Valganciclovir 450mg Film-coated Tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Valganciclovir

Tilgjengelig fra:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATC-kode:

J05AB; J05AB14

INN (International Name):

Valganciclovir

Dosering :

450 milligram(s)

Legemiddelform:

Film-coated tablet

Resept typen:

Product subject to prescription which may not be renewed (A)

Terapeutisk område:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir

Autorisasjon status:

Not marketed

Autorisasjon dato:

2015-01-30

Informasjon til brukeren

Page
28
of
34
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 is and what it is used for
2.
What you need to know before you take
3.
How to take
4.
Possible side effects
5.
How to store
6.
Contents of the pack and other information
1.
WHAT IS AND WHAT IT IS USED FOR
contains the active substance valganciclovir (as
valganciclovir hydrochloride).
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.
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
DO NOT TAKE :

if you are allergic to valganciclovir, ganciclovir or

Preparatomtale

Health Products Regulatory Authority
03 May 2019
CRN008XPD
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valganciclovir 450mg 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 twice daily is
therapeutically equivalent to intravenous ganciclovir 5 mg/kg twice
daily.
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 daily and, whenever possible, taken with
food. Patients whose retinitis worsens may repeat
induction treatment; howev