VEMLIDY

Χώρα: Ισραήλ

Γλώσσα: Αγγλικά

Πηγή: Ministry of Health

Δραστική ουσία:

TENOFOVIR ALAFENAMIDE

Διαθέσιμο από:

GILEAD SCIENCES ISRAEL LTD

Φαρμακολογική κατηγορία (ATC):

J05AF13

Φαρμακοτεχνική μορφή:

FILM COATED TABLETS

Σύνθεση:

TENOFOVIR ALAFENAMIDE 25 MG

Οδός χορήγησης:

PER OS

Τρόπος διάθεσης:

Required

Κατασκευάζεται από:

GILEAD SCIENCES IRELAND UC, IRELAND

Θεραπευτική περιοχή:

TENOFOVIR ALAFENAMIDE

Θεραπευτικές ενδείξεις:

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)

Ημερομηνία της άδειας:

2022-11-30

Φύλλο οδηγιών χρήσης

1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
This medicine is to be supplied by doctor’s prescription only
VEMLIDY
®
FILM-COATED TABLETS
ACTIVE INGREDIENT: each film-coated tablet contains -
Tenofovir alafenamide
25 mg
Each tablet contains 95 mg lactose monohydrate.
For the full list of inactive ingredients and allergens: See section
6: "_Additional Information_".
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.This leaflet
contains a summary of the information about the medicine. If you have
any further questions,
ask your doctor or pharmacist.
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to
others. It may harm them even if it seems to you that their signs of
illness are the same as
yours.
The medicine is not intended for children under the age of 12 years.
1.
WHAT IS THE MEDICINE INTENDED FOR?
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.
THERAPEUTIC GROUP: _antiviral medicine_, known as a _nucleotide
reverse transcriptase inhibitor_
(NtRTI).
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.
BEFORE USING THE MEDICINE
! SPECIAL WARNINGS RELATING TO THE USE OF THIS MEDICINE
Talk to your doctor or pharmacist before taking Vemlidy:
•
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 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 pote

Αρχείο Π.Χ.Π.

1
Vemlidy
®
(tenofovir alafenamide fumarate)
Film-coated tablets
1.
NAME OF THE MEDICINAL PRODUCT
Vemlidy
®
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.
2
•
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.
_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 and then