Neulasta（Pegfilgrastim）注射是一种人造蛋白质，刺激称为中性粒细胞的白细胞在身体里生长。白血细胞帮助人体抵抗感染的危害。 Neulasta®（Pegfilgrastim）注射用于治疗白细胞减少，治疗某些接受癌症化疗引起的白血球缺乏。也用在除了骨髓癌的其他癌症。 Neulasta®（培非司亭）注射，皮下使用 美国首次批准：2002  公司：Amgen 目前的主要变化 剂量和给药方法  12/2014 警告和注意事项  12/2014 适应症和用法 Neulasta是表示降低感染的发病率，其表现发热性中性粒细胞减少，患者接收与发热性中性粒细胞减少的临床显著发病率骨髓抑制抗癌药物的非髓系恶性血液病白细胞生长因子。 Neulasta未指示对外周血祖细胞的动员造血干细胞移植。 用法用量 6毫克每化疗周期皮下注射一次。 难道前14天，细胞毒性化疗的给药后24小时无法管理。 剂型和规格 注射：6毫克/在单次使用预充液注射器为仅手动使用0.6mL的溶液。 注射：6毫克/在一个单一的预充式注射器共同封装与在体喷油器Neulasta 0.6mL的溶液。 禁忌 不要给予Neulasta给患者带来严重的过敏反应培非司亭或格司亭的历史。 警告和注意事项 严重可发生脾破裂。评估脾肿大或脾破裂患者左上腹或肩部疼痛。 急性呼吸窘迫综合征（ARDS），可能会发生。评估在谁出现发热，肺浸润，或呼吸窘迫的病人急性呼吸窘迫综合征。在ARDS患者停止Neulasta。 严重的过敏反应，包括过敏性休克，可以发生。永久停止Neulasta的患者有严重的过敏反应。 在体喷油器Neulasta使用丙烯酸类粘合剂。对于谁拥有反应丙烯酸粘合剂的患者，使用本产品可能导致显著反应 严重的有时甚至是致命的镰状细胞危机可能发生。 不良反应 最常见的不良反应（发生率≥5％的差异）的安慰剂对照临床试验是骨骼疼痛和痛苦，肢体。 特殊人群中使用 妊娠：根据动物实验数据，可能会对胎儿造成伤害。鼓励医生致电1-800-772-6436（1-800-77-AMGEN）招收妊娠患者在Amgen公司的妊娠监察计划。 哺乳母亲：当给予哺乳妇女应谨慎。 儿童用药：Neulasta的安全性和有效性尚未确定。 老年用药：在安全性或有效性总体差别患者65岁及以上的变化。 肾损害：无需调整剂量。 Neulasta® (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. NeulastaPronunciation Generic Name: pegfilgrastim Dosage Form: injection Indications and Usage for Neulasta Neulasta is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia [see Clinical Studies (14)]. Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Neulasta Dosage and Administration The recommended dosage of Neulasta is a single subcutaneous injection of 6 mg administered once per chemotherapy cycle in adults. Do not administer Neulasta between 14 days before and 24 hours after administration of cytotoxic chemotherapy. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not administer Neulasta if discoloration or particulates are observed. NOTE: The needle cover on the single-use prefilled syringe contains dry natural rubber (latex); persons with latex allergies should not administer this product. Dosage Forms and Strengths 6 mg per 0.6 mL in single use prefilled syringe Contraindications Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Warnings and Precautions Splenic Rupture Splenic rupture, including fatal cases, can occur following the administration of Neulasta. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta. Acute Respiratory Distress Syndrome Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta, for ARDS. Discontinue Neulasta in patients with ARDS. Serious Allergic Reactions Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta. The majority of reported events occurred upon initial exposure. Allergic reactions, including anaphylaxis, can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta in patients with serious allergic reactions. Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Use in Patients With Sickle Cell Disorders Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim. Potential for Tumor Growth Stimulatory Effects on Malignant Cells The granulocyte-colony stimulating factor (G-CSF) receptor through which pegfilgrastim and filgrastim act has been found on tumor cell lines. The possibility that pegfilgrastim acts as a growth factor for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which pegfilgrastim is not approved, cannot be excluded. Adverse Reactions The following serious adverse reactions are discussed in greater detail in other sections of the labeling: •Splenic Rupture [See Warnings and Precautions (5.1)] •Acute Respiratory Distress Syndrome [See Warnings and Precautions (5.2)] •Serious Allergic Reactions [See Warnings and Precautions (5.3)] •Use in Patients with Sickle Cell Disorders [See Warnings and Precautions (5.4)] •Potential for Tumor Growth Stimulatory Effects on Malignant Cells [See Warnings and Precautions (5.5)] The most common adverse reactions occurring in ≥ 5% of patients and with a between-group difference of ≥ 5% higher in the pegfilgrastim arm in placebo controlled clinical trials are bone pain and pain in extremity. Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Neulasta clinical trials safety data are based upon 932 patients receiving Neulasta in seven randomized clinical trials. The population was 21 to 88 years of age and 92% female. The ethnicity was 75% Caucasian, 18% Hispanic, 5% Black, and 1% Asian. Patients with breast (n = 823), lung and thoracic tumors (n = 53) and lymphoma (n = 56) received Neulasta after nonmyeloablative cytotoxic chemotherapy. Most patients received a single 100 mcg/kg (n = 259) or a single 6 mg (n = 546) dose per chemotherapy cycle over 4 cycles. The following adverse reaction data in Table 1 are from a randomized, double-blind, placebo-controlled study in patients with metastatic or non-metastatic breast cancer receiving docetaxel 100 mg/m2 every 21 days (Study 3). A total of 928 patients were randomized to receive either 6 mg Neulasta (n = 467) or placebo (n = 461). The patients were 21 to 88 years of age and 99% female. The ethnicity was 66% Caucasian, 31% Hispanic, 2% Black, and <1% Asian, Native American or other. Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients. Table 1. Adverse Reactions With ≥ 5% Higher Incidence in Neulasta Patients Compared to Placebo in Study 3 System Organ Class Preferred Term  Placebo (N= 461)  Neulasta 6 mg SC on Day 2 (N= 467) Musculoskeletal and connective tissue disorders Bone pain 26% 31% Pain in extremity 4% 9% Leukocytosis In clinical studies, leukocytosis (WBC counts > 100 x 109/L) was observed in less than 1% of 932 patients with non-myeloid malignancies receiving Neulasta. No complications attributable to leukocytosis were reported in clinical studies. Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. Binding antibodies to pegfilgrastim were detected using a BIAcore assay. The approximate limit of detection for this assay is 500 ng/mL. Pre-existing binding antibodies were detected in approximately 6% (51/849) of patients with metastatic breast cancer. Four of 521 pegfilgrastim-treated subjects who were negative at baseline developed binding antibodies to pegfilgrastim following treatment. None of these 4 patients had evidence of neutralizing antibodies detected using a cell-based bioassay. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay, and the observed incidence of antibody positivity in an assay may be influenced by several factors, including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to Neulasta with the incidence of antibodies to other products may be misleading. Postmarketing Experience The following adverse reactions have been identified during post approval use of Neulasta. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) reported frequency of the reaction, or (3) strength of causal relationship to Neulasta. Gastro-intestinal disorders: Splenic rupture [see Warnings and Precautions (5.1)] Blood and lymphatic system disorder: Sickle cell crisis [see Warnings and Precautions (5.4)] Hypersensitivity reactions: Allergic reactions/hypersensitivity, including anaphylaxis, skin rash, and urticaria, generalized erythema and flushing [see Warnings and Precautions (5.3)] Respiratory, thoracic, and mediastinal disorder: ARDS [see Warnings and Precautions (5.2)] General disorders and administration site conditions: Injection site reactions Skin and subcutaneous tissue disorders: Sweet’s syndrome, Cutaneous vasculitis Drug Interactions No formal drug interaction studies between Neulasta and other drugs have been performed. Increased hematopoietic activity of the bone marrow in response to growth factor therapy may result in transiently positive bone-imaging changes. Consider these findings when interpreting bone-imaging results. USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Pegfilgrastim was embryotoxic and increased pregnancy loss in pregnant rabbits that received cumulative doses approximately 4 times the recommended human dose (based on body surface area). Signs of maternal toxicity occurred at these doses. Neulasta should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus. In animal reproduction studies, when pregnant rabbits received pegfilgrastim at cumulative doses approximately 4 times the recommended human dose (based on body surface area), increased embryolethality and spontaneous abortions occurred. Signs of maternal toxicity (reductions in body weight gain/food consumption) and decreased fetal weights occurred at maternal doses approximately equivalent to the recommended human dose (based on body