GRANISETRON FRESENIUS INJECTION 1MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

GRANISETRON HYDROCHLORIDE 1.12MG EQV TO GRANISETRON

Available from:

FRESENIUS KABI (SINGAPORE) PTE LTD

ATC code:

A04AA02

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

GRANISETRON HYDROCHLORIDE 1.12MG EQV TO GRANISETRON 1MG/ML

Administration route:

INTRAVENOUS DRIP, INTRAVENOUS BOLUS

Prescription type:

Prescription Only

Manufactured by:

PT ETHICA INDUSTRI FARMASI (PT ETHICA)

Authorization status:

ACTIVE

Authorization date:

2021-03-29

Summary of Product characteristics

COMPOSITION
Each mL contains:
Granisetron HCl equivalent to 1 mg of Granisetron.
LIST OF EXCIPIENTS
Sodium Chloride, Citric Acid Monohydrate, Sodium Hydroxide,
Hydrochloric
Acid, and Water for Injection.
PHARMACOLOGY
Serotonin receptors of the 5-HT
3
type are located peripherally on 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-HT
3
receptors.
This
evokes
vagal
afferent discharge and may induce vomiting. Granisetron is a highly
selective
antagonist
of
5-hydroxytryptamine
(5-HT
3
)
receptors
and
displays
potent
antiemetic activity.
PHARMACOKINETICS
_Absorption_
Absorption of Granisetron is generally not influenced by food and is
rapid and
complete, though oral bioavailability is reduced to around 60% as a
result of
first pass metabolism.
_Distribution_
Granisetron
is
widely
distributed
with
a
mean
volume
of
distribution
of
approximately 3 liters/kg; plasma protein binding is approximately
65%.
_Metabolism_
Biotransformation
pathways
involve
N-demethylation
and
aromatic
ring
oxidation followed by conjugation.
_Elimination_
Clearance
is
predominantly
by
hepatic
metabolism.
Urinary
excretion
of
unchanged Granisetron averages 12% of dose whilst that of metabolites
amounts to about 47% of dose. The remainder is excreted in feces as
metabolites. Mean plasma half-life in patients is approximately nine
hours, with
a wide inter-subject variability.
INDICATIONS
Granisetron is indicated for the prevention or treatment of nausea and
vomiting
induced
by
cytostatic
therapy
and
for
the
prevention
and
treatment
of
post-operative nausea and vomitting.
DOSAGE AND ADMINISTERING PROCEDURE
CYTOSTATIC THERAPY
INTRAVENOUS
Granisetron ampoules are for intravenous administration only.
ADULTS
3 mg Granisetron which should be administered either in 15 mL infusion
fluid
as an intravenous bolus over not less than 30 seconds or diluted in 20
to 50 mL
infusion fluid and administered over five m