塞替派注射剂|Thiotepa(Thiotepa Injection)

简介： 塞替派注射粉剂|Thioplex（thiotepa）【药物名称】中文通用名称：塞替派英文通用名称：Thiotepa其它名称：二胺硫磷、硫替哌、三胺硫磷、三乙撑硫代磷酰胺、三乙烯硫化磷酰胺、室安的宝、息安的宝、Led ...
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部份中文塞替派处方资料（仅供参考） 临床应用 0 w* ]; \* J) b9 e主要用于治疗乳腺癌、卵巢癌、膀胱癌(局部灌注)及癌性体腔积液(腔内注射)等，也曾用于治疗原发性肝癌、子宫颈癌、黑色素瘤、胃肠道肿瘤等。 2 L' \! \0 C7 n7 K注意事项 ( u4 r/ N" {8 ^, Z' N* x1、妊娠初期的3个月应避免使用此药，因其有致突变或致畸胎作用，可增加胎儿死亡及先天性畸形。 ( c7 V/ u# K  A  m" H( `  J2、下列情况应慎用或减量使用：骨髓抑制、肝功能损害、感染、肾功能损害、肿瘤细胞浸润骨髓、有泌尿系结石史和痛风病史。 3、用药期间每周都要定期检查外周血象，白细胞与血小板及肝、肾功能。 3 @! J- w( h2 }! \& V停药后3周内应继续进行相应检查，已防止出现持续的严重骨髓抑制4、肝肾功能较差时，塞替派注射液应用较低的剂量。 5、在白血病、淋巴瘤病人中为防止尿酸性肾病或高尿酸血症，可给予大量补液（或）给予别嘌呤醇。 6、尽量减少与其它烷化剂联合使用，或同时接受放疗。 用法与用量 静脉或肌肉注射（单一用药）：一次10mg（0.2mg/kg）每日一次，连续5天后改为每周3次，一疗程总量300mg。 ( c. m  y6 k& p) T, Y9 a胸腹腔或心包腔内注射：一次10～30mg，每周1～2次。 膀胱腔内灌注：每次排空尿液后将导尿管插入膀胱内向腔内注入60mg，溶于生理盐水60ml，每周1～2次，10次为一疗程。 3 k! D7 j/ _8 N) |" a& `动脉注射：每次10～20mg用法同静脉。 禁忌症 对塞替派注射液过敏者，有严重肝肾功能损害，严重骨髓抑制者 孕妇、哺乳期妇女用药注意事项 不向孕妇推荐此药，可能有致畸性。尚没有对受乳婴儿影响的报道。 5 a. O# [' z' o+ Q9 F1 X不良反应 骨髓抑制是最常见的剂量限制毒性，多在用药后l～6周发生，停药后大多数可恢复。有些病例在疗程结束时开始下降，少数病例抑制时间较长。可有食欲减退、恶心及呕吐等胃肠反应。 & b, L" g1 e  C个别报道用此药后再接受手术麻醉时，用琥珀酰胆碱后出现呼吸暂停。少见过敏，个别有发热及皮疹。有少量报告有出血性膀胱炎，注射部位疼痛，头痛、头晕，闭经、影响精子形成。 药物相互作用 2 A* W2 g" V& `: i- g" y- v! B1、塞替派可增加血尿酸水平，为了控制高尿酸血症可给予别嘌呤醇。 7 w4 }& Z7 m0 s" X& d) d7 c- O) e3 u9 p2、与放疗同时应用时，应适当调整剂量。 3、与琥珀胆碱同时应用可使呼吸暂停延长，在接受塞替派治疗的病人，应用琥珀胆碱前必须测定血中假胆碱酯酶水平。 7 y1 \5 x) A4 d; |9 w% _4、与尿激酶同时应用可增加塞替派治疗膀胱癌的疗效，尿激酶为纤维蛋白溶酶原的活化剂，可增加药物在肿瘤组织中的浓度。 8 e- L/ z5 v9 @/ j药理 8 x0 b) Y& @1 K: N塞替派为细胞周期非特异性药物，在生理条件下，形成不稳定的亚乙基亚胺基，具有较强的细胞毒作用。塞替派是多功能烷化剂，能抑制核酸的合成，与DNA发生交叉联结，干扰DNA和RNA的功能，改变DNA的功能，故也可引起突变。 6 A0 v# N# o3 |8 q( ?# A体外试验显示可引起染色体畸变，在小鼠的研究中可清楚看到有致癌性，但对人尚不十分清楚。近年来证明塞替派注射液对垂体促卵泡激素含量有影响。 药物代谢动力学 6 C9 R. B8 L, l' `/ l塞替派注射液不宜从消化道吸收。注射后广泛分布在各组织内。1～4小时后血浆浓度下降90%，24～48小时大部分药物通过肾脏排出。注射药物后血浆蛋白结合率为10%，主要和白蛋白、脂蛋白结合，对白蛋白亲和力最大。T1/2约3小时。尚无资料说明药物能否通过胎盘屏障。 ( ^, ]; E# [- y- \用药过量 药物过量后没有解毒药物。以往出现骨髓毒性后建议输注全血或白细胞、血小板悬液。目前，白细胞下降可使用粒细胞集落刺激因子。 ' C. b6 {8 c6 J8 F9 _1 }2 x                                登录/注册后可看大图 SPL UNCLASSIFIED SECTION Rx ONLY ; p" n% o$ }/ l! A8 L& d, D4 RDESCRIPTION Thiotepa for Injection, USP is an ethylenimine-type compound. It is supplied as a non-pyrogenic, sterile Iyophilized powder for intravenous, intracavitary or intravesical administration, containing 15 mg of thiotepa. Thiotepa is a synthetic product with antitumor activity. The chemical name for thiotepa is Tris(1-aziridinyl)phosphine sulfide. Thiotepa has the following structural formula:                                 登录/注册后可看大图 Thiotepa has the molecular formula C6H12N3PS, and a molecular weight of 189.22. When reconstituted with sterile water for injection, the resulting solution has a pH of approximately 5.5 to 7.5. Thiotepa is stable in alkaline medium and unstable in acid medium. CLINICAL PHARMACOLOGY Thiotepa is a cytotoxic agent of the polyfunctional type, related chemically and pharmacologically to nitrogen mustard. The radiomimetic action of thiotepa is believed to occur through the release of ethylenimine radicals which, like irradiation, disrupt the bonds of DNA. One of the principal bond disruptions is initiated by alkylation of guanine at the N-7 position, which severs the linkage between the purine base and the sugar and liberates