Valganciclovir 450mg tablets

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: MHRA (Medicines & Healthcare Products Regulatory Agency)

Wirkstoff:

Valganciclovir hydrochloride

Verfügbar ab:

Mawdsley-Brooks & Company Ltd

ATC-Code:

J05AB14

INN (Internationale Bezeichnung):

Valganciclovir hydrochloride

Dosierung:

450mg

Darreichungsform:

Oral tablet

Verabreichungsweg:

Oral

Klasse:

No Controlled Drug Status

Verschreibungstyp:

Valid as a prescribable product

Produktbesonderheiten:

BNF: 05030202

Gebrauchsinformation

Valganciclovir with food and drink
Valganciclovir should be taken with food. If you are unable to eat for
any reason, you should still take your dose of Valganciclovir as
usual.
Pregnancy and breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or
are planning to have a baby, ask your doctor or pharmacist for advice
before taking this medicine.
You should not take Valganciclovir if you are pregnant unless your
doctor recommends it.
Taking Valganciclovir when you are pregnant could harm your unborn
baby.
You must not take Valganciclovir if you are breastfeeding. If your
doctor wants you to begin treatment with Valganciclovir you must stop
breastfeeding before you start to take your tablets.
Women of childbearing age must use effective contraception when
taking Valganciclovir.
Men whose partners could become pregnant should use condoms
while taking Valganciclovir and should continue to use condoms for 90
days after treatment has finished.
Driving and using machines
Do not drive or use any tools or machines if you feel dizzy, tired,
shaky
or confused while taking this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Always take this medicine exactly as your doctor or pharmacist has
told you. Check with your doctor or pharmacist if you are not sure.
You have to be careful when handling your tablets. Do not break or
crush them. You should swallow them whole and with food whenever
possible. If you accidentally touch damaged tablets, wash your hands
thoroughly with soap and water. If any powder from the tablets gets in
your eyes, rinse your eyes with sterile water or clean water if you do
not have sterile water.
You must stick to the number of tablets as instructed by your
doctor to avoid overdose.
Valganciclovir tablets should, whenever possible, be taken with food
–
see section 2.
Other suitable dosage forms are available for children and
adolescents who need dose adjustments.
Adults:
Prevention of CMV disease in transplant patients
You should st

Fachinformation

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