Tenofovir Disoproxil Viatris

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Tenofovir disoproxil maleate 300mg equivalent to Tenofovir disoproxil 245mg

Mevcut itibaren:

Viatris Limited

INN (International Adı):

Tenofovir disoproxil maleate 300 mg (equivalent to Tenofovir disoproxil 245mg)

Doz:

300 mg

Farmasötik formu:

Film coated tablet

Kompozisyon:

Active: Tenofovir disoproxil maleate 300mg equivalent to Tenofovir disoproxil 245mg Excipient: Colloidal silicon dioxide Hyprolose Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry blue 32K505018

Reçete türü:

Prescription

Tarafından üretildi:

Mylan Laboratories Limited

Terapötik endikasyonlar:

Tenofovir Disoproxil Mylan is indicated for the treatment of chronic hepatitis B in adults and paediatric patients 12 years of age and older.

Ürün özeti:

Package - Contents - Shelf Life: Bottle, white opaque HDPE, white PP closure - 30 tablets - 24 months from date of manufacture stored at or below 25°C

Yetkilendirme tarihi:

2015-09-04

Bilgilendirme broşürü

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
TENOFOVIR DISOPROXIL VIATRIS
_TENOFOVIR DISOPROXIL MALEATE FILM COATED TABLET 300 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Tenofovir
Disoproxil Viatris.
This leaflet answers some common
questions about Tenofovir
Disoproxil Viatris.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Tenofovir
Disoproxil Viatris against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read it
again.
WHAT TENOFOVIR
DISOPROXIL VIATRIS IS
USED FOR
Tenofovir Disoproxil Viatris is used
to treat:

Human Immunodeficiency Virus
(HIV) infected adults and
children 12 years of age and
older

Chronic Hepatitis B (CHB) in
adults and children 12 years of
age and older.
Tenofovir Disoproxil Viatris contains
the active ingredient tenofovir
disoproxil maleate. It belongs to a
group of medicines called HBV
polymerase inhibitors and
nucleotide analog reverse
transcriptase inhibitors (NRTI).
HOW TENOFOVIR DISOPROXIL VIATRIS
WORKS IN THE TREATMENT OF CHB
Tenofovir Disoproxil Viatris is used
to treat CHB (an infection with
hepatitis B virus [HBV]) in adults
and paediatric patients 12 years
and older and weighing at least 35
kg.
Tenofovir Disoproxil Viatris works
by interfering with the normal
working enzymes (HBV DNA
polymerase) that are essential for
HBV to reproduce itself. Tenofovir
Disoproxil Viatris may help lower
the amount of hepatitis B virus in
your body by lowering the ability of
the virus to multiply and infect new
liver cells and can improve the
inflammation and scar tissue
caused by the hepatitis B virus in
your liver. Lowering the amount of
virus in your body may reduce the
chance of developing cirrhosis, liver
failure and liver cancer.
We do not know

Ürün özellikleri

NEW ZEALAND DATA SHEET
TENOFOVIR DISOPROXIL VIATRIS
1. PRODUCT NAME
Tenofovir Disoproxil Viatris 300 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 245 mg of tenofovir disoproxil (as
maleate), equivalent to 300 mg of
tenofovir.
TENOFOVIR DISOPROXIL MALEATE 300 MG IS EQUIVALENT TO TENOFOVIR
DISOPROXIL FUMARATE 300 MG.
MALEATE AND FUMARATE ARE ISOMERS OF EACH OTHER. THIS DATA SHEET MAKES
REFERENCE TO BOTH THE
FUMARATE AND MALEATE SALT FORM.
Excipients with known effect: Tenofovir Disoproxil Viatris tablets
contain sugars as lactose.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tenofovir Disoproxil Viatris 300 mg tablet: Light blue coloured,
round, biconvex, film coated tablets
debossed with ‘TM300’ on one side of the tablet and ‘M’ on
other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Tenofovir Disoproxil Viatris in combination with other antiretroviral
agents is indicated for the treatment of
HIV infected adults and paediatric patients 12 years of age and older.
Tenofovir Disoproxil Viatris is indicated for the treatment of chronic
hepatitis B in adults and in paediatric
patients 12 years of age and older.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
_ADULTS_
The recommended dose is 300 mg (one tablet) once daily taken orally
with or without food.
SPECIAL POPULATIONS
_PAEDIATRIC (≥ 12 YEARS OF AGE AND ≥ 35 KG)_
The recommended dose for paediatric patients (12 years of age and
older), who weigh ≥ 35 kg, is 300
mg (one tablet) once daily taken orally with or without food.
The safety and efficacy of Tenofovir Disoproxil Viatris in patients
under the age of 12 years have not been
established. Tenofovir Disoproxil Viatris must not be administered to
children under 12, until further data
become available.
_ELDERLY_
No data are available on which to make a dose recommendation for
patients over the age of 65 years.
The safety and efficacy of Tenofovir Disoproxil Viatris have not been
established in patients over