Drug Efficacy: Hearings Before a Subcommittee of the Committee on Government Operations, House of Representatives, Ninety-first Congress, First Session, 1. daļaU.S. Government Printing Office, 1970 - 415 lappuses |
No grāmatas satura
1.5. rezultāts no 40.
4. lappuse
... stocks on the market down to the user level bearing the September 1968 labeling by May 15 , 1969. This replacement is to be completed by June 30 , 1969 . 4. All promotional material , including ads and / or written and oral instructions ...
... stocks on the market down to the user level bearing the September 1968 labeling by May 15 , 1969. This replacement is to be completed by June 30 , 1969 . 4. All promotional material , including ads and / or written and oral instructions ...
8. lappuse
... stocks of these products and offered the firms the alternative of either stopping the sale and quarantining all such chloramphenicol , or recalling it to their possession . Early in 1968 , Rachelle did submit adequate blood level data ...
... stocks of these products and offered the firms the alternative of either stopping the sale and quarantining all such chloramphenicol , or recalling it to their possession . Early in 1968 , Rachelle did submit adequate blood level data ...
10. lappuse
... stocks . On January 14 , 1969 , I ordered a thorough investigation of outstanding stocks , not only in the Parke , Davis plant in Detroit , but also in its branch warehouses and at its Puerto Rico plant . This investigation , which was ...
... stocks . On January 14 , 1969 , I ordered a thorough investigation of outstanding stocks , not only in the Parke , Davis plant in Detroit , but also in its branch warehouses and at its Puerto Rico plant . This investigation , which was ...
13. lappuse
... we anticipated that the existing stocks would be exhausted and that the new production would move out promptly with the revised prescribing information . 37-327-70 - pt . 1-2 cases , ndications for intramuscular use still present in the 13.
... we anticipated that the existing stocks would be exhausted and that the new production would move out promptly with the revised prescribing information . 37-327-70 - pt . 1-2 cases , ndications for intramuscular use still present in the 13.
14. lappuse
... stocks . On January 14 , 1969 , I rough investigation of outstanding stocks , not only in the plant in Detroit , but also in its branch warehouses and at co plant . tigation , which was completed in early February 1969 , at the firm did ...
... stocks . On January 14 , 1969 , I rough investigation of outstanding stocks , not only in the plant in Detroit , but also in its branch warehouses and at co plant . tigation , which was completed in early February 1969 , at the firm did ...
Citi izdevumi - Skatīt visu
Bieži izmantoti vārdi un frāzes
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
Populāri fragmenti
66. lappuse - ... 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).
63. lappuse - 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.
64. lappuse - 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.
113. lappuse - 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.
57. lappuse - 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...
65. lappuse - 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...
65. lappuse - ... 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...
63. lappuse - 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).
65. lappuse - ... 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.
62. lappuse - 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.