Wirnazir 450 mg, filmomhulde tabletten

Country: Netherlands

Language: Dutch

Source: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Active ingredient:

VALGANCICLOVIRHYDROCHLORIDE 496,3 mg/stuk SAMENSTELLING overeenkomend met ; VALGANCICLOVIR 450 mg/stuk

Available from:

Vocate Pharmaceuticals SA 150 Gounari street 16674 GLYFADA (GRIEKENLAND)

ATC code:

J05AB14

INN (International Name):

VALGANCICLOVIRHYDROCHLORIDE 496,3 mg/stuk SAMENSTELLING overeenkomend met ; VALGANCICLOVIR 450 mg/stuk

Pharmaceutical form:

Filmomhulde tablet

Composition:

CELLULOSE, MICROKRISTALLIJN (E 460(i)) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171), CELLULOSE, MICROKRISTALLIJN (E 460) ; CROSPOVIDON (E 1202) ; HYPROMELLOSE, Type 2910 (3 - 15 mPa.s) (E 464) ; IJZEROXIDE ROOD (E 172) ; MACROGOL 400 ; POLYSORBAAT 80 (E 433) ; POVIDON K 30 (E 1201) ; STEARINEZUUR (E 570) ; TITAANDIOXIDE (E 171)

Administration route:

Oraal gebruik

Therapeutic area:

Valganciclovir

Authorization date:

1900-01-01

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
WIRNAZIR 450 MG, FILMOMHULDE TABLETTEN
Valganciclovir hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Wirnazir is and what it is used for
2.
What you need to know before you take Wirnazir
3.
How to take Wirnazir
4.
Possible side effects
5.
How to store Wirnazir
6.
Contents of the pack and other information
1.
WHAT WIRNAZIR IS AND WHAT IT IS USED FOR
Wirnazir belongs to a group of medicines, which work directly to
prevent the growth of viruses. In the
body the active ingredient in the tablets, valganciclovir, is changed
into ganciclovir. Ganciclovir prevents
a virus called cytomegalovirus (CMV) from multiplying and invading
healthy cells. In patients with a
weakened immune system, CMV can cause an infection in the body’s
organs. This can be life threatening.
Wirnazir is used:
•
for the treatment of CMV-infections of the retina of the eye in adult
patients with acquired
immunodeficiency syndrome (AIDS). CMV-infection of the retina of the
eye can cause vision
problems and even blindness.
•
to prevent CMV-infections in adults and children who are not infected
with CMV and who have
received an organ transplant from somebody who was infected by CMV.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE WIRNAZIR
DO NOT TAKE WIRNAZIR:
•
if you are allergic to valganciclovir, ganciclovir or any of the other
ingredients of this medicine
(listed in section 6).
•
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
:
Talk to your doctor or pharmac

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Wirnazir 450 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
film-coated
tablet
contains
496.3 mg
valganciclovir
hydrochloride
equivalent
to
450 mg
of
valganciclovir (as free base).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
16.7 x 7.8 mm approx., pink, oval, biconvex film coated tablets
debossed with ‘J’ on one side and ‘156’
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Wirnazir is indicated for the induction and maintenance treatment of
cytomegalovirus (CMV) retinitis in
adult patients with acquired immunodeficiency syndrome (AIDS).
Wirnazir is indicated for the prevention of CMV disease in
CMV-negative adults and children (aged
from birth to 18 years) who have received a solid organ transplant
from a CMV-positive donor.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
CAUTION – STRICT ADHERENCE TO DOSAGE RECOMMENDATIONS IS ESSENTIAL TO
AVOID OVERDOSE; SEE SECTIONS
4.4 AND 4.9.
Valganciclovir
is
rapidly
and
extensively
metabolized
to
ganciclovir
after
oral
dosing.
Oral
valganciclovir 900 mg b.i.d. is therapeutically equivalent to
intravenous ganciclovir 5 mg/kg b.i.d.
TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS
_Adult patients _
_Induction treatment of CMV retinitis: _
For patients with active CMV retinitis, the recommended dose is 900 mg
valganciclovir (two Wirnazir
450 mg tablets) twice a day for 21 days and, whenever possible, taken
with food. Prolonged induction
treatment may increase the risk of bone marrow toxicity (see section
4.4).
_Maintenance treatment of CMV retinitis: _
Following induction treatment, or in patients with inactive CMV
retinitis, the recommended dose is
900 mg valganciclovir (two Wirnazir 450 mg tablets) once daily and,
whenever possible, taken with
food. Patients whose retinitis worsens may repeat induction treatment;
however, consideration should be
given to the possibility of viral drug resistance.
The