Ledermix for Dental Use

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Triamcinolone acetonide; Triamcinolone acetonide; Demeclocycline hydrochloride; Demeclocycline hydrochloride

Mevcut itibaren:

Henry Schein UK Holdings Limited

ATC kodu:

A01AC; A01AC01

INN (International Adı):

Triamcinolone acetonide; Triamcinolone acetonide; Demeclocycline hydrochloride; Demeclocycline hydrochloride

Doz:

3 percent volume/volume

Farmasötik formu:

Dental solution

Reçete türü:

Product subject to prescription which may not be renewed (A)

Terapötik alanı:

Corticosteroids for local oral treatment; triamcinolone

Yetkilendirme durumu:

Not marketed

Yetkilendirme tarihi:

1983-04-01

Bilgilendirme broşürü

REVISION: 1.6
DATE: 21/11/2018
PRINTED COLOURS (3 COLOUR)
JOB:
LEDERMIX COMBINATION KIT LABEL
CODE:
14016_12
SIZE:
320MM X 105MM
DATE:
03/09/2015
Pantone 116
Pantone 5255
Black
Cutting Form (Not Printed)
FONTS USED
BODY COPY
HELVETICA CONDENSED:
SAMPLE Sample
SIZE: 9pt
HEADING/SUB HEADING COPY
HELVETICA BOLD CONDENSED:
SAMPLE Sample
SIZE: 10pt
Sample 12ly
Sample Only
1
2
Please read all of this leaflet carefully before you receive the
medicine.
Keep the leaflet as you may want to read it again.
If you have any further questions please ask your dentist.
If you experience any troublesome side effects or any effects not
listed in this
leaflet tell your dentist or doctor.
In this leaflet:
1.
What LEDERMIX is and what it is used for
2.
Before you receive LEDERMIX
3.
How LEDERMIX is used
4.
Possible side effects
5.
How to store LEDERMIX
6.
Further information
1.
What LEDERMIX is and what it is used for
cement LEDERMIX is a combination kit which contains a dental paste, a
dental
powder and two dental liquids (slow and fast setting hardeners).
LEDERMIX dental paste contains the active ingredients demeclocycline
calcium and triamcinolone acetonide.
LEDERMIX dental cement powder contains the active ingredients
demeclocycline
hydrochloride and triamcinolone acetonide.
Demeclocycline hydrochloride is one of a group of antibiotics called
tetracyclines
which is used to treat or prevent infections. Triamcinolone acetonide
is a corticosteroid used to reduce swelling or inflammation.
LEDERMIX is used by dentists to treat deep and possibly painful
cavities
(holes in the teeth) which are close to the nerve or involve the nerve
in the
tooth, and as a dressing during the treatment of the root canal.
2.
Before you receive LEDERMIX
You should not receive this medicine if:
you are allergic to any tetracycline antibiotic (e.g. oxytetracycline,
tetracycline,
chlortetracycline, demeclocycline, doxycycline or minocycline) or
any of the ingredients in this medicine (see section 6 for more
details)
you have badly infected dental pulp
This med

Ürün özellikleri

Health Products Regulatory Authority
27 March 2019
CRN008SGQ
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Ledermix for Dental Use
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1. Ledermix 30 mg/g + 10 mg/g Dental Paste. Each gram contains:
Demeclocycline calcium equivalent to Demeclocycline
hydrochloride 30mg. Triamcinolone acetonide 10mg.
2. Ledermix 20 mg/g + 6.7 mg/g Dental Cement Powder. Each gram
contains: Demeclocycline hydrochloride 20mg.
Triamcinolone acetonide 6.7mg. For use with Ledermix Hardener ‘F’
Dental Liquid and Ledermix Hardener ‘S’ Dental Liqud.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ledermix for Dental Use is a combination pack consisting of 4 separate
unit containers as follows:
1. Ledermix Dental Paste is a greyish yellow smooth paste, free from
gritty particles.
2. Ledermix Dental Cement Powder is a fine cream coloured powder.
3. Ledermix Hardener ‘F’ Dental Liquid is a clear colourless to
yellow liquid with an odour of oil of cloves.
4. Ledermix Hardener ‘S’ Dental Liquid is a clear colourless to
yellow liquid with an odour of oil of cloves.
Each of the units is also supplied separately.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A topical dental preparation with antibiotic and corticosteroid
properties. LEDERMIX is indicated in pulpitis (except total
purulent pulpitis) and periodontitis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
PULPITIS: LEDERMIX Dental Paste is applied with a small cotton pledget
to the dentine adjacent to the pulp or to the exposed
pulp. The cavity is then closed with a temporary dressing.
Approximately three to six days later the vitality of the tooth is
determined, the cavity is re-opened and the cotton pledget is removed.
The dentine close to the pulp, or the wound in the
pulp, is covered with LEDERMIX Dental Cement prepared in the following
manner: To one drop of the Hardener (no more) add
sufficient LEDERMIX Dental Cement Powder to obtain an homogeneous
mixture of cream-lik