Crixivan
Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
Uputa o lijeku
(PIL)
07-07-2022
Svojstava lijeka
(SPC)
07-07-2022
Izvješće o ocjeni javnog
(PAR)
07-07-2022
Aktivni sastojci:
indinavir sulfate ethanolate
Dostupno od:
Merck Sharp & Dohme B.V.
ATC koda:
J05AE02
INN (International ime):
indinavir
Terapijska grupa:
Antivirals for systemic use
Područje terapije:
HIV Infections
Terapijske indikacije:
Crixivan is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV-1 infected adults.,
Proizvod sažetak:
Revision: 39
Status autorizacije:
Withdrawn
Datum autorizacije:
1996-10-04
Uputa o lijeku
63
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
64
PACKAGE LEAFLET: INFORMATION FOR THE USER
CRIXIVAN 200 MG HARD CAPSULES
indinavir
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 CRIXIVAN is and what it is used for
2.
What you need to know before you take CRIXIVAN
3.
How to take CRIXIVAN
4.
Possible side effects
5.
How to store CRIXIVAN
6.
Contents of the pack and other information
1.
WHAT CRIXIVAN IS AND WHAT IT IS USED FOR
WHAT CRIXIVAN IS
CRIXIVAN contains a substance called indinavir. It belongs to a group
of medicines called ‘protease
inhibitors’.
WHAT CRIXIVAN IS USED FOR
CRIXIVAN is used to treat Human Immunodeficiency Virus (HIV) in
adults. CRIXIVAN is used at
the same time as other HIV treatments (antiretroviral medicines). This
is called combination
antiretroviral therapy.
An example of another medicine that might be given to you, at the same
time as CRIXIVAN,
is ritonavir.
HOW CRIXIVAN WORKS
CRIXIVAN treats HIV and helps to lower the number of HIV particles in
your blood.
CRIXIVAN helps to:
lower the risk that you get illnesses related to HIV
lower the amount of HIV in your body (your ‘viral load’)
raise your CD4 (T) cell count. CD4 cells are an important part of your
immune system. The
main role of the immune system is to protect you from infections.
CRIXIVAN may not do these things in all patients. Your doctor will
monitor how this medicine
works for you.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE CRIXIVAN
DO NOT TAKE CRIXIV
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Svojstava lijeka
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
CRIXIVAN 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains indinavir sulphate corresponding to 200 mg
of indinavir.
Excipient with known effect
Each 200 mg capsule contains 74.8 mg lactose.
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Hard capsule.
The capsules are semi–translucent white and coded ‘CRIXIVAN ™
200 mg’ in blue.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
CRIXIVAN is indicated in combination with antiretroviral nucleoside
analogues for the treatment of
HIV–1 infected adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
CRIXIVAN should be administered by physicians who are experienced in
the treatment of HIV
infection. On the basis of current pharmacodynamic data, indinavir
must be used in combination with
other antiretroviral agents. When indinavir is administered as
monotherapy resistant viruses rapidly
emerge (see section 5.1).
Posology
The recommended dose of indinavir is 800 mg orally every 8 hours.
Data from published studies suggest that CRIXIVAN 400 mg in
combination with ritonavir 100 mg,
both administered orally twice daily, may be an alternative dosing
regimen. The suggestion is based
on limited published data (see section 5.2).
A dose reduction of indinavir to 600 mg every 8 hours should be
considered when administering
itraconazole or ketoconazole concurrently (see section 4.5).
Special populations
_Hepatic impairment_
In patients with mild–to–moderate hepatic impairment due to
cirrhosis, the dose of indinavir should
be reduced to 600 mg every 8 hours. The recommendation is based on
limited pharmacokinetic data
(see section 5.2). Patients with severe hepatic impairment have not
been studied; therefore, no dosing
recommendations can be made (see section 4.4).
_Renal impairment_
Safety in patients with impaired renal function has not been studied;
however, less than 20 % of
indinavir is
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