ZIAGEN TABLETS 300 mg

Šalis: Singapūras

kalba: anglų

Šaltinis: HSA (Health Sciences Authority)

Veiklioji medžiaga:

ABACAVIR SULPHATE EQV ABACAVIR

Prieinama:

GLAXOSMITHKLINE PTE LTD

ATC kodas:

J05AF06

Dozė:

300 mg

Vaisto forma:

TABLET, FILM COATED

Sudėtis:

ABACAVIR SULPHATE EQV ABACAVIR 300 mg

Vartojimo būdas:

ORAL

Recepto tipas:

Prescription Only

Pagaminta:

GLAXO WELLCOME OPERATIONS

Autorizacija statusas:

ACTIVE

Leidimo data:

1999-09-01

Pakuotės lapelis

 
1 
ZIAGEN
TM
 TABLETS 
1. 
TRADE NAME OF THE MEDICINAL PRODUCT 
Ziagen

 Tablets. 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each tablet contains 300 mg of abacavir as abacavir sulfate. 
3. 
PHARMACEUTICAL FORM 
Film-coated scored tablets. 
4. 
CLINICAL PARTICULARS 
4.1. 
THERAPEUTIC INDICATIONS 
Ziagen is indicated in antiretroviral combination
therapy for the treatment of Human 
Immunodeficiency Virus (HIV) infection in adults and children. 
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Therapy should be initiated by a physician experienced
in the management of HIV 
infection. 
Ziagen can be taken with or without food. 

To ensure administration of the entire dose,
the tablet(s) should ideally be swallowed 
without crushing. 

For patients who are unable to swallow tablets, Ziagen
is available as an oral solution. 
Alternatively, the tablets may be crushed and added to
a small amount of semi-solid food 
or liquid, all of which should be consumed immediately (see 5.2
Pharmacokinetic 
Properties) 

_ _
_ADULTS AND ADOLESCENTS WEIGHING
AT LEAST 30 KG:_ The recommended dose of Ziagen 
Tablets is 600 mg daily. This may be administered
as either 300 mg (one tablet) twice 
daily or 600 mg (two tablets) once daily.       

_CHILDREN FROM THREE MONTHS AND WEIGHING
LESS THAN 30 KG: _A dosing regimen according 
to weight bands is recommended for Ziagen scored tablets.
This dosing regimen for 
paediatric patients weighing 14-30 kg is based primarily on
pharmacokinetic modelling. 
Clinicians should be aware that variability in drug
exposure is possible; and a 
pharmacokinetic over-exposure of abacavir can occur since accurate
dosing cannot be 
achieved with this formulation.
Therefore a close safety monitoring is warranted in these 
patients.  

2 
_TABLETS: _
_CHILDREN WEIGHING 14 TO 21 KG: _150 mg (one-ha

Prekės savybės

1
ZIAGEN TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 300 mg of abacavir as abacavir sulfate.
CLINICAL INFORMATION
THERAPEUTIC INDICATIONS
_ZIAGEN_ is indicated in antiretroviral combination therapy for the
treatment of Human
Immunodeficiency Virus (HIV) infection in adults and children.
POSOLOGY AND METHOD OF ADMINISTRATION
PHARMACEUTICAL FORM: FILM-COATED SCORED TABLETS
Therapy should be initiated by a physician experienced in the
management of HIV
infection.
_ZIAGEN_ can be taken with or without food.
To ensure administration of the entire dose, the tablet(s) should
ideally be swallowed
without crushing.
For patients who are unable to swallow tablets, the tablets may be
crushed and added to a
small amount of semi-solid food or liquid, all of which should be
consumed immediately
(_see Pharmacokinetic Properties_).
_ _
_ADULTS, ADOLESCENTS AND CHILDREN WEIGHING AT LEAST 25 KG:_ The
recommended dose of
_ZIAGEN_ Tablets is 600 mg daily. This may be administered as either
300 mg (one tablet)
twice daily or 600 mg (two tablets) once daily.
_CHILDREN FROM THREE MONTHS AND WEIGHING LESS THAN 25 KG: _A dosing
regimen according
to weight bands is recommended for _ZIAGEN_ scored tablets.
_CHILDREN WEIGHING 14 TO < 20 KG: _150 mg (one-half of a scored
abacavir tablet) twice
daily or 300 mg (one whole tablet) taken once daily.
_CHILDREN WEIGHING _
_≥_
_ 20 KG TO < 25 KG_: 150 mg (one-half of a scored abacavir tablet)
taken in the morning and 300 mg (one whole tablet) taken in the
evening or 450 mg (one
and a half tablets) taken once daily.
_CHILDREN WEIGHING AT LEAST 25 KG: _the adult dosage of 300 mg (one
tablet) twice daily or
600 mg (two tablets) once daily should be taken.
_CHILDREN LESS THAN THREE MONTHS: _the data available on the use of
_ZIAGEN_ in this age
group are very limited (_see Pharmacokinetic Properties_).
2
Patients changing from the twice daily dosing regimen to the once
daily dosing regimen
should take the recommended once daily dose (as described above)
approximately 12
hours