盐酸缬更昔洛韦片VALCYTE 450MG TAB（VALGANCICLOVIR ）说明书
[caption id="attachment_22544" align="alignleft" width="300"]
VALCYTE 450MG TAB（VALGANCICLOVIR 盐酸缬更昔洛韦片）[/caption]
药店国别：
产地国家：美国
处 方 药：是
所属类别：450毫克/片 60片/瓶
包装规格：450毫克/片 60片/瓶
计价单位：瓶
生产厂家中文参考译名:GENENTECH USA
生产厂家英文名:GENENTECH USA
原产地英文商品名:VALCYTE 450MG TAB 60/EA
原产地英文药品名:VALGANCICLOVIR HYDROCHLORIDE
中文参考商品译名:VALCYTE 450毫克/片 60片/瓶
中文参考药品译名:缬更昔洛韦
简介：
盐酸缬更昔洛韦Valcyte(Valganciclovir Hcl)获美国FDA批准用于有巨细胞病毒(CMV)疾病风险的肾脏移植患者的长期治疗。
批准日期：2015年4月 公司：基因泰克公司
VALCYTE(缬更昔洛韦盐酸盐 Valganciclovir Hcl)片，供口服使用
VALCYTE(缬更昔洛韦盐酸盐 Valganciclovir Hcl)用于口服溶液
美国首次批准：2001
警告：血液学毒性，危害生育能力，胚胎毒性，诱变和CARCINOGENESISSee的完整处方信息了解完整的黑框警告。
血液学毒性：严重白细胞减少，中性粒细胞减少，贫血，血小板减少，全血细胞减少，骨髓再生障碍性贫血和再生障碍性贫血的报道与万赛维治疗的患者。
生育减值：根据动物实验数据，万赛维可能会导致精子的临时或永久的抑制。
胎儿毒性：根据动物实验数据，万赛维有可能导致出生缺陷的人的潜力。
突变和致癌作用：根据动物实验数据，万赛维有可能导致癌症的人的潜力。
目前的主要变化:
适应证和用法，儿童患者 04/2015
用法与用量，儿童患者 04/2015
作用机制:
缬更昔洛韦是一种抗病毒药物[见微生物学]。
适应症和用法:
万赛维是巨细胞病毒(CMV)核苷类似物的DNA聚合酶抑制剂表示为：
成年患者:
巨细胞病毒视网膜炎治疗患者获得性免疫缺陷综合症(艾滋病)。
预防巨细胞病毒病在肾，心脏和肾脏，胰腺移植的病人处于高风险的。
儿童患者:
预防巨细胞病毒病的肾脏和心脏移植的患者的高危人群。
用法用量：
成人剂量：
治疗巨细胞病毒性视网膜炎的诱导：900毫克(二450毫克片剂)，每天两次21天
维护：900毫克(二450毫克片剂)，每天一次
预防巨细胞病毒病的心脏或肾脏，胰腺移植的患者900毫克(二450毫克片剂)曾经在10天内移植的一天，直到百天移植后
预防巨细胞病毒病在肾移植患者900毫克(二450毫克片剂)曾经在10天内移植的日子，直到200天移植后
小儿用量：
4个月〜16周岁，剂量的一次10天之内移植天直到200天移植后根据剂量算法预防巨细胞病毒病的肾移植患者(使用在儿童的改性施瓦茨式注意肌酸酐清除率的计算)
预防巨细胞病毒病的心脏移植患者1个月至16周岁，剂量的10天之内移植了一天，直到百天移植后按用量算法(注意肌酐清除率的计算使用儿童修改施瓦茨公式)一次
万赛维用于口服溶液剂和片剂应与食物一起服用。
万赛维片剂不应破裂或压碎的。
成年患者应该使用万赛维片，不是万赛维口服溶液。
成人肾功能损害：调整剂量根据肌酐清除率。对于接受血液透析剂量的建议无法给出成年患者。
剂型和规格
片剂：450毫克
口服液：每毫升50毫克
禁忌：
过敏缬更昔洛韦或
警告和注意事项：
血液学毒性：严重白细胞减少，中性粒细胞减少，贫血，血小板减少，全血细胞减少，骨髓抑制和再生障碍性贫血发生与使用万赛维或更昔洛韦。避免使用万赛维如果中性粒细胞绝对计数小于500个/μL，血小板计数小于25,000/μL，或血红蛋白低于8克/升。请谨慎使用预先存在的血细胞减少和接受骨髓抑制药物或照射时。监测血小板的频繁测试和全血细胞计数。
生育障碍：基于动物研究，万赛维可能会导致精子的临时或永久的抑制。
胎儿毒性：基于动物研究，万赛维可能对胎儿造成伤害。生殖潜力的女性应该期间和之后的治疗有效的避孕和男性应该在和治疗后练习屏障避孕。
致突变性和致癌性：基于动物研究，万赛维是潜在的致突变和致癌性。
急性肾功能衰竭：可发生于老年患者(有或无肾功能减退)，急性肾功能衰竭，谁收到伴随肾毒性药物，或不充分水化的患者的患者。请谨慎使用老年患者或服用肾毒性药物，减少剂量肾功能不全患者，并监测肾功能。
不良反应：
成年患者：最常见的不良事件和实验室异常(由大于或等于20%的患者中报告的至少一个指示)是腹泻，发热，恶心，震颤，中性粒细胞减少，贫血，移植排斥，血小板减少症，和呕吐。
小儿患者：最常见的不良事件和实验室异常(报道的儿科实体器官移植受者大于或等于20%)有腹泻，发热，高血压，上呼吸道感染，泌尿道感染，呕吐，白细胞减少，白细胞减少，和头痛。
药物相互作用：
齐多夫定：可能造成中性粒细胞减少和贫血。监控与白细胞计数与差分和血红蛋白水平(7)频繁测试。
丙磺舒：可以增加更昔洛韦水平。监测更昔洛韦的毒性的证据。
霉酚酸酯(MMF)：可以增加更昔洛韦浓度和MMF代谢物水平患者的肾功能损害。监测更昔洛韦和MMF毒性。
去羟肌苷：可以增加去羟肌苷的浓度。监视去羟肌苷毒性。