surface area). There were no structural anomalies observed in rabbit offspring at any dose tested. No evidence of reproductive/developmental toxicity occurred in the offspring of pregnant rats that received cumulative doses of pegfilgrastim approximately 10 times the recommended human dose (based on body surface area) [see Nonclinical Toxicology (13.3)]. Women who become pregnant during Neulasta treatment are encouraged to enroll in Amgen’s Pregnancy Surveillance Program. Patients or their physicians should call 1-800-77-AMGEN (1-800-772-6436) to enroll. Nursing Mothers It is not known whether pegfilgrastim is secreted in human milk. Other recombinant G-CSF products are poorly secreted in breast milk and G-CSF is not orally absorbed by neonates. Caution should be exercised when administered to a nursing woman. Pediatric Use Safety and effectiveness of Neulasta in pediatric patients have not been established. The adverse reaction profile and pharmacokinetics of pegfilgrastim were studied in 37 pediatric patients with sarcoma. The mean (± standard deviation [SD]) systemic exposure (AUC0-inf) of pegfilgrastim after subcutaneous administration at 100 mcg/kg was 22.0 (± 13.1) mcg·hr/mL in the 6 to 11 years age group (n = 10), 29.3 (± 23.2) mcg·hr/mL in the 12 to 21 years age group (n = 13), and 47.9 (± 22.5) mcg·hr/mL in the youngest age group (0 to 5 years, n = 11). The terminal elimination half-lives of the corresponding age groups were 20.2 (± 11.3) hours, 21.2 (± 16.0) hours, and 30.1 (± 38.2) hours, respectively. The most common adverse reaction was bone pain. Geriatric Use Of the 932 patients with cancer who received Neulasta in clinical studies, 139 (15%) were age 65 and over, and 18 (2%) were age 75 and over. No overall differences in safety or effectiveness were observed between patients age 65 and older and younger patients. Renal Impairment In a study of 30 subjects with varying degrees of renal dysfunction, including end stage renal disease, renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. Therefore, pegfilgrastim dose adjustment in patients with renal dysfunction is not necessary [Clinical Pharmacology (12.3)]. Overdosage The maximum amount of Neulasta that can be safely administered in single or multiple doses has not been determined. Single subcutaneous doses of 300 mcg/kg have been administered to 8 healthy volunteers and 3 patients with non-small cell lung cancer without serious adverse effects. These patients experienced a mean maximum absolute neutrophil count (ANC) of 55 x 109/L, with a corresponding mean maximum WBC of 67 x 109/L. The absolute maximum ANC observed was 96 x 109/L with a corresponding absolute maximum WBC observed of 120 x 109/L. The duration of leukocytosis ranged from 6 to 13 days. The effectiveness of leukapheresis in the management of symptomatic individuals with Neulasta-induced leukocytosis has not been studied. Neulasta Description Neulasta (pegfilgrastim) is a covalent conjugate of recombinant methionyl human G-CSF (filgrastim) and monomethoxypolyethylene glycol. Filgrastim is a water-soluble 175 amino acid protein with a molecular weight of approximately 19 kilodaltons (kD). Filgrastim is obtained from the bacterial fermentation of a strain of E coli transformed with a genetically engineered plasmid containing the human G-CSF gene. To produce pegfilgrastim, a 20 kD monomethoxypolyethylene glycol molecule is covalently bound to the N-terminal methionyl residue of filgrastim. The average molecular weight of pegfilgrastim is approximately 39 kD. Neulasta is supplied in 0.6 mL prefilled syringes for subcutaneous injection. Each syringe contains 6 mg pegfilgrastim (based on protein weight) in a sterile, clear, colorless, preservative-free solution (pH 4.0) containing acetate (0.35 mg), polysorbate 20 (0.02 mg), sodium (0.02 mg), and sorbitol (30 mg) in Water for Injection, USP. Neulasta - Clinical Pharmacology Mechanism of Action Pegfilgrastim is a colony-stimulating factor that acts on hematopoietic cells by binding to specific cell surface receptors, thereby stimulating proliferation, differentiation, commitment, and end cell functional activation. Pharmacokinetics The