Tenofovir/Emtricitabine 300/200 ARX tenofovir disoproxil fumarate 300 mg emtricitabine 200 mg tablet bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

tenofovir disoproxil fumarate, Quantity: 300 mg; emtricitabine, Quantity: 200 mg

Disponível em:

Arrotex Pharmaceuticals Pty Ltd

Forma farmacêutica:

Tablet, film coated

Composição:

Excipient Ingredients: lactose; magnesium stearate; colloidal anhydrous silica; crospovidone; indigo carmine aluminium lake; macrogol 8000; purified talc; titanium dioxide; polyvinyl alcohol

Via de administração:

Oral

Unidades em pacote:

30

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Tenofovir/Emtricitabine 300/200 ARX 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/Emtricitabine 300/200 ARX is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to redcue the risk of sexually acquired HIV-1 in adutls 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.

Resumo do produto:

Visual Identification: Blue, capsule-shaped, biconvex, film-coated tablet. Engraved "APO" on one side "E-T" on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status de autorização:

Licence status A

Data de autorização:

2017-11-10

Folheto informativo - Bula

TENOFOVIR/EMTRICITABINE ARX 300/200 TABLETS
1
TENOFOVIR/EMTRICITABINE
ARX 300/200 TABLETS
_Tenofovir disoproxil fumarate and emtricitabine _
CONSUMER MEDICINE INFORMATION
FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about
Tenofovir/Emtricitabine 300/200
ARX tablets. 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 using this medicine
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 want to read it again.
WHAT THIS MEDICINE IS
USED FOR
Tenofovir/Emtricitabine 300/200
consist of both tenofovir and
emtricitabine combined into one
tablet. This medicine is used:
•
to treat Human
Immunodeficiency Virus (HIV)
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.
Tenofovir and emtricitabine belong
to a group of antiviral medicines
known as nucleoside and nucleotide
reverse transcriptase inhibitors
(NRTI). These medicines help
control HIV infection.
Tenofovir/Emtricitabine 300/200 is
not a cure for HIV infection or AIDS.
While taking this medicine, you may
still develop infections or other
illnesses associated with HIV
infection.
Tenofovir/Emtricitabine 300/200
does NOT reduce the risk of passing
HIV to others through sexual contact
or blood contamination. It is
important to continue to take
appropriate precautions to prevent
passing HIV to others.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may

Características técnicas

1
AUSTRALIAN PRODUCT INFORMATION
TENOFOVIR/EMTRICITABINE 300/200 APOTEX
(TENOFOVIR DISOPROXIL FUMARATE AND
EMTRICITABINE) TABLETS
1
NAME OF THE MEDICINE
Tenofovir disoproxil fumarate and emtricitabine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg tenofovir disoproxil fumarate (equivalent
to 245 mg of tenofovir
disoproxil) and 200 mg emtricitabine, as the active ingredients.
EXCIPIENTS WITH KNOWN EFFECT
Lactose
For the full list of excipients see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each tenofovir/emtricitabine tablet is capsule-shaped, biconvex and
blue. Engraved with
“APO” on one side and “E-T” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TREATMENT OF HIV-1 INFECTION
Tenofovir/Emtricitabine 300/200 APOTEX 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/Emtricitabine 300/200 APOTEX 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 - Clinical trials).
4.2
DOSE AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
For oral administration.
DOSAGE
RECOMMENDED DOSE FOR TREATMENT OF HIV-1 INFECTION
ADULTS: The recommended dose of tenofovir disoproxil
fumarate/emtricitabine is one tablet
(containing 300 mg tenofovir disoproxil fumarate and 200 mg
emtricitabine), taken orally, once
daily. In order to optimise the absorption of tenofovir, it is
recommended that tenofovir
disoproxil fumarate/emtricitabine should be taken with food.
2
RECOMMENDED DOSE FOR PRE-EXPOSURE PROPHYLAXIS
ADULTS: The dose of tenofovir disoproxil fumarate/emtricitabine in
HIV-1 uninfected adults is
one tablet (containing 300 mg tenofovir disoproxil fumarate and