KYTRIL FOR INFUSION 1MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

GRANISETRON HCl 1.12 mg/ml EQV GRANISETRON

Available from:

DKSH SINGAPORE PTE. LTD.

ATC code:

A04AA02

Dosage:

1mg

Pharmaceutical form:

INJECTION

Composition:

GRANISETRON HCl 1.12 mg/ml EQV GRANISETRON 1 mg/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

CENEXI SAS

Authorization status:

ACTIVE

Authorization date:

2008-08-26

Patient Information leaflet

 
1 
KYTRIL®             
Granisetron   

COMPOSITION 
_Active ingredient_: granisetron. 
_ _
_Ampoules _
Clear glass ampoules, each containing 1 mg granisetron present as the 
hydrochloride in 1 ml isotonic saline as a clear, colourless liquid. 
Clear glass ampoules, each containing 3 mg granisetron present as the 
hydrochloride in 3 ml isotonic saline as a clear, colourless liquid. 
_Excipients_:  ampoules  also  contain  sodium  chloride,  citric  acid 
monohydrate and water for injections Ph. Eur. 
_ _
_Tablets _
White triangular film-coated tablets, each containing 1 mg granisetron 
present as the hydrochloride.  
_Excipients_:  tablets  also  contain  lactose  monohydrate,  hypromellose, 
sodium  starch  glycolate,  cellulose,  magnesium  stearate,  titanium 
dioxide E171, macrogol 400 and polysorbate 80. 

PROPERTIES AND EFFECTS 
Granisetron  is  a  potent  and  highly  selective  5-hydroxytryptamine  (5-
HT3) receptor antagonist with anti-emetic activity.  

PHARMACOKINETICS 
_Absorption _
Absorption  of  Kytril  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 _
Kytril  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  Kytril  averages  12%  of  dose  whilst  that  of  metabolites 
amounts  to  about  47%  of

Summary of Product characteristics

1
KYTRIL®
Granisetron
COMPOSITION
_Active ingredient_
: granisetron.
_ _
_Ampoules _
Clear glass ampoules, each containing 1 mg granisetron present as the
hydrochloride in 1 ml isotonic saline as a clear, colourless liquid.
Clear glass ampoules, each containing 3 mg granisetron present as the
hydrochloride in 3 ml isotonic saline as a clear, colourless liquid.
_Excipients_
:
ampoules
also
contain
sodium
chloride,
citric
acid
monohydrate and water for injections Ph. Eur.
_ _
_Tab_
_lets _
White triangular film-coated tablets, each containing 1 mg granisetron
present as the hydrochloride.
_Excipients_
: tablets also contain lactose monohydrate, hypromellose,
sodium
starch
glycolate,
cellulose,
magnesium
stearate,
titanium
dioxide E171, macrogol 400 and polysorbate 80.
PROPERTIES AND EFFECTS
Granisetron is a potent and highly selective 5-hydroxytryptamine (5-
HT3) receptor antagonist with anti-emetic activity.
PHARMACOKINETICS
_Absorption _
Absorption of Kytril 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 _
Kytril 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 Kytril 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 AND USAGE
Tablets
Kytril is indicated for the prevention of nausea and vomiting induced
by cytostatic therapy.
Ampoules
Kytril
is
indicated
for
the
prevention
or
treatment
of
nausea
and
vomiting induced by cytostatic therapy and for the prevention and
treatment of post-operative n