Valganciclovir 450mg tablets

Land: Storbritannia

Språk: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv ingrediens:

Valganciclovir hydrochloride

Tilgjengelig fra:

Milpharm Ltd

ATC-kode:

J05AB14

INN (International Name):

Valganciclovir hydrochloride

Dosering :

450mg

Legemiddelform:

Oral tablet

Administreringsrute:

Oral

Klasse:

No Controlled Drug Status

Resept typen:

Valid as a prescribable product

Produkt oppsummering:

BNF: 05030202; GTIN: 8901175022663

Informasjon til brukeren

Pharmacode position may change as per the supplier’s m/c requirement
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 1.
WHAT VALGANCICLOVIR 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 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
DO NOT TAKE VALGANCICLOVIR:
-
if you are allergic to valganciclovir or any of the other ingredients
of this medicine (listed
in secti

Preparatomtale

1.
NAME OF THE MEDICINAL PRODUCT
Valganciclovir 450 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 496.3 mg of 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.
Oval, biconvex, pink colored film-coated tablets approx16.83 x 7.95
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
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 repeat
induction treatment; however, consideration should be given to the
possibility of viral drug
resistance.
The duration of maintenance treatment should be determined on a