Land: Irland
Språk: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
Valganciclovir
CHEPLAPHARM Arzneimittel GmbH
J05AB; J05AB14
Valganciclovir
Film-coated tablet
Nucleosides and nucleotides excl. reverse transcriptase inhibitors; valganciclovir
Marketed
2002-09-13
1 IE_PIL_Valcyte_ Film Coated Tablets_ PACKAGE LEAFLET: INFORMATION FOR THE USER VALCYTE 450 MG FILM-COATED TABLETS valganciclovir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What Valcyte is and what it is used for 2. What you need to know before you take Valcyte 3. How to take Valcyte 4. Possible side effects 5. How to store Valcyte 6. Contents of the pack and other information 1. WHAT VALCYTE IS AND WHAT IT IS USED FOR Valcyte belongs to a group of medicines, which work directly to prevent the growth of viruses. In the body the active ingredient in the tablets, valganciclovir, is changed into ganciclovir. Ganciclovir prevents a virus called cytomegalovirus (CMV) from multiplying and invading healthy cells. In patients with a weakened immune system, CMV can cause an infection in the body’s organs. This can be life threatening. Valcyte is used: • for the treatment of CMV-infections of the retina of the eye in adult patients with acquired immunodeficiency syndrome (AIDS). CMV-infection of the retina of the eye can cause vision problems and even blindness. • to prevent CMV-infections in adults and children who are not infected with CMV and who have received an organ transplant from somebody who was infected by CMV. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VALCYTE DO NOT TAKE VALCYTE: • if you are allergic to valganciclovir, ganciclovir or any of the other ingredients of this medicine (listed in section 6). • if you are breast-feeding. WARNINGS AND PRECAUTIONS: Talk to your docto Les hele dokumentet
Health Products Regulatory Authority 28 October 2022 CRN00D03Y Page 1 of 17 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Valcyte 450 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 496.3 mg of valganciclovir hydrochloride equivalent to 450 mg of valganciclovir (as free base). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. Pink, convex oval film-coated tablets, with "VGC" embossed on one side and "450" on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Valcyte is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). Valcyte is indicated for the prevention of CMV disease in CMV-negative adults and children (aged from birth to 18 years) who have received a solid organ transplant from a CMV-positive donor. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology CAUTION – STRICT ADHERENCE TO DOSAGE RECOMMENDATIONS IS ESSENTIAL TO AVOID OVERDOSE (SEE SECTIONS 4.4 AND 4.9). Valganciclovir is rapidly and extensively metabolised to ganciclovir after oral dosing. Oral valganciclovir 900 mg b.i.d. is therapeutically equivalent to intravenous ganciclovir 5 mg/kg b.i.d. TREATMENT OF CYTOMEGALOVIRUS (CMV) RETINITIS _Adult patients_ _Induction treatment of CMV retinitis_ For patients with active CMV retinitis, the recommended dose is 900 mg valganciclovir (two Valcyte 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 900mg valganciclovir (two Valcyte 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 the possibil Les hele dokumentet