Darunavir Krka d.d.
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
03-02-2023
Fachinformation
(SPC)
03-02-2023
Öffentlichen Beurteilungsberichts
(PAR)
03-02-2023
Wirkstoff:
darunavir
Verfügbar ab:
KRKA, d.d., Novo mesto
ATC-Code:
J05AE10
INN (Internationale Bezeichnung):
darunavir
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
HIV Infections
Anwendungsgebiete:
400mg and 800 mg Film-coated TabletsDarunavir Krka d.d., 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 d.d., co-administered with cobicistat is indicated in combination with other antiretroviral medicinal products for the treatment of patients with human immunodeficiency virus (HIV-1) infection in adult patients (see section 4.2).Darunavir Krka d.d. 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).600mg Film-coated TabletsDarunavir Krka d.d., 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 d.d. 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.
Produktbesonderheiten:
Revision: 8
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2018-01-18
Gebrauchsinformation
91
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
92
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
DARUNAVIR KRKA D.D. 400 MG FILM-COATED TABLETS
DARUNAVIR KRKA D.D. 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 d.d. is and what it is used for
2.
What you need to know before you take Darunavir Krka d.d.
3.
How to take Darunavir Krka d.d.
4.
Possible side effects
5.
How to store Darunavir Krka d.d.
6.
Contents of the pack and other information
1.
WHAT DARUNAVIR KRKA D.D. IS AND WHAT IT IS USED FOR
WHAT IS DARUNAVIR KRKA D.D.?
Darunavir Krka d.d. contains the active substance darunavir. Darunavir
Krka d.d. 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 d.d.
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 d.d. 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 d.d. must be taken in combination with a low dose of
cobicistat or ritonavir and other
anti-HIV medicines. Your doctor will d
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Darunavir Krka d.d. 400 mg film-coated tablets
Darunavir Krka d.d. 800 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Darunavir Krka d.d. 400 mg film-coated tablets:
Each film-coated tablet contains 400 mg darunavir.
Darunavir Krka d.d. 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 d.d. 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 d.d. 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 d.d., 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 d.d., co-administered with cobicistat is indicated in
combination with other
antiretroviral medicinal products for the treatment of patients with
human immunodeficiency virus
(HIV-1) infection in adults and adolescents (aged 12 years and older,
weighing at least 40 kg) (see
section 4.2).
Darunavir Krka d.d. 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 dar
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