ONIVYDE PEGYLATED LIPOSOMAL

Страна: Индонезия

Язык: индонезийский

Источник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Штук в упаковке:

DUS, 1 VIAL @ 10 ML @ 43 MG

Дата Авторизация:

2022-06-10

Характеристики продукта

1
SUMMARY OF PRODUCT CHARACTERISTICS
DISETUJUI OLEH BPOM: 11/01/2022
EREG10023812000068
2
1.
NAME OF THE MEDICINAL PRODUCT
ONIVYDE pegylated liposomal 4.3 mg/ml concentrate for dispersion for
infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One 10 ml vial of concentrate contains 43 mg irinotecan anhydrous free
base (as irinotecan
sucrosofate salt in a pegylated liposomal formulation).
One ml of concentrate contains 4.3 mg irinotecan anhydrous free base
(as irinotecan sucrosofate salt in
a pegylated liposomal formulation).
Excipient with known effect
One ml of concentrate contains 0.144 mmol (3.31 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for dispersion for infusion.
White to slightly yellow opaque isotonic liposomal dispersion.
The concentrate has a pH of 7.2 and an osmolality of 295 mOsm/kg.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ONIVYDE (irinotecan liposome for injection) is indicated for the
treatment of metastatic
adenocarcinoma of the pancreas, in combination with 5-fluorouracil
(5-FU) and leucovorin (LV), in
adult patients who have progressed following gemcitabine based
therapy.
DO NOT SUBSTITUTE ONIVYDE for or with other drug products containing
irinotecan. (See
Warnings and Precautions, General, Other Formulations of lrinotecan).
ONIVYDE
is
not
indicated
as
a
single
agent
for
the
treatment
of
patients
with
metastatic
adenocarcinoma of the pancreas.
ONIVYDE should be administered only under the supervision of a
physician who is experienced in
the use of cancer chemotherapeutic agents.
ONIVYDE should not be used in patients who have already received
Irinotecan.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
ONIVYDE pegylated liposomal (irinotecan) must only be prescribed and
administered to patients by
healthcare professionals experienced in the use of anti-cancer
therapies.
ONIVYDE pegylated liposomal (irinotecan) is not equivalent to
non-liposomal irinotecan
formulations and should not be interchanged.
Posology
ONIVYDE pegylated liposomal,