem. 2010 Dec 23;53(24):8627-41. Epub 2010 Nov 24 8. Lopez AI, Kumar A, Planas MR, Li Y, Nguyen TV, Cai C. Biofunctionalization of silicone polymers using poly (amidoamine) dendrimers and a mannose derivative for prolonged interference against pathogen colonization. Bimaterials. 2001 Jul;32(19):4336-46. Epub 2011 Mar 24 9. Kim J, Ahn Y, Park KM, Lee DW, Kim K. Glyco-psudopolyrotaxanes: carbohydrate wheels threaded on a polymer string and their inhibition of bacterial adhesion. Chemistry. 2010 Oct 25;16(40):12168-73 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
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RIGHT OF WITHDRAWAL 7.1. Deadline for Withdrawal The Consumer has a period of fourteen days to withdraw from the contract without having to give any reason. The communication of the withdrawal must be sent by registered letter with acknowledgment of receipt to: Farmacia Congedo Dr. Paolo Via Posillipo 323 - 80123 - Naples. The communication can also be anticipated by e-mail to the address indicated on the contact page, provided that it is confirmed by registered letter with return receipt within 48 hours. 7.2. Effective date The aforementioned term starts: a) in the event that a service is offered from the day of conclusion of the contract b) in the case of sale of a product, from the day on which the Consumer or a third party, other than the carrier and designated by the Consumer, acquires physical possession of the good or: - in the case of multiple goods ordered by the Consumer through a single order and delivered separately, from the day on which the Consumer or a third party, other than the carrier and designated by the Consumer, acquires physical possession of the last good; - in the case of delivery of a good made up of multiple lots or pieces, from the day on which the Consumer o a third party, other than the carrier and designated by the Consumer, acquires physical possession of the last lot or piece; - in the case of contracts for the periodic delivery of goods during a certain period of time, from the day on which the Consumer or a third party, other than the carrier and designated by Consumer, acquires physical possession of the first good.
7.3. Duties of the pharmacy The pharmacy, following the withdrawal of the consumer: - communicates without delay to the Consumer a confirmation of receipt, on a durable medium, of the Withdrawal exercised; - reimburses the same all payments received, including delivery costs, without undue delay and in any case within fourteen days from the day of communication of the Right of Withdrawal. - the pharmacy reimburses using the same means of payment used by the Consumer, unless otherwise agreed after payment. 7.4. Obligations on the part of the Consumer The shipping costs for returning the products received are borne by the Consumer and must be sent to the Dr. Paolo Congedo Pharmacy located in Via Posillipo, 323 - 80123 Naples (NA) within fourteen days from the date on which he communicated to the pharmacy his decision to withdraw from the contract (the deadline is met if the Consumer sends back the goods before the fourteen-day period has expired). 7.5. The substantial integrity of the goods is an essential condition for exercising the Right of Withdrawal. The Product must therefore be kept with normal diligence and returned intact, complete in all its parts, fully functional and free from signs of wear or dirt.
Furthermore, to limit damage to the original packaging, we recommend, where possible, to place it in a second box. Avoid affixing labels or adhesive tape directly to the original product packaging. By law, the shipping costs relating to the return of the goods are charged to the customer. The shipment, until the confirmation of receipt in our warehouse, is under the complete responsibility of the Customer; in case of damage to the goods during transport, Farmacia Congedo Dr. Paolo will notify the Customer of the incident (within 5 working days of receiving the goods in its warehouses), to allow him to promptly file a complaint against the courier and obtain a refund the value of the asset (if insured); in this case, the product will be made available to the Customer for its return, simultaneously canceling the request for withdrawal. Farmacia Congedo Dr. Paolo is not liable in any way for damage or theft/loss of goods returned by uninsured shipments; upon its arrival at the warehouse, the product will be examined to assess any damage or tampering not caused by transport. If the original package and/or packaging are damaged, Farmacia Congedo Dr. Paolo will deduct a percentage from the refund due, in any case not exceeding 10% of the same, as a contribution towards the costs of restoration. 7.6. Exceptions to the Right of Withdrawal – products for which the application of the Right of Withdrawal is excluded The right of Withdrawal cannot be exercised: a) in case of purchase of medicines and medical devices; b) in case of purchase of food, drinks and other goods intended for current consumption; c) in the case of purchases of less than 50 euros (unless the global consideration that the Consumer must pay regardless of the amount of the individual contracts exceeds 50 euros); d) in the case of a contract concerning a service after the complete provision of the service if the execution of the contract began with the express agreement of the Consumer; e) in case of supply of goods made to measure or clearly personalized; f) in case of supply of goods which are likely to deteriorate or expire rapidly; g) in the case of supply of sealed goods which do not lend themselves to being returned for hygienic or health protection reasons and which have been opened after delivery; h) in case of supply of goods which after delivery are by their nature inseparably mixed with other goods.
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