Invirase
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
25-09-2023
Fachinformation
(SPC)
25-09-2023
Öffentlichen Beurteilungsberichts
(PAR)
25-09-2023
Wirkstoff:
saquinavir
Verfügbar ab:
Roche Registration GmbH
ATC-Code:
J05AE01
INN (Internationale Bezeichnung):
saquinavir
Therapiegruppe:
Antivirals for systemic use
Therapiebereich:
HIV Infections
Anwendungsgebiete:
Invirase is indicated for the treatment of HIV-1-infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products.
Produktbesonderheiten:
Revision: 50
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
1996-10-03
Gebrauchsinformation
43
B. PACKAGE LEAFLET
Medicinal product no longer authorised
44
PACKAGE LEAFLET: INFORMATION FOR THE USER
INVIRASE 500 MG FILM-COATED TABLETS
SAQUINAVIR
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 Invirase is and what it is used for
2.
What you need to know before you take Invirase
3.
How to take Invirase
4.
Possible side effects
5.
How to store Invirase
6.
Contents of the pack and other information
1.
WHAT INVIRASE IS AND WHAT IT IS USED FOR
Invirase contains the active substance saquinavir which is an
antiviral agent. It is a member of a class
of medicines called protease inhibitors. It is for the treatment of
infection with the human
immunodeficiency virus (HIV).
Invirase is used by HIV-1-infected adults. Invirase is prescribed for
use in combination with ritonavir
(Norvir) and other antiretroviral medicines.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE INVIRASE
DO NOT TAKE INVIRASE IF YOU HAVE:
•
an allergy to saquinavir, ritonavir or any of the other ingredients
(see “Invirase contains lactose”
later in this section and “What Invirase contains” in Section 6)
•
any heart problems that show on an electrocardiogram (ECG, electrical
recording of the heart) -
you may have been born with that
•
a very slow heart rate (bradycardia)
•
a weak heart (heart failure)
•
a history of an irregular heart beat (arrhythmias)
•
a salt imbalance in your blood, especially low blood concentrations of
potassium (hypokalaemia),
which is not currently controlled by treatment
•
severe
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
INVIRASE 500 mg film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One film-coated tablet contains 500 mg of saquinavir as saquinavir
mesilate.
Excipient with known effect: Lactose monohydrate: 38.5 mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Light orange to greyish or brownish orange film-coated tablet of oval
cylindrical biconvex shape with
the marking "SQV 500" on the one side and "ROCHE" on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Invirase is indicated for the treatment of HIV-1 infected adult
patients. Invirase should only be given
in combination with ritonavir and other antiretroviral medicinal
products (see section 4.2).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Therapy with Invirase should be initiated by a physician experienced
in the management of HIV
infection.
_In combination with ritonavir _
The recommended dose of Invirase is 1000 mg (2 x 500 mg film-coated
tablets) two times daily with
ritonavir 100 mg two times daily in combination with other
antiretroviral agents. For treatment-naive
patients initiating treatment with Invirase/ritonavir, the starting
recommended dose of Invirase is
500 mg (1 x 500 mg film-coated tablet) two times daily with ritonavir
100 mg two times daily in
combination with other antiretroviral agents for the first 7 days of
treatment. After 7 days, the
recommended dose of Invirase is 1000 mg two times daily with ritonavir
100 mg two times daily in
combination with other antiretroviral agents. Patients switching
immediately from treatment with
another protease inhibitor taken with ritonavir or from a
non-nucleoside reverse transcriptase inhibitor
based regimen, except rilpivirine (see section 4.5), without a
wash-out period, should however initiate
and continue Invirase at the standard recommended dose of 1000 mg two
times daily with ritonavir
100 mg two t
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