pharmacokinetics of pegfilgrastim were studied in 379 patients with cancer. The pharmacokinetics of pegfilgrastim were nonlinear and clearance decreased with increases in dose. Neutrophil receptor binding is an important component of the clearance of pegfilgrastim, and serum clearance is directly related to the number of neutrophils. In addition to numbers of neutrophils, body weight appeared to be a factor. Patients with higher body weights experienced higher systemic exposure to pegfilgrastim after receiving a dose normalized for body weight. A large variability in the pharmacokinetics of pegfilgrastim was observed. The half-life of Neulasta ranged from 15 to 80 hours after subcutaneous injection. No gender-related differences were observed in the pharmacokinetics of pegfilgrastim, and no differences were observed in the pharmacokinetics of geriatric patients (≥ 65 years of age) compared with younger patients (< 65 years of age) [see Use in Specific Populations (8.5)]. The pharmacokinetics of pegfilgrastim were studied in pediatric patients with sarcoma [see Use in Specific Populations (8.4)]. Renal dysfunction had no effect on the pharmacokinetics of pegfilgrastim. [see Use in Specific Populations (8.6)]. The pharmacokinetic profile in patients with hepatic insufficiency has not been assessed. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity or mutagenesis studies have been performed with pegfilgrastim. Pegfilgrastim did not affect reproductive performance or fertility in male or female rats at cumulative weekly doses approximately 6 to 9 times higher than the recommended human dose (based on body surface area). Reproductive and Developmental Toxicology Pregnant rabbits were dosed with pegfilgrastim subcutaneously every other day during the period of organogenesis. At cumulative doses ranging from the approximate human dose to approximately 4 times the recommended human dose (based on body surface area), treated rabbits exhibited decreased maternal food consumption, maternal weight loss, as well as reduced fetal body weights and delayed ossification of the fetal skull; however, no structural anomalies were observed in the offspring from either study. Increased incidences of post-implantation losses and spontaneous abortions (more than half the pregnancies) were observed at cumulative doses approximately 4 times the recommended human dose, which were not seen when pregnant rabbits were exposed to the recommended human dose. Three studies were conducted in pregnant rats dosed with pegfilgrastim at cumulative doses up to approximately 10 times the recommended human dose at the following stages of gestation: during the period of organogenesis, from mating through the first half of pregnancy, and from the first trimester through delivery and lactation. No evidence of fetal loss or structural malformations was observed in any study. Cumulative doses equivalent to approximately 3 and 10 times the recommended human dose resulted in transient evidence of wavy ribs in fetuses of treated mothers (detected at the end of gestation but no longer present in pups evaluated at the end of lactation). Clinical Studies Neulasta was evaluated in three randomized, double blind, controlled studies. Studies 1 and 2 were active-controlled studies that employed doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic breast cancer. Study 1 investigated the utility of a fixed dose of Neulasta. Study 2 employed a weight-adjusted dose. In the absence of growth factor support, similar chemotherapy regimens have been reported to result in a 100% incidence of severe neutropenia (ANC < 0.5 x 109/L) with a mean duration of 5 to 7 days and a 30% to 40% incidence of febrile neutropenia. Based on the correlation between the duration of severe neutropenia and the incidence of febrile neutropenia found in studies with filgrastim, duration of severe neutropenia was chosen as the primary endpoint in both studies, and the efficacy of Neulasta was demonstrated by establishing comparability to filgrastim-treated patients in the mean days of severe neutropenia. In Study 1, 157 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) on day 2 of each