极速11选5

酒石酸布托啡诺鼻喷剂

发布时间:2012.08.26 来源:上海恒瑞 浏览次数:3043

HEZHUNRIQI:2007NIAN01YUE24RI

XIUGAIRIQI:2007NIAN04YUE20RI

XIUGAIRIQI:2009NIAN09YUE30RI

XIUGAIRIQI:2013NIAN05YUE06RI

极速11选5XIUGAIRIQI:2015NIAN12YUE01RI

 

 

酒石酸布托啡诺鼻喷剂说明书

请仔细阅读说明书并在医师指导下使用

【药品名称】

TONGYONGMINGCHENG:JIUSHISUANBUTUOFEINUOBIPENJI

商品名称:诺扬®

YINGWENMINGCHENG:Butorphanol Tartrate Nasal Spray

HANYUPINYIN:Jiushisuan Butuofeinuo Bipenji

【成份】

BENPINZHUYAOCHENGFENWEIJIUSHISUANBUTUOFEINUO。

HUAXUEMINGCHENG:ZUOXUAN-17-HUANDINGJIJIAJI3,14-ERQIANGJIMAFEINAND (-) JIUSHISUAN(1:1)YAN

HUAXUEJIEGOUSHI:

分子式:C21H29NO2 · C4H6O6

FENZILIANG:477.56

极速11选5JIUSHISUANBUTUOFEINUOBIPENJI,DINGLIANGPENWUYUBIQIANGZHANMOJIYAO,SHI10mg /mlDEJIUSHISUANBUTUOFEINUODESHUIRONGYE。GAISHUIRONGYEHANYOULVHUANA、NINGMENGSUAN、 LVBIANYIANDENGCHENGFEN,JINGQINGYANGHUANADIAOJIEpHZHIWEI4.5,MEICIPINGJUNPENLIANGWEI1.0 mgJIUSHISUANBUTUOFEINUO。

【性状】

极速11选5BENPINWEIWUSECHENGQINGYETI,QINYAFAMEN,YAOYEJICHENGWUZHUANGPENCHU

【适应症】

极速11选5YONGYUGEZHONGAIXINGTENGTONG、SHOUSHUHOUTENGTONG。

【规格】

极速11选510mg/ml,MEIPENHANJIUSHISUANBUTUOFEINUO1mg。

【用法用量】

极速11选5MEICI1~2PEN,MEIRI3~4CI。YIBANQINGKUANGXIA,CHUSHIJILIANGWEI1 mg(YIPENDEPENLIANG)。RUGUO60~90FENZHONGMEIYOUJIAOHAODEZHENTONGZUOYONG,KEZAIPEN1 mg。RUGUOXUYAO,CHUSHIJILIANGPENHOU3~4XIAOSHIHOUKEZAICIJIYAO。

极速11选5BINGRENJUTONGSHI,CHUSHIJILIANGKEWEI2mg。BINGRENKEZHITONGXIUXIHEBAOCHISHUIYI,ZHEIZHONGQINGKUANG3~4XIAOSHIBUYAOZHONGFUJIYAO。

LAONIANBINGREN、GAN、SHENGONGNENGBUQUANZHEDECHUSHIJILIANGYINGKONGZHIZAI1 mgYINEI,RUYOUXUYAO,ZAI90~120FENZHONGZAIJIYAO1 mg。ZHEIXIERENDEZHONGFUJIYAOJILIANGXUGENJUBINGRENDEYAOWUFANYINGQINGKUANGERDING,BUBIGUDINGJIYAOJIANGESHIJIAN,JIANGESHIJIANYIBANYINGBUSHAOYU6XIAOSHI。

SHIYONGFANGFA:

1.LADIAOBIPENQIDEGAIZI(TU1),YAODONGYAOPING。JIANGLIANGGEZHITOUFANGZAIPINGZIDE“ERJIAN”,DAMUZHIDIZAIPINGDIZHONGYANG,YONGLIQINYAFAMEN(TU2),ZHIZHICHUXIANLIANGHAODEPENWUZHUANGTAI。

