ODEFSEY emtricitabine (200 mg), rilpivirine (25 mg), tenofovir alafenamide (25 mg) fixed-dose combination tablet

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

emtricitabine, Quantity: 200 mg; tenofovir alafenamide fumarate, Quantity: 28.04 mg; rilpivirine hydrochloride, Quantity: 27.5 mg

थमां उपलब्ध:

Gilead Sciences Pty Ltd

INN (इंटरनेशनल नाम):

Emtricitabine,rilpivirine hydrochloride,tenofovir alafenamide fumarate

फार्मास्यूटिकल फॉर्म:

Tablet, film coated

रचना:

Excipient Ingredients: magnesium stearate; lactose monohydrate; microcrystalline cellulose; povidone; croscarmellose sodium; polysorbate 20; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350; ferrosoferric oxide

प्रशासन का मार्ग:

Oral

पैकेज में यूनिट:

30

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

ODEFSEY is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents (12 years and older with body weight at least 35 kg) with plasma HIV-1 RNA <= 100,000 copies/mL at the start of therapy. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of ODEFSEY.

उत्पाद समीक्षा:

Visual Identification: F/R/TAF 200/25/25 mg tablets are grey, oval-shaped, film-coated tablets debossed with GSI on one side and 255 on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

प्राधिकरण का दर्जा:

Licence status A

प्राधिकरण की तारीख:

2016-08-30

सूचना पत्रक

ODEFSEY®
1
ODEFSEY®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING ODEFSEY?
ODEFSEY contains the active ingredients emtricitabine, rilpivirine and
tenofovir alafenamide in one tablet. ODEFSEY is used to
help control Human Immunodeficiency Virus (HIV) infection.
For more information, see Section 1. Why am I using ODEFSEY?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE ODEFSEY?
Do not use if you have ever had an allergic reaction to ODEFSEY or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
ODEFSEY?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with ODEFSEY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines?
in the full CMI.
4.
HOW DO I USE ODEFSEY?
•
The usual dose is one ODEFSEY tablet orally, once daily with food.
More instructions can be found in Section 4. How do I use ODEFSEY?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING ODEFSEY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
ODEFSEY.
THINGS YOU
SHOULD NOT DO
•
Do not stop using this medicine suddenly.
•
Do not breastfeed.
•
Avoid doing things that can spread HIV infection.
DRIVING OR USING
MACHINES
•
Be careful driving or operating machinery until you know how ODEFSEY
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your ODEFSEY tablets in the bottle with the cap tightly closed
until you take them.
•
Keep ODEFSEY tablets in a cool, dry place where it stays below 30°C.
For more information, see Section 5. What should I know while using
ODEFSEY? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
The most common side effect of ODEFSEY

उत्पाद विशेषताएं

ODEFSEY Product Information v4.1 – (23 November 2021)
1
AUSTRALIAN PRODUCT INFORMATION - ODEFSEY®
(EMTRICITABINE/RILPIVIRINE/TENOFOVIR ALAFENAMIDE) TABLETS
1
NAME OF THE MEDICINE
ODEFSEY (emtricitabine/ rilpivirine/ tenofovir alafenamide) tablets
for oral use.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each oral tablet of ODEFSEY contains 200 mg emtricitabine (FTC), 25 mg
rilpivirine (RPV) and 25
mg tenofovir alafenamide (TAF).
For the full list of excipients, see section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Each ODEFSEY tablet is capsule shaped, film-coated and gray in colour.
Each tablet is
debossed with ‘GSI’ on one side and the number “255” on the
other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ODEFSEY is indicated as a complete regimen for the treatment of HIV-1
infection in adults and
adolescents (12 years and older with body weight at least 35 kg) with
plasma HIV-1 RNA
≤ 100,000 copies/mL at the start of therapy. The patients must not
have a history of treatment
failure or known mutations associated with resistance to the
individual components of
ODEFSEY.
4.2
DOSE AND METHOD OF ADMINISTRATION
In adults and paediatric patients ≥ 12 years of age and weighing ≥
35 kg, the dose of ODEFSEY
is one tablet taken orally once daily with food.
No data are available on which to make a dose recommendation for
children < 12 years of age or
weighing < 35 kg.
_ELDERLY: _
No dose adjustment is required for elderly patients (see section 4.4
Special warnings and
precautions for use).
_RENAL IMPAIRMENT:_
No dose adjustment of ODEFSEY is required in adult patients with
estimated
creatinine clearance greater than or equal to 30 mL/min.
ODEFSEY should not be initiated in patients with estimated creatinine
clearance below 30
mL/min as there are insufficient data available regarding the use of
ODEFSEY in this population.
No data are available to make dose recommendations in paediatric
patients with renal
impairment.
ODEFSEY Product Information v4.1 – (23 November 2021)
2
_HEPATIC IMPAIRME