Vemlidy

Երկիր: Նոր Զելանդիա

Լեզու: անգլերեն

Աղբյուրը: Medsafe (Medicines Safety Authority)

Ակտիվ բաղադրիչ:

Tenofovir alafenamide fumarate 28.04mg equivalent to Tenofovir alafenamide 25 mg;  

Հասանելի է:

Gilead Sciences (NZ)

INN (Միջազգային անվանումը):

Tenofovir alafenamide fumarate 28.04 mg (equivalent to Tenofovir alafenamide 25 mg)

Դոզան:

25 mg

Դեղագործական ձեւ:

Film coated tablet

Կազմը:

Active: Tenofovir alafenamide fumarate 28.04mg equivalent to Tenofovir alafenamide 25 mg   Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry Yellow 85F120028 Purified water

Ռեկվիզորի տեսակը:

Prescription

Պատրաստված է:

Esteve Quimica SA

Թերապեւտիկ ցուցումներ:

Indicated for the treatment of chronic hepatitis B in adults.

Ապրանքի ամփոփագիր:

Package - Contents - Shelf Life: Bottle, white 60 mL HDPE with PP CRC lined with an induction sealed and Alu-faced liner - 30 tablets - 48 months from date of manufacture stored at or below 30°C

Հաստատման ամսաթիվը:

2017-03-28

Տեղեկատվական թերթիկ

VEMLIDY®
1
VEMLIDY®
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 VEMLIDY?
VEMLIDY contains the active ingredient tenofovir alafenamide. VEMLIDY
is used for the treatment of chronic (long-lasting)
hepatitis B virus (HBV) in adults.
For more information, see Section 1. Why am I using VEMLIDY? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE VEMLIDY?
Do not use if you have ever had an allergic reaction to VEMLIDY 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
VEMLIDY?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VEMLIDY 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 VEMLIDY?
•
The usual dose is one VEMLIDY tablet orally, once daily.
More instructions can be found in Section 4. How do I use VEMLIDY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VEMLIDY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
VEMLIDY.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how VEMLIDY
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your VEMLIDY tablets in the bottle with the cap tightly closed
until you take them.
•
Keep VEMLIDY tablets in a cool, dry place where it stays below 30°C.
For more information, see Section 5. What should I know while using
VEMLIDY? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
The most common side effect of VEMLIDY is nausea.
For more information, including what to do if you have any side
effects, see Section 6. Are there any si

Ապրանքի հատկությունները

NEW ZEALAND DATA SHEET
VEMLIDY Data Sheet v5.0 (15 March 2022)
1 VEMLIDY (TENOFOVIR ALAFENAMIDE 25 MG) TABLETS
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenofovir alafenamide 25 mg.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Film-coated tablet.
VEMLIDY tablets are yellow, round, film-coated, debossed with
“GSI” on one side and “25”
on the other side.
4 CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VEMLIDY is indicated for the treatment of chronic hepatitis B in
adults.
4.2
DOSE AND METHOD OF ADMINISTRATION
The recommended dose of VEMLIDY is one tablet once daily, with or
without food.
Special populations
_Children and Adolescents up to 18 Years of Age _
No data are available on which to make a dose recommendation for
patients younger than 18
years.
_ _
_Elderly _
No dose adjustment is required in patients age of 65 years and older.
In clinical trials, 89
HBV-infected patients aged 65 years and over received VEMLIDY. No
differences in safety
or efficacy have been observed between elderly patients and those
between 18 and less than
65 years of age (see Section 5.2).
_ _
_Renal Impairment _
No dose adjustment of VEMLIDY is required in patients with renal
impairment.
_ _
_Hepatic Impairment _
No dose adjustment of VEMLIDY is required in patients with hepatic
impairment (see
Section 5.2).
4.3
CONTRAINDICATIONS
VEMLIDY tablets are contraindicated in patients with known
hypersensitivity to the active
substance or to any other component of the tablets listed in section
6.1.
NEW ZEALAND DATA SHEET
VEMLIDY Data Sheet v5.0 (15 March 2022)
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Exacerbation of Hepatitis after Discontinuation of Treatment
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may be
associated with
severe acute exacerbations of hepatitis. Patients who discontinue
VEMLIDY should be
closely monitored with both clinical and laboratory follow-up for at
least several months after
stopping treatment. If appropriate, resumption of anti-hepatitis B
therapy may be wa