ARTICAINE HCL 4 % AND EPINEPHRINE 1 : 200000

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

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Last ned Preparatomtale (SPC)
19-09-2022

Aktiv ingrediens:

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Tilgjengelig fra:

HENRY SCHEIN SHVADENT (2009 ) LTD

ATC-kode:

N01BB08

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

EPINEPHRINE BITARTRATE 0.015 MG / 1.7 ML; ARTICAINE HYDROCHLORIDE 68 MG / 1.7 ML

Administreringsrute:

DENTAL NERVE BLOCK, DENTAL INFILTRATION INJ.

Resept typen:

Required

Produsert av:

NOVOCOL PHARMACEUTICAL OF CANADA INC.

Terapeutisk område:

ARTICAINE

Indikasjoner:

For infiltration anaesthesia and nerve block anaesthesia in clinical dentistry.

Autorisasjon dato:

2021-10-30

Preparatomtale

                                PHYSICIAN’S PRESCRIBING INFORMATION
1)
NAME OF THE MEDICINAL PRODUCTS:
Articaine HCl 4% and Epinephrine 1:200,000
Articaine HCl 4% and Epinephrine 1:100,000
2)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Articaine HCl 4% and Epinephrine 1:200,000:
1 ml of solution for injection contains 40 mg of articaine
hydrochloride and 5
micrograms of epinephrine (as epinephrine bitartrate).
Each cartridge of 1.7 ml of solution for injection contains 68 mg of
articaine
hydrochloride and 8.5 micrograms of epinephrine (as epinephrine
bitartrate).
Articaine HCl 4% and Epinephrine 1:100,000:
1 ml of solution for injection contains 40 mg of articaine
hydrochloride and 10
micrograms of epinephrine (as epinephrine bitartrate).
Each cartridge of 1.7 ml of solution for injection contains 68 mg of
articaine
hydrochloride and 17 micrograms of epinephrine (as epinephrine
bitartrate).
Excipient(s) with known effect: sodium metabisulfite For the full list
of
excipients, see section 6.1.
3)
PHARMACEUTICAL FORM:
Solution for Injection. Clear and colourless solution, practically
free from
particles.
4)
CLINICAL PARTICULARS:
4.1)
THERAPEUTIC INDICATIONS: for infiltration anaesthesia and nerve block
anaesthesia in clinical dentistry.
4.2)
POSOLOGY AND METHOD OF ADMINISTRATION: As with all local
anaesthetics the dosage varies and depends upon the area to be
anaesthetized, the vascularity of the tissues, the number of numeral
segments
to be blocked, individual tolerance and the technique of anaesthesia.
ADULTS:
•
For most common operations, one infiltration with 1.7 ml Articaine HCl
4%
and Epinephrine 1: 200,000 or Articaine HCl 4% and Epinephrine 1:
100,000 is sufficient. In all cases, the injection must be
administered slowly
(About 1 ml/min).
•
For an infiltration in the interdental septum, a quantity of 0.3 to
0.5 ml is
indicated as generally sufficient.
Do not exceed the equivalent of 7 mg/kg articaine hydrochloride body
weight
which corresponds, for a subject weighing 60 Kg, to 6 standard 1.7 ml
cartridges. The duration of anaesthesia d
                                
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