Valganciclovir 450mg Film-coated Tablets

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: myHealthbox

Aktiivinen ainesosa:

valganciclovir

Saatavilla:

Milpharm Limited

ATC-koodi:

J05AB14

INN (Kansainvälinen yleisnimi):

valganciclovir

Annos:

450mg

Lääkemuoto:

Film-coated tablets

Antoreitti:

Oral use

Kpl paketissa:

60 film-coated tablets

Prescription tyyppi:

POM - Prescription Only Medicine

Valmistaja:

APL Swift Services (Malta) Limited

Terapeuttinen ryhmä:

Antivirals for systemic use, nucleosides and nucleotides excl. reverse transcriptase inhibitors

Käyttöaiheet:

It is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS) and for the prevention of CMV disease in CMVnegative adults and children (aged from birth to 18 years) who have received a solid organ transplant from a CMV-positive donor.

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2014-12-23

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
VALGANCICLOVIR 450 MG FILM-COATED TABLETS
Valganciclovir
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 Valganciclovir is and what it is used for
2. What you need to know before you take Valganciclovir 
3. How to take Valganciclovir 
4. Possible side effects
5. How to store Valganciclovir 
6. Contents of the pack and other information
Valganciclovir 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.
 Valganciclovir 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 patients who are not infected with CMV
and who have 
received an organ transplant from somebody who was infected by CMV.
DO NOT TAKE VALGANCICLOVIR:
-
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 infections.
-
if you are

Valmisteyhteenveto

SUMMARY OF PRODUCT CHARACTERISTICS 

1 
NAME OF THE MEDICINAL PRODUCT 

Valganciclovir 450 mg Film-coated Tablets 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each tablet contains 450 mg valganciclovir (as valganciclovir
hydrochloride). 

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 

Film-coated tablet. 

A pink film-coated, oval, biconvex, bevelled edge tablet debossed
with “M” 
on one side of the tablet and “V45” on the other side, with
dimensions 18.4 
mm x 8.4 mm. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 

Valganciclovir is indicated for the induction and maintenance
treatment of 
cytomegalovirus (CMV) retinitis in adult patients with acquired 
immunodeficiency syndrome (AIDS). 

Valganciclovir 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 

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. 

Posology 

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 Valganciclovir 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 Valganciclovir
tablets) once