Abacavir Mylan 300 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

Bron: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Werkstoffen:

ABACAVIR

Beschikbaar vanaf:

Mylan Ireland Limited 35/36 Grange Parade, Baldoyle Industrial Estate DUBLIN 13 (IERLAND)

ATC-code:

J05AF06

INN (Algemene Internationale Benaming):

ABACAVIR

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

CELLULOSE, MICROKRISTALLIJN (E 460) ; IJZEROXIDE GEEL (E 172) ; MACROGOL 3350 ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYVINYLALCOHOL, GEDEELTELIJK GEHYDROLYSEERD (E1203) ; SILICIUMDIOXIDE (E 551) ; TALK (E 553 B) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; GLYCEROLTRIACETAAT (E 1518) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE GEEL (E 172) ; MAGNESIUMSTEARAAT (E 470b) ; NATRIUMZETMEELGLYCOLAAT (E468) ; POLYSORBAAT 80 (E 433) ; SILICIUMDIOXIDE (E 551) ; TITAANDIOXIDE (E 171),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Abacavir

Product samenvatting:

Hulpstoffen: CELLULOSE, MICROKRISTALLIJN (E 460); GLYCEROLTRIACETAAT (E 1518); HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464); IJZEROXIDE GEEL (E 172); MAGNESIUMSTEARAAT (E 470b); NATRIUMZETMEELGLYCOLAAT (E468); POLYSORBAAT 80 (E 433); SILICIUMDIOXIDE (E 551); TITAANDIOXIDE (E 171);

Autorisatie datum:

2018-01-04

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ABACAVIR MYLAN 300 MG, FILMOMHULDE TABLETTEN
abacavir
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
Abacavir Mylan contains abacavir. 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 Abacavir Mylan 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 Abacavir Mylan is and what it is used for
2.
What you need to know before you take Abacavir Mylan
3.
How to take Abacavir Mylan
4.
Possible side effects
5.
How to store Abacavir Mylan
6.
Contents of the pack and other information
1.
WHAT ABACAVIR MYLAN IS AND WHAT IT IS USED FOR
Abacavir Mylan is used to treat HIV (human immunodeficiency virus)
infection.
Abacavir Mylan contains the active substance abacavir. Abacavir
belongs to a group of anti-retroviral
medicines called
_nucleoside analogue reverse transcriptase inhibitors (NRTIs)._
Abacavir does not completely cure HIV infection; it reduces the amount
of virus in your body, and
keeps it at a low level. It also increases the CD4 cell count in your
blood. CD4 cells are a type of
white blood cell that are important in helping your body to fight
infection.
Not everyone responds

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Abacavir Mylan 300 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 300 mg of abacavir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Yellow, capsule shaped, biconvex, film-coated tablet (approximately
18.5 x 7.3 mm), debossed with
‘H’ on one side with a score line and ‘A’ and ‘26’
separated by a score line on the other side.
The tablet can be divided into equal doses.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Abacavir Mylan is indicated in antiretroviral combination therapy for
the treatment of Human
Immunodeficiency Virus (HIV) infection in adults, adolescents and
children (see sections 4.4 and
5.1).
The demonstration of the benefit of abacavir is mainly based on
results of studies performed with a
twice daily regimen, in treatment-naïve adult patients on combination
therapy (see section 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
Posology
Abacavir Mylan should be prescribed by physicians experienced in the
management of HIV infection.
_ _
_Adults, adolescents and children (weighing at least 25 kg): _
The recommended dose of abacavir is 600 mg daily. This may be
administered as either 300 mg (one
tablet) twice daily or 600 mg (two tablets) once daily (see sections
4.4 and 5.1).
_ _
_Children (weighing less than 25 kg):_
Dosing according to weight bands is recommended for abacavir tablets.
_ _
_Children weighing ≥ 20 kg to < 25 kg_
: The recommended dose is 450 mg daily. This may be
administered as either one 150 mg (one half of a tablet) taken in the
morning and 300 mg (one whole
tablet) taken in the evening, or 450 mg (one and a half tablets) ta