Ubistesin Forte

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Adrenaline 0.01 mg/mL equivalent to 0.012 mg adrenaline hydrochloride; Articaine hydrochloride 40 mg/mL;  

Saatavilla:

3M New Zealand Ltd

INN (Kansainvälinen yleisnimi):

Adrenaline 0.01 mg/mL (equivalent to 0.012 mg adrenaline hydrochloride)

Annos:

4%/1:100,000

Lääkemuoto:

Solution for injection

Koostumus:

Active: Adrenaline 0.01 mg/mL equivalent to 0.012 mg adrenaline hydrochloride Articaine hydrochloride 40 mg/mL   Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Sodium sulfite Water for injection

Kpl paketissa:

Cartridge, glass, 50 x 1.7 mL, 50 dose units

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

Cambrex Profarmaco Milano Srl

Käyttöaiheet:

Infiltration anaesthesia and nerve block anaesthesia in dentistry. UBISTESIN FORTE is especially indicated for more complex dental procedures requiring prolonged anaesthesia.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Cartridge, glass, 50 x 1.7 mL - 50 dose units - 24 months from date of manufacture stored at or below 25°C protect from light

Valtuutus päivämäärä:

2006-03-03

Valmisteyhteenveto

NEW ZEALAND DATA SHEET
Ubistesin and Ubistesin Forte CCDSv3 DSv4-08mar19
Page 1 of 19
1 PRODUCT NAME
UBISTESIN 1/200 000 solution for injection
UBISTESIN FORTE 1/100 000 solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Amount per 1.7 mL cartridge
COMPONENT
UBISTESIN 1/200 000
UBISTESIN FORTE 1/100 000
ACTIVE INGREDIENTS:
Articaine hydrochloride
68 mg
68mg
Adrenaline
(epinephrine)
hydrochloride
_Equivalent _
_to _
_adrenaline _
_(epinephrine) _
0.0102 mg
_ _
_ _
_0.0085 mg _
0.0204 mg
_ _
_ _
_0.017 mg _
EXCIPIENTS
WITH
KNOWN
EFFECT:
Sodium chloride
1.91 mg
1.91 mg
Sodium sulfite
1.02 mg
1.02 mg
The
cartridges
contain
sodium
sulfite
as
an
antioxidant
and
are
free
from
preservatives.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
UBISTESIN and UBISTESIN FORTE are sterile isotonic aqueous solutions
for
injection. The solution is a clear, not opalescent, colourless
solution, practically free
from visible particles with a pH value of 3.6-4.4.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Infiltration anaesthesia and nerve block anaesthesia in dentistry.
UBISTESIN FORTE is especially indicated for more complex dental
procedures
requiring prolonged anaesthesia.
UBISTESIN and UBISTESIN FORTE must not be used in children under the
age of 4
years.
NEW ZEALAND DATA SHEET
Ubistesin and Ubistesin Forte CCDSv3 DSv4-08mar19
Page 2 of 19
4.2
DOSE AND METHOD OF ADMINISTRATION
UBISTESIN and UBISTESIN FORTE are exclusively for use in dentistry
.
The following dosage instructions apply:
The smallest possible volume of solution that will lead to effective
anaesthesia should
be used.
Adults:
For extraction of maxillary teeth, 1.7mL UBISTESIN or UBISTESIN FORTE
per tooth
suffices in most cases, thereby avoiding painful palatal injections. A
smaller injection
volume is often possible for serial extractions of neighbouring teeth.
If a cut or suture is required in the palate, a palatal injection of
approximately 0.1mL
per puncture is indicated.
For uncomplicated extractions of mandibular premola