Velsof tablets film-coated

Krajina: Arménsko

Jazyk: angličtina

Zdroj: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktívna zložka:

sofosbuvir, velpatasvir

Dostupné z:

M/s Hetero Labs Ltd.

ATC kód:

J05AP55

INN (Medzinárodný Name):

sofosbuvir, velpatasvir

Dávkovanie:

400mg+ 100mg

Forma lieku:

tablets film-coated

Počet v balení:

(28) in plastic bottle

Typ predpisu:

Prescription

Stav Autorizácia:

Registered

Dátum Autorizácia:

2020-12-30

Príbalový leták

VELSOF 400 MG / 100 MG FILM COATED TABLETS
MODULE – 1.3
NOV-2020
PACKAGE INFORMATION LEAFLET
VELSOF 400MG/100MG FILM-COATED TABLETS
Sofosbuvir & Velpatasvir
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side affects you may get.
1) WHAT VELSOFARE AND WHAT IT IS USED FOR?
Velsof is a medicine that contains the active substances sofosbuvir
and velpatasvir in a single tablet.
It is given to treat a chronic (long-term) viral infection of the
liver called hepatitis C in adults of 18 years and
older.
The active substances in this medicine work together by blocking two
different proteins that the virus needs to
grow and reproduce itself, allowing the infection to be permanently
eliminated from the body.
Velsof is sometimes taken with another medicine, ribavirin.
It is very important that you also read the leaflets for the other
medicines that you will be taking withVelsof. If
you have any questions about your medicines, please ask your doctor or
pharmacist.
2) WHAT YOU NEED TO KNOW BEFORE YOU TAKE VELSOF?
DO NOT TAKE VELSOF
• If you are allergic to sofosbuvir, velpatasvir or any of the other
ingredients of this medicine(listed in section 6
of this leaflet).
-
If this applies to you, do not take Velsof and tell your doctor
immediately.

If you are currently taking any of the following medicines:
-
rifampicin and rifabutin (antibiotics used to treat infections,
including tuberculosis);
-
St. John’s wort (Hypericumperforatum – herbal medicine used to
treat depression);
-
carbamazepine, phenobarbital and phenytoin (medicines used to treat
epilepsy andprevent seizures);
WARNINGS AND PRECAUTIONS
Talk to your doctor if you:

have liver problems other than from hepatitis C, for instance
-
if you have hepatitis B, since your doctor may want to monitor you
more closely;
-
if you have had a liver transplant

have kidney problems, since Velsof has not been fully tested in
patients with some severekidney problems;
VELS

Súhrn charakteristických

VELSOF 400 MG / 100 MG FILM COATED TABLETS
MODULE – 1.3
NOV-2020
1.3
:
PRODUCT INFORMATION
1.3.1
:
SUMMARY OF PRODUCT CHARACTERISTICS, LABELING AND PACKAGE INFORMATION
LEAFLET
SUMMARY OF PRODUCT CHARACTERISTICS:
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
1.NAME OF THE MEDICAL PRODUCT
Velsof 400 mg/100 mg Film-coated Tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains: Sofosbuvir 400 mg & Velpatasvir 100
mg.
EXCIPIENTS:
Microcrystalline
cellulose
(Avicel
PH101),
Croscarmellose
sodium
(Ac-Di-Sol),
Magnesium
stearate (Ligamed MF-2-V), Opadry II Blue (85F505115) &Purified Water.
3. PHARMACEUTICAL FORM
Film-coated Tablets
DESCRIPTION:
Blue coloured, oval shaped, Biconvex, Film coatedtablets debossed with
'S21" on the one side and 'H' on the
other side
4.0 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS.
Velsof is indicated for the treatment of chronic hepatitis C virus
(HCV) infection in adults (see sections 4.2, 4.4
and 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION.
Velsoftreatment should be initiated and monitored by a physician
experienced in the management of patients
with HCV infection.
Posology
The recommended dose of Velsofis one tablet, taken orally, once daily
with or without food (see section 5.2).
TABLE 1: RECOMMENDED TREATMENT AND DURATION FOR ALL HCV GENOTYPES
VELSOF 400 MG / 100 MG FILM COATED TABLETS
MODULE – 1.3
NOV-2020
PATIENT POPULATION
A
TREATMENT AND DURATION
Patients
without
cirrhosis
and
patients
with compensated cirrhosis
Velsoffor 12 weeks
Addition of ribavirin may be considered for genotype 3 infected
patients with compensated cirrhosis (see section 5.1.)
Patients with decompensated cirrhosis
Velsof+ ribavirin for 12 weeks
a. Includes patients co-infected with human immunodeficiency virus
(HIV) and patients with recurrent HCV
post-liver transplant (see section 4.4.)_. _
When used in combination with