PREVYMIS 240MG FILM-COATED TABLET

Země: Malajsie

Jazyk: angličtina

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

Aktivní složka:

Letermovir

Dostupné s:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Mezinárodní Name):

Letermovir

Jednotky v balení:

28 Tablets

Výrobce:

MSD International GmbH T/A MSD Ireland (Ballydine)

Informace pro uživatele

PREVYMIS
® FILM-
COATED TABLET
1
Letermovir (
240mg and 480mg
)
Consumer Medication Information Leaflet
(RiMUP)
WHAT IS IN THIS LEAFLET
1.
What PREVYMIS is used for
2.
How PREVYMIS works
3.
Before you take PREVYMIS
4.
How to take PREVYMIS
5.
While you are taking
PREVYMIS
6.
Side effects
7.
Storage and Disposal of
PREVYMIS
8.
Product Description
9.
Manufacturer, Packer and
Product Registration Holder
10.
Date of revision
Please read this information carefully
before
you
start
to
take
your
medicine,
even
if
you
have
just
refilled your prescription. Some of
the information may have changed.
Remember
that
your
doctor
has
prescribed
this
medicine
only
for
you. Never give it t
o anyone else.
WHAT PREVYMIS IS USED FOR
PREVYMIS
is
a
prescription
medicine
for
adults
who
have
recently
had
a
stem
cell
(bone
marrow)
transplant.
The
medicine
helps stop you from getting ill from
CMV (‘cytomegalovirus’).
CMV is a virus that a lot of people
have
without
knowing.
Normally,
CMV just stays in their body and it
does not hurt them.
However, if your
immune system is weak afte
r you get
a stem cell
transplant, you may be at
high risk of becoming ill from CMV
.
HOW PREVYMIS WORKS
PREVYMIS is an antiviral medicine
that
contains
the
active
substance
letermovir.
BEFORE YOU TAKE PREVYMIS
When you must not use it
Do not take PREVYMIS if:
•
you
are allergic to letermovir or
any of the other ingredients of
this medicine
(listed in section
Product Description)
.
•
You take either of these
medicines:
o
Pimozide
–
used for
Tourette’s
syndrome
o
Ergot alkaloids (such as
ergotamine and
dihydroergotamine)
- used
for migraine headaches
Do not take PREVYMIS if any of
the above apply to you. If you are
not sure, talk to your doctor,
pharmacist, or nurse before taking
PREVYMIS.
IF YOU ARE TAKING
PREVYMIS
WITH CYCLOSPORINE
, DO NOT TAKE THE
FOLLOWING MEDICINES
:
o
Dabigatran
–
used for
blood clots
o
Atorvastatin, simvastati
n,
rosuvastatin, pitavastatin
,
lovastatin
–
for high
cholesterol
Before you start to use it
WARNINGS AND PRECAUTIO

Charakteristika produktu

PREVYMIS
® (LETERMOVIR)
LPC-MK8228-MF-112022a
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).
Each 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 and
corporate lo