TENOFOVIR DISOPROXIL EMTRICITABINE VIATRIS 300/200 tenofovir disoproxil maleate 300 mg and emtricitabine 200 mg film coated tablet bottle

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

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

זמין מ:

Alphapharm Pty Ltd

INN (שם בינלאומי):

Emtricitabine,tenofovir disoproxil maleate

טופס פרצבטיות:

Tablet, film coated

הרכב:

Excipient Ingredients: magnesium stearate; lactose monohydrate; colloidal anhydrous silica; iron oxide red; microcrystalline cellulose; hyprolose; titanium dioxide; hypromellose; triacetin; iron oxide yellow; brilliant blue FCF aluminium lake

מסלול נתינה (של תרופות):

Oral

יחידות באריזה:

30

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

Treatment of HIV-1 infection: TENOFOVIR DISOPROXIL EMTRICITABINE MYLAN 300/200 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 MYLAN 300/200 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 CLINICAL STUDIES).

leaflet_short:

Visual Identification: A light green, film-coated, capsule shaped, biconvex tablet debossed with 'M' on one side of the tablet and 'ETM' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Licence status A

תאריך אישור:

2016-12-15

עלון מידע

TENOFOVIR
DISOPROXIL
EMTRICITABINE
MYLAN 300/200 TABLETS
_300 mg tenofovir disoproxil maleate/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 common
questions about TENOFOVIR
DISOPROXIL EMTRICITABINE
MYLAN 300/200.
It does not contain all 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 pharmacist.
KEEP THIS LEAFLET WITH YOUR
MEDICINE. YOU MAY NEED TO READ IT
AGAIN.
WHAT TENOFOVIR
DISOPROXIL
EMTRICITABINE
MYLAN 300/200 IS
USED FOR
TENOFOVIR DISOPROXIL
EMTRICITABINE MYLAN
300/200 is used to treat Human
Immunodeficiency Virus (HIV)
infection in adults. This medicine
must be taken in combination with
other anti-HIV medicines.
TENOFOVIR DISOPROXIL
EMTRICITABINE MYLAN
300/200 consists of two medicines:
•
tenofovir disoproxil maleate
•
emtricitabine
These are combined in one tablet to
help control Human
Immunodeficiency Virus (HIV)
infection.
TENOFOVIR DISOPROXIL
EMTRICITABINE MYLAN
300/200 contains two active
ingredients that belong to a group of
antiviral medicines known as
nucleoside and nucleotide reverse
transcriptase inhibitors (NRTI).
TENOFOVIR DISOPROXIL
EMTRICITABINE MYLAN
300/200 is used:
•
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 TENOFOVIR_
_DISOPROXIL_
_EMTRICITABINE MYLAN_
_300/200 IS USED TO TREAT HIV_
_INFECTION_
When used with other HIV-1
medicines to treat HIV-1 infection,
TENOFOVIR DISOPROXIL
EMTRICITABINE MYLAN
300/200 may help:
•
Reduce the amount of HIV-1 i

מאפייני מוצר

AUSTRALIAN PRODUCT INFORMATION
TENOFOVIR DISOPROXIL
EMTRICITABINE MYLAN 300/200
_Tenofovir disoproxil maleate 300 mg/Emtricitabine 200 mg _
_tablet _
1
NAME OF THE MEDICINE
tenofovir disoproxil maleate and emtricitabine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Tenofovir disoproxil maleate is a white to off-white crystalline
powder.
Emtricitabine is a white to off-white crystalline powder.
Each Tenofovir Disoproxil Emtricitabine Mylan 300/200 fixed dose
combination tablet contains 300 mg of
tenofovir disoproxil as maleate (equivalent to 245 mg of tenofovir
disoproxil) and 200 mg of emtricitabine.
Excipients with known effect: Tenofovir Disoproxil Emtricitabine Mylan
300/200 tablet also contains lactose
monohydrate.
For the full list of excipients, see
SECTION 6.1 LIST OF EXCIPIENTS
.
3
PHARMACEUTICAL FORM
Tenofovir Disoproxil Emtricitabine Mylan 300/200 (tenofovir disoproxil
maleate 300 mg/emtricitabine 200
mg) tablet is available as a light green, film coated, capsule shaped,
biconvex tablet debossed with ‘M’ on one
side of the tablet and ‘ETM’ on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_TREATMENT OF HIV-1 INFECTION _
Tenofovir Disoproxil Emtricitabine Mylan 300/200 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 Mylan 300/200 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
RECOMMENDED DOSE FOR TREATMENT OF HIV-1 INFECTION
ADULTS
: The recommended dose of Tenofovir Disoproxil Emtricitabine Mylan
300/200 is one tablet
(containing 300 mg tenofovir disoproxil maleate and 200 mg