Varistren 600 mg/300 mg, filmomhulde tabletten
Land: Nederland
Taal: Nederlands
Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)
Bijsluiter
(PIL)
26-10-2022
Productkenmerken
(SPC)
26-10-2022
Werkstoffen:
ABACAVIRSULFAAT 702,8 mg/stuk SAMENSTELLING overeenkomend met ; ABACAVIR 600 mg/stuk ; LAMIVUDINE 0-WATER 300 mg/stuk
Beschikbaar vanaf:
Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)
ATC-code:
J05AR02
INN (Algemene Internationale Benaming):
ABACAVIRSULFAAT 702,8 mg/stuk SAMENSTELLING overeenkomend met ; ABACAVIR 600 mg/stuk ; LAMIVUDINE 0-WATER 300 mg/stuk
farmaceutische vorm:
Filmomhulde tablet
Samenstelling:
CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110), CELLULOSE, MICROKRISTALLIJN (E 460) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; MACROGOL 400 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171) ; ZONNEGEEL FCF ALUMINIUMLAK (E 110),
Toedieningsweg:
Oraal gebruik
Therapeutisch gebied:
Lamivudine And Abacavir
Product samenvatting:
Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); MACROGOL 400; MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171); ZONNEGEEL FCF ALUMINIUMLAK (E 110);
Autorisatie datum:
1900-01-01
Bijsluiter
PACKAGE LEAFLET: INFORMATION FOR THE USER
Varistren 600 mg/300 mg,
filmomhulde tabletten
abacavir/lamivudine
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.
IMPORTANT —HYPERSENSITIVITY REACTIONS
VARISTREN CONTAINS ABACAVIR
(which is also an active substance in medicines such as
ABACAVIR
,
ABACAVIR/LAMIVUDINE/ZIDOVUDINE
and ABACAVIR/DOLUTEGRAVIR/LAMIVUDINE
). Some people who take
abacavir may develop a
HYPERSENSITIVITY REACTION
(a serious allergic reaction), which can be life-
threatening if they continue to take abacavir containing products.
YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY
REACTIONS’ IN THE PANEL IN
SECTION 4.
The Varistren pack includes an
ALERT CARD
, to remind you and medical staff about abacavir
hypersensitivity.
DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES
.
WHAT IS IN THIS LEAFLET
1.
What Varistren is and what it is used for
2.
What you need to know before you take Varistren
3.
How to take Varistren
4.
Possible side effects
5.
How to store Varistren
6.
Contents of the pack and other information
1.
WHAT VARISTREN IS AND WHAT IT IS USED FOR
VARISTREN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS)
INFECTION IN ADULTS, ADOLESCENTS
AND IN CHILDREN WEIGHING AT LEAST 25 KG.
Varistren contains two active ingredients that are used to treat HIV
infection: abacavir and lamivudine.
These belong to a group of anti-retroviral medicines called
_nucleoside analogue reverse transcriptase _
_inhibitors (NRTIs)_
.
Varistren does not completely cure HIV infection; it reduces the
amount of
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Productkenmerken
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Varistren 600 mg/300 mg,
filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and
300 mg lamivudine.
Excipient(s) with known effect: sunset yellow FCF (E110) 1.14 mg per
tablet and 2.31 mg sodium.
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Orange, modified capsule shaped, biconvex film-coated tablet
(approximately 20.6 x 8.6 mm),
debossed with “H” on one side and “A1” on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Varistren 600 mg/300 mg film-coated tablets is indicated in
antiretroviral combination therapy for the
treatment of Human Immunodeficiency Virus (HIV) infection in adults,
adolescents and children
weighing at least 25 kg (see sections 4.4 and 5.1).
Before initiating treatment with abacavir, screening for carriage of
the HLA-B*5701 allele should be
performed in any HIV-infected patient, irrespective of racial origin
(see section 4.4). Abacavir should
not be used in patients known to carry the HLA-B*5701 allele.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Therapy should be prescribed by a physician experienced in the
management of HIV infection.
Posology
_Adults, adolescents and children weighing at least 25 kg: _
The recommended dose of Varistren 600 mg/300 mg film-coated tablets is
one tablet once daily.
_Children Under 25 kg: _
Varistren 600 mg/300 mg film-coated tablets should not be administered
to children who weigh less
than 25 kg because it is a fixed-dose tablet that cannot be dose
reduced.
Varistren 600 mg/300 mg film-coated tablets is a fixed-dose tablet and
should not be prescribed for
patients requiring dose adjustments. Separate preparations of abacavir
or lamivudine are available in
cases where discontinuation or dose adjustment of one of the active
substances is indicated. In these
cases the physician should refer to the individual product information
for thes
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