Valcyte

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Valganciclovir hydrochloride 496.3mg Equivalent to 450 mg valganciclovir

Available from:

Roche Products (NZ) Ltd

INN (International Name):

Valganciclovir hydrochloride 496.3 mg (Equivalent to 450 mg valganciclovir)

Dosage:

450 mg

Pharmaceutical form:

Film coated tablet

Composition:

Active: Valganciclovir hydrochloride 496.3mg Equivalent to 450 mg valganciclovir Excipient: Crospovidone Microcrystalline cellulose Opadry pink 15B24005 Povidone Stearic acid

Units in package:

Bottle, plastic, HDPE, 60 tablets

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

F Hoffmann-La Roche Ltd

Therapeutic indications:

Valcyte is indicated for the treatment of cytomegalovirus (CMV) retinitis in acquired immunodeficiency syndrome (AIDS) patients. Valcyte is indicated for the prevention of CMV disease in solid organ transplant patients at risk.

Product summary:

Package - Contents - Shelf Life: Bottle, plastic, HDPE - 60 tablets - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2001-02-20

Patient Information leaflet

Valcyte

171129
1
CONSUMER MEDICINE INFORMATION
VALCYTE
®
VALGANCICLOVIR
450 MG TABLETS
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Valcyte tablets.
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 Valcyte against
the benefits expected for you.
IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT VALCYTE IS USED FOR
Valcyte contains the active ingredient valganciclovir.
After taking Valcyte tablets, valganciclovir is quickly changed in
your body to release ganciclovir,
which is the active medicine. Valcyte belongs to a class of medicines
used to prevent the growth of
viruses.
Valcyte acts against a virus called cytomegalovirus or CMV (a type of
herpes virus). It prevents the
virus from growing and multiplying in the body. CMV causes infections,
mainly in people with poor
immunity. Poor immunity can be caused by HIV/AIDS or by medications
taken after an organ
transplant.
Valcyte is used to treat eye infections (known as CMV retinitis) in
AIDS patients, which, if left
untreated can cause blindness. It is not a cure for CMV eye
infections.
Valcyte is not effective against any underlying HIV infection.
Valcyte is also used to prevent CMV infection in patients following
organ transplantation.
Your doctor, however, may have prescribed Valcyte for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY VALCYTE HAS BEEN
PRESCRIBED FOR YOU.
Valcyte is not addictive.
This medicine is available only with a doctor’s prescription.
Valcyte

171129
2
BEFORE YOU TAKE VALCYTE
Animal and other laboratory studies have shown Valcyte causes
infertility, birth defects and cancer. It
is possible that these effects may also occur in humans.
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE VALCYTE IF:
1. YOU HAVE HAD AN ALLERGIC REACTI

Summary of Product characteristics

NEW ZEALAND DATA SHEET
Valcyte 170907
1 of 22
1.
PRODUCT NAME
Valcyte 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
Pink convex oval tablets with “VGC” on one side and “450” on
the other
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Valcyte is indicated for the treatment of cytomegalovirus (CMV)
retinitis in acquired
immunodeficiency syndrome (AIDS) patients.
Valcyte is indicated for the prevention of CMV disease in solid organ
transplant patients at
risk.
4.2
Dose and method of administration
Caution – Strict adherence to dosage recommendations is essential to
avoid overdose.
Standard Dosage
Valcyte is administered orally, and should be taken with food (see
section 5.1).
Valcyte is rapidly and extensively converted into the active
ingredient ganciclovir. The
bioavailability of ganciclovir from Valcyte tablets is up to 10-fold
higher than from oral
ganciclovir.
The dosage and administration of Valcyte tablets as described below
should be closely
followed (see section 4.4).
Treatment of cytomegalovirus (CMV) retinitis
Adult Patients
Induction treatment of CMV retinitis
For patients with active CMV retinitis, the recommended dose is 900 mg
(two 450 mg
tablets) with food twice a day for 21 days. Prolonged induction
treatment may increase the
risk of bone marrow toxicity (see Warnings and Precautions).
NEW ZEALAND DATA SHEET
Valcyte 170907
2 of 22
Maintenance treatment of CMV retinitis
Following induction treatment, or in patients with inactive CMV
retinitis, the recommended
dose is 900 mg (two 450 mg tablets) with food once daily. Patients
whose retinitis worsens
may repeat induction treatment (see Induction treatment of CMV
retinitis).
The duration of maintenance treatment should be determined on an
individual basis.
Prevention of CMV disease in transplantation
For kidney tran