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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... September 1968 as a result of a study by the National Academy of Sciences . It appears that there has been no recall from hospitals , pharmacies or other trade channels of Chloromycetin Sodium Succinate which bears the old labeling ...
... September 1968 as a result of a study by the National Academy of Sciences . It appears that there has been no recall from hospitals , pharmacies or other trade channels of Chloromycetin Sodium Succinate which bears the old labeling ...
Seite 1
... September 1968 as a result of a study by the National Academy of Sciences . ( 2 ) It appears that there has been no recall , from hospitals , pharmacies , or other trade channels , of Chloromycetin Succinate which bears the old labeling ...
... September 1968 as a result of a study by the National Academy of Sciences . ( 2 ) It appears that there has been no recall , from hospitals , pharmacies , or other trade channels , of Chloromycetin Succinate which bears the old labeling ...
Seite 2
... September 1968 as a result of a study by the National Academy of Sciences . It appears that there has been no recall from hospitals , pharmacies or other trade channels of Chloromycetin Sodium Succinate which bears the old labeling ...
... September 1968 as a result of a study by the National Academy of Sciences . It appears that there has been no recall from hospitals , pharmacies or other trade channels of Chloromycetin Sodium Succinate which bears the old labeling ...
Seite 3
... September 1968 as a result of a study by the National Academy of Sciences . ( 2 ) It appears that there has been no recall , from hospitals , pharmacies , or other trade channels , of Chloromycetin Succinate which bears the old labeling ...
... September 1968 as a result of a study by the National Academy of Sciences . ( 2 ) It appears that there has been no recall , from hospitals , pharmacies , or other trade channels , of Chloromycetin Succinate which bears the old labeling ...
Seite 4
... September 1968 is being sus- pended as of today , April 7 , 1969 . 2. All manufacturers , including Rachelle , are to revise labeling by April 14 , 1969 , using the following text in bold type : " Chloramphenicol sodium succinate is ...
... September 1968 is being sus- pended as of today , April 7 , 1969 . 2. All manufacturers , including Rachelle , are to revise labeling by April 14 , 1969 , using the following text in bold type : " Chloramphenicol sodium succinate is ...
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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
Beliebte Passagen
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.