PREVYMIS 240mg/12mL (20mg/mL) concentrate for solution for infusion

Страна: Малайзия

Язык: английский

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

Активный ингредиент:

Letermovir

Доступна с:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

ИНН (Международная Имя):

Letermovir

Штук в упаковке:

12 ml

Производитель:

MSD International GmbH T/A MSD Ireland (Carlow)

тонкая брошюра

Not Applicable

Характеристики продукта

PREVYMIS
® (LETERMOVIR)
LPC-MK8228-MF-092019c
TABLET AND CONCENTRATE FOR SOLUTION FOR INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
PREVYMIS 240 mg film
-
coated tablets
PREVYMIS 480
mg film-coated tablets
PREVYMIS 240 mg concentrate for solution for infusion
PREVYMIS 480 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE
COMPOSITION
PREVYMIS 240 mg film
-coated tablets
Each film-
coated tablet contains 240 mg of letermovir.
PREVYMIS 480 mg film
-coated tablets
Each film-
coated tablet contains 480 mg of letermovir.
PREVYMIS 240 mg concentrate for solution for infusion
Each vial contains 240 mg (12 mL per vial) of letermovir.
Each mL contains 20 mg of
letermovir.
PREVYMIS 480 mg concentrate for solution for infusion
Each vial contains 480 mg (24 mL per vial) of letermovir.
Each mL contains 20 mg of
letermovir.
Excipient with known effect
Each 240 mg film
-
coated tablet contains 4 mg of lactose (as monohydrate).
Each 480 mg film
-
coated tablet contains 6.4 mg of lactose (as monohydrate).
Each 240 mg film
-
coated tablet contains less than 1 mmol sodium (23 mg).
E
ach 480 mg film
-
coated tablet contains less than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
This medicinal product contains 23 mg (1.0 mmol) sodium per 240 mg
vial,
equivalent to 1.15% of the WHO
recommended
maximum
daily intake of 2 g sodium for an
adult.
This medicinal product contains 46 mg (2.0 mmol) sodium per 480 mg
vial,
equivalent to 2.30% of the WHO
recommended
maximum
daily intake of 2 g sodium for an
adult.
Each
240
mg
dose
(12
mL
vial)
of
this
medicinal
product
contains
1800
mg
hydroxypropylbetadex (cyclodextrin).
Each
480
mg
dose
(24
mL
vial)
of
this
medicinal
product
contains
3600
mg
hydroxypropylbetadex (cyclodextrin).
For additional information, see section 4.2.
For the full list of excipients, see
section 6.1.
3.
PHARMACEUTICAL FORM
3.1
FILM-
COATED TABLET (TABLET)
PREVYMIS 240 mg film
-coated tablets
Yellow oval tablet of dimensions 16.5 mm x 8.5 mm, debossed with
“591” on one side