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

Land: Australien

Sprog: engelsk

Kilde: Department of Health (Therapeutic Goods Administration)

Aktiv bestanddel:

valganciclovir, Quantity: 450 mg

Tilgængelig fra:

Hetero Australia Pty Ltd

Lægemiddelform:

Tablet, film coated

Sammensætning:

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

Indgivelsesvej:

Oral

Enheder i pakken:

60 tablets

Recept type:

(S4) Prescription Only Medicine

Terapeutiske indikationer:

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 oversigt:

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: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Autorisation status:

Registered

Autorisation dato:

2020-04-22

Indlægsseddel

VALGANCICLOVIR HETERO 450MG TABLET VERSION 01
1
VALGANCICLOVIR HETERO
_valganciclovir hydrochloride tablet _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Valganciclovir
Hetero.
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 Hetero 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
HETERO
Animal and other laboratory studies
have shown Valganciclovir causes
infertility, birth defects and cancer. It
is possible that these effects may also
occur in human