Vemlidy
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
05-09-2022
Fachinformation
(SPC)
05-09-2022
Öffentlichen Beurteilungsberichts
(PAR)
10-03-2017
Wirkstoff:
tenofovir alafenamide fumarate
Verfügbar ab:
Gilead Sciences Ireland UC
ATC-Code:
J05AF
INN (Internationale Bezeichnung):
tenofovir alafenamide
Therapiegruppe:
Antivirals for systemic use,
Therapiebereich:
Hepatitis B
Anwendungsgebiete:
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).,
Produktbesonderheiten:
Revision: 14
Berechtigungsstatus:
Authorised
Berechtigungsdatum:
2017-01-09
Gebrauchsinformation
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VEMLIDY 25 MG FILM-COATED TABLETS
tenofovir alafenamide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vemlidy is and what it is used for
2.
What you need to know before you take Vemlidy
3.
How to take Vemlidy
4.
Possible side effects
5.
How to store Vemlidy
6.
Contents of the pack and other information
1.
WHAT VEMLIDY IS AND WHAT IT IS USED FOR
Vemlidy contains the active substance
_tenofovir alafenamide._
This is an
_antiviral medicine,_
known as
a
_nucleotide reverse transcriptase inhibitor_
(NtRTI).
Vemlidy is used to
TREAT CHRONIC (LONG-TERM) HEPATITIS B
in adults and adolescents 12 years of age
and older, who weigh at least 35 kg. Hepatitis B is an infection
affecting the liver, caused by the
hepatitis B virus. In patients with hepatitis B, this medicine
controls the infection by stopping the virus
from multiplying.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEMLIDY
DO NOT TAKE VEMLIDY
•
IF YOU ARE ALLERGIC
to tenofovir alafenamide or any of the other ingredients of this
medicine
(listed in section 6).
If this applies to you,
DO NOT TAKE VEMLIDY AND TELL YOUR DOCTOR IMMEDIATELY.
WARNINGS AND PRECAUTIONS
•
TAKE CARE NOT TO PASS ON YOUR HEPATITIS B TO OTHER PEOPLE.
You can still infect others when
taking this medicine. This medicine 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
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 (CHB) 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 CHB.
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
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 treatment for
more than 2 years, regular reassessment is recommended to confirm that
continuing the selected
therapy remains appropriate for the patient.
3
_Missed dose _
If a dose is missed and less than 18 hours have passed from the time
it is usually taken, the patient
should take this medicinal product as soon as possible an
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