BUPIVACAINE HYDROCHLORIDE INJECTION USP .25% SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

BUPIVACAINE HYDROCHLORIDE

Disponível em:

HOSPIRA HEALTHCARE ULC

Código ATC:

N01BB01

DCI (Denominação Comum Internacional):

BUPIVACAINE

Dosagem:

2.5MG

Forma farmacêutica:

SOLUTION

Composição:

BUPIVACAINE HYDROCHLORIDE 2.5MG

Via de administração:

BLOCK/INFILTRATION

Unidades em pacote:

10/20ML

Tipo de prescrição:

Ethical

Área terapêutica:

LOCAL ANESTHETICS

Resumo do produto:

Active ingredient group (AIG) number: 0108896001; AHFS:

Status de autorização:

CANCELLED POST MARKET

Data de autorização:

2011-08-05

Características técnicas

PRODUCT MONOGRAPH
Pr
BUPIVACAINE HYDROCHLORIDE INJECTION, USP
(Bupivacaine Hydrochloride)
2.5 mg/mL, 5 mg/mL and 7.5 mg/mL
_Local Anesthetic_
Hospira Healthcare Corporation
DATE OF PREPARATION:
5400 Cote-de-Liesse
March 12, 2004
Town of Mount Royal (QC), CANADA
H4P 1A5
Control # 090308
- 2 -
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
BUPIVACAINE HYDROCHLORIDE INJECTION, USP
(Bupivacaine Hydrochloride)
2.5 mg/mL, 5 mg/mL and 7.5 mg/mL
THERAPEUTIC CLASSIFICATION
Local Anesthetic
ACTION AND CLINICAL PHARMACOLOGY
Bupivacaine stabilizes the neuronal membrane and prevents both the
generation and the
conduction of nerve impulses, thereby exerting a local anesthetic
action.
The onset of action is rapid, and anesthesia is long lasting. The
advantage of bupivacaine over
other local anesthetics is in the prolonged duration of effective
anesthesia. It is to be noted
however, that the duration of action of a local anesthetic is
dependent on a number of factors
including site of injection, route of administration, concentration
and volume. It has also been
noted that there is a period of analgesia that persists after the
return of sensation, during which
time the need for strong analgesics is reduced.
Systemic absorption of local anesthetics produces effects on the
cardiovascular and central
nervous systems. At blood concentrations achieved with therapeutic
doses, changes in cardiac
conduction, excitability, refractoriness, contractility, and
peripheral vascular resistance are
minimal. However, toxic blood concentrations depress cardiac
conduction and excitability,
which may lead to atrioventricular block, ventricular arrhythmias and
to cardiac arrest. In
addition, myocardial contractility is depressed and peripheral
vasodilation occurs, leading to
decreased cardiac output and arterial blood pressure. Recent clinical
reports and animal
research suggest that these cardiovascular changes are more likely to
occur with bupivacaine
than other local anesthetics.
- 3 -
Following
systemic
absorption,
local
anesthetics
can
produce
central
nervo