MYLAN ONDANSETRON CONCENTRATE FOR SOLUTION FOR INFUSION OR INJECTION 2MGML

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Dostępny od:

MYLAN HEALTHCARE SDN. BHD.

INN (International Nazwa):

ONDANSETRON HYDROCHLORIDE DIHYDRATE

Sztuk w opakowaniu:

1vial Vials

Wyprodukowano przez:

Mylan Laboratories Limited [Specialty Formulation Facility}

Charakterystyka produktu

MYLAN ONDANSETRON CONCENTRATE FOR SOLUTION
FOR INFUSION OR INJECTION 2MG/ML
PRODUCT DESCRIPTION:
Mylan Ondansetron Concentrate Solution for Infusion or Injection
2mg/mL is a clear colour
less solution free from visible particles. The reconstituted solution
is a clear colourless solution.
Ondansetron
injection
should
only
be
mixed with
those
infusion
solutions
which
are
recommended:
• Sodium chloride 0.9%w/v
• Dextrose 5.0%w/v
• Sodium chloride 0.9%w/v and Dextrose 5.0%w/v
• Sodium chloride 0.45%w/v and Dextrose 5.0%w/v
• Sodium chloride 3.0%w/v
COMPOSITION:
EACH ML CONTAINS:
Ondansetron hydrochloride equivalent to Ondansetron 2 mg
PHARMACOLOGY:
Ondansetron is a highly selective 5 HT
3
receptor antagonist, which inhibits nausea and
vomiting caused by cytotoxic agents and radiation. Its precise mode of
action is not known
but believed to be mediated via antagonism of 5-hydroxytryptamine
receptors located in the
chemoreceptor trigger zone in the area postrema of the brain and
possibly on vagal afferents in
the upper gastrointestinal tract. It is used in the management of
nausea and vomiting induced
by
cytotoxic
chemotherapy
and
radiotherapy,
particularly
where
this
is
severe
or
unresponsive to other therapy. It has also been given for
postoperative nausea and vomiting.
PHARMACOKINETICS:
It is extensively distributed in the body and about 70-75% of the drug
in plasma is protein
bound. It is cleared from the systemic circulation predominantly by
hepatic metabolism through
multiple enzymatic pathways, with less than 5% of a dose being
excreted unchanged in urine.
The disposition of ondansetron following IM or IV dosing is similar
with a terminal elimination
half-life of about 3 hours and steady-state volume of distribution of
about 140L.
Special Patient Populations:
_Elderly: _
Studies in healthy elderly volunteers have shown prolonged elimination
half-life
(5hrs).
_Children: _
Studies in children (above 2 years) also showed reduced clearance and
volume
of distribution, which is age-related; use of weight-bas