(microsoft word - ledermix- \362\354\345\357 \354\340\366\345\345\344 \370\340\371\345\360\344.doc)


LEDERMIX® active compound is highly effective anti-inflammatory cortisone derivative (triamcinolone acetonide) combined with a broad-range antibiotic Therapeutical results: Rapid relief of pain associated with acute pulpal and periodontal inflammations.

1g paste contains: Triamcinolone acetonide 10.0 mg Triethanolamine, Calcium chloride, Zinc Oxide, Macrogol 3000, Macrogol 400, Sodium Sulphite Anhydrous, Sodium Calcium Edetate, Col oidal Silicon Dioxide,
Pharmaceutical form and packaging size

Therapeutic indications

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 administration
A: Pulpitis where exposing the pulp cannot be avoided during cavity work, Ledermix® Paste may be applied.
First stage: Whenever removing of carious dentine exposes the pulp subsequent to cavity preparation and forming of extension and retention elements, careful y clean cavity and wound in pulp (using 3% H202 or physiological salt solution). Put a smal quantity of LEDERMIX paste to smal cotton or felt pledget and apply to exposed pulp. Close cavity using zinc oxide eugenol or some other temporary cavity fil er having good sealing properties. Second stage: (two or three days later): Confirm vitality. Remove temporary fil ing and pledget. Clean cavity and wound in pulp (using 3% H202 or physiological salt solution). Inspect pulp wound. If necessary, apply local anesthetic. Since exposing inflamed pulp wil endanger its vitality, avoiding exposure by indirect capping ought to be tried. If clinical symptoms suggest suppuration within coronal pulp (cryalgesia, thermo-algesia), pretreatment using Ledermix® Paste, i.e. a two-phase procedure as described in A) above, is to be recommended.
Important notice
Corticoid suppression of inflammatory processes wil obviously bring about some passing reduction in pulpal inogeneses. Thus, care is to be taken during pulp exposure not to have LEDERMIX Paste, a water-soluble preparation, remain excessively long on the pulp (cf. A) above). Whenever this water-soluble preparation remains excessively long on the pulp, or if the temporary fil ing is flawed, the pulp may become devitalized.
C: Periodontitis
In primary acute periodontitis (immediately fol owing total purulent pulpitis), and in acute exacerbations of chronic periodontitis (incipient parulis) prepare the canal to the apex at the first visit (mechanical and chemical preparation: sodium hypochlorite, H202), dry, and fil with LEDERMIX Paste using a reverse spiral fil er operated at low speed. During the second visit (about one week later) flush LEDERMIX Paste from canal (using H202) and complete gangrene treatment according to one of the general y accepted methods. Moreover, LEDERMIX Paste may be used as a generalized intermediate inlay in any kind of root treatment.
D: Hypersensitive dentine
A dressing of LEDERMIX Paste wil prevent the development of acute periodontitis in those cases where periapical trauma has been caused by over instrumentation or where it is feared that irritant drugs or necrotic materials have been forced into the periapical tissues.
Known hypersensitivity to corticoids and tetracyclines, purulent pulpitis and root canal treatment of milk teeth.
Pregnancy and lactation
Ledermix Paste should not be used during pregnancy or lactation. Teratogenic effects due to demoeclocycline are been seen in humans and animals. Animal experiments have shown that triamcinolone causes damage to the fetus. Both substances pass into breast milk.
Interactions with other medicaments


The 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 a reducing healing capacity. Therefore, Ledermix® Paste should not be in contact with the exposed pulp for too long. If the application of this water-soluble preparation is uncontrol ed, 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 kept clean and tightly closed after use. If severe reactions or idiosyncrasies are encountered, the restorations should be removed and appropriate measures instituted.
Side effects
Since Ledermix® paste is only administered local y, and the various constituents are leached from the site in minute amounts over a long period of time, the possibility of systemic side effects is remote. It has been suggested that in certain situations pulpal necrosis may occur. It is therefore advisable to monitor pulp vitality regularly and carry out endodontic treatment as appropriate.
Storage information

The 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.
Please note
So 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 may change 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, Germany Importer: NEOPHARM LTD, P.O.Box 7063 PETACH TIQVA, 49170

Source: http://doriotdent.ro/en/files/2012/06/ledermix.pdf

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