LEDERMIX® Paste For Dental Use - Doriot Dent (Ro)

LEDERMIX ® PasteFor Dental UseDescriptionLEDERMIX ® active compound is highly effective anti-inflammatory cortisone derivative (triamcinolone acetonide) combined with a broad-range antibiotic(demethylchlortetracyline).Therapeutical results: Rapid relief of pain associated with acute pulpal and periodontal inflammations.CompositionMedicinal active substance:1g paste contains: Triamcinolone acetonide 10.0 mgDemeclocycline calcium 30.21 mgMedicinal inactive substance:Triethanolamine, Calcium chloride, Zinc Oxide, Macrogol 3000, Macrogol 400, Sodium Sulphite Anhydrous, Sodium Calcium Edetate, Colloidal Silicon Dioxide,Purified Water.Pharmaceutical form and packaging sizeLedermix ® PasteTube containing 5 g pasteTherapeutic indications1. Prophylactic pulpitis treatment:2. Conservative treatment of acute pulpits (“pulpitis acuta”) while maintaining pulp vitality.3. Treatment of acute periodontites (initiating root canal treatment in total purulent pulpitis and gangrene).Posology, method of administrationA: Pulpitis where exposing the pulp cannot be avoided during cavity work, Ledermix ® Paste may be applied.Procedure:First stage: Whenever removing of carious dentine exposes the pulp subsequent to cavity preparation and forming of extension and retention elements, carefullyclean cavity and wound in pulp (using 3% H 20 2 or physiological salt solution). Put a small quantity of LEDERMIX paste to small cotton or felt pledget and apply toexposed pulp. Close cavity using zinc oxide eugenol or some other temporary cavity filler having good sealing properties.Second stage: (two or three days later): Confirm vitality. Remove temporary filling and pledget. Clean cavity and wound in pulp (using 3% H 20 2 or physiological saltsolution). Inspect pulp wound. If necessary, apply local anesthetic.B: Closed-cavity pulpitisSince exposing inflamed pulp will endanger its vitality, avoiding exposure by indirect capping ought to be tried. If clinical symptoms suggest suppuration withincoronal pulp (cryalgesia, thermo-algesia), pretreatment using Ledermix ® Paste, i.e. a two-phase procedure as described in A) above, is to be recommended.Important noticeCorticoid suppression of inflammatory processes will obviously bring about some passing reduction in pulpal inogeneses. Thus, care is to be taken during pulpexposure not to have LEDERMIX Paste, a water-soluble preparation, remain excessively long on the pulp (cf. A) above). Whenever this water-soluble preparationremains excessively long on the pulp, or if the temporary filling is flawed, the pulp may become devitalized.

C: PeriodontitisIn primary acute periodontitis (immediately following total purulent pulpitis), and in acute exacerbations of chronic periodontitis (incipient parulis) prepare the canal tothe apex at the first visit (mechanical and chemical preparation: sodium hypochlorite, H 20 2) , dry, and fill with LEDERMIX Paste using a reverse spiral filler operated atlow speed. During the second visit (about one week later) flush LEDERMIX Paste from canal (using H 20 2) and complete gangrene treatment according to one of thegenerally accepted methods. Moreover, LEDERMIX Paste may be used as a generalized intermediate inlay in any kind of root treatment.D: Hypersensitive dentineA dressing of LEDERMIX Paste will prevent the development of acute periodontitis in those cases where periapical trauma has been caused by over instrumentationor where it is feared that irritant drugs or necrotic materials have been forced into the periapical tissues.ContraindicationsKnown hypersensitivity to corticoids and tetracyclines, purulent pulpitis and root canal treatment of milk teeth.Pregnancy and lactationLedermix Paste should not be used during pregnancy or lactation. Teratogenic effects due to demoeclocycline are been seen in humans and animals. Animalexperiments have shown that triamcinolone causes damage to the fetus. Both substances pass into breast milk.Interactions with other medicamentsNone known with use as directedPrecautionsThe suppression of the inflammatory process by the use of a corticosteroid may result in a temporary reduction of the resistance of the pulp to infection and areducing healing capacity. Therefore, Ledermix ® Paste should not be in contact with the exposed pulp for too long. If the application of this water-soluble preparationis uncontrolled, or if the temporary dressing fits loosely, the danger exists that the pulp may not survive. The tip of the Ledermix ® Paste tube should always be keptclean and tightly closed after use. If severe reactions or idiosyncrasies are encountered, the restorations should be removed and appropriate measures instituted.Side effectsSince Ledermix ® paste is only administered locally, and the various constituents are leached from the site in minute amounts over a long period of time, thepossibility of systemic side effects is remote. It has been suggested that in certain situations pulpal necrosis may occur. It is therefore advisable to monitor pulpvitality regularly and carry out endodontic treatment as appropriate.Storage informationThe product should be stored in the original pack at 25° C.Each container must be kept tightly closed.The outer carton contains the expiry date. Do not use Ledermix ® paste after expiry.Keep out of the reach of children.Please noteSo as to prevent any hardening of the Ledermix ® paste at or around the tube opening, keep tube tip clean and close tightly after use. Ledermix ® Paste color maychange without impairing product efficiency.License Holder: RIEMSER Arzneimittel AG, Ander Wiek 7, 17489 Insel Riems, Germany.Manufacturer: Haupt Pharma GmbH, Pfaffenrieder Strasse 5, 82515 Wolfratshausen, GermanyImporter: NEOPHARM LTD, P.O.Box 7063 PETACH TIQVA, 49170