VALCYTE 50 Mg/Ml Powder for Oral Solution

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

VALGANCICLOVIR HYDROCHLORIDE

Pieejams no:

Roche Products Limited

ATĶ kods:

J05AB14

SNN (starptautisko nepatentēto nosaukumu):

VALGANCICLOVIR HYDROCHLORIDE

Deva:

50 Mg/Ml

Zāļu forma:

Powder for Oral Solution

Receptes veids:

Product subject to prescription which may not be renewed (A)

Ārstniecības joma:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors

Autorizācija statuss:

Authorised

Autorizācija datums:

2008-08-15

Lietošanas instrukcija

1
uk-ie-mt-pil-Valcyte-clean-171005-50mg-pos
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, ganciclovir or any of the other
ingredients of this medicine
(listed in section 6).
•
if you are breast-feeding.
WARNINGS AND PRECAUTIONS
Talk to y

Produkta apraksts

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_
_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 CMV
retinitis, the recommended dose