TAKIPRIL

País: Indonésia

Língua: indonésio

Origem: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredientes ativos:

PRILOCAINE HYDROCHLORIDE

Disponível em:

B.BRAUN PHARMACEUTICAL INDONESIA - Indonesia

DCI (Denominação Comum Internacional):

PRILOCAINE HYDROCHLORIDE

Dosagem:

20 Mg

Forma farmacêutica:

INJEKSI

Unidades em pacote:

DUS, 10 AMPUL @ 5 ML

Fabricado por:

SINTETICA SA - Switzerland

Data de autorização:

2021-05-01

Características técnicas

COMPOSITION
Each mL of TAKIPRIL contains prilocaine hydrochloride 20 mg.
DESCRIPTION
TAKIPRIL is a clear and colourless solution for injection that
contains prilocaine hyperbaric, a local anaesthetic, belonging to the
category of the amides. TAKIPRIL is used to anaesthetise specific
parts of the body and prevent pain during surgery in adults. By
means of the excipient glucose, the density of TAKIPRIL is 1.026
g/g at 20°C, equivalent to 1.021 g/g at 37°C. This medicinal product
contains less than 1 mmol sodium (23 mg) per dose (maximum dose
equal to 4 mL of TAKIPRIL), i.e. essentially “sodium-free”.
PHARMACOLOGY
_PHARMACODYNAMIC_
Prilocaine is an amide-type local anaesthetic. Prilocaine inhibits the
function of the excitable structures (e.g. all types of nerve fibres
[sensory,
motor,
autonomous
nerve
fibres]).
It
inhibits
the
excitability of sensory pain receptors and the conductivity of the
sensory nerve fibres, at local level and in a reversible way, reducing
the perception of pain and, subsequently, that of cold, heat, touch
and pressure.
Prilocaine reduces membrane permeability to sodium. This reduces
the
excitability
of
the
nerve
fibres
in
accordance
with
its
concentration,
through
reducing
the
sudden
peak
sodium
permeability, needed to form the potential for action. The effect
depends on the pH of the substance and the pH of the environment.
The local anaesthetic effect is due to the protonated form. In
inflamed tissues, the effect of the local anaesthetics is lower
because of the lower pH of the environment.
_PHARMACOKINETIC _
The plasma concentration should be negligible for intrathecal use.
The terminal elimination half-life of prilocaine is 1.6 hours. The
plasma protein bond is approximately 55%. The bioavailability of
prilocaine at the application site is 100%.
INDICATIONS
TAKIPRIL is indicated in adults for spinal anaesthesia in short
term surgical procedures (not more than 45 minutes).
CONTRAINDICATIONS
TAKIPRIL is must not be used in patients with:

Hypersensitivity
to
prilocaine
hydrochlori