EPIVIR ORAL SOLUTION 10 mgml

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

LAMIVUDINE

Dostupné z:

GLAXOSMITHKLINE PTE LTD

ATC kód:

J05AF05

Dávkovanie:

10 mg/ml

Forma lieku:

SOLUTION

Zloženie:

LAMIVUDINE 10 mg/ml

Spôsob podávania:

ORAL

Typ predpisu:

Prescription Only

Výrobca:

GLAXO WELLCOME OPERATIONS

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

1997-01-11

Príbalový leták

1
EPIVIR
TM
 TABLETS 
EPIVIR
TM 
ORAL SOLUTION (ALCOHOL FREE) 

QUALITATIVE AND QUANTITATIVE COMPOSITION 
_EPIVIR_ oral solution contains 10mg/ml lamivudine in a solution
containing 20% (w/v) 
sucrose. It is a clear, colourless to pale yellow solution. 
_EPIVIR_ tablets contain 150 mg of lamivudine. 
_EPIVIR_ 150 mg tablets are white, diamond shaped, scored and
engraved with the code “GX 
CJ7” on both faces. 
PHARMACEUTICAL FORM 
Oral Solution. 
Film-coated tablets. 
CLINICAL PARTICULARS 
INDICATIONS 
_EPIVIR_, in combination with other anti-retroviral agents is
indicated for the treatment of HIV 
infected adults and children.   
DOSAGE AND ADMINISTRATION 
_EPIVIR_ therapy should be initiated by a physician experienced
in the management of HIV 
infection. 
_EPIVIR_ 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, lamivudine 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
Pharmacokinetics_). 
  ADULTS AND ADOLESCENTS WEIGHING AT LEAST 30 KG 
The recommended dose of _EPIVIR_ is
300 mg daily. This may be administered as 150 mg (15 
ml oral solution, 1 x 150 mg tablet) twice
daily or 300 mg (30 ml oral solution, 2 x 150 mg 
tablet) once daily. 
Patients changing to the
once daily regimen should take 150 mg twice a day and switch
to 
300 mg once a day the following morning. When an evening once
a day regimen is preferred, 

2
150 mg of _EPIVIR_ should be taken on the first morning
only, followed by 300 mg in the 
evening. When changing back to a twice daily regimen patients
should complete the days 
treatment and start 150 mg twice a day the foll

Súhrn charakteristických

1
EPIVIR TABLETS
EPIVIR
ORAL SOLUTION (ALCOHOL FREE)
QUALITATIVE AND QUANTITATIVE COMPOSITION
_EPIVIR_ oral solution contains 10 mg/mL lamivudine in a solution
containing 20% (w/v)
sucrose. It is a clear, colourless to pale yellow solution.
_EPIVIR_ tablets contain 150 mg of lamivudine.
_EPIVIR_ 150 mg tablets are white, diamond shaped, scored and engraved
with the code “GX
CJ7” on both faces.
CLINICAL INFORMATION
INDICATIONS
_EPIVIR_, in combination with other antiretroviral agents, is
indicated for the treatment of
HIV-infected adults and children.
DOSAGE AND ADMINISTRATION
Pharmaceutical Form:
Oral Solution.
Film-coated tablets.
_EPIVIR_ therapy should be initiated by a physician experienced in the
management of HIV
infection.
_EPIVIR_ 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, lamivudine
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_
Pharmacokinetics_).

ADULTS, ADOLESCENTS AND CHILDREN WEIGHING AT LEAST 25 KG
The recommended dose of _EPIVIR_ is 300 mg daily. This may be
administered as 150 mg (15
mL oral solution, 1 x 150 mg tablet) twice daily or 300 mg (30 mL oral
solution, 2 x 150 mg
tablets) once daily (see _Warnings and Precautions_).
Patients changing to the once daily regimen should take 150 mg twice a
day and switch to
300 mg once a day the following morning. When an evening once a day
regimen is preferred,
150 mg of _EPIVIR_ should be taken on the first morning only, followed
by 300 mg in the
2
evening. When changing back to a twice daily regimen, patients should
complete the day’s
treatment and start 150 mg twice a day the following morning.

CHILDREN WEIGHING LESS THAN 25 KG
ORAL SOLUTION
_Children from one year of age:_ The recommended dose is 0.5 mL/kg (5
mg/kg) twice daily or
1 mL/kg (10 mg/kg) once daily