Lagevrio 200mg Hard Capsule

Krajina: Malajzia

Jazyk: angličtina

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

Aktívna zložka:

Molnupiravir

Dostupné z:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Medzinárodný Name):

Molnupiravir

Počet v balení:

40 Capsules

Výrobca:

MSD International GmbH (Puerto Rico Branch) LLC

Príbalový leták

CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
LAGEVRIO
® HARD CAPSULES
Molnupiravir (200mg)
1
PLEASE READ THIS INFORMATION CAREFULLY
BEFORE YOU START TO TAKE YOUR MEDICINE.
REMEMBER THAT YOUR DOCTOR HAS
PRESCRIBED THIS MEDICINE ONLY FOR YOU.
NEVER GIVE IT TO ANYONE ELSE.
WHAT IS IN THIS LEAFLET
1.
What LAGEVRIO
®
is used for
2.
How LAGEVRIO
®
works
3.
Before you use LAGEVRIO
®
4.
How to use LAGEVRIO
®
5.
While you are using LAGEVRIO
®
6.
Side effects
7.
Storage and Disposal of
LAGEVRIO
®
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT LAGEVRIO
®
IS USED FOR
•
LAGEVRIO
®
is an antiviral
medicine
used to treat mild to
moderate COVID
- 19 (caused by
SARS-CoV-2) in adults who are at
risk for
developing severe illness.
•
LAGEVRIO
®
may help people with
COVID-
19 stay out of the hospital
and feel better.
HOW LAGEVRIO
®
WORKS
•
LAGEVRIO
®
contains the active
substance molnupiravir.
•
LAGEVRIO
®
is an antiviral
medicine
that works against the
virus that causes COVID-19.
BEFORE YOU USE LAGEVRIO
®
When you must not use it
Do not take LAGEVRIO
®
if you are
allergic to molnupiravir or any of the
o
ther ingredients of this medicine
(listed in section
PRODUCT
DESCRIPTION
).
Before you start to use it
TELL YOUR DOCTOR OR PHARMACIST ABOUT
ALL OF YOUR MEDICAL CONDITIONS,
INCLUDING IF YOU:
•
have any allergies
•
are pregnant or plan to become
pregnant.
•
are breast-feeding or plan
to breast-feed.
•
have any serious illnesses.
•
a
re taking any medicines
(prescription, over
-the-counter,
vitamins, or herbal products).
PREGNANCY AND BREAST-FEEDING
•
Animal studies with
molnupiravir
have shown harmful
effects to the
unborn animal.
LAGEVRIO
® IS
NOT RECOMMENDED IN PREGNANCY.
LAGEVRIO
®
has
not been studied
in pregnancy and it is
not known if
LAGEVRIO
®
will harm your baby
while you are pregnant.
•
IF YOU ARE PREGNANT, THINK YOU
MAY BE PREGNANT, OR A
RE PLANNING
TO HAVE A BABY, A
SK YOUR DOCTOR
FOR ADVICE. IF
YOU CAN BECOME
PREG

Súhrn charakteristických

1
LOCAL PRODUCT CIRCULAR
LAGEVRIO
®
(MOLNUPIRAVIR)
HARD CAPSULE
LPC-MK4482-C-112021a
(UK SmPC)
1.
NAME OF
T
HE MEDICINAL PRODUCT
LAGEVRIO
®
200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOS
ITION
Each hard capsule contains 200 mg of molnupiravir. For the full list
of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule.
Swedish Orange, opaque, size 0
(approximately
21.7 mm x 7.6 mm) hard capsule, printed with
MSD corporate logo on the cap and “82” on the body in white ink.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LAGEVRIO
®
is
indicated for
treatment
of mild to moderate c
oronavirus
disease 2019 (COVID-19) in
adults with a positive SARS-COV-2
diagnostic
test and who have at least one risk factor for
developing
severe illness (see sections 4.2 and 5.1 for
information
on
posology
and limits of clinical
trial populati
on).
4.2
POSOLOGY AND METHOD OF ADM
INISTRATION
Posology
Adults
The
recommended
dose of
LAGEVRIO
®
is 800 mg (four 200 mg
capsules)
taken orally every 12
hours for 5 days.
The safety and efficacy of
molnupiravir
when
administered
for periods longer than 5 days have not
been established (see
section 5.1).
LAGEVRIO
® SHOULD BE
ADMINISTERED
AS SOON AS POSSIBLE AFTER A
DIAGNOSIS
OF COVID-19 HAS
BEEN MADE AND WITHIN 5 DAYS OF SYMPTOM ONSET (SEE SECTION 5.1).
Missed dose
If the patient misses a dose of LAGEVRIO
®
within
10 hours of the time it is
usually taken, the patient
should take as soon as possible and resume the normal dosing schedule.
If a patient misses a dose
by more than 10 hours, the patient should not take the missed dose and
instead take the next dose
at the regularly
scheduled
time. The patient should not double the dose to make up for a missed
dose.
2
Special populations
Elderly
No dose adjustment of LAGEVRIO
®
is required based on age (see section 5.2).
Renal impairment
No dose adjustment is req
uired for
patients with renal impairment (see section 5.2).
Hepatic impairment
No dose adjustment is required for patients with hepatic impairment
(see sec