Ubistesin

Ország: Örményország

Nyelv: angol

Forrás: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktív összetevők:

articaine (articaine hydrochloride), epinephrine (epinephrine hydrochloride)

Beszerezhető a:

3M Deutschland GmbH

INN (nemzetközi neve):

articaine (articaine hydrochloride), epinephrine (epinephrine hydrochloride)

Adagolás:

40mg/ml+0,006mg/ml

Gyógyszerészeti forma:

solution for injection

Recept típusa:

Prescription

Termékjellemzők

_RMS COMMENT:_ Please find changes proposed by MAH shown as track
changes and RMS
comments within boxes. Please note that the RMS comments are included
in the SmPC of
Ubistesin 1/200 000 only but should also be considered in the SmPC of
Ubistesin 1/100 000.
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Ubistesin 1/200 000
40 mg/ml + 5 micrograms/ml
solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection
contains
1.7 ml solution for injection
contains
Articaine hydrochloride
40 mg
68 mg
Epinephrine (adrenaline) as
Epinephrine (adrenaline)
hydrochloride
5 micrograms
8.5 micrograms
Excipients
Sodium sulphite (E 221)
0.6 mg
1.02 mg
Sodium
0.443 mg
0.753 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection
The solution is a clear, not opalescent, colourless liquid with a pH
value of 3.6 to 4.4.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Local anaesthesia (infiltration and nerve-block anaesthesia) in
dentistry during minor procedures.
Ubistesin 1/200 000 is indicated in adults and children over 4 years.
1
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Ubistesin 1/200 000 is exclusively recommended for use in dentistry.
Ubistesin 1/200 000 should
not be administered to children below 4 years of age (see section
4.3).
_POSOLOGY_
The smallest possible volume of solution which will lead to an
effective anaesthesia should be
used.
Adults:
For extraction of maxillary teeth, 1.7 ml Ubistesin 1/200 000 per
tooth (68 mg articaine
hydrochloride, 8.5 micrograms epinephrine (adrenaline) as
hydrochloride) suffices in most cases;
painful palatal injections can thus be avoided. In the case of serial
extractions of neighbouring
teeth, a reduction of the injection volume is often possible.
If a cut or suture is required in the palate, a palatal infiltration
of approximately 0.1 ml per
puncture is indicated.
For uncomplicated extraction of mandibular premolar teeth,
infiltration anaesthesia with 1.7 ml
Ubistesin 1/200 000 per toot