Drug Efficacy: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-first Congress, First Session, Teil 1U.S. Government Printing Office, 1970 - 415 Seiten |
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Seite 40
... dissolution rates on the same lot , and I think that was the basis of that action at that time . We were not sure we had a homogeneous lot . Mr. GRAY . Are you saying you only recalled that in Massachusetts ? Dr. MINCHEW . As I recall ...
... dissolution rates on the same lot , and I think that was the basis of that action at that time . We were not sure we had a homogeneous lot . Mr. GRAY . Are you saying you only recalled that in Massachusetts ? Dr. MINCHEW . As I recall ...
Seite 41
... dissolution rate time we found that they varied greatly . They also did not meet the dissolution rate times of ... rates . You also stated that you realized this mistake in December and switched from the chemical test to the blood level ...
... dissolution rate time we found that they varied greatly . They also did not meet the dissolution rate times of ... rates . You also stated that you realized this mistake in December and switched from the chemical test to the blood level ...
Seite 42
... dissolution rates ? Dr. LEY . There is variation in the dissolution rate even of the Parke , Davis ' capsule despite reasonably constant blood level responses . Dr. GOLDBERG . How would you compare the variation in dissolution rates of ...
... dissolution rates ? Dr. LEY . There is variation in the dissolution rate even of the Parke , Davis ' capsule despite reasonably constant blood level responses . Dr. GOLDBERG . How would you compare the variation in dissolution rates of ...
Seite 44
... dissolution rates ; rather it is why did you take Rachelle's off the market on that basis ? Mr. GOODRICH . Because it didn't meet the blood level standard . Mr. GRAY . But it did meet the blood level standard . And the fact that the ...
... dissolution rates ; rather it is why did you take Rachelle's off the market on that basis ? Mr. GOODRICH . Because it didn't meet the blood level standard . Mr. GRAY . But it did meet the blood level standard . And the fact that the ...
Seite 45
... dissolution rates of Parke , Davis ' versus Rachelle's , because we haven't looked at them recently , and I think to leave the impression that the magnitude of variation is similar between the two would be hazardous until we have looked ...
... dissolution rates of Parke , Davis ' versus Rachelle's , because we haven't looked at them recently , and I think to leave the impression that the magnitude of variation is similar between the two would be hazardous until we have looked ...
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Häufige Begriffe und Wortgruppen
Academy action amphenicol antibiotic aplastic anemia approved April blood level data blood level studies Brandenburg BROWN Bureau of Medicine certification Chairman chloram chloramphenicol capsules chloramphenicol products chloramphenicol sodium succinate chloramphenicol succinate Chloromycetin sodium succinate Chloromycetin succinate clinical data CONGRESS THE LIBRARY Davis & Co Davis product Dear Doctor decision Director dissolution rates Documentation dosage forms dose Drug Administration effective efficacy evaluation evidence files firm Food and Drug FOUNTAIN GOLDBERG GOODRICH gram GRAY HERBERT L Hodges hospital indicated injection insert intramuscular route intravenous JENNINGS July July 26 KIRK letter LIBRARY OF CONGRESS LOCKHART memorandum meningitis MINCHEW Office old labeling oral product parenteral parenteral form Parke patients pediatric percent phenicol physicians Pirtle problem question Rachelle Laboratories Rachelle product Rachelle's recall recommended record relabeling routes of administration September 1968 Staphylococcal statement subcommittee subcutaneous submitted therapeutic therapy tion typhoid fever vials warehouses
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Seite 66 - ... should be decreased as soon as possible. Adults with impairment of hepatic or renal function or both may have reduced ability to metabolize and excrete the drug. In instances of impaired metabolic processes, dosages should be adjusted accordingly. (See discussion under Newborn Infants.) Precise control of concentration of the drug in the blood should be carefully followed in patients with impaired metabolic processes by the available microtechniques (information available on request).
Seite 63 - In addition, there have been reports of aplastic anemia attributed to chloramphenicol which later terminated in leukemia. Blood dyscrasias have occurred after both short-term and prolonged therapy with this drug. Chloramphenicol must not be used when less potentially dangerous agents will be effective, as described in the Indications section.
Seite 64 - Warning Box and this Indications section, chloramphenicol must be used only in those serious Infections for which less potentially dangerous drugs are ineffective or contraindlcated.
Seite 113 - Chloramphenicol should not be used when other less potentially dangerous agents will be effective, or in the treatment of trivial infections such as colds, influenza, or viral infections of the throat, or as a prophylactic agent.
Seite 57 - It must not be used in the treatment of trivial infections or where it is not indicated, as in colds, influenza, infections of the throat; or as a prophylactic agent to prevent bacterial infections. Precautions: It is essential that adequate blood studies be made during treatment with the drug. While blood studies may detect early peripheral blood changes, such as leukopenia, reticulocytopenia, or granulocytopenia. before they become irreversible, such studies cannot be relied on to detect bone marrow...
Seite 65 - An exact determination of the risk of serious and fatal blood dyscrasias is not possible because of lack of accurate information regarding (1) the size of the population at risk, (2) the total number of drug-associated dyscrasias, and (3) the total number of nondrugassociated dyscrasias. In a report to the California State Assembly by the California Medical Association and the State Department of Public Health...
Seite 65 - ... after the administration of chloramphenicol. An irreversible type of marrow depression leading to aplastic anemia with a high rate of mortality is characterized by the appearance weeks or months after therapy of bone marrow aplasia or hypoplasia. Peripherally...
Seite 63 - Sensitivity testing is essential to determine its indicated use. but may be performed concurrently with therapy initiated on clinical impression that one of the indicated conditions exists (see Indications section).
Seite 65 - ... Treatment should not be continued longer than required to produce a cure with little or no risk of relapse of the disease. 3. Concurrent therapy with other drugs that may cause bone marrow depression should be avoided. 4. Excessive blood levels may result from administration of the recommended dose to patients with impaired liver or kidney function, including that due to immature metabolic processes in the infant.
Seite 62 - Gray Syndrome" Toxic reactions including fatalities have occurred in the premature and newborn; the signs and symptoms associated with these reactions have been referred to as the gray syndrome. One case of gray syndrome has been reported in an infant born to a mother having received chloramphenicol during labor.