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Propofol fumarate tenofovir tablets (velide) (TAF)

Propofol tenofovir fumarate tablets are suitable for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and over, weighing at least 35 kg) (see [pharmacology and toxicology]). More role
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Common name:
Propofol fumarate tenofovir tablets
Product No.:
D14202856835
Approval No.:
H20180060 (inquired by the State Drug Administration)
Jianke price:
¥539.40
Product specification:
25mg * 30 tablets
Manufacturer:
Patheon Inc.
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Product name Propofol fumarate tenofovir tablets (velide) (TAF)
Main raw materials Propyl-2-yl n - [(s) - ({[(2R) - 1 - (6-amino-9h-purin-9-yl) propyl-2-yl] - oxidized} methyl) (phenoxy) phosphoryl] - L-alanine ester, (2e) - butyl-2-enediacid (2:1)
Main role Propofol tenofovir fumarate tablets are suitable for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and over, weighing at least 35 kg) (see [pharmacology and toxicology]).
Product specification 25mg * 30 tablets
Usage and dosage Treatment should be started by a doctor with experience in the management of chronic hepatitis B. Adults and adolescents (aged 12 years and over and weighing at least 35 kg): one tablet once a day. Oral. It should be taken with food. Missed dose If one dose of propofol tenofovir fumarate tablets is missed and the usual medication time is less than 18 hours, the patient should take one dose as soon as possible and return to the normal administration time. If the usual medication time has been exceeded for more than 18 hours, the patient should not take missed medication, but only return to the normal medication time. If a patient vomits within 1 hour after taking propofol tenofovir fumarate tablets, the patient should take another tablet. If a patient vomits more than 1 hour after taking propofol tenofovir fumarate tablets, the patient does not need to take another tablet. Special population aged There is no need to adjust the dose of propofol tenofovir fumarate tablets for patients aged 65 years and older (see [pharmacology and toxicology]). Impairment of renal function There is no need to adjust the dose of propofol tenofovir fumarate tablets for adults or adolescents (aged at least 12 years and weighing at least 35 kg) with an estimated creatinine clearance (CrCl) of ≥ 15 ml / min or patients with CrCl < 15 ml / min and undergoing hemodialysis. On the day of hemodialysis, tenofovir fumarate tablets should be given after hemodialysis treatment (see [pharmacology and toxicology]). For patients with CrCl < 15 ml / min and without hemodialysis, there is no recommended dosage (see [pharmacology and toxicology]). There is no need to adjust the dose of propofol tenofovir fumarate tablets for patients with liver function impairment (see [precautions] and [pharmacology and toxicology]). Children population The safety and efficacy of propofol tenofovir fumarate tablets in children under 12 years of age or weight < 35 kg have not been determined. No data available.
manufacturing enterprise Patheon Inc.
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[drug name] Propofol fumarate tenofovir tablets (velide) (TAF)

[common name] Propofol fumarate tenofovir tablets

[specification and model] 25mg * 30 tablets

[manufacturer] Patheon Inc.

[drug type] Western medicine

[approval No.] H20180060

[validity period] 48 months

[functional indications] Propofol tenofovir fumarate tablets are suitable for the treatment of chronic hepatitis B in adults and adolescents (aged 12 years and over, weighing at least 35 kg) (see [pharmacology and toxicology]).

[usage and dosage] Treatment should be started by a doctor with experience in the management of chronic hepatitis B. Adults and adolescents (aged 12 years and over and weighing at least 35 kg): one tablet once a day. Oral. It should be taken with food. Missed dose If one dose of propofol tenofovir fumarate tablets is missed and the usual medication time is less than 18 hours, the patient should take one dose as soon as possible and return to the normal administration time. If the usual medication time has been exceeded for more than 18 hours, the patient should not take missed medication, but only return to the normal medication time. If a patient vomits within 1 hour after taking propofol tenofovir fumarate tablets, the patient should take another tablet. If a patient vomits more than 1 hour after taking propofol tenofovir fumarate tablets, the patient does not need to take another tablet. Special population aged There is no need to adjust the dose of propofol tenofovir fumarate tablets for patients aged 65 years and older (see [pharmacology and toxicology]). Impairment of renal function There is no need to adjust the dose of propofol tenofovir fumarate tablets for adults or adolescents (aged at least 12 years and weighing at least 35 kg) with an estimated creatinine clearance (CrCl) of ≥ 15 ml / min or patients with CrCl < 15 ml / min and undergoing hemodialysis. On the day of hemodialysis, tenofovir fumarate tablets should be given after hemodialysis treatment (see [pharmacology and toxicology]). For patients with CrCl < 15 ml / min and without hemodialysis, there is no recommended dosage (see [pharmacology and toxicology]). There is no need to adjust the dose of propofol tenofovir fumarate tablets for patients with liver function impairment (see [precautions] and [pharmacology and toxicology]). Children population The safety and efficacy of propofol tenofovir fumarate tablets in children under 12 years of age or weight < 35 kg have not been determined. No data available.

