Valganciclovir Viatris

Riik: Uus-Meremaa

keel: inglise

Allikas: Medsafe (Medicines Safety Authority)

Toimeaine:

Valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg

Saadav alates:

Viatris Limited

INN (Rahvusvaheline Nimetus):

Valganciclovir hydrochloride 496.3 mg (= valganciclovir 450 mg)

Annus:

450 mg

Ravimvorm:

Film coated tablet

Koostis:

Active: Valganciclovir hydrochloride 496.3mg equivalent to valganciclovir 450 mg Excipient: Crospovidone Microcrystalline cellulose Opadry brown 15B565009 Purified water Stearic acid

Retsepti tüüp:

Prescription

Valmistatud:

Mylan Laboratories Limited

Näidustused:

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

Toote kokkuvõte:

Package - Contents - Shelf Life: Bottle, HDPE white bottle with white opaque polypropylene cap with Al induction sealing wad - 60 tablets - 36 months from date of manufacture stored at or below 25°C

Loa andmise kuupäev:

2013-10-10

Infovoldik

Page 1 of 5
NEW ZEALAND CONSUMER MEDICINE INFORMATION
VALGANCICLOVIR VIATRIS
_VALGANCICLOVIR FILM COATED TABLET 450 MG_
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before you start taking
Valganciclovir Viatris.
This leaflet answers some common
questions about Valganciclovir
Viatris.
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
Valganciclovir Viatris 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. You may need to read it
again.
WHAT VALGANCICLOVIR
VIATRIS IS USED FOR
Valganciclovir Viatris is used to treat
CMV 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.
Valganciclovir Viatris is not effective
against any underlying HIV
infection.
Valganciclovir Viatris is also used to
prevent CMV infection in patients
following organ transplantation.
Valganciclovir Viatris contains the
active ingredient valganciclovir. It
belongs to a group of medicines
used to prevent the growth of
viruses.
Valganciclovir Viatris acts against a
virus called cytomegalovirus or
CMV (a type of herpes virus). It
prevents this 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.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED FOR
YOU.
Valganciclovir Viatris is not
addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU TAKE
VALGANCICLOVIR
VIATRIS
Animal and other laboratory studies
have shown valganciclovir causes
infertility, birth defects and cancer. It
is possible that these

Toote omadused

Page 1 of 29
NEW ZEALAND DATA SHEET
VALGANCICLOVIR VIATRIS
1. PRODUCT NAME
Valganciclovir Viatris 450 mg film-coated tablet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 496.3 mg of valganciclovir
hydrochloride equivalent to 450 mg of
valganciclovir.
Excipient with known effect: Crospovidone
Allergen Declaration: Sulfites
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
A pink film-coated, oval, biconvex, beveled edge tablet debossed with
“M” on one side of the tablet
and “V45” on the other side.
4. CLINICAL PARTICULARS
_4.1 _
_THERAPEUTIC INDICATIONS_
Valganciclovir Viatris is indicated for the treatment of
cytomegalovirus (CMV) retinitis in acquired
immunodeficiency syndrome (AIDS) patients.
Valganciclovir Viatris 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.
DOSE
Valganciclovir Viatris is rapidly and extensively metabolised to
ganciclovir after oral dosing. Oral
valganciclovir 900 mg twice daily is therapeutically equivalent to
intravenous ganciclovir 5 mg/kg
twice daily.
The dosage and administration of Valganciclovir Viatris tablets as
described below should be closely
followed (see section 4.4).
TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS
_ADULT PATIENTS_
_INDUCTION TREATMENT OF CMV RETINITIS_
Page 2 of 29
For patients with active CMV retinitis, the recommended dose is 900 mg
(two 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 (two 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