alkylated guanines. The pharmacokinetics of thiotepa and TEPA in thirteen female patients (45 to 84 years) with advanced stage ovarian cancer receiving 60 mg and 80 mg thiotepa by intravenous infusion on subsequent courses given at 4-week intervals are presented in the following table: 0 M; G( b/ O! _: w+ m# W Mean ± SEM Pharmacokinetic Parameters Thiotepa TEPA (units) 60 mg 80 mg 60 mg 80 mg Peak Serum concentration (ng/mL) 1331 ± 119 1828 ± 135 273 ± 46 353 ± 46 Elimination half-life (h) 2.4 ± 0.3 2.3 ± 0.3 17.6 ± 3.6 15.7 ± 2.7 Area under the curve (ng/h/mL) 2832 ± 412 4127 ± 668 4789 ± 1022 7452 ± 1667 Total body clearance (mL/min) 446 ± 63 419 ± 56 TEPA, which possesses cytotoxic activity, appears to be the major metabolite of thiotepa found in human serum and urine. Urinary excretion of 14C-labeled thiotepa and metabolites in a 34 year old patient with metastatic carcinoma of the cecum who received a dose of 0.3 mg/kg intravenously was 63%. Thiotepa and TEPA in urine each accounts for less than 2% of the administered dose. The pharmacokinetics of thiotepa in renal and hepatic dysfunction patients have not been evaluated. Possible pharmacokinetic interactions of thiotepa with any concomitantly administered medications have not been formally investigated. INDICATIONS AND USAGE Thiotepa for Injection, USP has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: " p; O, j" k& @6 B; f1.Adenocarcinoma of the breast. 2.Adenocarcinoma of the ovary. 3.For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. # {9 ]& K# Y" I: E! m4.For the treatment of superficial papillary carcinoma of the urinary bladder. ' @6 H8 I9 \8 L) G$ a) {While now largely superseded by other treatments, thiotepa has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease. CONTRAINDICATIONS 4 i1 h0 \0 j* x$ h4 A- q5 rThiotepa is contraindicated in patients with a known hypersensitivity (allergy) to this preparation. Therapy is probably contraindicated in cases of existing hepatic, renal, or bone-marrow damage. However, if the need outweighs the risk in such patients, thiotepa may be used in low dosage, and accompanied by hepatic, renal and hemopoietic function tests. WARNINGS Death has occurred after intravesical administration, caused by bone-marrow depression from systematically absorbed drug. Death from septicemia and hemorrhage has occurred as a direct result of hematopoietic depression by thiotepa. Thiotepa is highly toxic to the hematopoietic system. A rapidly falling white blood cell or platelet count indicates the necessity for discontinuing or reducing the dosage of thiotepa. Weekly blood and platelet counts are recommended during therapy and for at least 3 weeks after therapy has been discontinued. 2 a" _( i- g5 V  V7 YThiotepa can cause fetal harm when administered to a pregnant woman. Thiotepa given by the intraperitoneal (IP) route was teratogenic in mice at doses ≥ 1 mg/kg (3.2 mg/m2), approximately 8-fold less than the maximum recommended human therapeutic dose (0.8 mg/kg, 27 mg/m2), based on body-surface area. Thiotepa given by the IP route was teratogenic in rats at doses ≥ 3 mg/kg (21 mg/m2), approximately equal to the maximum recommended human therapeutic dose, based on body-surface area. Thiotepa