VALCYTE TABLETS 450MG

देश: मलेशिया

भाषा: अंग्रेज़ी

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

सक्रिय संघटक:

VALGANCICLOVIR

थमां उपलब्ध:

DKSH MALAYSIA SDN BHD

INN (इंटरनेशनल नाम):

VALGANCICLOVIR

पैकेज में यूनिट:

60Tablet Tablets

द्वारा बनाया गया:

PATHEON INC

सूचना पत्रक

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
CAR

उत्पाद विशेषताएं

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 Composit ion 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, micro crystalline 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 tr eatment 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 a nd 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 descri bed 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 increase the risk of bone marrow toxicity (see Section 2.4 , Warnings and Precautions ). Maintenance treatment of CMV retinitis: Following induction treatment,