http://www.jiuyuangene.net/fin....ished-dosage-form/on
OncologyInjectionManufacturs Active ingredient: Recombinant Human Interleukin-11,0.75mg,1.5mg & 3mg with inactive ingredients of Glycine 23 mg, Na2HPO4 0.85 mg, NaH2 PO4 0.48mg per vial. Pharmacology: Recombinant Human Interleukin-11, produced by recombinant DNA technology, is a thrombopoietic growth factor that directly stimulates the proliferation of hematopoietic stem cells and megakaryocyte progenitor cells and induces megakaryocyte maturation resulting in increased platelet production, so as to elevate platelet count without significant change of platelet function. Pre-clinical studies have shown that mature megakaryocytes which develop during in vivo treatment with rhIL-11 are ultra-structurally and functionally normal and possessed a normal life span. Toxicology: Safety Pharmacology: IL-11 has shown to have non-hematopoietic activities in animals including the regulation of intestinal epithelium growth (enhanced healing of gastrointestinal lesions), the inhibition of adipogenesis, the induction of acute phase protein synthesis, inhibition of pro-inflammatory cytokine production by macrophages, and the stimulation of osteoclastogenesis and neurogenesis. Toxicity of Repetitive Administration: Continuous dosage (2 to 13 weeks) in nonhuman primates produced joint capsule and tendon fibrosis and periosteal hyperostosis. The relevance of these findings to human is unclear. Genetic Toxicity: In vitro studies have shown that rhIL-11 is not mutagenic. Reproduction Toxicity: Although prolonged estrus cycles have been noted at 2 to 20 times the human dose, no effects on fertility have been observed in rats treated with rhIL-11 at doses up to 1000碌g/kg/day. The studies on fertility and early embryonic development of rats and organogenesis of rats and rabbits have shown that parental toxicity was observed when rhIL-11 was given at dose of 2~20 times the human dose (>100碌g/kg/day) in the rat and at 0.02~2.0 times of human dosage (>1碌g/kg/day) in the rabbit. Findings in pregnant rats consisted of transient hypoactivity and dyspnea after administration (maternal toxicity), as well as prolonged estrus cycle, increased early embryonic deaths and decreased numbers of live fetuses. In addition, low fetal body weights and a reduced number of ossified sacral and caudal vertebrae (i.e. retarded fetal development) occurred in rats at 20 times the human dose without long-term abnormality of behavior or development. Findings in pregnant rabbits consisted of decreased fecal/urine eliminations as well as decreased food consumption, body weight loss, abortion, increased embryonic and fetal deaths, and decreased numbers of live fetuses, without observation of teratogenic effects. There are no adequate and well-controlled studies of rhIL-11 in pregnant women. rhIL-11 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if rhIL-11 is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from rhIL-11, a decision should be made whether to discontinue nursing or to discontinue rhIL-11, taking into account the importance of the drug to the mother. [Name] Generic Name: Oprelvekin Trade Name: JIJUFEN Chemical Name: Human Interleukin-11 for Injection The only drug approved by FDA for prevention and treatment of Chemoradiotherapy-induced thrombocytopenia. Dosage: Injection Specification: 0.75mg锛?00MU锛?vial锛?.5mg锛?200MU锛?vial锛?mg锛?400MU锛?vial The only preparation of interleukin-11 expressed by eukaryotic cells [Indication] Prevention and treatment of Chemoradiotherapy-induced thrombocytopenia. Entrepreneurship Imprint 1993 On December 31, Hangzhou Jiuyuan Gene Engineering Co., Ltd. was registered and established in Hangzhou High-tech Development Zone. Year 2013 In October, the company reformed its marketing system and established a development strategy of "market first, overall marketing". 2018 The company embarked on a major transformation, taking the road of placing equal emphasis on innovative drugs and generic drugs. 2020 year The company's R&D center settled in Hangzhou Pharmaceutical Town as a whole. The company's sales exceeded 1 billion yuan. Company Honor Zhejiang province per mu benefit leading enterprises Gene-engineering New Drug R&D Technology and Service Sub-platform Provincial Post-doctoral Scientific Research Working Center Excellent industrial products in Zhejiang Province Hangzhou Academician Expert Working Center Hangzhou Top Ten New High-tech Enterprise Zhejiang Green Enterprise FAQ Q: Are you trading company or manufacturer? A: We are professional manufacturer specialized in the research, development, manufacture and marketing of pharmaceuticals based on gene engineering and biochemical technology since 1993. And we trade our products with our clients directly. Q: How many different types of products your company manufactures? A: Now we have 36 products including pipeline products. All the pharmaceutical manufacturing activities are carried as per GMP requirements. The day to day licensing and regulatory activities are controlled by SFDA.OncologyInjectionManufacturs website:http://www.jiuyuangene.net/fin....ished-dosage-form/on