Viracept

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

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Patient Information leaflet Patient Information leaflet (PIL)
10-06-2014
Summary of Product characteristics Summary of Product characteristics (SPC)
10-06-2014
Public Assessment Report Public Assessment Report (PAR)
10-06-2014

Active ingredient:

nelfinavir

Available from:

Roche Registration Ltd.

ATC code:

J05AE04

INN (International Name):

nelfinavir

Therapeutic group:

Antivirals for systemic use

Therapeutic area:

HIV Infections

Therapeutic indications:

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.

Product summary:

Revision: 25

Authorization status:

Withdrawn

Authorization date:

1998-01-22

Patient Information leaflet

                                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
                                
                                Read the complete document

Summary of Product characteristics

                                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
                                
                                Read the complete document

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Active ingredient nelfinavir

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ATC code J05AE04

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Patient Information leaflet Patient Information leaflet Bulgarian 10-06-2014
Summary of Product characteristics Summary of Product characteristics Bulgarian 10-06-2014
Public Assessment Report Public Assessment Report Bulgarian 10-06-2014
Patient Information leaflet Patient Information leaflet Spanish 10-06-2014
Summary of Product characteristics Summary of Product characteristics Spanish 10-06-2014
Public Assessment Report Public Assessment Report Spanish 10-06-2014
Patient Information leaflet Patient Information leaflet Czech 10-06-2014
Summary of Product characteristics Summary of Product characteristics Czech 10-06-2014
Public Assessment Report Public Assessment Report Czech 10-06-2014
Patient Information leaflet Patient Information leaflet Danish 10-06-2014
Summary of Product characteristics Summary of Product characteristics Danish 10-06-2014
Public Assessment Report Public Assessment Report Danish 10-06-2014
Patient Information leaflet Patient Information leaflet German 10-06-2014
Summary of Product characteristics Summary of Product characteristics German 10-06-2014
Public Assessment Report Public Assessment Report German 10-06-2014
Patient Information leaflet Patient Information leaflet Estonian 10-06-2014
Summary of Product characteristics Summary of Product characteristics Estonian 10-06-2014
Public Assessment Report Public Assessment Report Estonian 10-06-2014
Patient Information leaflet Patient Information leaflet Greek 10-06-2014
Summary of Product characteristics Summary of Product characteristics Greek 10-06-2014
Public Assessment Report Public Assessment Report Greek 10-06-2014
Patient Information leaflet Patient Information leaflet French 10-06-2014
Summary of Product characteristics Summary of Product characteristics French 10-06-2014
Public Assessment Report Public Assessment Report French 10-06-2014
Patient Information leaflet Patient Information leaflet Italian 10-06-2014
Summary of Product characteristics Summary of Product characteristics Italian 10-06-2014
Public Assessment Report Public Assessment Report Italian 10-06-2014
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Summary of Product characteristics Summary of Product characteristics Latvian 10-06-2014
Public Assessment Report Public Assessment Report Latvian 10-06-2014
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Public Assessment Report Public Assessment Report Lithuanian 10-06-2014
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Public Assessment Report Public Assessment Report Hungarian 10-06-2014
Patient Information leaflet Patient Information leaflet Maltese 10-06-2014
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Public Assessment Report Public Assessment Report Maltese 10-06-2014
Patient Information leaflet Patient Information leaflet Dutch 10-06-2014
Summary of Product characteristics Summary of Product characteristics Dutch 10-06-2014
Public Assessment Report Public Assessment Report Dutch 10-06-2014
Patient Information leaflet Patient Information leaflet Polish 10-06-2014
Summary of Product characteristics Summary of Product characteristics Polish 10-06-2014
Public Assessment Report Public Assessment Report Polish 10-06-2014
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Summary of Product characteristics Summary of Product characteristics Portuguese 10-06-2014
Public Assessment Report Public Assessment Report Portuguese 10-06-2014
Patient Information leaflet Patient Information leaflet Romanian 10-06-2014
Summary of Product characteristics Summary of Product characteristics Romanian 10-06-2014
Public Assessment Report Public Assessment Report Romanian 10-06-2014
Patient Information leaflet Patient Information leaflet Slovak 10-06-2014
Summary of Product characteristics Summary of Product characteristics Slovak 10-06-2014
Public Assessment Report Public Assessment Report Slovak 10-06-2014
Patient Information leaflet Patient Information leaflet Slovenian 10-06-2014
Summary of Product characteristics Summary of Product characteristics Slovenian 10-06-2014
Public Assessment Report Public Assessment Report Slovenian 10-06-2014
Patient Information leaflet Patient Information leaflet Finnish 10-06-2014
Summary of Product characteristics Summary of Product characteristics Finnish 10-06-2014
Public Assessment Report Public Assessment Report Finnish 10-06-2014
Patient Information leaflet Patient Information leaflet Swedish 10-06-2014
Summary of Product characteristics Summary of Product characteristics Swedish 10-06-2014
Public Assessment Report Public Assessment Report Swedish 10-06-2014
Patient Information leaflet Patient Information leaflet Norwegian 10-06-2014
Summary of Product characteristics Summary of Product characteristics Norwegian 10-06-2014
Patient Information leaflet Patient Information leaflet Icelandic 10-06-2014
Summary of Product characteristics Summary of Product characteristics Icelandic 10-06-2014

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