Telzir

מדינה: האיחוד האירופי

שפה: אנגלית

מקור: EMA (European Medicines Agency)

מרכיב פעיל:

fosamprenavir calcium

זמין מ:

ViiV Healthcare BV

קוד ATC:

J05AE07

INN (שם בינלאומי):

fosamprenavir

קבוצה תרפויטית:

Antivirals for systemic use

איזור תרפויטי:

HIV Infections

סממני תרפויטית:

Telzir in combination with low-dose ritonavir is indicated for the treatment of human-immunodeficiency-virus-type-1-infected adults, adolescents and children of six years and above in combination with other antiretroviral medicinal products. In moderately antiretroviral-experienced adults, Telzir in combination with low-dose ritonavir has not been shown to be as effective as lopinavir / ritonavir. No comparative studies have been undertaken in children or adolescents. In heavily pretreated patients, the use of Telzir in combination with low-dose ritonavir has not been sufficiently studied. In protease-inhibitor-experienced patients, the choice of Telzir should be based on individual viral resistance testing and treatment history.,

leaflet_short:

Revision: 48

מצב אישור:

Authorised

תאריך אישור:

2004-07-12

עלון מידע

77
B. PACKAGE LEAFLET
78
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELZIR 700 MG FILM-COATED TABLETS
Fosamprenavir
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 TELZIR IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELZIR
3.
HOW TO TAKE TELZIR
4.
POSSIBLE SIDE EFFECTS
5. HOW TO STORE TELZIR
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TELZIR IS AND WHAT IT IS USED FOR
TELZIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION.
Telzir is a type of medicine known as an anti-retroviral. It is taken
with low doses of another
medicine, ritonavir, which boosts the level of Telzir in the blood.
Telzir belongs to a group of
anti-retroviral medicines called
_protease inhibitors_
. Protease is an enzyme produced by HIV which
enables the virus to multiply in white blood cells
_(CD4 cells)_
in your blood. By stopping protease
from working, Telzir stops HIV multiplying and infecting more CD4
cells.
Telzir with low doses of ritonavir is used in combination with other
anti-retroviral medicines
(‘combination therapy’) to treat adults, adolescents and children
aged over 6 years infected with
HIV.
HIV can become resistant to anti-HIV medicines. To avoid this
happening, and to stop your illness
getting worse, it is very important that you keep taking all your
medicines exactly as prescribed.
Telzir will not stop you passing on HIV. HIV infection is spread by
sexual contact with someone
who’s got the infection, or by transfer of infected blood (for
example by

מאפייני מוצר

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Telzir 700 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
Each film-coated tablet contains 700 mg of fosamprenavir as
fosamprenavir calcium (equivalent to
approximately 600 mg of amprenavir).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
Pink film coated, capsule shaped, biconvex tablets, marked with GXLL7
on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Telzir in combination with low dose ritonavir is indicated for the
treatment of Human
Immunodeficiency Virus Type 1 (HIV-1) infected adults, adolescents and
children of 6 years and
above in combination with other antiretroviral medicinal products.
In moderately antiretroviral experienced adults, Telzir in combination
with low dose ritonavir has not
been shown to be as effective as lopinavir / ritonavir. No comparative
studies have been undertaken in
children or adolescents.
In heavily pretreated patients the use of Telzir in combination with
low dose ritonavir has not been
sufficiently studied.
In protease inhibitor (PI) experienced patients the choice of Telzir
should be based on individual viral
resistance testing and treatment history (see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Telzir must only be given with low dose ritonavir as a pharmacokinetic
enhancer of amprenavir 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 Telzir.
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Fosamprenavir is a pro-drug of amprenavir and must not be administered
concomitantly with other
medicinal products containing amprenavir.
The importance of complying with the full recommended dosing regimen
should be stressed to all
patients.
Caution is advised if the recommended doses of Telzir with ritonavir
detailed below are exceeded (s