Valganciclovir 450mg tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Valganciclovir hydrochloride

Tilgængelig fra:

Viatris UK Healthcare Ltd

ATC-kode:

J05AB14

INN (International Name):

Valganciclovir hydrochloride

Dosering:

450mg

Lægemiddelform:

Oral tablet

Indgivelsesvej:

Oral

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 05030202; GTIN: 5016695007335

Indlægsseddel

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PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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 450 mg Film-coated Tablets are and what they are
used for
2.
What you need to know before you take Valganciclovir 450 mg
Film-coated Tablets
3.
How to take Valganciclovir 450 mg Film-coated Tablets
4.
Possible side effects
5.
How to store Valganciclovir 450 mg Film-coated Tablets
6.
Contents of the pack and other information
1.
WHAT VALGANCICLOVIR 450 MG FILM-COATED TABLETS ARE AND WHAT THEY ARE
USED FOR
Valganciclovir 450 mg Film-coated Tablets contains the active
substance valganciclovir (as
valganciclovir hydrochloride). Valganciclovir 450 mg Film-coated
Tablets belong 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 450 mg Film-coated Tablets are 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 tra

Produktets egenskaber

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