Valganciclovir Rowex 450 mg film coated tablet

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Valganciclovir hydrochloride

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

J05AB; J05AB14

INN (International Name):

Valganciclovir hydrochloride

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:

Marketed

Autorisasjon dato:

2015-01-09

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VALGANCICLOVIR ROWEX 450 MG FILM-COATED TABLETS
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 Valganciclovir Rowex is and what it is used for
2.
What you need to know before you take Valganciclovir Rowex
3.
How to take Valganciclovir Rowex
4.
Possible side effects
5.
How to store Valganciclovir Rowex
6.
Contents of the pack and other information
1.
WHAT VALGANCICLOVIR ROWEX IS AND WHAT IT IS USED FOR
Valganciclovir Rowex 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 Rowex 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 VALGANCICLOVIR ROWEX
DO NOT TAKE VALGANCICLOVIR ROWEX
-
if you are allergic to valganciclovir, ganciclovir or any of the other
ingredients of this medicine
(l

Preparatomtale

Health Products Regulatory Authority
23 April 2020
CRN008VFH
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valganciclovir Rowex 450 mg film coated tablet
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
Valganciclovir Rowex is indicated for the induction and maintenance
treatment of cytomegalovirus (CMV) retinitis in adult
patients with acquired immunodeficiency syndrome (AIDS).
Valganciclovir Rowex 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 Valganciclovir Rowex 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 900mg valganciclovir (two
Valganciclovir Rowex 450 mg tablets) once daily and, whenever
possible, taken with food. Patients whose retinitis worsens may
repeat induction treatment; however, consideration should