特殊人群中使用：
哺乳期：哺乳，不建议使用与万赛维。
包装规格：
VALCYTE 450MG TAB 60/EA VALGANCICLOVIR HYDROCHLORIDE GENENTECH USA 00004-0038-22
VALCYTE TAB 450MG 60 VALGANCICLOVIR HCL GENENTECH USA ROCHE 00004-0038-22
VALCYTE PWD OS 50MG/ML 1 VALGANCICLOVIR HCL GENENTECH USA ROCHE 00004-0039-09
Adult Patients: Valcyte® (valganciclovir hydrochloride) tablets are an antiviral prescription medication given to patients who have a high chance of developing cytomegalovirus (CMV) disease after receiving a heart, kidney, or kidney-pancreas transplant. Valcyte helps prevent CMV disease in these patients.
Pediatric Patients: Valcyte tablets or oral solution is prescribed for the prevention of CMV disease in patients that are 4 months to 16 years of age who have received a kidney transplant or in patients that are 1 month to 16 years of age who have received a heart transplant and have a high chance of developing CMV disease.
Important Safety Information and Most Serious Side EffectsValcyte can affect blood cells and bone marrow causing serious and life-threatening problems. Patients’ doctors may do regular blood tests to check blood cells and may change the dose or tell patients to stop taking Valcyte. Patients must tell their doctor right away if they have any unexpected bruising or bleeding, unusual tiredness, fever, lack of energy, dizziness, or fainting.
Valcyte may cause cancer. Valcyte causes cancer in animals. It is not known if Valcyte causes cancer in people.
Valcyte may cause birth defects. Pregnant women who take Valcyte have a higher chance of having a baby with birth defects. Valcyte should not be used during pregnancy.
Women who can get pregnant must use a reliable method of birth control during treatment with Valcyte and continue birth control for at least 30 days after they stop taking Valcyte. Women must tell their doctor right away if they get pregnant or plan to become pregnant while taking Valcyte.
Men must use a condom during treatment with Valcyte, and for at least 90 days after treatment, if their partner can get pregnant. Patients should talk to their doctor if they have questions about birth control.
Valcyte may lower the amount of sperm in a man's body and cause fertility problems. Valcyte may also cause fertility problems in women.
