Valganciclovir CF 450 mg, filmomhulde tabletten

Država: Nizozemska

Jezik: nizozemski

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

Aktivni sastojci:

VALGANCICLOVIRHYDROCHLORIDE SAMENSTELLING overeenkomend met ; VALGANCICLOVIR

Dostupno od:

Centrafarm B.V.

ATC koda:

J05AB14

INN (International ime):

VALGANCICLOVIRHYDROCHLORIDE COMPOSITION corresponding to ; VALGANCICLOVIR

Farmaceutski oblik:

Filmomhulde tablet

Sastav:

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),

Administracija rute:

Oraal gebruik

Područje terapije:

Valganciclovir

Proizvod sažetak:

Hulpstoffen: 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);

Datum autorizacije:

2015-03-04

Uputa o lijeku

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALGANCICLOVIR CF 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, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What [Invented name] is and what it is used for
2. What you need to know before you take [Invented name]
3. How to take [Invented name]
4. Possible side effects
5. How to store [Invented name]
6. Contents of the pack and other information
1. WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented name] 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.
[Invented name] 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 [INVENTED NAME]
DO NOT TAKE [INVENTED NAME]:

if you are allergic to valganciclovir or any of the other ingredients
of this medicine (listed in
section 6).

if you are allergic to ganc

Svojstava lijeka

SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Valganciclovir CF 450 mg, filmomhulde tabletten
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
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.
Pink, oval, biconvex film coated tablets approx 16.7 x 7.8 mm,
debossed with ‘J’ on one side
and ‘156’ on the other side.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
[Invented name] is indicated for the induction and maintenance
treatment of cytomegalovirus
(CMV) retinitis in adult patients with acquired immunodeficiency
syndrome (AIDS).
[Invented name] 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 metabolised 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
[Invented name] 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
[Invented
name]
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 v