LEDERMIX PASTE

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

DEMECLOCYCLINE CALCIUM; TRIAMCINOLONE ACETONIDE

Available from:

NEOPHARM LTD

ATC code:

D07CB01

Pharmaceutical form:

PASTE

Composition:

DEMECLOCYCLINE CALCIUM 30.21 MG/G; TRIAMCINOLONE ACETONIDE 10 MG/G

Administration route:

LOCAL ORAL

Prescription type:

Required

Manufactured by:

RIEMSER PHARMA GMBH, GERMANY

Therapeutic group:

TRIAMCINOLONE AND ANTIBIOTICS

Therapeutic area:

TRIAMCINOLONE AND ANTIBIOTICS

Therapeutic indications:

Compound for dental use, prophylaxis or treatment of acute pulpitis and periodontitis.

Authorization date:

2020-03-31

Summary of Product characteristics

דומע
1
ךותמ
5
1.
NAME OF THE MEDICINAL PRODUCT
Ledermix
®
paste.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 g paste contains: 30.21 mg demeclocycline calcium (equivalent to
30.00 mg demeclocycline
hydrochloride) and 10 mg triamcinolone acetonide.
Excipients with known effect: 1 g paste contains 3 mg sodium sul
phite anhydrous.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dental paste
Ledermix Paste is a greyish-yellow soft paste
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Compound for dental use, prophylaxis or treatment of acute pulpitis
and periodontitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The dosage depends on the nature and scope of use.
_Paediatric population _
Insufficient data are available for use in children (aged 3 years and
older) (see section 4.4).
_ _
Method of administration
_A: CASES OF PULPITIS, WITH EXPOSURE OF THE PULP _ _ _
PRACTICAL PROCEDURE:
1
st
session: If after preparing the cavity and creating the extension and
retention element,
removal of the carious dentine close to the pulp has resulted in
exposure of the pulp, carefully
clean the cavity and pulp wound (H
2
O
2
3% or physiological NaCl solution). Squeeze a small
amount of Ledermix Paste onto a small pellet of cotton wool or felt
and apply to the exposed
pulp. Seal the cavity with ZnO eugenol or another, tightly sealing,
temporary cavity filling
material.
2
nd
session (two to three days later): Vitality test, remove the temporary
filling and pellet. Clean
the cavity and pulp wound (H
2
O
2
3% or physiological NaCl solution). Inspect the pulp wound. If
necessary, local anaesthesia. Cap the exposed pulp. Then perform
underfilling and final cavity
filling in the same session.
_B: CASES OF PULPITIS WITH CLOSED PULP CAVITY. _
As exposure of the inflamed pulp represents an inherent drawback in
terms of preserving its
vitality, attempts should be made to avoid such exposure by observing
the principles of indirect
capping. Then place the final filling. The same approach as for
pu