ARTINIBSA 4% SOLUTION FOR INJECTION

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

ARTICAINE HYDROCHLORIDE; adrenaline tartrate

Disponible desde:

Ar Dental Supplies Sdn Bhd

Designación común internacional (DCI):

ARTICAINE HYDROCHLORIDE; adrenaline tartrate

Unidades en paquete:

1.8ml of 50 cartridges ml; 1.8ml of 50 cartridges ml

Fabricado por:

Laboratorios Inibsa, S.A.

Ficha técnica

*All adverse events compiled as not known are observed
during postmarketing surveillance.
The observation indicate that the risk of adverse events due to
dental local anaesthetic with Artinibsa 4% is very low.
C) DESCRIPTION OF SELECTED ADVERSE EVENTS
Two types of adverse events are of special clinical interest,
but not the most frequently reported adverse events. The
presentation is based mainly on postmarketing surveillance
data.
Nerve disturbances
Nerve disturbances in dentistry may have different reasons,
caused by underlying dental disease, by dental procedure, but
also by direct adverse events of dental local anaesthetics.
With an observation frequency of two events (1.15 of them
non-serious) per 10 millions of sold carpules the risk of such
disturbances is low. The data discussion is focused on serious
adverse events, because of the clinical relevance of these
adverse events with the risk of permanent damage.
The majority of these adverse events were reversible.
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
1ml solution for injection contains:
_Active ingredients:_
Articaine hydrochloride
40mg
Adrenaline tartrate
0.018mg
(equivalent to adrenaline base 0.01mg)
Excipients
Sodium
chloride,
Sodium
metabisulphite,
Citric
acid
monohydrate, Water for injection, Hydrochloric acid, Sodium
hydroxide.
2. PRODUCT DESCRIPTION
Solution for injection.
Clear, non opalescence, colourless solution.
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
Local anaesthesia (infiltration and nerve-block anaesthesia) in
dentistry.
Artinibsa 4% Solution for Injection is especially indicated for
complicated procedures requiring prolonged anaesthesia.
3.2 POSOLOGY AND METHOD OF ADMINISTRATION
The following dosage instructions apply:
The smallest possible volume of solution which will lead to an
effective anaesthesia should be used.
Adults:
For extraction of maxillary teeth, 1 cartridge per tooth suffices
in most cases; painful palatal injections can thus be avoided. In
the case of serial extractions of neighbouring teeth, a reduc-
tion