VORITROP 50 (Voriconazole Tablets 50 mg)

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

VORICONAZOLE

Boleh didapati daripada:

ACCORD HEALTHCARE SDN.BHD.

INN (Nama Antarabangsa):

VORICONAZOLE

Unit dalam pakej:

10 (1x10) Tablets

Dikeluarkan oleh:

INTAS PHARMACEUTICALS LIMITED

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
VORITROP
Voriconazole Tablets (50 mg and 200 mg)
1
WHAT IS IN THIS LEAFLET
1.
What VORITROP tablets
are used for
2.
How VORITROP tablets
works
3.
Before you use VORITROP
tablets.
4.
How to use VORITROP
tablets
5.
While you are using
VORITROP tablets.
6.
Side effects
7.
Storage and disposal of
VORITROP tablets.
8.
Product description.
9.
Manufacturer and Product
registration holder.
10.
Date of revision.
11.
Serial No.
WHAT VORITROP TABLETS ARE
USED FOR:
It is used for the treatment of
patients (adults and children over
the age of 2) with:
- Invasive aspergillosis (a type of
fungal
infection
due
to
Aspergillus sp),
-
candidaemia (another type of
fungal infection due to Candida
sp) in non-neutropenic patients
(patients without abnormally low
white blood cells count),
-
Serios
Candida
infections
including
infection
in
the
esophagus,
-
Serious
invasive
Candida
sp.infections when the fungus is
resistant to fluconazole (another
Anti-fungal medicine),
-
Serious
fungal
infections
caused
by
Scedosporium
sp.or
Fusarium
sp.
(two
different
species of fungi).
Voriconazole
is
intended
for
patients
with
worsening,
possibly life-threatening, fungal
infections.
Prevention
of
breakthrough
fungal infections in febrile high-
risk neutropenic patients.
Prevention of fungal infections in
high risk bone marrow transplant
in patients ≥12 years old..
HOW
VORITROP
TABLETS
WORKS
VORITROP contains the active
substance
voriconazole.
Voriconazole
is
an
antifungal
medicine. It works by killing or
stopping the growth of the fungi
that cause infections.
BEFORE
YOU
USE
VORITROP
TABLETS
-
_When you must not take it_
Voriconazole must not be taken
during
pregnancy
or
breastfeeding,
unless
indicated
by
your
doctor.
Effective
contraception must be used in
women of childbearing potential.
Contact your doctor immediately
if you become pregnant while
taking Voriconazole. If you are
pregnant or breast-feeding, think
you
may
be
pregnant
or
are
planning to have a baby, ask your
doctor or pharmacist for a

Ciri produk

Interaction table
Interactions between voriconazole and other medicinal products are
listed in the
table below (once daily as “QD”, twice daily as “BID”, three
times daily as “TID” and
not determined as “ND”). The direction of the arrow for each
pharmacokinetic
parameter is based on the 90% confidence interval of the geometric
mean ratio
being within (↔), below (↓) or above (↑) the 80- 125% range. The
asterisk (*)
indicates a two-way interaction. AUCτ, AUCt and AUC0-∞ represent
area under the
curve
over
a
dosing
interval,
from
time
zero
to
the
time
with
detectable
measurement and from time zero to infinity, respectively.
The interactions in the table are presented in the following order:
contraindications,
those requiring dose adjustment and careful clinical and/or biological
monitoring,
and finally those that have no significant pharmacokinetic interaction
but may be of
clinical interest in this therapeutic field.
10. FERTILITY, PREGNANCY AND LACTATION
Pregnancy
There are no adequate data from the use of voriconazole in pregnant
women. The potential risk for
humans is unknown.
Voriconazole must not be used during pregnancy unless the benefit to
the mother clearly outweighs the
potential risk to the foetus.
Women of child-bearing potential
Women of child-bearing potential must always use effective
contraception during treatment.
Breast-feeding
The excretion of voriconazole into breast milk has not been
investigated. Breast-feeding must be
stopped on initiation of treatment with Voriconazole.
11. EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
Voriconazole has moderate influence on the ability to drive and use
machines. It may cause transient
and reversible changes to vision, including blurring, altered/enhanced
visual perception and/or
photophobia. Patients must avoid potentially hazardous tasks, such as
driving or operating machinery
while experiencing these symptoms.
12. UNDESIRABLE EFFECTS
Summary of safety profile
The most commonly reported adverse reactions were visual impairment,
pyrex