Odefsey

Land: New Zealand

Sprog: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv bestanddel:

Emtricitabine 200mg;  ;  ;  ;  ; Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg;  ; Tenofovir alafenamide fumarate 28.04mg equivalent to tenofovir alafenamide 25 mg;  

Tilgængelig fra:

Gilead Sciences (NZ)

INN (International Name):

Emtricitabine 200 mg

Dosering:

200mg/25mg/25mg

Lægemiddelform:

Film coated tablet

Sammensætning:

Active: Emtricitabine 200mg         Rilpivirine hydrochloride 27.5mg equivalent to rilpivirine 25 mg   Tenofovir alafenamide fumarate 28.04mg equivalent to tenofovir alafenamide 25 mg   Excipient: Croscarmellose sodium Opadry II Grey 85F17636 Lactose monohydrate Magnesium stearate Microcrystalline cellulose Polysorbate 20 Povidone

Recept type:

Prescription

Fremstillet af:

Union Quimico Farmaceutica SA (Uquifa SA)

Terapeutiske indikationer:

Indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents (12 years and older with a body weight at least 35 kg) with plasma HIV-1 RNA less than or equal to 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.

Produkt oversigt:

Package - Contents - Shelf Life: Bottle, plastic, HDPE bottle with child-resistant cap, containing a desiccant, in outer carton - 30 tablets - 24 months from date of manufacture stored at or below 30°C

Autorisation dato:

2016-12-12

Indlægsseddel

ODEFSEY® Consumer Medicine Information v 5.0 – (15 April 2024)
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

Produktets egenskaber

NEW ZEALAND DATA SHEET
ODEFSEY Data Sheet v5.0 – 15 April 2024
1
ODEFSEY
® (EMTRICITABINE/RILPIVIRINE/TENOFOVIR ALAFENAMIDE) TABLETS
1 PRODUCT NAME
ODEFSEY (emtricitabine/rilpivirine/tenofovir alafenamide)
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ODEFSEY is available as tablets. Each tablet contains 200 mg
emtricitabine (FTC), 25 mg
rilpivirine (RPV), and 25 mg tenofovir alafenamide (TAF).
Contains sugars as lactose.
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.
The tablets are supplied in bottles
with child resistant closures.
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 no data available regarding the use of ODEFSEY in this
population.
NEW ZEALAND DATA SHEET
ODEFSEY Data Sheet v5.0 – 15 April 2024
2
No data are available to make dose recommendations in paed