2.QINGJIEBIKONG,SHIBIKONGTONGCHANG。

极速11选53.JIANGPENTOUSHENRUBIKONGDAYUE1cmSHEN,TOUBULVEXIANGQIANQING(TU3),YONGSHIZHIDUZHULINGYIGEBIKONG(TU4),HELONGZUIBU,QINGQINGXIQIDETONGSHI,QIANGERKUAIDIQINYAFAMEN,PENRUGUIDINGLIANGDEYAOWU,PENWUJIESHUHOU,CONGBIBUYIKAIPENBIQI,YANGTOU,QINGQINGXIQISHUMIAOZHONG。RUOZENGJIAJILIANG,HUANLINGYIBIKONGZHONGFUSHANGSHUBUZHOU。

4.YONGYAOHOU15FENZHONGNEI,BUYAOXINGBITI。

5.YONGBIHOU,CAJINGPENTOU,GAISHANGPINGGAI。

【不良反应】

极速11选5ZHUYAOWEISHISHUI、TOUYUN、EXINHUOOUTU,FASHENGLVZAI1%ZUOYOU。KAOLVKENENGYUJIUSHISUANBUTUOFEINUOYOUGUANDEBULIANGFANYINGBAOGAO:

QUANSHEN:XURUO、TOUTONG、REGAN。

XINXUEGUANXITONG:HENSHAOJIANBINGRENDIXUEYAXINGYUNJUE、XUEGUANSHUZHANG、XINJI。

XIAOHUAXITONG:YANSHI、KOUGAN、WEITONG、BIANMI。

SHENJINGXITONG:YICHANGMENGJING、JIAOLV、HUANJUE、DIYI、YAOWUJIEDUANZHENGZHUANG:YISHIMOHU、XINKUAIGAN、PIAOFUGAN、SHIMIAN、SHENJINGZHI、GANJUEYICHANG、ZHENZHAN。

HUXIXITONG:ZHIQIGUANYAN、KESOU、HUXIKUNNAN、BICHUXUE、BICHONGXUE、BICIJI、BIYAN、BIDOUYAN、BIDOUCHONGXUE、YANYAN、SHANGHUXIDAOGANRAN。

PIFU:DUOHAN、SAOYANG、PIZHEN、FENGTUAN。

MINIAOXITONG:PAINIAOKUNNAN。

极速11选5TESHUGANJUE:SHILIMOHU、ERTONG、ERMING、WEIJUEYICHANG。

【禁忌】

极速11选51.DUIJIUSHISUANBUTUOFEINUOHELVBIANYIANGAOMINGANDERENJINYONG。

极速11选52.YINAPIANDEJIEKANGTEZHENG,BENPINBUYIYONGYUYILAINEIKETINGDEHUANZHE

3.NIANLINGSHAOYU18SUIHUANZHEJINYONG。

【注意事项】

极速11选51. PENJIRUGUO48XIAOSHIYISHANG(BAOKUO48XIAOSHI)WEISHIYONG,SHIYONGQIANYINGQINGYAO1~2XIA。

2. YONGYAOHOU15FENZHONGNEIBUYAOXINGBITI。

3. DUIYUZHONGFUSHIYONGMAZUIZHITONGYAO,QIEDUIAPIANNAISHOUDEBINGRENSHENYONG。

4. NAOSUNSHANGHELUNEIYASHENGGAODEHUANZHESHENYONG。

5. GANSHENJIBINGHUANZHECHUSHIJILIANGJIANGESHIJIANYINGYANZHANGZHI6~8XIAOSHI,SUIHOUDEJILIANGSUIBINGRENFANYINGDIAOZHENG,ERBUSHIANGUDINGFANGANJIYAO。

6. DUIXINJIGENGSAI、XINGONGNENGZHANGAI、GUANZHUANGDONGMAIGONGNENGBUQUANDEHUANZHESHENYONG。FASHENGGAOXUEYASHIYINGLIJITINGYAO。

7. BENPINKEZHIHUXIYIZHI,YOUQISHITONGSHIFUYONGXINGFENZHONGSHUSHENJINGXITONGYAOWUHUOHUANYOUZHONGSHUSHENJINGXITONGJIBINGHUOHUXIGONGNENGQUEXIANDEHUANZHESHENYONG。

