국가: 영국
언어: 영어
출처: MHRA (Medicines & Healthcare Products Regulatory Agency)
Valganciclovir hydrochloride
Teva UK Ltd
J05AB14
Valganciclovir hydrochloride
450mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030202; GTIN: 5017007034193
Valganciclovir with food and drink Valganciclovir should be taken with food. If you are unable to eat for any reason, you should still take your dose of Valganciclovir as usual. Pregnancy and breast-feeding and fertility If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. You should not take Valganciclovir if you are pregnant unless your doctor recommends it. Taking Valganciclovir when you are pregnant could harm your unborn baby. You must not take Valganciclovir if you are breastfeeding. If your doctor wants you to begin treatment with Valganciclovir you must stop breastfeeding before you start to take your tablets. Women of childbearing age must use effective contraception when taking Valganciclovir. Men whose partners could become pregnant should use condoms while taking Valganciclovir and should continue to use condoms for 90 days after treatment has finished. Driving and using machines Do not drive or use any tools or machines if you feel dizzy, tired, shaky or confused while taking this medicine. Ask your doctor or pharmacist for advice before taking any medicine. Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. You have to be careful when handling your tablets. Do not break or crush them. You should swallow them whole and with food whenever possible. If you accidentally touch damaged tablets, wash your hands thoroughly with soap and water. If any powder from the tablets gets in your eyes, rinse your eyes with sterile water or clean water if you do not have sterile water. You must stick to the number of tablets as instructed by your doctor to avoid overdose. Valganciclovir tablets should, whenever possible, be taken with food – see section 2. Other suitable dosage forms are available for children and adolescents who need dose adjustments. Adults: Prevention of CMV disease in transplant patients You should st 전체 문서 읽기
1. NAME OF THE MEDICINAL PRODUCT Valganciclovir 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 tablet. Oval, biconvex, pink colored film-coated tablets approx16.83 x 7.95 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Valganciclovir is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in adult patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir 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 Valganciclovir 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 900 mg valganciclovir (two Valganciclovir 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 possibility of viral drug resistance. The duration of maintenance treatment should be determined on a 전체 문서 읽기