XYZAL

Country: Индонезија

Језик: Индонежански

Извор: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активни састојак:

LEVOCETIRIZINE DIHYDROCHLORIDE

Доступно од:

GLAXO WELLCOME INDONESIA - Indonesia

INN (Међународно име):

LEVOCETIRIZINE DIHYDROCHLORIDE

Дозирање:

5 MG

Фармацеутски облик:

KAPLET SALUT SELAPUT

Јединице у пакету:

DUS, 5 BLISTER @ 10 KAPLET SALUT SELAPUT

Произведен од:

UCB FARCHIM SA - Switzerland

Датум одобрења:

2022-01-21

Карактеристике производа

_Page 1 of 8_
XYZAL
LEVOCETIRIZINE DIHYDROCHLORIDE
1. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 5 mg levocetirizine dihydrochloride.
2. PHARMACEUTICAL FORM
White to off-white, oval, film-coated tablet with a Y logo on one
side.
3. CLINICAL INFORMATION_ _
3.1 INDICATIONS
Symptomatic treatment of allergic rhinitis (including persistent
allergic rhinitis) and chronic idiopatic
urticaria.
3.2 DOSAGE AND ADMINISTRATION
The film-coated tablet must be taken orally, swallowed whole with
liquid and may be taken with or
without food. It is recommended to take the daily dose in one single
intake.
DURATION OF USE
The duration of use depends on the type, duration and cause of the
complaints. For hay fever 3-6
weeks and in case of short-term pollen exposure as little as one week,
is generally sufficient.
Clinical experience with 5 mg levocetirizine as a film-coated tablet
formulation is currently available
for a 6-month treatment period. For chronic urticaria and chronic
allergic rhinitis, up to one year's
clinical experience is available for the racemate and up to 18 months
in patients with pruritus
associated with atopic dermatitis.
ROUTE OF ADMINISTRATION
For oral use.
ADULTS AND CHILDREN 6 YEARS ABOVE:
The daily recommended dose is 5 mg (1 film coated tablet). For
children aged less than 6 years no
adjusted dosage is yet possible.
ELDERLY
Adjustment of the dose is recommended in elderly patients with
moderate to severe renal impairment
_(see renal impairment). _
_ _
RENAL IMPAIRMENT
The dosing intervals must be individualised according to renal
function. Refer to the following table
and adjust the dose as indicated. To use this dosing table, an
estimate of the patient's creatinine
clearance (CLcr) in mL/min is needed. The CLcr (mL/min) may be
estimated from serum creatinine
(mg/dL) determination using the following formula:
[140
_ - age (years_
)] x
_ weight (kg) _
CLcr
_ = _
_ _
_ _
_ _
_ ( _
x 0.85
_ for women) _
72 x
_ serum creatinine (mg / dL) _
_ _
Dosing Adjustment for Patients with I