[adverse reactions] Summary of safety characteristics of overseas patients The adverse reaction assessment was based on the pooled safety data from two controlled phase 3 studies in which 866 HBV infected patients were treated with propofol tenofovir 25 mg once daily until week 96 in a double-blind manner (the median duration of blind study drug exposure was 104 weeks). The most frequently reported adverse reactions were headache (12%), nausea (6%) and fatigue (6%). After 96 weeks, the patient continued to receive his original blind treatment or open label propofol tenofovir fumarate tablets. No other adverse reactions of propofol tenofovir fumarate tablets were found in the subgroup of subjects treated with open label propofol tenofovir fumarate tablets from week 96 to week 120 of the double-blind period (see [pharmacology and toxicology]). Summary of adverse reactions The following adverse drug reactions have been found when propofol tenofovir is used in patients with chronic hepatitis B (Table 1). Based on the analysis of the 96th week of overseas research, the adverse reactions are listed according to the classification and frequency of body systems and organs. The frequency is defined as follows: very common (≥ 1 / 10), common (≥ 1 / 100 to < 1 / 10), rare (≥ 1 / 1000 to < 1 / 100), rare (≥ 1 / 10000 to < 1 / 1000) or very rare (< 1 / 10000). Table 1: adverse reactions found in overseas subjects when using propofol tenofovir Systematic organ classification frequency Adverse reaction Gastrointestinal diseases common Diarrhea, vomiting, nausea, abdominal pain, abdominal distention, flatulence Systemic diseases and medication site common fatigue Nervous system diseases Very common headache common dizzy Skin and subcutaneous tissue diseases common Rash and pruritus Hepatobiliary diseases common Increased alanine aminotransferase Musculoskeletal and connective tissue diseases Common joint pain Safety characteristics of Chinese mainland patients The adverse reactions in Chinese mainland patients were evaluated based on 2 3 phase studies (227 Chinese mainland patients with HBV infection received 25 mg daily daily of propofol tenofovir), and the safety data were analyzed from ninety-sixth to 6 weeks. The safety characteristics of propofol tenofovir in Chinese mainland patients with HBV infection are basically consistent with the safety characteristics observed in 2 overseas 3 phase studies. Chinese mainland patients did not stop treatment with propofol and tenofovir for adverse events. Report of suspected adverse reactions The report of suspected adverse reactions after drug approval is very important. In this way, the benefit / risk balance of the use of the drug can be continuously monitored. In China, healthcare professionals are required to report any suspected adverse reactions through the national reporting system.

