Darunavir Accord 600 mg film-coated tablets

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Darunavir

から入手可能:

Accord Healthcare Ireland Ltd.

ATCコード:

J05AE; J05AE10

INN（国際名）:

Darunavir

投薬量:

600 milligram(s)

医薬品形態:

Film-coated tablet

治療領域:

Protease inhibitors; darunavir

承認日:

2019-08-30

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 75 MG FILM-COATED TABLETS
[INVENTED NAME] 150 MG FILM-COATED TABLETS
[INVENTED NAME] 300 MG FILM-COATED TABLETS
[INVENTED NAME] 600 MG FILM-COATED TABLETS
darunavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What [Invented name] is and what it is used for
2.
What you need to know before you take [Invented name]
3.
How to take [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
WHAT IS [INVENTED NAME]?
[Invented name] contains the active substance darunavir. [Invented
name] is an antiretroviral medicine
used in the treatment of Human Immunodeficiency Virus (HIV) infection.
It belongs to a group of
medicines called protease inhibitors. This medicine works by reducing
the amount of HIV in your
body. This will improve your immune system and reduces the risk of
developing illnesses linked to
HIV infection.
WHAT IT IS USED FOR?
[Invented name] is used to treat adults and children of 3 years of age
and above, and at least
15 kilogram body weight who are infected by HIV and who have already
used other antiretroviral
medicines.
[Invented name] must be taken in combination with a low dose of
ritonavir and other anti-HIV
medicines. Your doctor will discuss with you which combination of
medicines is best for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]
-
if you are
ALLERGIC

製品の特徴

Health║Products║Regulatory║Authority
22║November║2019
CRN008YH4
Page║1║of║32
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Darunavir║Accord║600║mg║film-coated║tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir Accord 600 mg film-coated tablets
Each║film-coated║tablet║contains║600║mg║of║darunavir║(as
║propylene║glycolate).
_Excipients with known effect_
Each║film-coated║tablet║contains║2.88║mg║of║Sunset║Yellow║FCF║Aluminum║Lake║(E110).
Each║film-coated║tablet║contains║113.90║mg║of║lactose║monohydrate.
Each║film-coated║tablet║contains║83.33║mg║of║propylene║glycol║(E1520).
For║the║full║list║of║excipients,║see║section║6.1.
3 PHARMACEUTICAL FORM
Film-coated║tablet.
Orange║oval║shaped║tablet,║debossed║with║"600"║on║one║side║with║dimensions:║Length:║20.2±0.2║mm,║Width:║10.2║±║0.2║mm║and
Thickness:║6.8±0.4mm.║
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Darunavir║Accord║co-administered║with║low║dose║ritonavir║is║indicated║in║combination║with║other║antiretroviral║medicinal║
products║for║the║treatment║of║patients║with║human║immunodeficiency║virus║(HIV-1)║infection
║(see║section║4.2).
Darunavir║Accord║600║mg║tablets║may║be║used║to║provide║suitable║dose║regimens║(see║section║4.2):

For║the║treatment║of║HIV-1║infection║in║antiretroviral║treatment║(ART)-experienced║adult║patients,║including║those║
that║have║been║highly║pre-treated.

For║the║treatment║of║HIV-1║infection║in║paediatric║patients║from║the║age║of║3║years║and║at║least║15║kg║body║weight.
In║deciding║to║initiate║treatment║with║Darunavir║Accord║co-administered║with║low║dose║ritonavir,║careful║consideration║should║
be║given║to║the║treatment║history║of║th