英文药名: Teriparatide Acetate Inj(Teriparatide Acetate)
中文药名: 醋酸特立帕肽注射剂
生产厂家: 旭化成制药
テリパラチド酢酸塩静注用100「旭化成」
治疗类别名称 甲状旁腺功能诊断 商標名 Teriparatide Acetate Inj.100 一般名 *テリパラチド酢酸塩(Teriparatide Acetate,JAN) (Teriparatide r-INN) 化学名 L-seryl-L-valyl-L-seryl-L-α-glutamyl-L-isoleucyl-L-glutaminyl-L-leucyl-L-methionyl-L-histidyl-L-asparaginyl-L-leucyl-glycyl-L-lysyl-L-histidyl-L-leucyl-L-asparaginyl-L-seryl-L-methionyl-L-α-glutamyl-L-arginyl-L-valyl-L-α-glutamyl-L-tryptophyl-L-leucyl-L-arginyl-L-lysyl-L-lysyl-L-leucyl-L-glutaminyl-L-α-aspartyl-L-valyl-L-histidyl-L-asparaginyl-L-phenylalanine pentaacetate 分子式 C181H291N55O51S2・5CH3COOH 分子量 4418.00 構造式
融点 210℃(分解) 性状 本品是一种白色粉末,或者有没有异味或微有醋酸气味,没有味道。 此产品是很容易在水中或乙酸(100)以使其溶解。 此产品(1→1000)的水溶液的pH为4.0至6.0。 本产品是吸湿。 成分含量(1瓶) 醋酸特立帕肽 100特立帕肽醋酸装置 药效药理 1.血钙和血磷作用 醋酸特立帕肽甲状腺引起甲状旁腺切除大鼠的血清钙水平,降低血清磷值。 2.对肾脏的作用 在手术后的甲状旁腺功能减退病模型大鼠,的特立帕肽醋酸磷酸和尿中尿环AMP排泄给药显著增加。 适应病症 Ellsworth-Howard試験 骨质疏松症与骨折的高风险 用法与用量 在使用一次100特立帕肽酯单元的时候,溶解在一天站盐水3毫升,静脉注射。 另外,体表面积是在将被施用100特立帕肽酯单元/平方米小于1平方米小孩的情况下。 ●使用和剂量的描述 见原处方内说明 包装规格 静脉 100:1瓶
制造厂商 旭化成制药株式会社 完整处方资料附件:http://www.info.pmda.go.jp/go/pack/7223403D1045_1_02/ Teriparatide Acetate Inj(Teriparatide acetate 中文译名:醋酸特立帕肽注射剂) Teriparatide Acetate Inj.100 "Asahi Kasei"(テリパラチド酢酸塩静注用100「旭化成」) Brand name : Teriparatide Acetate Inj.100 "Asahi Kasei" Active ingredient: Teriparatide acetate Dosage form: injection Print on wrapping: Effects of this medicine This medicine is a synthetic human parathyroid hormone preparation. It is a diagnostic agent for parathyroid function. It is usually used in the Ellsworth-Howard test. Before using this medicine, be sure to tell your doctor and pharmacist •If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines. If you have hypercalcemia. •If you are pregnant, possibly pregnant or breastfeeding. •If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.) Dosing schedule (How to take this medicine) •Your dosing schedule prescribed by your doctor is ((to be written by a healthcare professional)) •In general, this medicine is injected intravenously gradually over a period of 3 minutes or longer, once at the time of inspection. •Pay attention to the following points for accurate diagnosis. (A) Standard method 1. Do not take phosphorus absorption inhibitor or calcium agents. If you are taking these agents, the inspection will be conducted approximately 1 week after discontinuing those agents. 2. The day before the inspection, do not take dairy products. 3. On the day of inspection, breakfast must be non-dairy, and small in portion. 4. Every 1 hour from 9 am to 3 pm, water is ingested. The water amount for an adult is 200mL, for children, 5mL per 1 kg of body weight (upper limit 200mL) . 5. At 10 am, urinate completely. 6. Every 1 hour from 11 am to 4 pm, urine is collected. 7. At 1 pm, blood is collected and this medicine is injected immediately after. (B) Modified method for infants 1. Do not give phosphorus absorption inhibitor or calcium agents. If the infant is given these agents, the inspection will be conducted approximately 1 week after discontinuing those agents. 2. The day before the inspection, do not give dairy products. 3. On the day of inspection, no meal can be given until the completion of the inspection. 4. Every 1 hour from 6 am to 12 pm, water is ingested. The water amount is 5mL per 1 kg of body weight (upper limit 200mL). 5. At 7 am, urinate completely . 6. Every 1 hour from 8 am to 1 pm, urine is collected. 7. At 10 am, blood is collected and this medicine is injected immediately after. Precautions while taking this medicine • Possible adverse reactions to this medicine The most commonly reported adverse reactions include hot flush, feverish, palpitation, tachycardia, decreased blood pressure, nausea, rash and hives. If any of these symptoms occur, consult with your doctor or pharmacist. The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, see your doctor immediately. •facial pallor, cold sweat, shortness of breath [shock] The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above. Asahi Kasei Pharma CorporationInjection Revised: 10/2016 The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
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