Fuzeon

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

enfuvirtide

Saadav alates:

Roche Registration GmbH

ATC kood:

J05AX07

INN (Rahvusvaheline Nimetus):

enfuvirtide

Terapeutiline rühm:

Antivirals for systemic use

Terapeutiline ala:

HIV Infections

Näidustused:

Fuzeon is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected patients who have received treatment with and failed on regimens containing at least one medicinal product from each of the following antiretroviral classes: protease inhibitors, non-nucleoside reverse-transcriptase inhibitors and nucleoside reverse-transcriptase inhibitors, or who have intolerance to previous antiretroviral regimens.In deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the treatment history of the individual patient and the patterns of mutations associated with different medicinal products. Where available, resistance testing may be appropriate.

Toote kokkuvõte:

Revision: 24

Volitamisolek:

Authorised

Loa andmise kuupäev:

2003-05-27

Infovoldik

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
FUZEON 90 MG/ML POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Enfuvirtide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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 Fuzeon is and what it is used for
2.
What you need to know before you use Fuzeon
3.
How to use Fuzeon
4.
Possible side effects
5.
How to store Fuzeon
6.
Contents of the pack and other information
7.
STEP-BY-STEP GUIDE TO INJECTING FUZEON
1.
WHAT FUZEON IS AND WHAT IS IT USED FOR
WHAT FUZEON IS
Fuzeon contains the active substance enfuvirtide and belongs to a
group of medicines called
‘antiretrovirals’.
WHAT FUZEON IS USED FOR
Fuzeon is used for the treatment of Human Immune deficiency Virus
(HIV) - in combination with
other antiretroviral medicines in patients infected with HIV.
•
Your doctor has prescribed Fuzeon to help control your HIV infection.
•
Fuzeon is not a cure for HIV infection.
HOW FUZEON WORKS
HIV attacks cells in your blood called CD4 or T-cells. The virus needs
to make contact with, and get
inside these cells in order for the virus to multiply. Fuzeon helps by
preventing this.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE FUZEON
DO NOT USE FUZEON IF
•
you are allergic to enfuvirtide or any of the other ingredients of
this medicine (listed in
section 6).
If you are not sure, talk to your doctor, pharmacist or nurse before
using Fuzeon.
31
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before using Fuzeon if:
•
you have ever had any lung problems
�

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
_ _
2
1.
NAME OF THE MEDICINAL PRODUCT
Fuzeon 90 mg/ml powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 108 mg enfuvirtide.
Each ml of reconstituted solution contains 90 mg enfuvirtide.
Excipient with known effect: sodium. Contains less than 1 mmol sodium
(23 mg) per dose, that is to
say essentially ‘sodium-free’.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to off-white lyophilised powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fuzeon is indicated in combination with other antiretroviral medicinal
products for the treatment of
HIV-1 infected patients who have received treatment with and failed on
regimens containing at least
one medicinal product from each of the following antiretroviral
classes: protease inhibitors, non-
nucleoside reverse transcriptase inhibitors and nucleoside reverse
transcriptase inhibitors, or who have
intolerance to previous antiretroviral regimens (see section 5.1).
_ _
_ _
In deciding on a new regimen for patients who have failed an
antiretroviral regimen, careful
consideration should be given to the treatment history of the
individual patient and the patterns of
mutations associated with different medicinal products. Where
available, resistance testing may be
appropriate
_ _
(see sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Fuzeon should be prescribed by physicians who are experienced in the
treatment of HIV infection.
Posology
_Adults and adolescents _
≥
_ 16 years:_
The recommended dose of Fuzeon is 90 mg twice daily injected
subcutaneously into the upper arm, anterior thigh or abdomen.
In case a Fuzeon dose is missed, patients should be instructed to
administer the dose as soon as
possible. However, if it is less than 6 hours before the next regular
dose, the missed dose should be
skipped.
_Elderly_
: There is no experience in patients > 65 years old.
3
_Childre