Valganciclovir Sandoz 450 mg, filmomhulde tabletten

Country: Olanda

Lingwa: Olandiż

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

Ingredjent attiv:

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

Disponibbli minn:

Sandoz B.V. Veluwezoom 22 1327 AH ALMERE

Kodiċi ATC:

J05AB14

INN (Isem Internazzjonali):

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

Għamla farmaċewtika:

Filmomhulde tablet

Kompożizzjoni:

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),

Rotta amministrattiva:

Oraal gebruik

Żona terapewtika:

Valganciclovir

Sommarju tal-prodott:

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);

Data ta 'l-awtorizzazzjoni:

1900-01-01

Fuljett ta 'informazzjoni

Sandoz B.V.
Page 1/9
Valganciclovir Sandoz 450 mg, filmomhulde tabletten
RVG 114137
V4
1.3.1.3 Bijsluiter
April 2020
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALGANCICLOVIR SANDOZ
® 450 MG, FILMOMHULDE TABLETTEN
valganciclovir (as 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 [Nationally completed name] is and what it is used for
2.
What you need to know before you take [Nationally completed name]
3.
How to take [Nationally completed name]
4.
Possible side effects
5.
How to store [Nationally completed name]
6.
Content of the pack and other information
1.
WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed 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.
[Nationally completed 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 BE

Karatteristiċi tal-prodott

Sandoz B.V.
Page 1/25
Valganciclovir Sandoz 450 mg, filmomhulde tabletten
RVG 114137
v4
1.3.1.1 Samenvatting van de Productkenmerken
April 2020
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valganciclovir Sandoz 450 mg, filmomhulde tabletten
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 450 mg valganciclovir (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Pink, oval, biconvex, film-coated tablets (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
[nationally completed name] is indicated for the induction and
maintenance treatment of
cytomegalovirus (CMV) retinitis in adult patients with acquired
immunodeficiency syndrome
(AIDS).
[nationally completed 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
[nationally completed name] 450 mg tablets) twice a day for 21 days
and, whenever possible,
Sandoz B.V.
Page 2/25
Valganciclovir Sandoz 450 mg, filmomhulde tabletten
RVG 114137
v4
1.3.1.1 Samenvatting van de Productkenmerken
April 2020
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 in