LEDERMIX

Paste
For Dental Use

Description
LEDERMIX

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.

Composition
Medicinal active substance:
1g paste contains: Triamcinolone acetonide 10.0 mg
Demeclocycline calcium 30.21 mg
Medicinal 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 size
Ledermix

Paste
Tube containing 5 g paste

Therapeutic indications
1. 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 administration
A: 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, carefully
clean cavity and wound in pulp (using 3% H202 or physiological salt solution). Put a small quantity of LEDERMIX paste to small cotton or felt pledget and apply to
exposed 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% H202 or physiological salt
solution). Inspect pulp wound. If necessary, apply local anesthetic.

B: Closed-cavity pulpitis
Since exposing inflamed pulp will 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 will 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 filling is flawed, the pulp may become devitalized.





C: Periodontitis
In primary acute periodontitis (immediately following 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 fill with LEDERMIX Paste using a reverse spiral filler 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
generally 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 will 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.

Contraindications
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
None known with use as directed

Precautions
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 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 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 locally, 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 25C.
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 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

The format of this leaflet has been defined by the NOH, its content was checked and approved - April 2005.