Darunavir Krka

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

darunavir

Available from:

KRKA, d.d., Novo mesto

ATC code:

J05AE10

INN (International Name):

darunavir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

400 and 800 mgDarunavir Krka, 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.Darunavir Krka 400 mg and 800 mg tablets may be used to provide suitable dose regimens for the treatment of HIV-1 infection in adult and paediatric patients from the age of 3 years and at least 40 kg body weight who are:antiretroviral therapy (ART)-naïve (see section 4.2).ART-experienced with no darunavir resistance associated mutations (DRV-RAMs) and who have plasma HIV-1 RNA < 100,000 copies/ml and CD4+ cell count ≥ 100 cells x 106/l. In deciding to initiate treatment with darunavir in such ART-experienced patients, genotypic testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4 and 5.1).600 mg Darunavir Krka, 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.Darunavir Krka 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 co-administered with low dose ritonavir, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different agents. Genotypic or phenotypic testing (when available) and treatment history should guide the use of darunavir.

Product summary:

Revision: 10

Authorization status:

Authorised

Authorization date:

2018-01-26

Patient Information leaflet

90
B. PACKAGE LEAFLET
91
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARUNAVIR KRKA 400 MG FILM-COATED TABLETS
DARUNAVIR KRKA 800 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 or pharmacist.
-
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Darunavir Krka is and what it is used for
2.
What you need to know before you take Darunavir Krka
3.
How to take Darunavir Krka
4.
Possible side effects
5.
How to store Darunavir Krka
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR KRKA IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR KRKA?
Darunavir Krka contains the active substance darunavir. Darunavir Krka
is an antiretroviral medicine
used in the treatment of Human Immunodeficiency Virus (HIV) infection.
It belongs to a group of
medicines called protease inhibitors. Darunavir Krka 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?
The Darunavir Krka 400 and 800 milligram tablets are used to treat
adults and children (3 years of age
and above, at least 40 kilograms body weight) who are infected by HIV
and

who have not used antiretroviral medicines before.

in certain patients who have used antiretroviral medicines before
(your doctor will determine
this).
Darunavir Krka 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 DARUNAVIR KRK

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir Krka 400 mg film-coated tablets
Darunavir Krka 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir Krka 400 mg film-coated tablets
Each film-coated tablet contains 400 mg darunavir.
Darunavir Krka 800 mg film-coated tablets
Each film-coated tablet contains 800 mg darunavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet)
Darunavir Krka 400 mg film-coated tablets
Yellowish brown, oval, biconvex film-coated tablets, engraved with a
mark S1 on one side. Tablet
dimension: 17 x 8.5 mm.
Darunavir Krka 800 mg film-coated tablets
Brownish red, oval, biconvex film-coated tablets, engraved with a mark
S3 on one side. Tablet
dimension: 20 x 10 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Darunavir Krka, 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.
Darunavir Krka 400 mg and 800 mg tablets may be used to provide
suitable dose regimens for the
treatment of HIV-1 infection in adult and paediatric patients from the
age of 3 years and at least 40 kg
body weight who are:
-
antiretroviral therapy (ART)-naïve (see section 4.2).
-
ART-experienced with no darunavir resistance associated mutations
(DRV-RAMs) and who
have plasma HIV-1 RNA < 100 000 copies/ml and CD4+ cell count ≥ 100
cells x 10
6
/l. In
deciding to initiate treatment with darunavir in such ART-experienced
patients, genotypic
testing should guide the use of darunavir (see sections 4.2, 4.3, 4.4
and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a healthcare provider experienced in
the management of HIV infection.
After therapy with darunavir has been initiated, patients should be
advised not to alter the dose, dose
form or discontinue therapy without discussing with their healthcare
provider.
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