Viracept
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
10-06-2014
Produktets egenskaber
(SPC)
10-06-2014
Offentlige vurderingsrapport
(PAR)
10-06-2014
Aktiv bestanddel:
nelfinavir
Tilgængelig fra:
Roche Registration Ltd.
ATC-kode:
J05AE04
INN (International Name):
nelfinavir
Terapeutisk gruppe:
Antivirals for systemic use
Terapeutisk område:
HIV Infections
Terapeutiske indikationer:
Viracept is indicated in antiretroviral combination treatment of human-immunodeficiency-virus (HIV-1)-infected adults, adolescents and children of three years of age and older.In protease-inhibitor (PI)-experienced patients, the choice of nelfinavir should be based on individual viral resistance testing and treatment history.
Produkt oversigt:
Revision: 25
Autorisation status:
Withdrawn
Autorisation dato:
1998-01-22
Indlægsseddel
58
B. PACKAGE LEAFLET
Medicinal product no longer authorised
59
PACKAGE LEAFLET: INFORMATION FOR THE USER
VIRACEPT 50 MG/G ORAL POWDER
Nelfinavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE.
•
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. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
•
If any of the side effects become serious or troublesome, or if you
notice any side effects not
listed in this leaflet, please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Viracept is and what it is used for
2.
Before you take Viracept
3.
How to take Viracept
4.
Possible side effects
5.
How to store Viracept
6.
Further information
1.
WHAT VIRACEPT IS AND WHAT IT IS USED FOR
WHAT VIRACEPT IS
Viracept contains a medicine called nelfinavir, which is a ‘protease
inhibitor’. This belongs to a group
of medicines called ‘anti-retrovirals’.
WHAT VIRACEPT IS USED FOR
Viracept is used with other ‘anti-retroviral’ medicines to:
•
Work against the Human Immunodeficiency Virus (HIV). It helps to
reduce the number of HIV
particles in your blood.
•
Increase the number of some cells in your blood that help fight
infection. These are called CD4
white blood cells. They are particularly reduced in numbers when you
have HIV infection. This
can lead to an increased risk of many types of infections.
Viracept is not a cure for HIV infection. You may continue to get
infections or other illnesses due to
your HIV. Treatment with Viracept does not stop you giving HIV to
others through contact with blood
or sexual contact. Therefore you must keep taking appropriate
precautions to avoid giving the virus to
others when you are taking Viracept.
2.
BEFORE YOU TAKE VIRACEPT
DO NOT TAKE VIRACEPT IF:
•
You are allergic to nelfinavir or to any of the other ingredients
(listed in Section 6 ‘Further
information’).
•
You are taking any o
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
VIRACEPT 50 mg/g oral powder.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The bottle contains 144 g of oral powder. Each gram of oral powder
contains nelfinavir mesilate
corresponding to 50 mg of nelfinavir.
Excipients
:
-
Contains sucrose palmitate: 10.0 mg per gram of oral powder. 10.0 mg
of sucrose palmitate,
which is an ester, theoretically corresponds to maximally 5.9 mg of
sucrose when fully
hydrolysed.
-
Contains aspartame (E951): 20.0 mg of aspartame per gram of oral
powder.
-
Contains potassium: 50.0 mg of dibasic potassium phosphate
corresponding to 22.5 mg of
potassium per gram of oral powder.
See section 4.4
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral powder.
White to off-white amorphous powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VIRACEPT is indicated in antiretroviral combination treatment of human
immunodeficiency virus
(HIV-1) infected adults, adolescents and children of 3 years of age
and older.
In protease inhibitor (PI) experienced patients the choice of
nelfinavir should be based on individual
viral resistance testing and treatment history.
See section 5.1.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy with VIRACEPT should be initiated by a physician experienced
in the management of HIV
infection.
VIRACEPT is administered orally and should always be ingested with
food (see section 5.2).
_Patients older than 13 years:_
VIRACEPT 250 mg tablets are recommended for adults and older
children (see Summary of Product Characteristics for VIRACEPT 250 mg
tablets). The recommended
dose of VIRACEPT 50 mg/g oral powder is 1250 MG TWICE A DAY (BID) OR
750 MG THREE TIMES A DAY
(TID), for patients unable to take tablets. All patients older than 13
years should take EITHER 5 level
scoops of the blue 5 gram spoon twice daily OR 3 level scoops of the
blue 5 gram spoon three times
daily. The efficacy of the BID (twice daily) regimen has been
ev
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