Alvanocyt 450 mg, filmomhulde tabletten

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

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

Beschikbaar vanaf:

Zentiva k.s. U kabelovny 130 102 37 PRAGUE 10 (TSJECHIË)

ATC-code:

J05AB14

INN (Algemene Internationale Benaming):

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

farmaceutische vorm:

Filmomhulde tablet

Samenstelling:

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),

Toedieningsweg:

Oraal gebruik

Therapeutisch gebied:

Valganciclovir

Product samenvatting:

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);

Autorisatie datum:

1900-01-01

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ALVANOCYT 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 Alvanocyt is and what it is used for
2.
What you need to know before you use Alvanocyt
3.
How to use Alvanocyt
4.
Possible side effects
5.
How to store Alvanocyt
6.
Contents of the pack and other information
1.
WHAT ALVANOCYT IS AND WHAT IT IS USED FOR
Alvanocyt 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.
Alvanocyt is used:
-
For treatment of CMV-infections of the retina of the eye in 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 chilcren 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 USE ALVANOCYT
DO NOT TAKE ALVANOCYT
-
If you are allergic to valganciclovir or any of the other ingredients
of this medicine (listed in
section 6).
-
If you are allergic to ganciclovir, acyclovir or valaciclovir, which
are medicines used to treat
other virus in

Productkenmerken

1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Alvanocyt 450 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 496.3 mg valganciclovir (as 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
Alvanocyt is indicated for the induction and maintenance treatment of
cytomegalovirus (CMV)
retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Alvanocyt is indicated for the prevention of CMV disease in
CMV-negative patients 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
Alvanocyt 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 Alvanocyt 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.
3
_Paediatric population _
The safety and efficacy