Truvada

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

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

Available from:

Gilead Sciences (NZ)

INN (International Name):

Emtricitabine 200 mg

Dosage:

300mg/200mg

Pharmaceutical form:

Tablet

Composition:

Active: Emtricitabine 200mg       Tenofovir disoproxil fumarate 300mg equivalent to tenofovir disoproxil 245 mg       Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry blue Y-30-10701 Pregelatinised maize starch

Units in package:

Bottle, plastic, HDPE, 30 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Gilead Alberta ULC

Therapeutic indications:

TRUVADA is indicated for the treatment of HIV infected adults over the age of 18 years, in combination with other antiretroviral agents.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 30 tablets - 48 months from date of manufacture stored at or below 25°C

Authorization date:

2004-11-08

Patient Information leaflet

TRUVADA Consumer Medicine Information v16.0 – (06 November 2020)
Page
1
TRUVADA
® TABLETS
_300_
_ _
_mg tenofovir disoproxil fumarate / 200 mg emtricitabine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Read all of this leaflet carefully before
you start taking this medicine.
This leaflet answers some of the
common questions about TRUVADA
tablets. It does not contain all of the
available information.
It does not take the place of talking to
your doctor or pharmacist about your
medical condition or treatment. If you
have further questions, please ask your
doctor or your pharmacist.
Keep this leaflet with your TRUVADA
medicine. You may need to read it
again.
WHAT IS TRUVADA
_HOW TRUVADA WORKS _
TRUVADA consists of two medicines
combined in one tablet:
•
tenofovir disoproxil fumarate, also
called tenofovir DF
•
emtricitabine or FTC
These are
combined in one tablet to help
control Human Immunodeficiency Virus
(HIV) infection.
TRUVADA contains two active
ingredients that belong to a group of
antiviral medicines known as nucleoside
and nucleotide reverse transcriptase
inhibitors (NRTI).
_WHAT IS TRUVADA USED FOR _
•
to treat Human Immunodeficiency
Virus-1 (HIV-1) infection in adults
when taken in combination with
other anti-HIV medicines;
•
to help reduce the risk of getting
HIV infection when used with safer
sex practices in:
•
HIV-negative men who have
sex with men, who are at high
risk of getting infected with
HIV-1 through sex.
•
Male-female sex partners when
one partner has HIV-1 infection
and the other does not.
_WHEN TRUVADA IS USED TO _
_TREAT HIV INFECTION _
When used with other HIV-1 medicines
to treat HIV-1 infection, TRUVADA
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 wh

Summary of Product characteristics

Truvada Data Sheet v19.0 (06 November 2020)
Page 1
NEW ZEALAND DATA SHEET
1. TRUVADA
® (TENOFOVIR DISOPROXIL FUMARATE 300 MG, EMTRICITABINE 200
MG) TABLETS
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenofovir disoproxil fumarate 300 mg and emtricitabine 200 mg
For full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Film-coated tablet.
TRUVADA tablets are capsule-shaped, blue in colour and are debossed on
one side with the word
“GILEAD” and on the other side with “701”.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
TREATMENT OF HIV-1 INFECTION
TRUVADA is indicated for the treatment of HIV infected adults over the
age of 18 years, in
combination with other antiretroviral agents.
PRE-EXPOSURE PROPHYLAXIS
TRUVADA 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 Pharmacodynamic
properties).
4.2 DOSE AND METHOD OF ADMINISTRATION
RECOMMENDED DOSE FOR TREATMENT OF HIV-1 INFECTION
ADULTS
: The recommended dose of TRUVADA is one tablet (containing 300 mg
tenofovir
disoproxil fumarate and 200 mg emtricitabine), taken orally, once
daily with or without food.
Truvada Data Sheet v19.0 (06 November 2020)
Page 2
RECOMMENDED DOSE FOR PRE-EXPOSURE PROPHYLAXIS
ADULTS:
The dose of TRUVADA in HIV-1 uninfected adults is one tablet
(containing 300 mg
tenofovir disoproxil fumarate and 200 mg of emtricitabine), taken
orally, once daily. In order to
optimise the absorption of tenofovir, it is recommended that TRUVADA
should be taken with food.
Special Populations
_Children _
The safety and efficacy of TRUVADA has not been established in
patients under the age of
18 years. Consequently, TRUVADA should not be administered to children
or adolescents.
_Elderly _
No data are available on which to make a dose recommendation for
patients ov