chemotherapy cycle or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. In Study 2, 310 patients were randomized to receive a single subcutaneous injection of Neulasta (100 mcg/kg) on day 2 or daily subcutaneous filgrastim (5 mcg/kg/day) beginning on day 2 of each chemotherapy cycle. Both studies met the major efficacy outcome measure of demonstrating that the mean days of severe neutropenia of Neulasta-treated patients did not exceed that of filgrastim-treated patients by more than 1 day in cycle 1 of chemotherapy. The mean days of cycle 1 severe neutropenia in Study 1 were 1.8 days in the Neulasta arm compared to 1.6 days in the filgrastim arm [difference in means 0.2 (95% CI -0.2, 0.6)] and in Study 2 were 1.7 days in the Neulasta arm compared to 1.6 days in the Filgrastim arm [difference in means 0.1 (95% CI -0.2, 0.4)]. A secondary endpoint in both studies was days of severe neutropenia in cycles 2 through 4 with results similar to those for cycle 1. Study 3 was a randomized, double-blind, placebo-controlled study that employed docetaxel 100 mg/m2 administered every 21 days for up to 4 cycles for the treatment of metastatic or non-metastatic breast cancer. In this study, 928 patients were randomized to receive a single subcutaneous injection of Neulasta (6 mg) or placebo on day 2 of each chemotherapy cycle. Study 3 met the major trial outcome measure of demonstrating that the incidence of febrile neutropenia (defined as temperature ≥ 38.2°C and ANC ≤ 0.5 x109/L) was lower for Neulasta-treated patients as compared to placebo-treated patients (1% versus 17%, respectively, p < 0.001). The incidence of hospitalizations (1% versus 14%) and IV anti-infective use (2% versus 10%) for the treatment of febrile neutropenia was also lower in the Neulasta-treated patients compared to the placebo-treated patients. How Supplied/Storage and Handling Neulasta is supplied in a prefilled single use syringe containing 6 mg pegfilgrastim, supplied with a 27-gauge, 1/2-inch needle with an UltraSafe® Needle Guard. The needle cover of the prefilled syringe contains dry natural rubber (a derivative of latex). Neulasta is provided in a dispensing pack containing one syringe (NDC 55513-190-01). Store refrigerated between 2° to 8°C (36° to 46°F) in the carton to protect from light. Do not shake. Discard syringes stored at room temperature for more than 48 hours. Avoid freezing; if frozen, thaw in the refrigerator before administration. Discard syringe if frozen more than once. 聚乙二醇化非格司亭（Neulasta）。Neulasta学名pegfilgrastim，中文名聚乙二醇化非格司亭，由美国Amgen公司研发。Neulasta于2002年1月22日获美国食物与药品管理局（FDA）批准，4月9日，Neulasta在美国首次上市，当年就获4.635亿美元销售额佳绩，创2002年入市美国新药销售额/年的最高记录。同年8月，该产品在欧洲和澳大利亚以相似的适应症获准上市。 新药Neulasta(TM) (pegfilgrastim)通过美国食品与药品管理局（FDA）的审批。Neulasta在每个化疗疗程中只需要使用一次，主要适应征是用于减低化疗过程中感染的发生率,这种感染常常表现为中性粒细胞减少症相关的发热(即发热与抗感染的白细胞数量的严重下降有关)。中性粒细胞是白细胞的一种，在人体抵抗病原微生物感染中发挥着重要的作用。在非骨髓来源的恶心肿瘤肿瘤患者的化疗过程中，化疗药物也会引起髓系粒细胞的抑制作用，因而会出现中性粒细胞减少症，常常会增加临床中性粒细胞减少症相关的发热的发病率。中性粒细胞减少症是大多数肿瘤化疗中最常见也是最严重的一种并发症。有超过一半的肿瘤患者会在化疗中出现严重的中性粒细胞减少症，这使得他们极易发生严重的危及生命的感染。平均只有不到10%的患者在化疗前接受过预防中性粒细胞减少症的治疗，研究表明30%-40%未接受此方面预防治疗的化疗患者将会出现带有发热症状的中性粒细胞减少症。 每年都有数千患者因为中性粒细胞减少症及其并发症而就医,并且会因此而需要重新住院治疗。 Neulasta每个化疗疗程只用一次，减少了频繁注射给患者带来的痛苦以及医生与患者相聚带来感染的几率，也不用在化疗期间由于严重的感染疾病而频繁中断治疗。现在通过审批表明成千上万的化疗患者可以在每一轮化疗出现感染并发症之前使用Neulasta进行保护，从而减少了化疗风险。''Neulasta Neulasta(TM)是一种蛋白质，它可以刺激抗感染的白细胞(中性粒细胞)的产生。而中性粒细胞正是化疗的细胞毒性作用的对象。 ------------------------------------------------------------------- 产地国家: 美国 原产地英文商品名: NEULASTA 6MG/0.6ML/SYRINGE 原产地英文药品名: PEGFILGRASTIM 中文参考商品译名: 纽拉思塔 6毫克/0.6毫升/注射器 中文参考药品译名: 培非格司亭 生产厂家中文参考译名: 安进 生产厂家英文名: Amgen --------------------------------------------------------- 产地国家: 德国 原产地英文商品名: NEULASTA 6MG/0.6ML/SYRINGE 原产地英文药品名: PEGFILGRASTIM 中文参考商品译名: 纽拉思塔 6毫克/0.6毫升/注射器 中文参考药品译名: 培非格司亭 生产厂家中文参考译名: 安进 生产厂家英文名: Amgen --------------------------------------------------------- 产地国家: 西班牙 原产地英文商品名: NEULASTA 6MG/0.6ML/SYRINGE 原产地英文药品名: PEGFILGRASTIM 中文参考商品译名: 纽拉思塔 6毫克/0.6毫升/注射器 中文参考药品译名: 培非格司亭 生产厂家中文参考译名: 安进 生产厂家英文名: Amgen --------------------------------------------------------- 产地国家: 意大利 原产地英文商品名: NEULASTA 6MG/0.6ML/SYRINGE 原产地英文药品名: PEGFILGRASTIM 中文参考商品译名: 纽拉思塔 6毫克/0.6毫升/注射器 中文参考药品译名: 培非格司亭 生产厂家中文参考译名: 安进 生产厂家英文名: Amgen