Do not take Cytovene-IV if you are taking VALCYTE. You could overdose and become very sick if VALCYTE is taken with Cytovene-IV. Talk to your healthcare provider or pharmacist if you have questions about your medicine.
Patients should not receive Valcyte if they are allergic to any of its ingredients or if they have ever had a serious reaction to ganciclovir capsules or Cytovene-IV. Symptoms of an allergic reaction to Valcyte may include cold, sudden trouble breathing, wheezing, hives all over the body, swelling around the mouth, or feeling anxious.
Valcyte can affect the kidneys, including serious problems such as kidney failure. The patient’s doctor may do regular blood tests to check kidney function while patients are taking Valcyte.
The doctor may adjust the dose based on these tests.
Patients must not take Valcyte tablets if they are receiving hemodialysis. Patients should talk to their doctor if they are receiving hemodialysis.
Before starting Valcyte, patients should tell their doctor if they:
•are pregnant or plan to become pregnant. It is not known if Valcyte causes birth defects in an unborn baby
•are breast feeding, or plan to breast feed
•have kidney problems or any other medical condition
•have problems with their blood cells
•are taking any prescription or non-prescription medicines, vitamins, and herbal supplements
•are having radiation treatment
•are receiving hemodialysis
Valcyte can cause seizures, sleepiness, dizziness, unsteady movements, and confusion. Patients should not drive a car or operate other dangerous machinery until they know how Valcyte affects them.
Patients must take Valcyte exactly as their doctor prescribes it. Adult patients should use Valcyte tablets, not Valcyte for oral solution. Valcyte must be taken with food. Do not break or crush tablets.
Common side effects of Valcyte in adults and children include: diarrhea, nausea, vomiting, fever, shaky movements (tremors), low blood cell counts in a blood test, and rejection of the transplanted organ (graft).
Other common side effects in children include: headache, upper respiratory tract infection, high blood pressure, and urinary tract infection.
Patients should tell their doctor if they have any side effect that bothers them or that does not go away.
VALCYTE 450MG TAB（VALGANCICLOVIR 盐酸缬更昔洛韦片）[/caption]
药店国别：
产地国家：美国
处 方 药：是
所属类别：450毫克/片 60片/瓶
包装规格：450毫克/片 60片/瓶
计价单位：瓶
生产厂家中文参考译名:GENENTECH USA
生产厂家英文名:GENENTECH USA
原产地英文商品名:VALCYTE 450MG TAB 60/EA
原产地英文药品名:VALGANCICLOVIR HYDROCHLORIDE
