PAXLOVID (NIRMATRELVIR 150 MG FILM-COATED TABLETS AND RITONAVIR 100 MG FILM-COATED TABLETS)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

nirmatrelvir; Ritonavir

Boleh didapati daripada:

PFIZER (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

nirmatrelvir; Ritonavir

Unit dalam pakej:

30 Tablets

Dikeluarkan oleh:

PFIZER IRELAND PHARMACEUTICALS

Risalah maklumat

Pfizer Confidential
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
PAXLOVID FILM COATED TABLET
Nirmatrelvir 150 mg and Ritonavir 100 mg
1
WHAT IS IN THIS LEAFLET
1.
What Paxlovid is used for
2.
How Paxlovid works
3.
Before you use Paxlovid
4.
How to use Paxlovid
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Paxlovid
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT PAXLOVID IS USED FOR
Paxlovid is an antiviral medicine used
for treating mild-to-moderate
COVID-19.
COVID-19 is caused by a virus.
Paxlovid is used in adults 18 years of
age and older with mild-to-moderate
COVID-19. It is only used in patients
who are at high risk for progression
to severe COVID-19, including
hospitalisation or death.
You must talk to a doctor if you do
not feel better or if you feel worse
while on treatment with Paxlovid.
HOW PAXLOVID WORKS
Paxlovid stops the virus multiplying
in cells and this stops the virus
multiplying in the body. This can
help your body to overcome the virus
infection, and may help you get better
faster.
BEFORE YOU USE PAXLOVID
-
_When you must not use it_
-
if you are allergic to
nirmatrelvir, ritonavir or any of
the other ingredients of this
medicine
-
if you have severe liver or
kidney disease
-
if you are taking any of the
following medicines. Taking
Paxlovid with these medicines
may cause serious or life-
threatening side effects or
affect how Paxlovid works:
-
alfuzosin (used to treat
symptoms of an enlarged
prostate)
-
pethidine, piroxicam,
propoxyphene (used to
relieve pain)
-
ranolazine (used to treat
chronic chest pain [angina])
-
dronedarone (used to correct
irregular heartbeats)
-
colchicine (used to treat
gout)
-
lurasidone (used to treat
depression)
-
pimozide and clozapine
(used to treat abnormal
thoughts or feelings)
-
dihydroergotamine and
ergotamine (used to treat
migraine headaches)
-
methylergonovine (used to
stop excessive bleeding that
may occur following
childbirth or an abortion)
-
cisapride (used to

Ciri produk

PFIZER (MALAYSIA) SDN BHD
197801003134 (40131-T)
Level 10 & 11, Wisma Averis, Tower 2
Avenue 5, Bangsar South, No. 8 Jalan Kerinchi
59200 Kuala Lumpur, Malaysia
Tel: [phone] Fax: [phone]
30 September 2022
Dear Healthcare Professionals,
CONDITIONAL REGISTRATION OF PAXLOVID (NIRMATRELVIR 150 MG FILM-COATED
TABLETS AND RITONAVIR
100 MG FILM-COATED TABLETS) WITH UNITED KINGDOM LABEL ON PRODUCT
CARTON AND PRINTED
PATIENT INFORMATION LEAFLET (PIL)
With regards to the matter above, Pfizer would like to inform that the
label on the product carton and
printed PIL is the label approved by the Medicines and Healthcare
products Regulatory Agency (MHRA).
The approved label by MHRA will be used by markets which reference to
UK dossier including Malaysia.
There will not be country-specific packs for Malaysia until commercial
supply stage which has not been
determined yet. QR code will be printed on the product carton where
HCP may access to the latest
approved version of country specific package insert from the Paxlovid
global website, including the label
approved by Malaysia National Pharmaceutical Regulatory Authority
(NPRA).
2. The name and address for the Marketing Authorization Holder (MAH)
in UK is reflected on the product
carton, Pfizer Limited with the address of Ramsgate Road, Sandwich,
Kent CT13 9NJ United Kingdom. The
manufacturer and batch releaser information will not be reflected on
the product carton.
3. Enclosed are the product information approved in Malaysia for your
reference.
PRODUCT INFORMATION
DETAILS
PRODUCT NAME
PAXLOVID (nirmatrelvir 150 mg film-coated tablets and ritonavir 100
mg film-coated tablets)
LOI NO.
202201046462A (First source - Germany)
202202186938A (Second source - Ireland)
STRENGTH OF ACTIVE
INGREDIENTS
Nirmatrelvir 150 mg film-coated tablets and ritonavir 100 mg film-
coated tablets
MANUFACTURER AND BATCH
RELEASER (FOR MALAYSIA)
Nirmatrelvir
_Manufacturer and Batch Releaser _
Pfizer Manufacturing Deutschland GmbH
Betriebsstätte Freiburg
Mooswaldallee 1
79090 Freiburg, Germany
P