Tenofovir Disoproxil Emtricitabine Viatris

Krajina: Nový Zéland

Jazyk: angličtina

Zdroj: Medsafe (Medicines Safety Authority)

Aktívna zložka:

Emtricitabine 200mg;  ; Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg; Emtricitabine 200mg; Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg

Dostupné z:

Viatris Limited

INN (Medzinárodný Name):

Emtricitabine 200 mg

Dávkovanie:

200 mg/300 mg

Forma lieku:

Film coated tablet

Zloženie:

Active: Emtricitabine 200mg   Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg Excipient: Colloidal silicon dioxide Hyprolose Iron oxide red Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry green 31K510010 Active: Emtricitabine 200mg Tenofovir disoproxil maleate 300mg equivalent to tenofovir disoproxil 245 mg Excipient: Colloidal silicon dioxide Hyprolose Iron oxide red Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry green 32K510087

Typ predpisu:

Prescription

Výrobca:

Mylan Laboratories Limited

Terapeutické indikácie:

Treatment of HIV-1 infection Tenofovir Disoproxil Emtricitabine Viatris is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.

Prehľad produktov:

Package - Contents - Shelf Life: Blister pack, Form pack laminate with desiccant layer on one side and hard tempered aluminium foil - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Form pack laminate with desiccant layer on one side and hard tempered aluminium foil - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Blister pack, Form pack laminate with desiccant layer on one side and hard tempered aluminium foil - 90 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, White opaque HDPE with white opaque PP screw or child-resistant cap - 30 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, White opaque HDPE with white opaque PP screw or child-resistant cap - 60 tablets - 24 months from date of manufacture stored at or below 25°C - Bottle, White opaque HDPE with white opaque PP screw or child-resistant cap - 90 tablets - 24 months from date of manufacture stored at or below 25°C

Dátum Autorizácia:

2015-10-16

Príbalový leták

Page 1 of 7
NEW ZEALAND CONSUMER MEDICINE INFORMATION
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS
_TENOFOVIR DISOPROXIL / EMTRICITABINE FILM COATED TABLET 300MG/200MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Tenofovir
Disoproxil Emtricitabine Viatris.
This leaflet answers some common
questions about Tenofovir
Disoproxil Emtricitabine 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 Emtricitabine 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
EMTRICITABINE VIATRIS
IS USED FOR
Tenofovir Disoproxil Emtricitabine
Viatris is used to:

Treat Human
Immunodeficiency Virus-1
(HIV-1) infection in adults when
taken in combination with other
anit-HIV medicines.

Help reduce the risk of getting
HIV infection when used with
safer sex practices in:
o
HIV-negative men who
have sex with men, who
are at high risk of getting
infected with HIV-1
through sex.
o
Male-female
sex
partners
when one partner has HIV-1
infection and the other does
not.
WHEN TENOFOVIR DISOPROXIL
EMTRICITABINE VIATRIS IS USED TO
TREAT HIV INFECTION
When used with other HIV-1
medicines to treat HIV-1 infection,
Tenofovir Disoproxil Emtricitabine
Viatris may help:

Reduce the amount of HIV-1 in
your blood. This is called “viral
load”.

Increase the number of CD4+
(T) cells in your blood that help
fight off other infections.
Reducing the amount of HIV-1
and increasing the CD4+ (T)
cells in your blood may help
improve your immune system.
This may reduce your risk of
death
or infections
that
can
happen
when
your immune
system is weak.
This medicine belongs to a group of
antiviral medicines known as
nucleoside and nucleoside reverse
t

Súhrn charakteristických

Page 1 of 35
NEW ZEALAND DATA SHEET
TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS
1. PRODUCT NAME
Tenofovir Disoproxil Emtricitabine Viatris 300 mg / 200 mg film coated
tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenofovir Disoproxil Emtricitabine Viatris immediate release
film-coated tablets, each contains 300
mg tenofovir disoproxil maleate (equivalent to 245 mg tenofovir
disoproxil) and 200 mg emtricitabine.
TENOFOVIR DISOPROXIL MALEATE 300MG 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.
_EXCIPIENT(S) WITH KNOWN EFFECT_
Tenofovir Disoproxil Emtricitabine Viatris tablets contain lactose.
For the full list of excipients, see
section 6.1.
3. PHARMACEUTICAL FORM
A light green, film-coated, capsule shaped, biconvex tablet debossed
with ‘M’ on one side of the
tablet and ‘ETM’ on the other side.
Dimensions: 19.80 mm x 9.00 mm (Length x Width).
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
TREATMENT OF HIV-1 INFECTION
Tenofovir Disoproxil Emtricitabine Viatris is indicated for the
treatment of HIV infected adults over
the age of 18 years, in combination with other antiretroviral agents.
PRE-EXPOSURE PROPHYLAXIS
Tenofovir Disoproxil Emtricitabine Viatris is indicated in combination
with safer sex practices for pre-
exposure prophylaxis (PrEP) to reduce the risk of sexually acquired
HIV-1 in adults at high risk. This
indication is based on clinical trials in men who have sex with men
(MSM) at high risk for HIV-1
infection and in heterosexual serodiscordant couples (see section
5.1).
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
Tenofovir Disoproxil Emtricitabine Viatris tablets cannot be halved.
Page 2 of 35
RECOMMENDED DOSE FOR TREATMENT OF HIV-1 INFECTION
_ADULTS_
The recommended dose of Tenofovir Disoproxil Emtricitabine Viatris is
one tablet (containing 300
mg tenofovir disoproxil maleate and 200 mg emtricitabine), taken
orally, once daily with or without
food.
RECO