中文参考商品译名:VALCYTE 450毫克/片 60片/瓶
中文参考药品译名:缬更昔洛韦
简介：
盐酸缬更昔洛韦Valcyte(Valganciclovir Hcl)获美国FDA批准用于有巨细胞病毒(CMV)疾病风险的肾脏移植患者的长期治疗。
批准日期：2015年4月 公司：基因泰克公司
VALCYTE(缬更昔洛韦盐酸盐 Valganciclovir Hcl)片，供口服使用
VALCYTE(缬更昔洛韦盐酸盐 Valganciclovir Hcl)用于口服溶液
美国首次批准：2001
警告：血液学毒性，危害生育能力，胚胎毒性，诱变和CARCINOGENESISSee的完整处方信息了解完整的黑框警告。
血液学毒性：严重白细胞减少，中性粒细胞减少，贫血，血小板减少，全血细胞减少，骨髓再生障碍性贫血和再生障碍性贫血的报道与万赛维治疗的患者。
生育减值：根据动物实验数据，万赛维可能会导致精子的临时或永久的抑制。
胎儿毒性：根据动物实验数据，万赛维有可能导致出生缺陷的人的潜力。
突变和致癌作用：根据动物实验数据，万赛维有可能导致癌症的人的潜力。
目前的主要变化:
适应证和用法，儿童患者 04/2015
用法与用量，儿童患者 04/2015
作用机制:
缬更昔洛韦是一种抗病毒药物[见微生物学]。
适应症和用法:
万赛维是巨细胞病毒(CMV)核苷类似物的DNA聚合酶抑制剂表示为：
成年患者:
巨细胞病毒视网膜炎治疗患者获得性免疫缺陷综合症(艾滋病)。
预防巨细胞病毒病在肾，心脏和肾脏，胰腺移植的病人处于高风险的。
儿童患者:
预防巨细胞病毒病的肾脏和心脏移植的患者的高危人群。
用法用量：
成人剂量：
治疗巨细胞病毒性视网膜炎的诱导：900毫克(二450毫克片剂)，每天两次21天
维护：900毫克(二450毫克片剂)，每天一次
预防巨细胞病毒病的心脏或肾脏，胰腺移植的患者900毫克(二450毫克片剂)曾经在10天内移植的一天，直到百天移植后
预防巨细胞病毒病在肾移植患者900毫克(二450毫克片剂)曾经在10天内移植的日子，直到200天移植后
小儿用量：
4个月〜16周岁，剂量的一次10天之内移植天直到200天移植后根据剂量算法预防巨细胞病毒病的肾移植患者(使用在儿童的改性施瓦茨式注意肌酸酐清除率的计算)
预防巨细胞病毒病的心脏移植患者1个月至16周岁，剂量的10天之内移植了一天，直到百天移植后按用量算法(注意肌酐清除率的计算使用儿童修改施瓦茨公式)一次
万赛维用于口服溶液剂和片剂应与食物一起服用。
万赛维片剂不应破裂或压碎的。
成年患者应该使用万赛维片，不是万赛维口服溶液。
成人肾功能损害：调整剂量根据肌酐清除率。对于接受血液透析剂量的建议无法给出成年患者。
剂型和规格
片剂：450毫克
口服液：每毫升50毫克
禁忌：
过敏缬更昔洛韦或
警告和注意事项：
血液学毒性：严重白细胞减少，中性粒细胞减少，贫血，血小板减少，全血细胞减少，骨髓抑制和再生障碍性贫血发生与使用万赛维或更昔洛韦。避免使用万赛维如果中性粒细胞绝对计数小于500个/μL，血小板计数小于25,000/μL，或血红蛋白低于8克/升。请谨慎使用预先存在的血细胞减少和接受骨髓抑制药物或照射时。监测血小板的频繁测试和全血细胞计数。
生育障碍：基于动物研究，万赛维可能会导致精子的临时或永久的抑制。
胎儿毒性：基于动物研究，万赛维可能对胎儿造成伤害。生殖潜力的女性应该期间和之后的治疗有效的避孕和男性应该在和治疗后练习屏障避孕。
致突变性和致癌性：基于动物研究，万赛维是潜在的致突变和致癌性。
急性肾功能衰竭：可发生于老年患者(有或无肾功能减退)，急性肾功能衰竭，谁收到伴随肾毒性药物，或不充分水化的患者的患者。请谨慎使用老年患者或服用肾毒性药物，减少剂量肾功能不全患者，并监测肾功能。
不良反应：
成年患者：最常见的不良事件和实验室异常(由大于或等于20%的患者中报告的至少一个指示)是腹泻，发热，恶心，震颤，中性粒细胞减少，贫血，移植排斥，血小板减少症，和呕吐。
小儿患者：最常见的不良事件和实验室异常(报道的儿科实体器官移植受者大于或等于20%)有腹泻，发热，高血压，上呼吸道感染，泌尿道感染，呕吐，白细胞减少，白细胞减少，和头痛。
药物相互作用：
齐多夫定：可能造成中性粒细胞减少和贫血。监控与白细胞计数与差分和血红蛋白水平(7)频繁测试。
丙磺舒：可以增加更昔洛韦水平。监测更昔洛韦的毒性的证据。
霉酚酸酯(MMF)：可以增加更昔洛韦浓度和MMF代谢物水平患者的肾功能损害。监测更昔洛韦和MMF毒性。
去羟肌苷：可以增加去羟肌苷的浓度。监视去羟肌苷毒性。
特殊人群中使用：
哺乳期：哺乳，不建议使用与万赛维。
包装规格：
VALCYTE 450MG TAB 60/EA VALGANCICLOVIR HYDROCHLORIDE GENENTECH USA 00004-0038-22
VALCYTE TAB 450MG 60 VALGANCICLOVIR HCL GENENTECH USA ROCHE 00004-0038-22
VALCYTE PWD OS 50MG/ML 1 VALGANCICLOVIR HCL GENENTECH USA ROCHE 00004-0039-09
Adult Patients: Valcyte® (valganciclovir hydrochloride) tablets are an antiviral prescription medication given to patients who have a high chance of developing cytomegalovirus (CMV) disease after receiving a heart, kidney, or kidney-pancreas transplant. Valcyte helps prevent CMV disease in these patients.
