Agenerase
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
21-06-2011
Produktets egenskaber
(SPC)
21-06-2011
Offentlige vurderingsrapport
(PAR)
21-06-2011
Aktiv bestanddel:
amprenavir
Tilgængelig fra:
Glaxo Group Ltd.
ATC-kode:
J05AE05
INN (International Name):
amprenavir
Terapeutisk gruppe:
Antivirals for systemic use
Terapeutisk område:
HIV Infections
Terapeutiske indikationer:
Agenerase, in combination with other antiretroviral agents, is indicated for the treatment of protease inhibitor (PI) experienced HIV-1 infected adults and children above the age of 4 years. Agenerase capsules should normally be administered with low dose ritonavir as a pharmacokinetic enhancer of amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should be based on individual viral resistance testing and treatment history of patients (see section 5.1).The benefit of Agenerase boosted with ritonavir has not been demonstrated in PI nave patients (see section 5.1)
Produkt oversigt:
Revision: 18
Autorisation status:
Withdrawn
Autorisation dato:
2000-10-20
Indlægsseddel
Medicinal product no longer authorised
74
B. PACKAGE LEAFLET
Medicinal product no longer authorised
75
PACKAGE LEAFLET : INFORMATION FOR THE USER
AGENERASE 50 MG SOFT CAPSULES
Amprenavir
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 gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1)
What Agenerase is and what it is used for
2)
Before you take Agenerase
3)
How to take Agenerase
4)
Possible side effects
5)
How to store Agenerase
6)
Further information
1.
WHAT AGENERASE IS AND WHAT IT IS USED FOR
Agenerase belongs to a group of antiviral medicines called protease
inhibitors. These medicines are
used for treating human immunodeficiency virus (HIV) infection.
Agenerase is used in protease inhibitor experienced HIV-1 infected
adults and children above the age
of 4 years. Agenerase is prescribed for use in combination with other
antiretroviral medicinal products.
Your doctor will normally direct that Agenerase capsules should be
taken with low doses of ritonavir
to boost its efficacy. The choice of Agenerase will be based on any
resistance testing your doctor may
have carried out and your treatment history.
The benefit of amprenavir boosted with ritonavir has not been
demonstrated in PI naïve patients.
2.
BEFORE YOU TAKE AGENERASE
DO NOT TAKE AGENERASE
-
if you are allergic (hypersensitive) to amprenavir or to any of the
other ingredients in
Agenerase.
-
if you have severe liver disease (see ‘Take special care with
Agenerase’).
-
you are currently taking any of the following medicines:
-
astemizole or terfenadine (commonly used to treat allergy symptoms –
these medicines may
be available without prescription)
-
pim
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Produktets egenskaber
Medicinal product no longer authorised
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Agenerase 50 mg soft capsules.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains 50 mg of amprenavir.
Excipients:
d-sorbitol (E420)
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Soft capsule.
Oblong, opaque, off-white to cream coloured, printed with ‘GX
CC1’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Agenerase, in combination with other antiretroviral agents, is
indicated for the treatment of protease
inhibitor (PI) experienced HIV-1 infected adults and children above
the age of 4 years. Agenerase
capsules should normally be administered with low dose ritonavir as a
pharmacokinetic enhancer of
amprenavir (see sections 4.2 and 4.5). The choice of amprenavir should
be based on individual viral
resistance testing and treatment history of patients (see section
5.1).
The benefit of Agenerase boosted with ritonavir has not been
demonstrated in PI naïve patients (see
section 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be initiated by a physician experienced in the
management of HIV infection.
The importance of complying with the full recommended dosing regimen
should be stressed to all
patients.
Agenerase is administered orally and can be taken with or without
food.
Agenerase is also available as an oral solution for use in children or
adults unable to swallow capsules.
Amprenavir is 14 % less bioavailable from the oral solution than from
the capsules; therefore,
Agenerase capsules and Agenerase oral solution are not interchangeable
on a milligram per milligram
basis (see section 5.2).
Adults and adolescents of 12 years of age and older (greater than 50
kg body weight):
the
recommended dose of Agenerase capsules is 600 mg twice daily with
ritonavir, 100 mg twice daily, in
combination with other antiretroviral agents.
If Agenerase capsules are used without the boosting effect of
ritonavir high
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