was lethal to rabbit fetuses at a dose of 3 mg/kg (41 mg/m2), approximately two times the maximum recommended human therapeutic dose based on body-surface area. , x3 x# H3 q" g6 E/ B' U/ OEffective contraception should be used during thiotepa therapy if either the patient or partner is of childbearing potential. There are no adequate and well-controlled studies in pregnant women. If thiotepa is used during pregnancy, or if pregnancy occurs during thiotepa therapy, the patient and partner should be apprised of the potential hazard to the fetus. 2 ^  @+ |- X, B1 |8 Q- R3 }Thiotepa is a polyfunctional alkylating agent, capable of cross-linking the DNA within a cell and changing its nature. The replication of the cell is, therefore, altered, and thiotepa may be described as mutagenic. An in vitro study has shown that it causes chromosomal aberrations of the chromatid type and that the frequency of induced aberrations increases with the age of the subject. Like many alkylating agents, thiotepa has been reported to be carcinogenic when administered to laboratory animals. Carcinogenicity is shown most clearly in studies using mice, but there is some evidence of carcinogenicity in man. In patients treated with thiotepa, cases of myelodysplastic syndromes and acute non-lymphocytic leukemia have been reported.   n+ B6 z1 b  t4 H( \PRECAUTIONS GeneralThe serious complication of excessive thiotepa therapy, or sensitivity to the effects of thiotepa, is bone-marrow depression. If proper precautions are not observed thiotepa may cause leukopenia, thrombocytopenia, and anemia. ( T# G: G! J$ c% ?3 WInformation for PatientsThe patient should notify the physician in the case of any sign of bleeding (epistaxis, easy bruising, change in color of urine, black stool) or infection (fever, chills) or for possible pregnancy to patient or partner. Effective contraception should be used during thiotepa therapy if either the patient or the partner is of childbearing potential. Laboratory TestsThe most reliable guide to thiotepa toxicity is the white blood cell count. If this falls to 3000 or less, the dose should be discontinued. Another good index of thiotepa toxicity is the platelet count; if this falls to 150,000, therapy should be discontinued. Red blood cell count is a less accurate indicator of thiotepa toxicity. If the drug is used in patients with hepatic or renal damage (see CONTRAINDICATIONS section), regular assessment of hepatic and renal function tests are indicated. - \! Y, c2 ~4 Z) G& v) s# u% u/ HDrug InteractionsIt is not advisable to combine, simultaneously or sequentially, cancer chemotherapeutic agents or a cancer chemotherapeutic agent and a therapeutic modality having the same mechanism of action. Therefore, thiotepa combined with other alkylating agents such as nitrogen mustard or cyclophosphamide or thiotepa combined with irradiation would serve to intensify toxicity rather than to enhance therapeutic response. If these agents must follow each other, it is important that recovery from the first agent, as indicated by white blood cell count, be complete before therapy with the second agent is instituted. 