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Podcast
Podcast
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Questions and Answers
Questions and Answers
Which of the following is not included in the list of controlled drugs in the text?
Which of the following is not included in the list of controlled drugs in the text?
- Vancomycin
- Streptomycin penicillin mixtures
- Colistin Sulfate
- Erythromycin (correct)
What is the maximum level of use for Chloramphenicol and its salts?
What is the maximum level of use for Chloramphenicol and its salts?
- 50 ppb
- 200 ppm
- 10 ppm
- 100 ppb (correct)
Which drug is authorized by L.N. 144/1995 according to the text?
Which drug is authorized by L.N. 144/1995 according to the text?
- Chlortetracycline
- Fortified procaine penicillin (correct)
- Cycloserine
- Viomycin pantothenate
What is the active ingredient in Spiramycin?
What is the active ingredient in Spiramycin?
Which poison is listed in the text as a controlled drug?
Which poison is listed in the text as a controlled drug?
What type of derivatives are prohibited in the list provided?
What type of derivatives are prohibited in the list provided?
'Dihydro-streptomycin' is a derivative of which antibiotic listed?
'Dihydro-streptomycin' is a derivative of which antibiotic listed?
What is a requirement for selling aminopyrine or dipyrone for oral or parenteral use?
What is a requirement for selling aminopyrine or dipyrone for oral or parenteral use?
What is emphasized regarding the use of aminopyrine or dipyrone in the text?
What is emphasized regarding the use of aminopyrine or dipyrone in the text?
What action is advised if agranulocytosis is suspected during treatment with aminopyrine or dipyrone?
What action is advised if agranulocytosis is suspected during treatment with aminopyrine or dipyrone?
What statement must be included on the outer label or package insert for aminopyrine or dipyrone?
What statement must be included on the outer label or package insert for aminopyrine or dipyrone?
What should be done if fatal agranulocytosis is known to occur after administration of aminopyrine or dipyrone?
What should be done if fatal agranulocytosis is known to occur after administration of aminopyrine or dipyrone?
What action is emphasized if any alteration in the blood count or signs of agranulocytosis are observed?
What action is emphasized if any alteration in the blood count or signs of agranulocytosis are observed?
'What should be done if agranulocytosis may occur suddenly without prior warning?' - This question is primarily testing understanding of...
'What should be done if agranulocytosis may occur suddenly without prior warning?' - This question is primarily testing understanding of...
'When should aminopyrine or dipyrone be discontinued?' - This question primarily focuses on...
'When should aminopyrine or dipyrone be discontinued?' - This question primarily focuses on...
'How should aminopyrine or dipyrone be used to minimize risks?' - This question directly relates to...
'How should aminopyrine or dipyrone be used to minimize risks?' - This question directly relates to...
'What should be included in the inner label when selling aminopyrine or dipyrone?' - This question primarily tests understanding of...
'What should be included in the inner label when selling aminopyrine or dipyrone?' - This question primarily tests understanding of...
Questions and Answers
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Flashcards
Flashcards
Antibiotic Residue Limit
Antibiotic Residue Limit
Time limit after antibiotic treatment to ensure milk is residue-free.
Reporting Drug Side Effects
Reporting Drug Side Effects
Reporting unexpected adverse effects or toxicity from new drugs is mandatory.
Investigational Drug Import
Investigational Drug Import
Drugs imported for research purposes only.
Investigational Use Label
Investigational Use Label
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Ministerial Discretion
Ministerial Discretion
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Safety Testing Reports
Safety Testing Reports
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Cephalosporins
Cephalosporins
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Macrolides
Macrolides
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Tetracyclines
Tetracyclines
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Aminoglycosides
Aminoglycosides
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Continued Monitoring
Continued Monitoring
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Cattle Antibiotic Treatment
Cattle Antibiotic Treatment
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Vitamin and Drug Examples
Vitamin and Drug Examples
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Study Notes
Study Notes
Antibiotics and Their Regulation
- Vitamin and drug list: Includes Vitamin E, Warfarin, Zidovudine, and several antibiotics such as Amikacin, Chloramphenicol, and Doxycycline.
- Antibiotics for cattle treatment: Specific regulations differentiate between lactating and non-lactating cattle.
- Labeling requirements: Antibiotic preparations must clearly state if not for use in lactating cattle, and include warnings about milk consumption post-treatment.
- Residue limits: Maximum elapsed time of 96 hours specified to ensure milk from treated animals is free of antibiotic residues.
- Reporting side effects: Immediate reporting to the Minister is required upon awareness of unexpected side effects or toxicity from new drugs.
Importation of New Drugs
- Investigational use: New drugs may be imported for clinical research under strict conditions, including having proper authorization from the Minister.
- Labeling rules: Packages of new drugs must indicate "To be used for investigational purposes only."
- Investigator qualifications: Only qualified investigators with written authority from the Minister can carry out clinical research on imported new drugs.
- Safety testing: The Minister may refuse license applications unless adequate safety testing documentation is provided by the applicant.
Ministerial Authority
- Discretion over applications: The Minister holds the authority to approve or reject applications based on compliance with established safety testing requirements.
- Detailed reports required: Applicants must submit comprehensive reports regarding the safety of new drugs, accompanied by any additional information requested by the Minister.
Relevant Antibiotic Classes
- Broad classes include: Cephalosporins, Macrolides, Tetracyclines, and Aminoglycosides, each with distinct drugs like Cefadroxil, Erythromycin, and Neomycin relevant for specific treatments.
- Continued monitoring of new drugs: Ensures safety under recommended conditions of use, emphasizing the importance of regulatory compliance in pharmaceutical use.
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