RETROVIR CAPSULE 250 mg

Land: Singapore

Sprog: engelsk

Kilde: HSA (Health Sciences Authority)

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Hent Indlægsseddel (PIL)
10-06-2014

Aktiv bestanddel:

ZIDOVUDINE

Tilgængelig fra:

GLAXOSMITHKLINE PTE LTD

ATC-kode:

J05AF01

Dosering:

250 mg

Lægemiddelform:

CAPSULE

Indgivelsesvej:

ORAL

Recept type:

Prescription Only

Fremstillet af:

GLAXO WELLCOME OPERATIONS

Autorisation dato:

1993-08-06

Indlægsseddel

                                1 
 
 RETROVIR™  
ZIDOVUDINE 
 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
_RETROVIR_ 100mg Capsules 
Hard gelatin capsules with opaque white cap and body and a central
dark-blue band, printed 
“Wellcome”, “100” and coded Y9C and each containing 100mg
Zidovudine.  
_RETROVIR_ 250mg Capsules  
Hard gelatin capsules with opaque blue cap, opaque white body and a
central dark-blue band, 
printed “Wellcome”, “250” and coded H2F and each containing
250mg Zidovudine.  
_RETROVIR_ Oral Solution  
Oral solution containing 50 mg zidovudine per 5 ml. It is clear,
pale yellow, and strawberry-
flavoured. Contains sodium benzoate. 
PHARMACEUTICAL FORM 
Hard capsules. 
Oral solution. 
CLINICAL PARTICULARS 
INDICATIONS  
_RETROVIR_ is indicated in combination with other anti-retroviral
agents for the treatment of 
Human Immunodeficiency Virus (HIV) infection in adults and children.
 
DOSAGE AND ADMINISTRATION 
_RETROVIR_ therapy should be initiated by a physician experienced in
the management of HIV 
infection. 
  DOSAGE IN ADULTS 
Although a broad range of dosages has been employed, 500 or 600mg/day
in three to five 
divided doses is commonly used worldwide. Alternatively 1000mg/day
in two (or four) divided 
doses is effective. The effectiveness of the lower dosages in the
treatment or prevention of HIV-
associated neurological dysfunction and malignancies is unknown.  
  DOSAGE IN CHILDREN 
2 
 
In children over the age of 3 months, the recommended starting dosage
is 180mg/m
2
 body 
surface area every 6 hours (720mg/m
2
/day). The maximum dosage should not exceed 200mg 
every 6 hours. The optimum dosage regimen remains to be determined
and may vary from 
patient to patient. A range of dosages, generally between 120 and
180mg/m
2 
body surface area 
every 6 hours (between 480 and 720mg/m
2
/day), has been used. The effectiveness of lower 
dosages in the treatment or
prevention of HIV-associated neurological dysfunction and 
malignancies i
                                
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