LIGNOSPAN FORTE LIQUID

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LIDOCAINE HYDROCHLORIDE; EPINEPHRINE (EPINEPHRINE BITARTRATE)

Διαθέσιμο από:

SEPTODONT

Φαρμακολογική κατηγορία (ATC):

N01BB52

INN (Διεθνής Όνομα):

LIDOCAINE, COMBINATIONS

Δοσολογία:

36MG; 36MCG

Φαρμακοτεχνική μορφή:

LIQUID

Σύνθεση:

LIDOCAINE HYDROCHLORIDE 36MG; EPINEPHRINE (EPINEPHRINE BITARTRATE) 36MCG

Οδός χορήγησης:

BLOCK/INFILTRATION

Μονάδες σε πακέτο:

50X1.8ML

Τρόπος διάθεσης:

Ethical

Θεραπευτική περιοχή:

LOCAL ANESTHETICS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0201284011; AHFS:

Καθεστώς αδειοδότησης:

MARKETED

Ημερομηνία της άδειας:

1976-12-31

Αρχείο Π.Χ.Π.

_Novocol Pharmaceutical of Canada, Inc._
Page 1 of 23
PRESCRIBING INFORMATION
LIGNOSPAN
® FORTE
LIGNOSPAN
® STANDARD
(LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION USP)
_ _
(lidocaine hydrochloride 2% with epinephrine 1:50,000 and with
epinephrine
1:100,000)
_ _
_ _
Local Anaesthetic for Dental Use
Sponsor: Manufacturer:
Septodont, Novocol Pharmaceutical of Canada,
Inc.
58, RUE DU Pont de Creteil 25 Wolseley Court,
94107 Saint-Maur-des-Fosses Cambridge, Ontario,
Cedex France N1R 6X3
Date of Preparation:
June 30, 2015
Submission Control No: 184186
_Novocol Pharmaceutical of Canada, Inc._
Page 2 of 23
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................................
3
SUMMARY PRODUCT INFORMATION
....................................................................................................
3
INDICATIONS AND CLINICAL USE
..........................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................................................
5
ADVERSE REACTIONS
...............................................................................................................................
9
DRUG INTERACTIONS
..............................................................................................................................
10
DOSAGE AND ADMINISTRATION
..........................................................................................................
12
OVERDOSAGE
............................................................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................................................
14
STORAGE AND STABILITY
.....................................................................................................................
16
SPECIAL HANDLING INSTRUCT