Descovy

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Emtricitabine 200mg;  ;  ;  ;  ; Tenofovir alafenamide fumarate 11.2mg equivalent to 10 mg Tenofovir alafenamide;  

Dostopno od:

Gilead Sciences (NZ)

INN (mednarodno ime):

Emtricitabine 200 mg

Odmerek:

200mg/10mg

Farmacevtska oblika:

Film coated tablet

Sestava:

Active: Emtricitabine 200mg         Tenofovir alafenamide fumarate 11.2mg equivalent to 10 mg Tenofovir alafenamide   Excipient: Croscarmellose sodium Magnesium stearate Microcrystalline cellulose Opadry grey 85F97517

Tip zastaranja:

Prescription

Izdeluje:

Union Quimico Farmaceutica SA (Uquifa SA)

Terapevtske indikacije:

DESCOVY is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and adolescents aged 12 years and older with body weight at least 35 kg. The patients must not have a history of treatment failure or known mutations associated with resistance to the individual components of DESCOVY. DESCOVY is not for use in Pre-Exposure Prophylaxis (PrEP)?.

Povzetek izdelek:

Package - Contents - Shelf Life: Bottle, plastic, 60 mL HDPE white bottle with PP CRC cap lined with an induction activated al foil liner - 30 tablets - 36 months from date of manufacture stored at or below 30°C

Datum dovoljenje:

2016-07-13

Navodilo za uporabo

DESCOVY®
1
DESCOVY®
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.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I USING DESCOVY?
DESCOVY contains the active ingredients emtricitabine and tenofovir
alafenamide. DESCOVY is used to:
•
treat Human Immunodeficiency Virus-1 (HIV-1) infection in adults and
children aged 12 years of age and older and
weighing ≥ 35 kg when taken in combination with other anti-HIV
medicines
For more information, see Section 1. Why am I using DESCOVY? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE DESCOVY?
Do not use if you have ever had an allergic reaction to DESCOVY 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
DESCOVY?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with DESCOVY 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 DESCOVY?
•
The usual dose is one DESCOVY tablet orally, once daily.
•
Take DESCOVY with or without food.
More instructions can be found in Section 4. How do I use DESCOVY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING DESCOVY?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
DESCOVY.
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 DESCOVY
affects you.
LOOKING AFTER
YOUR MEDICINE
•
Keep your DESCOVY tablets in the bottle with the cap tightly closed
until yo

Lastnosti izdelka

DESCOVY Data Sheet v6.0 – (15 March 2022) Page 1
NEW ZEALAND DATA SHEET
1
DESCOVY® (EMTRICITABINE/TENOFOVIR ALAFENAMIDE) TABLETS
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Emtricitabine (FTC) 200 mg/Tenofovir Alafenamide (TAF) 25 mg,
Emtricitabine 200 mg/Tenofovir Alafenamide 10 mg.
For full list of excipients, see section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Film-coated tablet.
Each 200/25 mg DESCOVY tablet is rectangular shaped, film-coated and
blue in colour. Each
tablet is debossed with “GSI” on one side and the number “225”
on the other side.
Each 200/10 mg DESCOVY tablet is rectangular shaped, film-coated and
gray in colour.
Each tablet is debossed with “GSI” on one side and the number
“210” on the other side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DESCOVY is indicated in combination with other antiretroviral agents
for the treatment of
human immunodeficiency virus (HIV-1) infection in adults and
adolescents aged 12 years and
older with body weight at least 35 kg. The patients must not have a
history of treatment failure
or known mutations associated with resistance to the individual
components of DESCOVY
(see section 5.2 Pharmacokinetic Properties).
DESCOVY is not for use in Pre
‐
Exposure Prophylaxis (PrEP).
4.2
DOSE AND METHOD OF ADMINISTRATION
In adults and adolescent patients aged 12 years and older and weighing
≥ 35 kg DESCOVY is
taken orally once daily with or without food.
The recommended dose of DESCOVY is 200/25 mg.
If DESCOVY is used in combination with an HIV-1 protease inhibitor
(PI) that is
administered with either ritonavir or cobicistat (COBI), the
recommended dose of DESCOVY
is 200/10 mg (see Table 1).
DESCOVY Data Sheet v6.0 – (15 March 2022) Page 2
TABLE 1.
DOSE OF DESCOVY ACCORDING TO THIRD AGENT IN THE HIV TREATMENT
REGIMEN
DOSE OF DESCOVY
THIRD AGENT IN HIV TREATMENT REGIMEN
a
DESCOVY 200/10 mg once daily
Atazanavir with ritonavir or cobicistat
Darunavir with ritonavir or cobicistat
b
Lopinavir with ritonavir
DESCOVY 200/25 mg once daily
Do