8. SHIYONGBENPINSHI,JINZHIHEJIU。KAICHEHECAOZUOYOUWEIXIANXINGDEJIQISHIXIAOXINSHIYONG。

9. QINGJIANGBIPENJIFANGZAIERTONGBUYICHUJIDEDIFANG。

【孕妇及哺乳期妇女用药】

ZAIDONGWUSHIYANZHONGFAXIAN,SHIYONGBENPINZUDESITAIFASHENGLVGAOYUDUIZHAOZU,SHIPEIPAOZHECHUANGHOUDIUSHIDEFASHENGLVSHENGGAO,FASHENGSICHANLVHUIBIDUIZHAOZUSHENGGAO。YINCI,YUNFUBUYINGSHIYONGBENPIN,ZHIYOUDUITAIERKENENGDEHUOYIDAYUKENENGDEWEIXIANSHI,CAIKAOLVRANGYUNFUSHIYONGBUTUOFEINUO。BENPINKEJINGGUORUZHIFENMI,YINCI,ZAIBURUQIFUNVYINGJINLIANGBUSHIYONGBENPIN,ZAIBIXUSHIYONGSHI,YINGTINGZHIBURU。

【儿童用药】

BENPINZAIYINGYOUERJI18SUIYIXIAQINGSHAONIANDEANQUANXINGSHANGWEIQUEDING,YINCIBUYIYONGYU18SUIYIXIADEXIAOERJIQINGSHAONIAN。

【老年用药】

极速11选5LAONIANHUANZHECHANGYOUGANSHENGONGNENGJIANTUI,XUJIANLIANGYINGYONG,QIEJIANGESHIJIANYINGYANZHANGZHI6~8XIAOSHI。

【药物相互作用】

1. BUTUOFEINUOHEZHONGSHUSHENJINGXITONGZHENJINGJI(LIRUJIUJINGLEI、BABITUOLEI、BENERDANZHUOLEI、KANGZUANYAO)TONGSHISHIYONG,KENENGHUIDAOZHIZHONGSHUSHENJINGXITONGYIZHIZUOYONGXIAOYINGZENGQIANG。DANGYUNENGJIAQIANGAPIANLEIYAOWUYAOXIAODEYAOWUHEYONGSHI,BUTUOFEINUOYINGGAIYONGZUIXIAODEYOUXIAOJILIANGBINGQIEJIYAOPINLVYEYAOJINKENENGDEJIANSHAO。

2. JIYUSHUMAQUTANBIPENJIHOULIJIJIYUBUTUOFEINUOBIPENJI,HUIJIANRUOHOUZHEDEZHENTONGXIAOYING;DANSHIRUOJIANGE30FENZHONGYISHANG,QIANZHEDUIHOUZHEDEXUERUOXIAOYINGJIUHENXIAOLE,ZHEILIANGZHONGCHANPINDOUKENENGYINQIZANSHIXINGXUEYASHENGGAO。

极速11选53. YUYINGXIANGGANDAIXIEDEYAOWU(HONGMEISU、CHAJIANDENG)HEYONGSHIHUIBUHUIGAIBIANBUTUOFEINUODEYAOXIAO,MUQIANHAIBUQINGCHU;DANSHINEIKEYISHENGYINGGAIZHUYI,LIANGZHEHEYONGSHI,KENENGXUYAOJIANSHAOBUTUOFEINUODECHUSHIJILIANG,BINGYANZHANGJIYAOJIANGE。

极速11选54. YUBIQIANGXUEGUANSHOUSUOJITONGSHISHIYONGHUOZHESHAOHOULIJISHIYONG,KEYIYUJIDAOJIUSHISUANBUTUOFEINUOBIPENJIQIXIAOJIANMAN。

5. SHIYONGBUTUOFEINUOTONGSHIYONGMAO(DANANYANGHUAMEI)YIZHIJISHIFOUHUICHANSHENGXIANGHUYINGXIANGSHANGWEIMINGQUE。

【药物过量】

BUTUOFEINUOGUOLIANGSHIYONGDELINCHUANGBIAOXIANYIBANYUAPIANLEIYAOWUXIANGTONG,ZUIYANZHONGDEHOUGUOSHIFEIHUANQIBUZU、XINXUEGUANGONGNENGBUQUAN、HUNMI、ZHIZHISIWANG。

