VALGANCICLOVIR SANDOZ valganciclovir (as hydrochloride) 450 mg film coated tablet blister pack

Land: Australia

Språk: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv ingrediens:

valganciclovir, Quantity: 450 mg

Tilgjengelig fra:

Sandoz Pty Ltd

INN (International Name):

Valganciclovir

Legemiddelform:

Tablet, film coated

Sammensetning:

Excipient Ingredients: povidone; stearic acid; microcrystalline cellulose; crospovidone; titanium dioxide; hypromellose; polysorbate 80; iron oxide red; macrogol 400

Administreringsrute:

Oral

Enheter i pakken:

60 tablets

Resept typen:

(S4) Prescription Only Medicine

Indikasjoner:

Valganciclovir is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir is indicated for the prophylaxis of CMV infection and disease following solid organ transplantation in patients at risk of CMV disease.

Produkt oppsummering:

Visual Identification: Pink oval biconvex film coated tablets debossed with 'J' on one side and '156' on the other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisasjon status:

Licence status A

Autorisasjon dato:

2016-12-09

Informasjon til brukeren

VALGANCICLOVIR SANDOZ 450MG TABLET VERSION 01
1
VALGANCICLOVIR SANDOZ
_valganciclovir hydrochloride tablet _
CONSUMER MEDICINE INFORMATION / NEW ZEALAND CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Valganciclovir
Sandoz.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
WHAT IS USED FOR
This medicine is used to treat:
•
CMV retinitis in patients with
acquired immunodeficiency
syndrome (AIDS)
•
Prophylaxis of CMV infection
and disease following solid organ
transplantation in patients at risk
of CMV disease.
It contains the active ingredient
valganciclovir hydrochloride.
Valganciclovir belongs to a group of
medicines used to prevent the growth
of viruses.
It works by acting against a virus
called cytomegalovirus or CMV (a
type of herpes virus). It prevents this
virus from growing and multiplying
in the body. In people with poor
immunity, CMV can cause
infections. Poor immunity can be
caused by: HIV/AIDS or by
medicines taken after an organ
transplant.
Valganciclovir is also used to:
−
CMV eye infections in AIDS
patients, which if left untreated
may cause blindness. It is not a
cure for CMV eye infections
−
Prevent CMV infection in
patients following organ
transplantation.
Valganciclovir Sandoz is not
effective against any underlying HIV
infection
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only with
a doctor's prescription.
BEFORE YOU TAKE
VALGANCICLOVIR
SANDOZ
Animal and other laboratory studies
have shown Valganciclovir causes
infertility, birth defects and cancer. It
is possibl

Preparatomtale

190129-Valganciclovir Sandoz-pi
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
VALGANCICLOVIR SANDOZ (VALGANCICLOVIR HYDROCHLORIDE)
1
NAME OF THE MEDICINE
Valganciclovir hydrochloride
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains valganciclovir 450 mg (as valganciclovir
hydrochloride 496 mg).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Valganciclovir Sandoz (valganciclovir HCl) is available as 450 mg pink
convex oval tablets
with "J" on one side and "156" on the other side. Each tablet contains
450 mg valganciclovir.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Valganciclovir is indicated for the treatment of cytomegalovirus (CMV)
retinitis in adult
patients with acquired immunodeficiency syndrome (AIDS).
Valganciclovir
is
indicated
for
the
prophylaxis
of
CMV
disease
in
adult
solid
organ
transplantation (SOT) patients who are at risk.
4.2
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
Caution – Strict adherence to dosage recommendations is essential to
avoid overdose.
Valganciclovir is rapidly and extensively converted to the active
ingredient ganciclovir. The
bioavailability of ganciclovir from valganciclovir is up to 10-fold
higher than from oral
ganciclovir, therefore the dosage and administration of valganciclovir
tablets or powder for
oral solution as described below should be closely followed (see
Sections 4.4 Special warnings
and precautions for use and 4.9 Overdose).
_TREATMENT OF CMV RETINITIS _
_Adult patients _
_Induction Treatment _
For patients with active CMV retinitis, the recommended dosage is 900
mg twice daily for 21
days with food. Prolonged induction treatment may increase the risk of
bone marrow toxicity
(see Section 4.4 Special warnings and precautions for use -
Haematologic).
_Maintenance Treatment _
Following induction treatment, or in patients with inactive CMV
retinitis the recommended
dose is 900 mg once daily with food. Patients whose retinitis worsens
may repeat induction
treatment (see Induction Treatment).
190129-Valg