[precautions] 1、肝炎恶化 停止治疗后突发 警告:已有报告指出,停止乙型肝炎治疗的患者出现了肝炎急性加重的情况(通常与血浆中 HBV DNA 水平升高相关)。大部分病例属于自限型,但严重加重的情况(包括致命性结局)可能在停止乙型肝炎治疗之后出现。应在停止乙型肝炎治疗至少6 个月内,通过临床和实验室随访定期进行肝功能监测。如果合适,可能需要恢复乙型肝炎治疗。 在进展期肝病或肝硬化患者中,不建议停止治疗,因为治疗后肝炎加重可能导致肝功能失代偿。在失代偿期肝病患者中,肝病突发尤其严重,有时甚至致命。 治疗期间突发 慢性乙型肝炎自发性加重相对较为常见,特点是血清丙氨酸氨基转移酶 (ALT) 短暂增加。开始抗病毒治疗后,一些患者的血清 ALT 可能有所增加。在代偿性肝病患者中,此类血清 ALT 增加通常不伴有血清胆红素浓度增加或肝功能失代偿。肝硬化患者在肝炎恶化后出现肝功能失代偿的风险可能更高,因此,应在治疗期间加以严密监测。 2、HBV 传播 必须告知患者富马酸丙酚替诺福韦片不能预防通过性接触或血液污染的方式传播 HBV 的风险。必须继续采取适当预防措施。 3、失代偿性肝病患者 对于患有失代偿性肝病以及 Child Pugh Turcotte (CPT) 评分 >9 (i.e. grade C) HBV infected patients, there is no data on the safety and efficacy of propofol tenofovir fumarate tablets. These patients may have a higher risk of severe liver or kidney adverse reactions. Therefore, the indexes and parameters of liver, gallbladder and kidney of this patient population should be closely monitored (see [pharmacology and toxicology]). 4. Lactic acidosis / severe fatty hepatomegaly Lactic acidosis and severe fatty hepatomegaly have been reported, including fatal cases, when treated with nucleoside analogues alone (including tenofovir fumarate or other tenofovir precursors) or in combination with other antiretroviral drugs. If the clinical or laboratory results of any patient suggest lactic acidosis or significant hepatotoxicity (which may include hepatomegaly and steatosis, even if there is no significant increase in transaminase), the treatment of propofol tenofovir fumarate tablets should be suspended. 5. Impairment of renal function Creatinine clearance< 30 mL/min 的患者 在 CrCl ≥ 15 mL/min 但 < 30 mL/min 的患者以及 CrCl < 15 mL/min 且正在接受血液透析的患者中,每日一次富马酸丙酚替诺福韦片的使用是基于极为有限的药代动力学数据和建模与模拟而确定。尚无使用富马酸丙酚替诺福韦片治疗 CrCl < 30 mL/min 的 HBV 感染患者的安全性数据。 不推荐富马酸丙酚替诺福韦片用于 CrCl < 15 mL/min 且未接受血液透析的患者(参见【用法用量】)。 6、肾毒性 无法排除丙酚替诺福韦给药导致长期暴露于低水平替诺福韦而引起肾毒性的潜在风险(请参见【药理毒理】)。 7、合并感染 HBV 和丙型肝炎或丁型肝炎病毒的患者 尚无关于富马酸丙酚替诺福韦片在合并感染丙型肝炎或丁型肝炎病毒患者中的安全性和疗效的数据。应遵循关于丙型肝炎治疗的联合用药指南(参见【药物相互作用】)。 8、乙型肝炎和 HIV 合并感染 由于存在出现 HIV 耐药性的风险,不建议将富马酸丙酚替诺福韦片用于 HIV-1 感染的治疗。尚未确定富马酸丙酚替诺福韦片在合并感染 HIV-1 和 HBV 的患者中的安全性和疗效。在开始富马酸丙酚替诺福韦片治疗前,应为所有 HBV 感染患者进行HIV 抗体检测,如果为阳性,应使用为合并感染 HIV-1 的患者推荐的相应抗逆转录病毒联合方案。 9、与其他药品合用 富马酸丙酚替诺福韦片不应与含丙酚替诺福韦、富马酸替诺福韦酯或阿德福韦酯的产品合用。 10、乳糖不耐受 富马酸丙酚替诺福韦片含有α乳糖。因此,患有半乳糖不耐受、Lapp 乳糖酶缺乏症或葡萄糖-半乳糖吸收不良的罕见遗传问题的患者不应服用此药品。 11、对驾驶及操作机械能力的影响 富马酸丙酚替诺福韦片对驾驶和操作机械的能力无影响或影响可忽略。应该告知患者在富马酸丙酚替诺福韦片治疗期间已有头晕报告。

[taboo] Allergic to active ingredients or any of the following excipients: α Lactose, microcrystalline cellulose, sodium cross-linked carboxymethyl cellulose, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc powder and iron oxide yellow.

[listing Permit Holder] Gilead Sciences Ireland UC

[packaging unit] box

[main ingredients] Propyl-2-yl n - [(s) - ({[(2R) - 1 - (6-amino-9h-purin-9-yl) propyl-2-yl] - oxidized} methyl) (phenoxy) phosphoryl] - L-alanine ester, (2e) - butyl-2-enediacid (2:1)

[character] This product is yellow and round film coated tablets. After removing the coating, it is white or off white. The tablet has a diameter of 8 mm, with "GSI" engraved on one side and "25" engraved on the other side.

[applicable population] adult

[medication for pregnant and lactating women] gestation There are no data on the use of propofol tenofovir in pregnant women or such data are very limited (less than 300 pregnancy outcomes). However, a large number of data on pregnant women (more than 1000 exposure outcomes) show that there are no malformations or fetal / neonatal toxicity associated with tenofovir fumarate. With regard to reproductive toxicity, animal studies have not shown direct or indirect harmful effects (see [pharmacology and toxicology]). If necessary, consider using propofol fumarate tenofovir tablets during pregnancy. lactation It is unclear whether propofol tenofovir is secreted into human milk. However, animal studies have shown that tenofovir can be secreted into milk. Insufficient information on the effects of tenofovir in newborns / infants. Risks to lactating children cannot be excluded. Therefore, propofol fumarate and tenofovir tablets should not be used during lactation. fertility There is no data on the effect of propofol tenofovir fumarate tablets on human fertility. Animal studies have not shown that propofol tenofovir has a harmful effect on fertility.

[medication for children] The safety and efficacy of propofol tenofovir fumarate tablets in children under 12 years of age or weight < 35 kg have not been determined. No data available.

[medication for elderly patients] There is no need to adjust the dose of propofol tenofovir fumarate tablets for patients aged 65 years and older (see [pharmacology and toxicology]).

[storage] Storage below 30 ° C

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    Propofol fumarate tenofovir tablets (velide) (TAF)

    ¥539.40

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