Valganciclovir

Ország: Málta

Nyelv: angol

Forrás: Malta Medicines Authority

Aktív összetevők:

VALGANCICLOVIR

Beszerezhető a:

Aurobindo Pharma (Malta) Limited Vault 14, Level 2, Valletta Waterfront, Floriana FRN 1913, Malta

ATC-kód:

J05AB14

INN (nemzetközi neve):

VALGANCICLOVIR 450 mg

Gyógyszerészeti forma:

FILM-COATED TABLET

Összetétel:

VALGANCICLOVIR 450 mg

Recept típusa:

POM

Terápiás terület:

ANTIVIRALS FOR SYSTEMIC USE

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2014-10-28

Betegtájékoztató

Page 1 of 7
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 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 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
section 6).
-
if you are allergic to ganciclovir, acyclovir or valaciclovir, which
ar

Termékjellemzők

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valganciclovir 450 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains valganciclovir hydrochloride,
equivalent to 450 mg Valganciclovir.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film- coated tablet.
Pink colored, oval shaped, biconvex, film-coated tablets, debossed
with ‘H’ on one side and ‘96’ on
the other side. The size is 16.8 mm X 7.9 mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Valganciclovir is indicated for the induction and maintenance
treatment of cytomegalovirus (CMV)
retinitis in patients with acquired immunodeficiency syndrome (AIDS).
Valganciclovir is indicated for the prevention of CMV disease in
CMV-negative patients 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.
Standard dosage in adults
_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:_
Page 2 of 18
Following induction treatment, or in patients with inactive CMV
retinitis, the recommended dose is
900mg 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.
_Prevention of CMV disease in solid organ transpl