Granisetron-AFT Solution for Injection 1mgml

Land: Malasía

Tungumál: enska

Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Virkt innihaldsefni:

GRANISETRON HYDROCHLORIDE

Fáanlegur frá:

AFT PHARMACEUTICALS (SE ASIA) SDN BHD

INN (Alþjóðlegt nafn):

GRANISETRON HYDROCHLORIDE

Einingar í pakka:

1ampoule Ampoules; 1ml mL; 3ml mL

Framleitt af:

Qilu Pharmaceutical Co.,Ltd

Vara einkenni

PRODUCT INFORMATION
GRANISETRON-AFT
AFT Pharmaceuticals Pty. Ltd.
NAME OF MEDICINE
Granisetron-AFT Solution for Injection 1mg/ml
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Granisetron hydrochloride 3.3501mg/3ml equivalent to 3mg/3ml
Granisetron
and
Granisetron hydrochloride 1.1167mg/ml equivalent to 1mg/ml Granisetron
PRODUCT DESCRIPTION
Granisetron-AFT Solution for Injection 1 mg/ml is a clear, colourless,
non-pyrogenic,
sterile
solution
containing
Granisetron
hydrochloride
equivalent
to
1mg
of
Granisetron free base in 1ml and equivalent to 3mg of Granisetron free
base in 3ml;
It also contains the sodium chloride 0.9% in water for injections,
Citric acid
monohydrate and Sodium citrate as the excipients.
A reconstitute solution also shall be clear and colourless.
Granisetron-AFT Solution for Injection is filled in 1ml/5ml colorless
Type I glass
ampoules. The ampoules are supplied in packs of 1 or 5 ampoules per
PVC tray. One
tray with 1 or 5 ampoules is packaged into one paper carton.
PHARMACOLOGICAL
PHARMACODYNAMICS PROPERTIES
Pharmacotherapeutic
group:
Antiemetics
and
antinauseants,
Serotonin
(5-HT3)
antagonists.
ATC code: A04AA02
Mechanism of Action
Serotonin
receptors
of
the
5-HT3
type
are
located
peripherally
in
vagal
nerve
terminals and centrally in the chemoreceptor trigger zone of the area
postrema.
During
chemotherapy-induced
vomiting,
mucosal
enterochromaffin
cells
release
serotonin, which stimulates 5-HT3 receptors. This invokes vagal
afferent discharge,
inducing vomiting. Granisetron is a potent antiemetic and highly
selective antagonist
of
5-hydroxytryptamine
(5-HT3)
receptors.
Radioligand
binding
studies
have
demonstrated that Granisetron has negligible affinity for other
receptor types including
5-HT and dopamine D2 binding sites.
PHARMACOKINETICS PROPERTIES
_ABSORPTION _
Absorption of Granisetron is rapid and complete, though oral
bioavailability is reduced
to about 60% as a result of first pass metabolism. Oral
bioavailability is generally not
influenced by food.
_DISTRIBUTION _
Granisetron
is
extensi