6 l' [4 [0 P+ H1 @Other drugs which are known to produce bone-marrow depression should be avoided. Carcinogenesis, Mutagenesis, Impairment of FertilityAlso see WARNINGS section. Carcinogenesis In mice, repeated IP administration of thiotepa (1.15 or 2.3 mg/kg three times per week for 52 or 43 weeks, respectively) produced a significant increase in the combined incidence of squamous-cell carcinomas of the skin, preputial gland, and ear canal, and combined incidence of lymphoma and lymphocytic leukemia. In other studies in mice, repeated IP administration of thiotepa (4 or 8 mg/kg three times per week for 4 weeks followed by a 20 week observation period or 1.8 mg/kg three times per week for 4 weeks followed by a 35 week observation period) resulted in an increased incidence of lung tumors. In rats, repeated IP administration of thiotepa (0.7 or 1.4 mg/kg three times per week for 52 or 34 weeks, respectively) produced significant increases in the incidence of squamous-cell carcinomas of the skin or ear canal, combined hematopoietic neoplasms, and uterine adenocarcinomas. Thiotepa given intravenously (IV) to rats (1 mg/kg once per week for 52 weeks) produced an increased incidence of malignant tumors (abdominal cavity sarcoma, lymphosarcoma myelosis, seminoma, fibrosarcoma, salivary gland hemangioendothelioma, mammary sarcoma, pheochromocytoma) and benign tumors.   E! {  _6 H% j: `The lowest reported carcinogenic dose in mice (1.15 mg/kg, 3.68 mg/m2) is approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area. The lowest reported carcinogenic dose in rats (0.7 mg/kg, 4.9 mg/m2) is approximately 6-fold less than the maximum recommended human therapeutic dose based on body-surface area. Mutagenesis 5 P3 I3 J" `( J2 B7 ], W! U  fThiotepa was mutagenic in in vitro assays in Salmonella typhimurium, E coli, Chinese hamster lung and human lymphocytes. Chromosomal aberrations and sister chromatid exchanges were observed in vitro with thiotepa in bean root tips, human lymphocytes, Chinese hamster lung, and monkey lymphocytes. Mutations were observed with oral thiotepa in mouse at doses > 2.5 mg/kg (8 mg/m2). The mouse micronucleus test was positive with IP administration of > 1 mg/kg (3.2 mg/m2). Other positive in vivo chromosomal aberration or mutation assays included Drosophila melanogaster, Chinese hamster marrow, murine marrow, monkey lymphocyte, and murine germ cell. # j1 V8 S$ U/ G. }0 `$ Y0 P& ], D5 @Impairment of Fertility Thiotepa impaired fertility in male mice at PO or IP doses ≥ 0.7 mg/kg (2.24 mg/m2), approximately 12-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa (0.5 mg) inhibited implantation in female rats when instilled into the uterine cavity. Thiotepa interfered with spermatogenesis in mice at IP doses ≥ 0.5 mg/kg (1.6 mg/m2), approximately 17-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa interfered with spermatogenesis in hamsters at an IP dose of 1 mg/kg (4.1 mg/m2), approximately 7-fold less than the maximum recommended human therapeutic dose based on body-surface area. : D" b' M7 Y( }+ ^: f6 q0 DPregnancy ! {1 K9 X) x5 }3 q0 A  UTeratogenic Effects- Category D See WARNINGS section. ' X; b% v0 p* ]; \1 vThiotepa can cause fetal harm when administered to a pregnant woman. Thiotepa given by the IP route was teratogenic in mice at doses ≥ 1 mg/kg (3.2 mg/m2), approximately 8-fold less than the maximum recommended human therapeutic dose based on body-surface area. Thiotepa given by the IP route was teratogenic in rats at doses ≥3 mg/kg (21 mg/m2), approximately equal to the maximum recommended human therapeutic dose based on body-surface area. Thiotepa was lethal to rabbit fetuses at a dose of 3 mg/kg (41 mg/m2), approximately 2 times the maximum recommended human therapeutic dose based on body-surface area. Patients of childbearing potential should be advised to avoid pregnancy. There are no adequate and well-controlled studies in pregnant women. If thiotepa is used during pregnancy, or if pregnancy occurs during thiotepa therapy, the patient and partner should be apprised of the potential hazard to the fetus. 5 y$ Y, F. X" f5 T, f# NNursing MothersIt is not known whether thiotepa is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for tumorigenicity shown for thiotepa in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. ( _$ m* ~+ f- g6 x2 GPediatric UseSafety and effectiveness in pediatric patients have not been established. $ `' h$ a4 t# i7 D$ U1 @- FGeriatric UseClinical studies of thiotepa did not include sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreasing hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. 6 Z- @9 G6 m+ i, Z- _ADVERSE REACTIONS In addition to its effect on the blood-forming elements (see WARNINGS and PRECAUTIONS sections), thiotepa may cause other adverse reactions. 4 r: O3 X/ ^  ~) V4 s6 {6 A6 r0 ~2 |GeneralFatigue, weakness. Febrile reaction and discharge from a subcutaneous lesion may occur as the result of breakdown of tumor tissue. Hypersensitivity ReactionsAllergic reactions - rash, urticaria, laryngeal edema, asthma, anaphylactic shock, wheezing. Local ReactionsContact dermatitis, pain at the injection site. GastrointestinalNausea, vomiting, abdominal pain, anorexia. RenalDysuria, urinary retention. There have been rare reports of chemical cystitis or hemorrhagic cystitis following intravesical, but not parenteral administration of thiotepa. RespiratoryProlonged apnea has been reported when succinylcholine was administered prior to surgery, following combined use of thiotepa and other anticancer agents. It was theorized that this was caused by decrease of pseudocholinesterase activity caused by the anticancer drugs. 4 t+ G6 Q% r5 kNeurologicDizziness, headache, blurred vision. SkinDermatitis, alopecia. Skin depigmentation has been reported following topical use. Special SensesConjunctivitis. 7 C2 X7 G8 Q* wReproductiveAmenorrhea, interference with spermatogenesis. OVERDOSAGE 1 B/ O; Q+ T% e8 }: \' r* z& lHematopoietic toxicity can occur following overdose, manifested by a decrease in the white cell count and/or platelets. Red blood cell count is a less accurate indicator of thiotepa toxicity. Bleeding manifestations may develop. The patient may become more vulnerable to infection, and less able to combat suchinfection. Dosages within and minimally above the recommended therapeutic doses have been associated with potentially life-threatening hematopoietic toxicity. Thiotepa has a toxic effect on the hematopoietic system that is dose related. Thiotepa is dialyzable. * ?  