Valcyte 50mg/ml powder for oral solution

Ország: Málta

Nyelv: angol

Forrás: Malta Medicines Authority

Aktív összetevők:

VALGANCICLOVIR

Beszerezhető a:

Roche Products Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

ATC-kód:

J05AB14

INN (nemzetközi neve):

VALGANCICLOVIR 50 mg/ml

Gyógyszerészeti forma:

POWDER FOR ORAL SOLUTION

Összetétel:

VALGANCICLOVIR 50 mg/ml

Recept típusa:

POM

Terápiás terület:

ANTIVIRALS FOR SYSTEMIC USE

Engedélyezési státusz:

Withdrawn

Engedély dátuma:

2013-12-16

Betegtájékoztató

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
VALCYTE
® 50 MG/ML POWDER FOR ORAL SOLUTION
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 Valcyte is and what it is used for
2.
What you need to know before you take Valcyte
3.
How to take Valcyte
4.
Possible side effects
5.
How to store Valcyte
6.
Contents of the pack and other information
1.
WHAT VALCYTE IS AND WHAT IT IS USED FOR
Valcyte belongs to a group of medicines, which work directly to
prevent the growth of viruses. In
the body the active ingredient in the powder, 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.
Valcyte 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 VALCYTE
DO NOT TAKE VALCYTE:

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
are medicines used to treat
other

Termékjellemzők

Page 1 of 21
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Valcyte 50 mg/ml powder for oral solution.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each bottle contains 5.5 g valganciclovir hydrochloride per 12 g
powder for oral solution.
Each ml of the reconstituted solution contains 50 mg valganciclovir
(as hydrochloride).
Excipients with known effect:
This medicinal product contains a total of 0.188 mg/ml sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for oral solution.
The powder is a granulate with a white to slightly yellow colour.
When the powder is dissolved, it forms a clear, colourless to brown
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Valcyte is indicated for the induction and maintenance treatment of
cytomegalovirus (CMV)
retinitis in adult patients with acquired immunodeficiency syndrome
(AIDS).
Valcyte 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 taken twice daily is therapeutically equivalent
to intravenous ganciclovir
5 mg/kg taken twice daily. The ganciclovir systemic exposure following
administration of 900 mg
valganciclovir oral solution is equivalent to valganciclovir 900 mg
tablets.
Treatment of cytomegalovirus (CMV) retinitis
_Adult patients _
Page 2 of 21
_Induction treatment of CMV retinitis: _
For patients with active CMV retinitis, the recommended dose is 900 mg
valganciclovir twice a day
for 21 days. 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 CM