Vemlidy (tenofovir alafenamide 25mg) film-coated tablets

国: マレーシア

言語: 英語

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

有効成分:

Tenofovir alafenamide fumarate

から入手可能:

Gilead Sciences Malaysia Sdn. Bhd.

INN（国際名）:

Tenofovir alafenamide fumarate

パッケージ内のユニット:

30 Tablets

製:

PATHEON INC.

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VEMLIDY
® FILM-COATED TABLETS
TENOFOVIR ALAFENAMIDE 25 MG
1
WHAT IS IN THIS LEAFLET
1.
What Vemlidy is used for
2.
How Vemlidy works
3.
Before you take Vemlidy
4.
How to take Vemlidy
5.
While you are taking
Vemlidy
6.
Side effects
7.
Storage and disposal of
Vemlidy
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
1.
WHAT VEMLIDY IS USED FOR
Vemlidy is used to
TREAT
CHRONIC (LONG-TERM)
HEPATITIS B
in adults and
adolescents aged 12 years and
older, who weigh at least
35 kg. Hepatitis B is an
infection affecting the liver,
caused by the hepatitis B virus.
2.
HOW VEMLIDY WORKS
Vemlidy contains the active
substance
_tenofovir _
_alafenamide_
. This is an
_antiviral medicine_
, known as a
_nucleotide reverse _
_transcriptase inhibitor_
(NtRTI).
In patients with hepatitis B,
Vemlidy controls the infection
by stopping the virus from
multiplying.
3.
BEFORE YOU TAKE VEMLIDY
_-When you must not use it: _
DO NOT TAKE VEMLIDY
•
IF YOU ARE ALLERGIC
to
tenofovir alafenamide or
any of the other ingredients
of this medicine (listed in
section 8).
→
If this applies to you,
DO
NOT TAKE VEMLIDY AND TELL
YOUR DOCTOR IMMEDIATELY
.
_-Before you start to use it: _
WARNINGS AND PRECAUTIONS
•
TAKE CARE NOT TO PASS ON
YOUR HEPATITIS B TO OTHER
PEOPLE.
You can still infect
others when taking this
medicine. Vemlidy does
not reduce the risk of
passing on hepatitis B to
others through sexual
contact or blood
contamination. You must
continue to take precautions
to avoid this. Discuss with
your doctor the precautions
needed to avoid infecting
others.
•
TELL YOUR DOCTOR IF YOU
HAVE A HISTORY OF LIVER
DISEASE.
Patients with liver
disease, who are treated for
hepatitis B with antiviral
medicines, have a higher
risk of severe and
potentially fatal liver
complications. Your doctor
may need to carry out blood
tests to monitor your liver
function.
•
TALK TO YOUR DOCTOR OR
PHARMACIST IF YOU HAVE
HAD KIDNEY DISEASE OR IF
TESTS HAVE SHOWN PROBLEMS
WITH

製品の特徴

1
VEMLIDY
®
tenofovir alafenamide 25 mg film-coated tablets for oral use
FULL PRESCRIBING INFORMATION
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Vemlidy 25 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains tenofovir alafenamide fumarate
equivalent to 25 mg of tenofovir
alafenamide.
Excipient with known effect
Each tablet contains 95 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Yellow, round, film-coated tablets, 8 mm in diameter, debossed with
“GSI” on one side of the tablet
and “25” on the other side of the tablet.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vemlidy is indicated for the treatment of chronic hepatitis B in
adults and adolescents (aged 12 years
and older with body weight at least 35 kg) (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of chronic hepatitis B.
Posology
Adults and adolescents (aged 12 years and older with body weight at
least 35 kg): one tablet once
daily.
_Treatment discontinuation _
Treatment discontinuation may be considered as follows (see section
4.4):
•
In HBeAg-positive patients without cirrhosis, treatment should be
administered for at least
6-12 months after HBe seroconversion (HBeAg loss and HBV DNA loss with
2
anti-HBe detection) is confirmed or until HBs seroconversion or until
there is loss of efficacy
(see section 4.4). Regular reassessment is recommended after treatment
discontinuation to
detect virological relapse.
•
In HBeAg-negative patients without cirrhosis, treatment should be
administered at least until
HBs seroconversion or until there is evidence of loss of efficacy.
With prolonged treatmen