z7 p2 o9 Q  V5 R6 M& KThere is no known antidote for overdosage with thiotepa. Transfusions of whole blood or platelets have proven beneficial to the patient in combating hematopoietic toxicity. 0 w( [6 [* I* w; _6 m* gDOSAGE AND ADMINISTRATION ) j5 r0 n- X$ s6 Y( c& K& |- L0 kSince absorption from the gastrointestinal tract is variable, thiotepa should not be administered orally. 5 p  C  j. \: NDosage must be carefully individualized. A slow response to thiotepa does not necessarily indicate a lack of effect. Therefore, increasing the frequency of dosing may only increase toxicity. After maximum benefit is obtained by initial therapy, it is necessary to continue the patient on maintenance therapy (1 to 4 week intervals). In order to continue optimal effect, maintenance doses should not be administered more frequently than weekly in order to preserve correlation between dose and blood counts. Preparation and Administration PrecautionsThiotepa is a cytotoxic anticancer drug and as with other potentially toxic compounds, caution should be exercised in handling and preparation of thiotepa. Skin reactions associated with accidental exposure to thiotepa may occur. The use of gloves is recommended. If thiotepa solution contacts the skin, immediately wash the skin thoroughly with soap and water. If thiotepa contacts mucous membranes, the membranes should be flushed thoroughly with water. & _+ A' x" R$ ?0 \% }- qPreparation of SolutionThiotepa for injection should be reconstituted with 1.5 mL of sterile water for injection resulting in a drug concentration of approximately 10 mg/mL. The actual withdrawable quantities and concentration achieved are illustrated in the following table: ) g8 q: i! C9 O- y- v7 Z) G. D - _0 O! V. H5 a2 {* L Label Claim (mg/vial) Actual Content (mg/vial) Amount of Diluent to be Added $ _0 G" b/ f! Z: U1 i% }0 x(mL) Approximate Withdrawable % G  D2 o: A, S- V3 H& eVolume ! B3 G$ g8 d% T" [' X" M(mL) Approximate Withdrawable Amount (mg/vial) Approximate Reconstituted Concentration (mg/mL) 15 15.6 1.5 1.4 14.7 10.4 The reconstituted solution is hypotonic and should be further diluted with sodium chloride injection (0. 9% sodium chloride) before use. When reconstituted with sterile water for injection, solutions of thiotepa should be stored in a refrigerator and used within 8 hours. Reconstituted solutions further diluted with sodium chloride injection should be used immediately. ( ?; Y% ^/ v: K. g3 y9 r4 fIn order to eliminate haze, filter solutions through a 0.22 micron filter* prior to administration. Filtering does not alter solution potency. Reconstituted solutions should be clear. Solutions that remain opaque or precipitate after filtration should not be used. # X( H) N" D6 a4 z8 L6 TPolysulfone membrane (Gelman’s Sterile Aerodisc®, Single Use) or triton-free mixed ester of cellulose/PVC (Millipore’s MILLEX®-GS Filter Unit). Initial and Maintenance DosesInitially the higher dose in the given range is commonly administered. The maintenance dose should be adjusted weekly on the basis of pretreatment control blood counts and subsequent blood counts. Intravenous AdministrationThiotepa may be given by rapid intravenous administration in doses of 0.3 to 0.4 mg/kg. Doses should be given at 1 to 4 week intervals. 