UBISTESIN

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

ARTICAINE HYDROCHLORIDE; EPINEPHRINE HYDROCHLORIDE

Available from:

3M ISRAEL

ATC code:

N01BB08

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

EPINEPHRINE HYDROCHLORIDE 0.006 MG/ML; ARTICAINE HYDROCHLORIDE 40 MG/ML

Administration route:

DENTAL INFILTRATION INJ., DENTAL NERVE BLOCK

Prescription type:

Required

Manufactured by:

3M DEUTSCHLAND GMBH, GERMANY

Therapeutic group:

ARTICAINE

Therapeutic area:

ARTICAINE

Therapeutic indications:

Infiltration anesthesia and nerve-block in dentistry. Ubistesin is especially indicated for routine interventions such as: Uncomplicated single and serial extractions. Cavity and coronal stump preparations.

Authorization date:

2011-04-30

Summary of Product characteristics

SEITE 1
-
148 X 210 MM
-
44000722320/07
-
ROT (PANTONE 206U)
• SCHWARZ
-
11-385 (SR)
Ubistesin
™
Solution for Injection
Oromucosal use
FOR USE IN DENTAL ANAESTHESIA ONLY
PACKAGE LEAFLET
Registration No 134 30 29975 00
Name and address of importer and registration holder
3M Israel
91 Medinat Hayehudim St., Herzlia 46120
Name and adress of manufacturer
3M Deutschland GmbH
Carl-Schurz-Straße 1
41453 Neuss
Germany
44000722320/07 COMPOSITION
1 ml solution for injection contains:
Active ingredients:
Articaine hydrochloride
40
mg
Adrenaline hydrochloride
0.006 mg
(corresponding to 0.005 mg adrenaline)
Other ingredients:
Sodium sulphite
max. 0.6 mg
(equivalent to max. 0.31mg SO
2
)
Sodium chloride
Water for injections
Hydrochloric acid and sodium hydroxide for adjusting the pH-value
PHARMACEUTICAL FORM AND CONTENT
Solution for injection; one tin contains 50 cartridges of 1.7 ml each
LOCAL ANAESTHETIC (AGENT THAT ABOLISH SENSATION AFFECTING A PARTICULAR
AREA OF REGION) OF THE AMIDE TYPE WITH VASOCONSTRICTIVE (NARROWING
OF BLOOD VESSEL) COMPONENT FOR ADMINISTRATION IN DENTISTRY
THERAPEUTIC INDICATIONS
Infiltration anaesthesia and nerve-block in dentistry. Ubistesin is
especially
indicated for routine interventions such as: Uncomplicated single and
serial
extractions. Cavity and coronal stump preparations.
CONTRAINDICATIONS
Ubistesin is not allowed to be used in the event of
-
children under 4 years of age
-
hypersensitivity (allergic) to any of the components
Due to the local anaesthetic ingredient articaine, Ubistesin is not
allowed
to be used in the event of
-
known allergy or hypersensitivity to local anaesthetics of the amide
type
-
severe impairment of the impulse initiation and conduction system of
the heart (e.g. grade II and III AV block, pronounced bradycardia
(slow
heart rate))
-
acutely decompensated cardiac insufficiency (acute failure of cardiac
performance)
-
severe hypotension (low blood pressure)
-
patients who are known to have a deficiency in plasma cholinesterase
activity (a naturally occurring chem