Pediatric Patients: Valcyte tablets or oral solution is prescribed for the prevention of CMV disease in patients that are 4 months to 16 years of age who have received a kidney transplant or in patients that are 1 month to 16 years of age who have received a heart transplant and have a high chance of developing CMV disease.
Important Safety Information and Most Serious Side EffectsValcyte can affect blood cells and bone marrow causing serious and life-threatening problems. Patients’ doctors may do regular blood tests to check blood cells and may change the dose or tell patients to stop taking Valcyte. Patients must tell their doctor right away if they have any unexpected bruising or bleeding, unusual tiredness, fever, lack of energy, dizziness, or fainting.
Valcyte may cause cancer. Valcyte causes cancer in animals. It is not known if Valcyte causes cancer in people.
Valcyte may cause birth defects. Pregnant women who take Valcyte have a higher chance of having a baby with birth defects. Valcyte should not be used during pregnancy.
Women who can get pregnant must use a reliable method of birth control during treatment with Valcyte and continue birth control for at least 30 days after they stop taking Valcyte. Women must tell their doctor right away if they get pregnant or plan to become pregnant while taking Valcyte.
Men must use a condom during treatment with Valcyte, and for at least 90 days after treatment, if their partner can get pregnant. Patients should talk to their doctor if they have questions about birth control.
Valcyte may lower the amount of sperm in a man's body and cause fertility problems. Valcyte may also cause fertility problems in women.
Do not take Cytovene-IV if you are taking VALCYTE. You could overdose and become very sick if VALCYTE is taken with Cytovene-IV. Talk to your healthcare provider or pharmacist if you have questions about your medicine.
Patients should not receive Valcyte if they are allergic to any of its ingredients or if they have ever had a serious reaction to ganciclovir capsules or Cytovene-IV. Symptoms of an allergic reaction to Valcyte may include cold, sudden trouble breathing, wheezing, hives all over the body, swelling around the mouth, or feeling anxious.
Valcyte can affect the kidneys, including serious problems such as kidney failure. The patient’s doctor may do regular blood tests to check kidney function while patients are taking Valcyte.
The doctor may adjust the dose based on these tests.
Patients must not take Valcyte tablets if they are receiving hemodialysis. Patients should talk to their doctor if they are receiving hemodialysis.
Before starting Valcyte, patients should tell their doctor if they:
•are pregnant or plan to become pregnant. It is not known if Valcyte causes birth defects in an unborn baby
•are breast feeding, or plan to breast feed
•have kidney problems or any other medical condition
•have problems with their blood cells
•are taking any prescription or non-prescription medicines, vitamins, and herbal supplements
•are having radiation treatment
•are receiving hemodialysis
Valcyte can cause seizures, sleepiness, dizziness, unsteady movements, and confusion. Patients should not drive a car or operate other dangerous machinery until they know how Valcyte affects them.
Patients must take Valcyte exactly as their doctor prescribes it. Adult patients should use Valcyte tablets, not Valcyte for oral solution. Valcyte must be taken with food. Do not break or crush tablets.
Common side effects of Valcyte in adults and children include: diarrhea, nausea, vomiting, fever, shaky movements (tremors), low blood cell counts in a blood test, and rejection of the transplanted organ (graft).
Other common side effects in children include: headache, upper respiratory tract infection, high blood pressure, and urinary tract infection.
Patients should tell their doctor if they have any side effect that bothers them or that does not go away.
用药温馨提示：当您服用此药物时，需定期接受医疗专业人士的检查，以便随时针对其药效、副作用等情况进行监测。本网站所包含的信息旨在为患者提供帮助，不能代替医学建议和治疗。
药品价格查询,专业药品查询网站,药品说明书查询,药品比价 » 盐酸缬更昔洛韦片VALCYTE 450MG TAB（VALGANCICLOVIR ）说明书
药品价格查询,专业药品查询网站,药品说明书查询,药品比价 » 盐酸缬更昔洛韦片VALCYTE 450MG TAB（VALGANCICLOVIR ）说明书
