Fluimucil 100 mg/ mL Solution For Injection (I.M./ I.V.)

Land: Filipijnen

Taal: Engels

Bron: FDA (Food And Drug Administration)

Werkstoffen:

Acetylcysteine

Beschikbaar vanaf:

The Cathay Drug Co., Inc.

INN (Algemene Internationale Benaming):

Acetylcysteine

Dosering:

100 mg/ mL

farmaceutische vorm:

Solution For Injection (I.M./ I.V.)

Eenheden in pakket:

Amber glass ampoule x 3mL (box of 5's)

Geproduceerd door:

Zambon S.p.A., Italy

Autorisatie datum:

2020-02-13

Bijsluiter

FLUIMUCIL 100 MG/ML SOLUTION FOR INJECTION
(I.M./I.V.)
(ACETYLCYSTEINE)
MUCOLYTIC
Category: Injectables
DESCRIPTION
THE CATHAY DRUG CO., INC.
FORMULATION
Each mL of solution contains 100 mg of Acetylcysteine, Ph. Eur.
PRODUCT DESCRIPTION
Acetylcysteine (Fluimucil) is a clear, colourless solution with a
slightly sulphureous odour.
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
N-acetylcysteine (Acetylcysteine), the active ingredient of FLUIMUCIL,
exerts marked mucolytic-
fluidifying action on mucous and mucopurulent secretions by
depolymerizing the mucoproteic
complexes and the nucleic acids that confers viscosity to the vitreous
and purulent component of the
sputum and other secreta. Additional properties are: reduction of
induced hyperplasia of mucous
cells increase in surfactant production by stimulation of type II
pneumocytes, stimulation of
mucociliary activity, leading to improved mucociliary clearance.
Acetylcysteine also exerts a direct antioxidant action, being endowed
with a nucleophilic free thiol
(-SH) group able to interact directly with the electrophilic group of
the oxidizing radicals.
Particularly interesting is the recent finding that acetylcysteine
protects α1-antitrypsin, an elastase
inhibiting enzyme, from the inactivation by hypochlorous acid (HOCl),
a powerful oxidizing agent
produced by the myeloperoxidase enzyme of activated phagocytes.
Moreover, its molecular structure allows acetylcysteine to easily
cross the cellular membranes.
Inside the cell, acetylcysteine is deacetylated, thus yielding
L-cysteine, an indispensable amino acid
for the glutathione synthesis (GSH). Acetylcysteine exerts in addition
an indirect antioxidant effect
through its role as GSH precursor. GSH is a highly reactive
tripeptide, ubiquitously diffused in the
various tissues of animal organisms, whichis essential for the
maintenance of functional capacity as
well as cellular morphological integrity. It represents the most
important protective intracellular
defense mechanism against oxidizing radicals, both exog