Prezista 600mg tablets

Ülke: Birleşik Krallık

Dil: İngilizce

Kaynak: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktif bileşen:

Darunavir ethanolate

Mevcut itibaren:

Janssen-Cilag Ltd

ATC kodu:

J05AE10

INN (International Adı):

Darunavir ethanolate

Doz:

600mg

Farmasötik formu:

Tablet

Uygulama yolu:

Oral

Sınıf:

No Controlled Drug Status

Reçete türü:

Valid as a prescribable product

Ürün özeti:

BNF: ; GTIN: 5012674901861

Bilgilendirme broşürü

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PREZISTA 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 PREZISTA is and what it is used for
2.
What you need to know before you take PREZISTA
3.
How to take PREZISTA
4.
Possible side effects
5.
How to store PREZISTA
6.
Contents of the pack and other information
1.
WHAT PREZISTA IS AND WHAT IT IS USED FOR
WHAT IS PREZISTA?
PREZISTA contains the active substance darunavir. PREZISTA is an
antiretroviral medicine used in
the treatment of Human Immunodeficiency Virus (HIV) infection. It
belongs to a group of medicines
called protease inhibitors. PREZISTA 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?
PREZISTA 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.
PREZISTA 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 PREZISTA
DO NOT TAKE PREZISTA
-
if you are
ALLERGIC
to darunavir or any of the other ingredients of this medicine (listed
in section
6) or to ritonavir.
-
if you have
SEVERE LIVER PROBLEMS
. Ask your doctor if you are unsure about the severity of your
liver disease. Some addi

Ürün özellikleri

OBJECT 1
PREZISTA 75 MG FILM-COATED TABLETS
Summary of Product Characteristics Updated 26-Mar-2018 | Janssen-Cilag
Ltd
1. Name of the medicinal product
PREZISTA 75 mg film-coated tablets
PREZISTA 150 mg film-coated tablets
PREZISTA 300 mg film-coated tablets
PREZISTA 600 mg film-coated tablets
2. Qualitative and quantitative composition
PREZISTA 75 mg film-coated tablets
Each film-coated tablet contains 75 mg of darunavir (as ethanolate).
PREZISTA 150 mg film-coated tablets
Each film-coated tablet contains 150 mg of darunavir (as ethanolate).
PREZISTA 300 mg film-coated tablets
Each film-coated tablet contains 300 mg of darunavir (as ethanolate).
Excipient with known effect: Each tablet contains 1.375 mg sunset
yellow FCF (E110).
PREZISTA 600 mg film-coated tablets
Each film-coated tablet contains 600 mg of darunavir (as ethanolate).
Excipient with known effect: Each tablet contains a maximum of 2.750
mg sunset yellow FCF (E110).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
PREZISTA 75 mg film-coated tablets
Film-coated tablet.
White caplet shaped tablet of 9.2 mm, debossed with “75” on one
side and “TMC” on the other side.
PREZISTA 150 mg film-coated tablets
Film-coated tablet.
White oval shaped tablet of 13.7 mm, debossed with “150” on one
side and “TMC” on the other side.
PREZISTA 300 mg film-coated tablets
Film-coated tablet.
Orange oval shaped tablet of 17.3 mm, debossed with “300MG” on one
side and “TMC114” on the other
side.
PREZISTA 600 mg film-coated tablets
Film-coated tablet.
Orange oval shaped tablet of 21.1 mm, debossed with “600MG” on one
side and “TMC” on the other
side.
4. Clinical particulars
4.1 Therapeutic indications
PREZISTA, 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).
PREZISTA 75 mg, 150 mg, 300 mg, and 600 mg tablets may be used to
provide suitable dose regimens
(s