Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
VALGANCICLOVIR
DKSH MALAYSIA SDN BHD
VALGANCICLOVIR
60Tablet Tablets
PATHEON INC
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 Lestu allt skjalið
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 Lestu allt skjalið