Epclusa

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Sofosbuvir 400mg;  ;  ;  ; Velpatasvir 100mg;  ;  ;  

Mevcut itibaren:

Gilead Sciences (NZ)

INN (International Adı):

Sofosbuvir 400 mg

Doz:

400mg/100mg

Farmasötik formu:

Tablet

Kompozisyon:

Active: Sofosbuvir 400mg       Velpatasvir 100mg       Excipient: Copovidone Croscarmellose sodium Opadry II Pink 85F94644 Magnesium stearate Microcrystalline cellulose

Reçete türü:

Prescription

Tarafından üretildi:

F.I.S. Fabbrica Italiana Sintetici SpA

Terapötik endikasyonlar:

Indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Ürün özeti:

Package - Contents - Shelf Life: Bottle, 75mL HDPE bottle, Closure: PP child resistance cap wth al foil liner - 28 dose units - 48 months from date of manufacture stored at or below 30°C

Yetkilendirme tarihi:

2016-01-22

Bilgilendirme broşürü

Epclusa® CMI v5.0 (24 May 2022)
1
EPCLUSA®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING EPCLUSA?
Epclusa contains the active ingredients sofosbuvir and velpatasvir in
a single tablet. Epclusa is used to treat hepatitis C virus
infection in adults and older.
For more information, see Section 1. Why am I using Epclusa? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EPCLUSA?
Do not use if you have ever had an allergic reaction to sofosbuvir,
velpatasvir or any of the ingredients listed at the end of the
CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Epclusa? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Epclusa and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE EPCLUSA?
The usual dose is one Epclusa tablet orally, once daily. Epclusa
tablets can be taken with or without food.
More instructions can be found in Section 4. How do I use Epclusa? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING EPCLUSA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Epclusa
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not give Epclusa to anyone else, even if they have the same
condition as you.
DRIVING OR USING
MACHINES
•
Be careful before you drive or use any machines or tools until you
know how Epclusa affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your Epclusa tablets in the bottle with the cap tightly closed
until you take them.
•
Store Epclusa in a cool, dry place where it stays below 30 °C.
For more information, see Section 5. What should I know while using
Epclusa? in the full CMI.
6.

Ürün özellikleri

EPCLUSA Data Sheet v7.0– (24 May 2022) Page
1
of
33
NEW ZEALAND DATA SHEET
1 EPCLUSA
® (SOFOSBUVIR/VELPATASVIR 400/100 MG) TABLETS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Sofosbuvir 400 mg/Velpatasvir 100 mg.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
EPCLUSA tablets are pink, diamond shaped debossed with “GSI” on
one side and the number
“7916” on the other side.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
EPCLUSA (sofosbuvir/velpatasvir fixed-dose combination) is indicated
for the treatment of
chronic hepatitis C virus (HCV) infection in adults.
4.2 DOSE AND METHOD OF ADMINISTRATION
The recommended dose of EPCLUSA is one tablet, taken orally, once
daily with or without food
_. _
Table 1 provides the recommended treatment regimen based on patient
population. For patients
with HCV/HIV-1 co-infection, follow the dosage recommendations in
Table 1.
TABLE 1
RECOMMENDED TREATMENT REGIMEN REGARDLESS OF HCV GENOTYPE
PATIENT POPULATION
RECOMMENDED TREATMENT REGIMEN
Patients without cirrhosis and patients with
compensated cirrhosis
EPCLUSA for 12 weeks
Patients with decompensated cirrhosis
EPCLUSA + ribavirin
a
for 12 weeks
a. When administered with EPCLUSA, the recommended dose of ribavirin
is based on weight: 1000 mg per day for patients less
than 75 kg and 1200 mg for those weighing at least 75 kg, divided and
administered twice daily with food. For ribavirin dose
modifications, refer to the ribavirin product information.
EPCLUSA Data Sheet v7.0– (24 May 2022) Page
2
of
33
CHILDREN AND ADOLESCENTS UP TO 18 YEARS OF AGE
No data are available on which to make a dose recommendation for
children < 18 years of age.
ELDERLY
No dose adjustment is warranted for elderly patients.
RENAL IMPAIRMENT
No dose adjustment of EPCLUSA is required for patients with mild or
moderate renal impairment.
The safety and efficacy of EPCLUSA have not been established in
patients with severe renal
impairment (estimated Glomerular Filtration Rate [eGFR] < 30
mL/min/1.73 m
2
) or en