ARTICAINE HCL 4 % AND EPINEPHRINE 1 : 200000

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Beli sekarang

Download Ciri produk (SPC)
19-09-2022
Download Laporan Penilaian Awam (PAR)
19-09-2022

Bahan aktif:

ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE

Boleh didapati daripada:

HENRY SCHEIN SHVADENT (2009 ) LTD

Kod ATC:

N01BB08

Borang farmaseutikal:

SOLUTION FOR INJECTION

Komposisi:

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

Laluan pentadbiran:

DENTAL NERVE BLOCK, DENTAL INFILTRATION INJ.

Jenis preskripsi:

Required

Dikeluarkan oleh:

NOVOCOL PHARMACEUTICAL OF CANADA INC.

Kawasan terapeutik:

ARTICAINE

Tanda-tanda terapeutik:

For infiltration anaesthesia and nerve block anaesthesia in clinical dentistry.

Tarikh kebenaran:

2021-10-30

Ciri produk

                                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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