Tenofovir Disoproxil Emtricitabine Efavirenz Viatris

Țară: Noua Zeelandă

Limbă: engleză

Sursă: Medsafe (Medicines Safety Authority)

Ingredient activ:

Efavirenz 600mg;  ; Emtricitabine 200mg;  ; Tenofovir disoproxil maleate 300mg equivalent to 245 mg Tenofovir disoproxil

Disponibil de la:

Viatris Limited

Forma farmaceutică:

Film coated tablet

Compoziție:

Active: Efavirenz 600mg   Emtricitabine 200mg   Tenofovir disoproxil maleate 300mg equivalent to 245 mg Tenofovir disoproxil Excipient: Colloidal silicon dioxide Croscarmellose sodium Hyprolose Low-substituted hydroxypropylcellulose, LH 11 Iron oxide red Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry pink 85F540043 Sodium metabisulfite

Tip de prescriptie medicala:

Prescription

Indicații terapeutice:

Indicated for the treatment of HIV infected adults over the age of 18 years, alone or in combination with other antiretroviral agents.

Rezumat produs:

Package - Contents - Shelf Life: Bottle, plastic, White HDPE with white opaque PP screw cap (CRC) - 30 tablets - 24 months from date of manufacture stored at or below 25°C

Data de autorizare:

2016-09-15

Prospect

Page 1 of 7
NEW ZEALAND CONSUMER MEDICINE INFORMATION
TENOFOVIR DISOPROXIL
EMTRICITABINE EFAVIRENZ VIATRIS
_TENOFOVIR DISOPROXIL MALEATE, EMTRICITABINE, EFAVIRENZ_
_FILM COATED TABLET 300MG, 200MG, 600MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking Tenofovir
Disoproxil Emtricitabine Efavirenz
Viatris.
This leaflet answers some common
questions about Tenofovir Disoproxil
Emtricitabine Efavirenz 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 Efavirenz
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
EFAVIRENZ VIATRIS IS USED
FOR
Tenofovir Disoproxil Emtricitabine
Efavirenz Viatris is used to treat
Human Immunodeficiency Virus
(HIV-1) infection in adults. This
medicine can be take alone or in
combination with other anti-HIV
medicines.
Tenofovir Disoproxil Emtricitabine
Efavirenz Viatris consists of three
medicines:

Tenofovir disoproxil maleate

Emtricitabine

Efavirenz
These are combined in one tablet to
help control Human
Immunodeficiency Virus (HIV-1)
infection.
Tenofovir disoproxil and
emtricitabine belong to a group of
antiviral medicines known as
nucleoside and nucleotide reverse
transcriptase inhibitors (NRTI).
Efavirenz belongs to a group of
antiviral medicines known as non-
nucleoside reverse transcriptase
inhibitors (NNRTI).
HOW TENOFOVIR DISOPROXIL
EMTRICITABINE EFAVIRENZ VIATRIS
WORKS
HIV-1 infection destroys CD4 T
cells, which are important to the
immune system. The immune
system helps fight infection. After a
large number of T cells are
destroyed, acquired immune
deficiency syndrome (AIDS) may
develop.
Tenofovir Disoproxil Emtricitabine
Efavirenz Viatris

Caracteristicilor produsului

Page 1 of 33
NEW ZEALAND DATA SHEET
TENOFOVIR DISOPROXIL EMTRICITABINE
EFAVIRENZ VIATRIS
1. PRODUCT NAME
Tenofovir disoproxil Emtricitabine Efavirenz Viatris, 300 mg/200
mg/600 mg film-coated tablets.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 300 mg tenofovir disoproxil maleate
(equivalent to 245 mg tenofovir
disoproxil), 200 mg emtricitabine and 600 mg efavirenz.
Excipients with known effect: Contains sulfites and sugars as lactose.
For the full list of excipients,
see section 6.1.
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.
3. PHARMACEUTICAL FORM
Each Tenofovir disoproxil Emtricitabine Efavirenz Viatris tablet is a
pink film-coated, capsule shaped,
biconvex tablet debossed with “M” on one side of the tablet and
“TEE” on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Tenofovir disoproxil Emtricitabine Efavirenz Viatris is indicated for
the treatment of HIV infected
adults over the age of 18 years, alone or in combination with other
antiretroviral agents.
_4.2_
_DOSE AND METHOD OF ADMINISTRATION_
ADULTS
The recommended dose of Tenofovir disoproxil Emtricitabine Efavirenz
Viatris is one tablet once
daily taken orally on an empty stomach. Dosing at bedtime may improve
the tolerability of nervous
system symptoms.
SPECIAL POPULATIONS
_CHILDREN AND ADOLESCENTS _
Tenofovir disoproxil Emtricitabine Efavirenz Viatris is not
recommended for use in children below 18
years of age due to insufficient data on safety and efficacy.
_ELDERLY _
Tenofovir disoproxil Emtricitabine Efavirenz Viatris should be
administered with caution to elderly
patients (see section 4.4).
Page 2 of 33
_RENAL IMPAIRMENT_
Tenofovir disoproxil Emtricitabine Efavirenz Viatris is not
recommended for patients with moderate
or severe renal impairment (Creatinine Clearance (CrCl) < 50 mL/min).
Patients with moderate or
se