VALCYTE valganciclovir (as hydrochloride) 50 mg/mL powder for oral solution bottle

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

valganciclovir, Quantity: 5 g

Доступна з:

Pharmaco Australia Ltd

ІПН (Міжнародна Ім'я):

Valganciclovir

Фармацевтична форма:

Solution, powder for

Склад:

Excipient Ingredients: mannitol; fumaric acid; sodium benzoate; saccharin sodium; povidone; Flavour

Адміністрація маршрут:

Oral

Одиниць в упаковці:

1 bottle containing 12 g powder for oral solution

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

VALCYTE is indicated for the treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). VALCYTE is indicated for the prophylaxis of CMV disease in adult and paediatric solid organ transplantation (SOT) patients who are at risk.

Огляд продуктів:

Visual Identification: White to slightly yellow powder; Container Type: Bottle; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Статус Авторизація:

Licence status A

Дата Авторизація:

2010-03-24

інформаційний буклет

VALCYTE
®
_POWDER FOR ORAL SOLUTION_
PRONOUNCED VAL-SITE
_contains the active ingredient valganciclovir_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VALCYTE Powder
for Oral Solution.
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 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 VALCYTE IS
USED FOR
VALCYTE contains the active
ingredient valganciclovir. In the body
valganciclovir rapidly changes to
ganciclovir.
VALCYTE belongs to a group 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 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.
VALCYTE 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.
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.
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
YOU HAVE HAD AN ALLERGIC REACTION
TO VALCYTE, GANCICL

Характеристики продукта

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AUSTRALIAN PRODUCT INFORMATION
VALCYTE
® (VALGANCICLOVIR HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Valganciclovir (as hydrochloride)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Valcyte is available as film-coated tablets and as powder for oral
solution.
Each film coated tablet contains 496.3 mg valganciclovir HCl
(corresponding to 450 mg
valganciclovir).
The powder is reconstituted to form an oral solution, containing 55 mg
valganciclovir HCl
per mL (equivalent to 50 mg valganciclovir).
Excipients with known effect
The powder for oral solution contains a total of 0.188 mg/mL sodium.
For the full list of excipients, see section 6.1. List of excipients
3.
PHARMACEUTICAL FORM
VALCYTE TABLETS
Valcyte (valganciclovir HCl) is available as 450 mg pink convex oval
tablets with "VGC" on
one side and "450" on the other side. Each film-coated tablet contains
450 mg valganciclovir.
Valcyte is supplied in bottles of 60 tablets.
VALCYTE POWDER FOR ORAL SOLUTION
Valcyte powder is white to slightly yellow. The reconstituted solution
contains 50 mg/mL
valganciclovir and appears clear, colourless to brownish-yellow in
colour.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Valcyte is indicated for the treatment of cytomegalovirus (CMV)
retinitis in adult patients
with acquired immunodeficiency syndrome (AIDS).
Valcyte is indicated for the prophylaxis of CMV disease in adult and
paediatric solid organ
transplantation (SOT) patients who are at risk.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
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 Valcyte is up to 10-fold higher
than from oral ganciclovir,
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therefore the dosage and administration of Valcyte 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
_A