Aptivus

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

tipranavir

זמין מ:

Boehringer Ingelheim International GmbH

קוד ATC:

J05AE09

INN (שם בינלאומי):

tipranavir

קבוצה תרפויטית:

Antivirals for systemic use

איזור תרפויטי:

HIV Infections

סממני תרפויטית:

Aptivus, co-administered with low-dose ritonavir, is indicated for combination antiretroviral treatment of HIV-1 infection in highly pretreated adults and adolescents 12 years of age or older with virus resistant to multiple protease inhibitors.Aptivus should only be used as part of an active combination antiretroviral regimen in patients with no other therapeutic options.This indication is based on the results of two phase-III studies, performed in highly pretreated adult patients (median number of 12 prior antiretroviral agents) with virus resistant to protease inhibitors and of one phase-II study investigating pharmacokinetics, safety and efficacy of Aptivus in mostly treatment-experienced adolescent patients aged 12 to 18 years.In deciding to initiate treatment with Aptivus, 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 Aptivus. Initiation of treatment should take into account the combinations of mutations which may negatively impact the virological response to Aptivus, co-administered with low-dose ritonavir.

leaflet_short:

Revision: 42

מצב אישור:

Authorised

תאריך אישור:

2005-10-25

עלון מידע

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
APTIVUS 250 MG SOFT CAPSULES
tipranavir
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, please ask your doctor or your
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 Aptivus is and what it is used for
2.
What you need to know before you take Aptivus
3.
How to take Aptivus
4.
Possible side effects
5.
How to store Aptivus
6.
Contents of the pack and other information
IF APTIVUS HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL
INFORMATION IN THIS LEAFLET IS
ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD”
INSTEAD OF “YOU”).
1.
WHAT APTIVUS IS AND WHAT IT IS USED FOR
Aptivus contains the active substance tipranavir. It belongs to a
group of medicines called protease
inhibitors and is used in the treatment of Human Immunodeficiency
Virus (HIV) infection. It blocks
an enzyme called protease that is involved in the reproduction of HIV.
When the enzyme is blocked,
the virus does not reproduce normally, slowing down the infection. You
must take Aptivus together
with:

low dose ritonavir (this helps Aptivus to reach a high enough level in
your blood)

other HIV medicines. Your doctor, together with you, will decide which
other medicines you
should take. This will depend on, for example:

which other medicines you have already taken for HIV

which medicines your HIV is resistant to. If your HIV is resistant to
some HIV
medicines, this means that the medicine will not work so well, or will
not work at all.
Aptivus is specifically used for the treatment of HIV which

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Aptivus 250 mg soft capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 250 mg tipranavir.
Excipients with known effect: Each soft capsule contains
100.0 mg ethanol, 455.0 mg macrogolglycerol ricinoleate and 12.6 mg
sorbitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
Pink, oblong soft gelatin capsules imprinted with “TPV 250” in
black.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Aptivus, co-administered with low dose ritonavir, is indicated for
combination antiretroviral treatment
of HIV-1 infection in highly pre-treated adults and adolescents 12
years of age or older who have a
Body Surface Area (BSA) of ≥1.3 m
2
or weight ≥36 kg and with virus resistant to multiple protease
inhibitors. Aptivus should only be used as part of an active
combination antiretroviral regimen in
patients with no other therapeutic options.
In deciding to initiate treatment with Aptivus, 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 Aptivus. Initiation of
treatment should take into account the
combinations of mutations which may negatively impact the virological
response to Aptivus, co-
administered with low dose ritonavir (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Aptivus must always be given with low dose ritonavir as a
pharmacokinetic enhancer, and in
combination with other antiretroviral medicinal products. The Summary
of Product Characteristics of
ritonavir must therefore be consulted prior to initiation of therapy
with Aptivus (especially as regards
the contraindications, warnings and undesirable effects sections).
Aptivus should be prescribed by physicians who are experienced in the
treatment of HIV-1 infectio