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奥美拉唑液体说明书.doc

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1、2006101620070209?-omeprazole sodium for injectionzhusheyong aomeilazuona-5-2-(4352)1hc17h18n3nao3sh2o385.41 42.6mg-40mg1210ml0.9%100ml5%100ml-204-1/100; 1/10001/100; 1/1000- 1(zollinger-ellison)2ph34 - -f4502c19(cyp2c19)(r-)20mg20mg-270mg650mgh+k+-atph+k+-atp-h2h2dcampph0.190.48l/kgt1/20.513-p450-80

2、%-18%23%-95% (20) (1+1)/ 24 h20059053-699211112025-52169999025-52167777- - omeprazole sodium for injection ?-5-2-(4-3, 5-2-)-1h- h+k+-atph+k+-atp-h2h2dcampph 0.190.48l/kgt1/20.513-p450-80%-1823%-95% (1)(2)(3)(4) 40mg(),1210ml22.54 1. -2. ph3. 4. 5. ecl- - 1. -2. -p450 270mg650mg -42.6mg-40mgthe pack

3、age insert of omeprazole sodium for injectiondrug namechinese pinyin: zhu sheyong aomeilazuonaingredients: omeprazole sodium, whose chemical name is 5-methoxy-2-4-methoxy-3, 5-dimethyl-2-pyridyl-methyl-sulphony-1h-benzimidazolesodrum salt-hydratemolecular formula: c17h18n3nao3s-h2omolecular weight:

4、385.41descriptionwhite loose lump or powder, the specific solvent is achromatic transparent liquid.pharmacology toxicologypharmacokineticsindication1. hemorrhage of peptic ulcer and marginal ulcer3. prevention of rehemorrhage after operation for glare disease, e.g. cerebral hemorrhage, severe trauma

5、.4. prevention of regurgitation of gastric acid reflux associated aspiratory pneumonia for patients who have gone through general anesthesia or major operation or who are in hypothetic narcosis.dosage and usagethis injection is administered by intravenous injection. it should be given to the patienc

6、e once or twice per day and 40mg for each time. inject 10 ml special solvent into vials for lyophilized powder before administrating,other solvent excluded. the drug must be used in 2 hours after distribution and the time of bolus should be no less than 20 minutes.adverse reactionslight nausea, diar

7、rhea, bellyache, paraesthesia, swirl and headache may occur occasionally but the treatment will not be affected.contradictiondo not administer this product to those who are hypersensitive to it.precautions2. it may affect the absorption of medicines because of its significant effect on raising ph in

8、 stomach.3. adjustment of dosages is not necessary for patients with impaired renal function but reduction in dosage is necessary for those with impaired liver function.4. the possibility of carcinoma ventriculi must be precluded before administering this for the treatment of gastric ulcer in case a

9、ny delay in diagnosis and treatment may occur.5. the zoopery revealed that high-dosage and chronic administering of this drug, hypergastrinemia, secondary gastric ecl-cell inflation and benign tumor are observed which also occur after using other administration of other anti-acid agents and operatio

10、ns of partial gastrectomy.usage during the pregnancy and suckling periodusage for childrenthe experience of administration for children is limited.drug interaction1. the effect of this drug is prolonged when administered along with diazepam, phenytoinum and other drugs metabolized via liver. for ins

11、tance, when used with phenytoinum, patients condition should be monitored with great care and less phenytoinum should be used according to the condition of the patients.2. interaction may be involved when used with drugs metabolized via cytochrome p450 enzyme system, such as warfarin.over dosageacco

12、rding to the clinical trial, no dosage-related adverse reaction arises when the drug is administered intravenously 270mg in one day or 650 in three days.specification 40mgstorage preserved in well closed containers, and stored in a cool and dry placepackage this product should be packaged in glass t

13、ube antibiotic vial with closure made of butyl rubber for pharmaceutical use.registered number of approval state drug permit doc(sdpd) h validity 24 months-omeprazole sodium for injectionzhusheyong aomeilazuona-5-2-(4-3,5-2-)-1h-c17h18n3nao3sh2o385.41h+k+-atph+k+-atp-h2h2dcampph0.190.48l/kgt1/20.513-p450-80%-1823%-95%40mg,1210ml2201-2ph345ecl-1-2-p450270mg650mg40mg/

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