Valganciclovir Accord 450 mg film-coated tablets

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Valganciclovir

Tilgjengelig fra:

Accord Healthcare Ireland Ltd.

ATC-kode:

J05AB; J05AB14

INN (International Name):

Valganciclovir

Dosering :

450 milligram(s)

Legemiddelform:

Film-coated tablet

Terapeutisk område:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir

Autorisasjon status:

Marketed

Autorisasjon dato:

2016-04-29

Informasjon til brukeren

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 tablet is and what it is used for
2.
What you need to know before you take Valganciclovir tablets
3.
How to take Valganciclovir tablets
4.
Possible side effects
5.
How to store Valganciclovir tablets
6.
Contents of the pack and other information
1.
WHAT VALGANCICLOVIR TABLET IS AND WHAT IT IS USED FOR
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 tablet 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 TABLETS
DO NOT TAKE VALGANCICLOVIR TABLETS:
−
if you are allergic to valganciclovir, ganciclovir
or any of the other ingredients of this medicine
(listed

Preparatomtale

Health Products Regulatory Authority
08 January 2021
CRN009TS2
Page 1 of 17
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Valganciclovir Accord 450mg film coated tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 496.3 mg valganciclovir 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
Valganciclovir Accord is indicated for the induction and maintenance
treatment of cytomegalovirus (CMV) retinitis in adult
patients with acquired immunodeficiency syndrome (AIDS).
Valganciclovir Accord 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 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
Valganciclovir 450 mg tablets) once daily and, whenever possible,
taken with food. Patients whose retinitis worsens may