KYTRIL Ampoules 1mg1ml

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

GRANISETRON HYDROCHLORIDE

Доступна с:

DKSH MALAYSIA SDN BHD

ИНН (Международная Имя):

GRANISETRON HYDROCHLORIDE

Штук в упаковке:

5Units Units

Производитель:

CENEXI SAS

Характеристики продукта

ANTIEMETICS, SEROTONIN (5HT3) ANTAGONISTS
1. PHARMACEUTICAL FORM
Kytril is supplied as film-coated tablets and ampoules
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient: granisetron HCL
Clear glass ampoules contain 1 mg of granisetron (free base
equivalent)
in 1 ml or 3 mg of granisetron (free base equivalent) in 3 ml. as a
clear
colourless liquid.
3. CLINICAL PARTICULARS
3.1 THERAPEUTIC INDICATIONS
KYTRIL is indicated for the prevention and treatment (control) of
a) acute and delayed nausea and vomiting associated with chemotherapy
and radiotherapy
b) post-operative nausea and vomiting
3.2 DOSAGE AND METHOD OF ADMINISTRATION
3.2.1 STANDARD DOSAGE
CHEMOTHERAPY INDUCED NAUSEA AND VOMITING (CINV)
_ADULTS_
_Prevention:_
A dose of 1-3 mg (10-40mcg/kg) of Kytril should be adminis-
tered either as a slow intravenous injection (over 30 seconds) or as
an intravenous infusion diluted in 20 to 50 ml infusion fluid and
adminis-
tered over 5 minutes, prior to the start of chemotherapy.
_Treatment: _
A dose of 1-3 mg (10-40mcg/kg) Kytril should be adminis-
tered either as a slow intravenous injection (over 30 seconds) or as
an
intravenous infusion diluted in 20 to 50 ml infusion fluid and
adminis-
tered over 5 minutes. Further treatment doses of Kytril may be
adminis-
tered, if required, at least 10 minutes apart. The maximum dose of
Kytril
to be administered over 24 hours should not exceed 9 mg.
PEDIATRICS
_Prevention and treatment: _
A dose of 10-40 mcg/kg body weight (up to
3 mg) should be administered as an intravenous infusion, diluted in 10
to 30 ml infusion fluid and administered over 5 minutes prior to the
start
of chemotherapy. One additional dose may be administered within a
24 hour period if required. This additional dose should not be
adminis-
tered until at least 10 minutes after the initial infusion.
RADIOTHERAPY INDUCED NAUSEA AND VOMITING (RINV)
_ADULTS_
_Prevention:_
A dose of 1-3 mg (10-40mcg/kg) of Kytril should be adminis-
tered either as a slow intravenous injection (over 30 seconds) or as
an