VALCYTE TABLETS 450MG

البلد: ماليزيا

اللغة: الإنجليزية

المصدر: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

العنصر النشط:

VALGANCICLOVIR

متاح من:

DKSH MALAYSIA SDN BHD

INN (الاسم الدولي):

VALGANCICLOVIR

الوحدات في الحزمة:

60Tablet Tablets

المصنعة من قبل:

PATHEON INC

نشرة المعلومات

VALCYTE
®
CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)
_Valganciclovir hydrochloride ( 450mg) _
_ _
_ _
1
WHAT IS IN THIS LEAFLET
1.
What Valcyte is used for
2.
How Valcyte works
3.
Before you use Valcyte
4.
How to use Valcyte
5.
While you are using Valcyte
6.
Side effects
7.
Storage and disposal of Valcyte
8.
Product Description
9.
Manufacturer
1.
WHAT VALCYTE IS USED FOR
Valcyte contains the active
ingredient
_valganciclovir _
_hydrochloride_
.
VALCYTE IS USED TO TREAT
CYTOMEGALOVIRUS (CMV) RETINITIS
(AN EYE INFECTION CAUSED BY A TYPE
OF HERPES VIRUS) IN ACQUIRED
IMMUNODEFICIENCY SYNDROME
(AIDS) PATIENTS AS IT CAN CAUSE
BLINDNESS IF UNTREATED.
VALCYTE IS ALSO USED TO PREVENT
CMV DISEASE IN PATIENTS WHO ARE
NOT INFECTED WITH CMV BUT
RECEIVED ORGAN TRANSPLANTATION
FROM A CMV INFECTED DONOR.
Ask your doctor if you have any
questions about why VALCYTE has
been prescribed for you.
Valcyte is not addictive
Valcyte is available only with a
doctor’s prescription
2.
HOW VALCYTE WORKS
Valcyte contains the active
ingredient valganciclovir
hydrochloride.
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 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.
3.
BEFORE YOU USE VALCYTE
_WHEN YOU MUST NOT USE IT _
_ _
Do not use Valcyte if:
1.
You are allergic to:
- VALCYTE, ACYCLOVIR, GANCICLOVIR,
VALACICLOVIR OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Some of the symptoms of an allergic
reaction may include:
-
SHORTNESS OF BREATH
-
WHEEZING OR DIFFICULTY IN
BREATHING
-
SWELLING OF THE FACE, LIPS, TONGUE
OR OTHER PARTS OF THE BODY
-
RASHES, ITCHING, HIVES ON THE SKIN
2.
YOU HAVE VERY LOW BLOOD COUNTS
FOR PLATELETS (USED FOR CLOTTING),
NEUTROPHILS (A TYPE OF WHITE
BLOOD CELL USED AS DEFENCE
AGAINST INFECTIONS),
HAEMOGLOBIN (AN OXYGEN

خصائص المنتج

Leaflet Valcyte MY 450 mg
DRAFT (DATE) 05.04.2023 [10:45 uhr] (1)
COLOURS Pantone Black linework
DIMENSIONS 450 x 500 mm
MATERIAL NUMBER 90007520/11
FONT SIZE 9 pt
PACK INSERT FOR MALAYSIA
VALCYTE
®
Valganciclovir
1. DESCRIPTION
1.1
THERAPEUTIC/PHARMACOLOGIC CLASS OF DRUG
Antiviral
ATC code: J05AB14
1.2
TYPE OF DOSAGE FORM
Film-coated tablet
1.3
ROUTE OF ADMINISTRATION
Oral
1.4
QUALITATIVE AND QUANTITATIVE COMPOSITION
_Active ingredient: _
valganciclovir hydrochloride
Film-coated tablets: 450 mg
The tablets are pink, film-coated, and convex oval with ‘VGC’
embossed on one side and ‘450’ on the other side.
_Excipients:_
Tablet:
_Tablet core:_
povidone, crospovidone, microcrystalline cellulose,
stearic acid powder
_Tablet coat:_
hydroxypropyl methylcellulose, titanium dioxide
(E171), polyethylene glycol, red iron oxide (E172), polysorbate
2. CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
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
CMV-negative patients who have received a solid organ
transplant from a CMV-positive donor.
2.2
DOSAGE AND 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 Sections 3.2.5,
_Pharmacokinetics in Special Populations_
, and
3.2.1,
_Absorption_
).
Valcyte is rapidly and extensively converted into the active
ingredient ganciclovir. The bioavailability of ganciclovir from
Valcyte 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 Sections 2.4,
_Warnings_
_and Precautions_
, and 2.7,
_Overdose_
).
TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS
_Induction treatment of CMV retinitis:_
For patients with active CMV retinitis, the recommended dose is
900 mg twice a day for 21 days. Prolonged induction treatment
may in