ZHILIAO: HUAIYIBUTUOFEINUOGUOLIANGSHIYONGDECHULICUOSHIBAOKUO:

1.BAOCHIBINGRENHUXICHANGTONG。YINGCHIXUJIANCEBINGREN,CAIQUCUOSHI,SHIBINGRENBAOCHILIANGHAODEJINGSHENZHUANGTAI、ZHENGCHANGDEFANYINGHESHENGMINGTIZHENG。

2.WEICHIBINGRENCHONGFENDETONGQI。

3.BAOCHIZHENGCHANGTIWENHEXUNHUANGUANZHU。RUGUOBINGRENHUNMI,YINGJINXINGQIGUANCHAGUAN。BAOCHISHIDANGDEJINGMAITONGDAO,YIBIANYUZHILIAOXUEGUANSHUZHANGYAOYINQIDEDIXUEYA。

KEYIKAOLVSHIYONGTEXIAODEAPIANLEIJIEKANGJI,PIRUNALUOTONG。YOUYUBUTUOFEINUOZUOYONGCHIXUSHIJIANWANGWANGBINALUOTONGZHANG,SUOYINALUOTONGKENENGXUYAOZHONGFUJIYAO。

【药理毒理】

药理作用

JIUSHISUANBUTUOFEINUOWEIJIDONG—JIEKANGHUNHEXINGAPIANSHOUTIJIDONGJI,YUμXINGAPIANSHOUTIYOUJIAODIDEQINHELI,YENENGJIDONGkAPIANSHOUTI。YUSHANGSHUZHONGSHUSHENJING(CNS)DESHOUTIXIANGHUZUOYONG,KECHANSHENGBAOKUOZHENTONGDEJIUSHISUANBUTUOFEINUODEDADUOSHUYAOLIZUOYONG:CHUZHENTONGZUOYONGWAI,QIZHONGSHUZUOYONGHAIBAOKUOZIFAHUXIHUODONGYIZHI、ZHIKE、CUITU、TONGKONGFANGDAHEZHENJINGDENG,JIDONGkAPIANSHOUTIKESHIMOUXIEBINGRENCHUXIANBUYUKUAIDENIJINGSHENBINGYANGZUOYONG。JIUSHISUANBUTUOFEINUOTONGGUOFEICNSJIZHIKEGAIBIANXINXUEGUANZULIHERONGLIANG、ZHIQIGUANZHANGLI、WEICHANGFENMIYIJIBANGGUANGKUOYUEJIHUODONGDENG。

毒理研究

遗传毒性:沙门氏伤寒杆菌和大肠杆菌试验、培养的人成纤维细胞DNA合成和修复试验均未表现出遗传毒性。

生殖毒性极速11选5:小鼠、大鼠和兔子致畸敏感期试验均未见致畸作用。但大鼠皮下注射给予酒石酸布托啡诺1mg/kg(5.9mg/㎡)时,死胎的发生率高于对照组。家兔经口给药30mg/kg(360mg/㎡)和60mg/kg(720mg/㎡)时,着床丢失率增加。尚未对妊娠前37周的孕妇进行充分和严格控制的研究,所以只有在本品的潜在益处大于对胎儿的潜在危险时,才能用于怀孕期。在分娩前2小时内给予本品一次、多次用药、同时服用其他止痛或镇静药、早产时用药等情况下,可能会引起婴儿呼吸抑制或呼吸暂停,但临床上这种反应的报道很少。对119例病人的研究发现,分娩前肌肉注射酒石酸布托啡诺1mg,胎儿出现治疗相关的暂时性正旋波样胎心率(持续10-90分钟),因此当胎儿心率异常时应慎用本品,本品可经乳汁分泌,但婴儿的摄入量可能无显著临床意义(哺乳期妇女肌肉注射酒石酸布托啡诺2mg/次,4次/d,乳汁浓度约为4μg/L)。尽管没有哺乳期妇女经鼻用药的临床经验,但可认为乳汁中酒石酸布托啡诺的水平与肌肉给药时会比较接近。