4 X" j( [! g+ c5 {% KIntracavitary AdministrationThe dosage recommended is 0.6 to 0.8 mg/kg. Administration is usually effected through the same tubing which is used to remove the fluid from the cavity involved. Intravesical AdministrationPatients with papillary carcinoma of the bladder are dehydrated for 8 to 12 hours prior to treatment. Then 60 mg of thiotepa in 30 to 60 mL of Sodium Chloride Injection is instilled into the bladder by catheter. For maximum effect, the solution should be retained for 2 hours. If the patient finds it impossible to retain 60 mL for 2 hours, the dose may be given in a volume of 30 mL. If desired, the patient may be positioned every 15 minutes for maximum area contact. The usual course of treatment is once a week for 4 weeks. The course may be repeated if necessary, but second and third courses must be given with caution since bone-marrow depression may be increased. Deaths have occurred after intravesical administration, caused by bone-marrow depression from systemically absorbed drug. ( A# u) M2 V& o7 |' Z2 o, FHandling and DisposalFollow safe cytotoxic agent handling procedures. Several guidelines on this subject have been published.1-7 There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. 5 [  Q" \/ q* f' _" z0 f4 A0 fHOW SUPPLIED Thiotepa for Injection, USP, for single use only, is available in vials containing 15 mg of nonpyrogenic, sterile lyophilized powder, supplied as follows: ( }9 `$ K/ P& j0 VNDC 0143-9565-01. Unit carton contains 1 x 15 mg single dose vial thiotepa. Store in a refrigerator between 2° to 8°C (36° to 46°F). PROTECT FROM LIGHT AT ALL TIMES. 2 ~. e" i1 L1 O! h& X% p2 |To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 4 [& j  w5 ?/ n6 m" e4 RFor Product Inquiry call 1-877-845-0689. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b19b03db-471d-4ee7-b1b8-6eccc39c41b0 ------------------------------------------------------------ 8 T0 ]3 K  \$ r" {# T产地国家：美国 : ]& L6 L: V- j; J1 O( j8 b原产地英文商品名: THIOTEPA INJ 15MG/2ML/VIAL 1VIAL/box 原产地英文药品名: . q( {# G0 q, P  m* LTHIOTEPA 4 K1 j! G' M# W中文参考商品译名: . y/ u2 @& z( y4 K. E; j塞替派 15毫克/2毫升/瓶  1瓶/盒 * ?, b8 P' w9 E7 d' X中文参考药品译名: 9 S" p" q  u3 [) d/ \6 {, [塞替派 - d. }" n$ y/ ]7 L( B) ~6 x; w生产厂家英文名: " W' h4 E5 `/ Q; Z- dWEST WARD PHARMACEUTICAL : M1 r& E" g9 cNDC: 00143-9565-01 ------------------------------------------------------------ 产地国家：美国 % h" C% C1 i  j* S" l9 ?/ ]/ I原产地英文商品名: ' B0 W  Q! P" C- V  c! E# `4 |! YTHIOTEPA 15MG SDV LYO PWD 1/EA 3 Z$ G% r+ K+ N& z/ \原产地英文药品名: 8 `  W* b! b9 ~1 D9 ?9 yTHIOTEPA 中文参考商品译名: 塞替派SDV 15毫克/瓶 4 |! q% e7 P3 _' s中文参考药品译名: 塞替派 + h, |, z- X' b* d, i2 l生产厂家英文名: WEST WARD PHARMACEUTICALS NDC: 00143-9565-01 ( D# ]0 w, j9 Z) i------------------------------------------------------------ + m9 [. t4 q. h1 `% A9 d产地国家：美国 , ~7 u% W* N1 C& ?; |' u& Z0 }原产地英文商品名: & \* q/ @3 d/ }! g* ~& W6 V' Z7 ^6 OTHIOTEPA SDV 15MG/2ML/VIAL / J. K" F- K* s1 ~& m9 N) \原产地英文药品名: THIOTEPA + p, t% A  A8 C0 p) I中文参考商品译名: 8 M9 h8 A6 E$ `* ^1 {' d/ C% o  P$ D9 Z塞替派SDV 15毫克/2毫升/瓶 中文参考药品译名: 塞替派 ! D3 c9 h5 h, z6 l( a8 y生产厂家中文参考译名: BEDFORD / t9 Y5 Q# F+ y  C3 X2 T0 l生产厂家英文名: BEDFORD

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