致癌作用:小鼠和大鼠经口给予酒石酸布托啡诺60mg/kg/ d(分别为180 mg/㎡和354 mg/㎡)为期2年的致癌研究,均未见致癌作用。

【药代动力学】

JUGUOWAIWENXIANBAODAO,JIUSHISUANBUTUOFEINUOBIPENJIYAO1mgHOU,30-60FENZHONGDADAOXUEYAONONGDUGAOFENG,QIPINGJUNFENGNONGDUWEI0.9-1.04ng/ml. JIUSHISUANBUTUOFEINUOBIPENJIDEJUEDUISHENGWULIYONGDUWEI60-70%.ZAIGUOMINXINGBIYANDEBINGRENZHONGYINGYONGSHI,QISHENGWULIYONGDUBUHUIGAIBIAN.ZAISHIYONGBIQIANGXUEGUANSHOUSUOYAODEBINGRENSHIYONGBENPIN,KESHIBENPINXISHOUSULVJIANMAN,DANZONGDEXISHOULIANGBUHUIGAIBIAN. JIUSHISUANBUTUOFEINUODEFENBURONGLIANGBIANHUAFANWEIZAI305-901SHENG,ZONGQINGCHULV2SHENG/XIAOSHI-154SHENG/XIAOSHI,XUEQINGDANBAIJIEHELVYUEWEI80%,BINGZAIBUDAYU7ng/mlDENONGDUFANWEINEICHENGNONGDUYILAIGUANXI,GAIYAONENGCHUANTOUXUENAOPINGZHANG、TAIPANPINGZHANG,BINGJINRURUZHI,ZHUYAOZAIGANZANGBEIDAIXIE,ZHUYAODAIXIECHANWUSHIQIANGHUABUTUOFEINUO,CIYAODEDAIXIEYAOWUDADUOSHU(70-80%)TONGGUONIAOPAIXIE,SHAOLIANGCONGFENBIANPAIXIE。

LAONIANHUANZHESHIYONGJIUSHISUANBUTUOFEINUOBIPENJIDEBANSHUAIQIJIAONIANQINGZHEMINGXIANYANZHANG。ZAISHENGONGNENGSHUAIJIEDEHUANZHE(JIGANQINGCHULV〈30ml/min〉SHIYONGBENYAO,QIXIAOCHUBANSHUAIQIJIEJINZHENGCHANGRENDELIANGBEI,YAOWUZONGTIQINGCHULVWEIZHENGCHANGRENDEYIBAN。ZAIGANGONGNENGBUQUANDEHUANZHESHIYONGGAIYAO,QIQINGCHUBANSHUAIQIWEIZHENGCHANGRENDE3BEI,YAOWUZONGTIQINGCHULVWEIZHENGCHANGRENDEYIBAN。

【贮藏】

极速11选5ZHISHIWENGANZAOCHUMIBIBAOCUN。

【包装】

极速11选5ZONGSEMIANXIMOZHIPING、DINGLIANGPENWUBENG,1.0ml/PING/HE,MEIPING10PEN。

极速11选5ZONGSEMIANXIMOZHIPING、DINGLIANGPENWUBENG,2.5ml/PING/HE,MEIPING25PEN。

【有效期】

24GEYUE。

【执行标准】

WS1-(X-161)-2012Z

【批准文号】

极速11选5GUOYAOZHUNZIH20046359。

【生产企业】

QIYEMINGCHENG:SHANGHAIHENGRUIYIYAOYOUXIANGONGSI

极速11选5SHENGCHANDIZHI:SHANGHAISHIMINXINGQUJINGJIJISHUKAIFAQUWENJINGLU279HAO

极速11选5YOUZHENGBIANMA:200245

极速11选5DIANHUAHAOMA:021-54759108、021-54759066ZHUAN3318

极速11选5MIANFEIZIXUNDIANHUA:8009881976

CHUAN ZHEN HAO MA:021-54759108

极速11选5WANG ZHI:http://blumblum.com



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