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Ciprofloxacin hydrochloride
Ciprofloxacin hydrochloride

... Ciprofloxacin is a broad-spectrum bactericidal antiinfective agent of the fluoroquinolone class. It is available in more than 100 countries, where it is approved for the treatment of 14 types of infections, especially urinary tract infections such as acute uncomplicated cystitis and chronic bacteria ...
Vol 1   Pg 22 ACETAMINOPHEN PRODUCTS
Vol 1 Pg 22 ACETAMINOPHEN PRODUCTS

... damage, as the term “severe” is not necessary for a liver warning for acetaminophen. In describing events, use of modifiers such as “severe” across the category of OTC analgesics must be consistently applied so that healthcare professionals and consumers can make appropriate and informed choices abo ...
Tartrazine: a potentially hazardous dye in Canadian drugs.
Tartrazine: a potentially hazardous dye in Canadian drugs.

... dairy products, juices, pickles, candies and cake mixes, as do most home food-colouring kits.6 Cosmetics and toiletries, such as shampoos, after-shave lotions, colognes, toothpastes and soaps, may all contain tartrazine. Pharmaceutical manufacturers use this dye in many types of drug products. Table ...
Benefit Rider - Sparrow Health System
Benefit Rider - Sparrow Health System

... Misc (nabumetone) Celebrex Clarinex Clarinex D 12 hour and 24 hour Xyzal ...
complaint  - AboutLawsuits.com
complaint - AboutLawsuits.com

... groups. Developmental retardation in off-spring and fetuses were noted – namely, areas of the parietal (body cavity) were not fully ossified, and the hyoid (neck) failed to ossify completely. 40. Study No. R10590 Oral Segment II teratological study of rats. Four groups of 30 pregnant rats (120 total ...
RE:Docket No.98N-0148 ;International Drug
RE:Docket No.98N-0148 ;International Drug

... is or is not a pharmacological ...
Pfizer Guitly of Violating California Unfair Competition Law
Pfizer Guitly of Violating California Unfair Competition Law

... scientifically accepted evidence that Neurontin is effective for the treatment of bipolar disorder, ...


... subject.’ The FDA publicly stated numerous times that it ...
Polyethylene Glycol 3350 (PEG 3350) Frequently Asked
Polyethylene Glycol 3350 (PEG 3350) Frequently Asked

... 1. What is PEG 3350? Polyethylene glycol (PEG) is a water-soluble, inactive ingredient of which only a very small amount is absorbed in the gut or gastrointestinal tract, the rest moves through the body. PEG is non-toxic and has no effect on the body. It is used in many products including medication ...
Tonicity Agents Clarity - Pharmacists Provide Care
Tonicity Agents Clarity - Pharmacists Provide Care

... • For Eye • Protect from Light ...
09107sgp04
09107sgp04

... some adverse effects on human, a similar study was taken on human. The result had shown that no clinically relevant serious adverse cardiac effects have been observed in studies in man. Co-administration did not modify other class-related toxicities in animals. Besides, The use of inhaled salmeterol ...
Aloe vera: Plant of Immortality - International Journal of Pharma
Aloe vera: Plant of Immortality - International Journal of Pharma

... Aloe vera gel should not be used externally after laparotomy or caesarean delivery because it may delay wound healing. Drug aloe should not be taken for more than 10 days. It should not be used by pregnant or lactating women and is contraindicated in the following conditions: intestinalobstruction o ...
united states district court
united states district court

... nociceptive pain, bipolar disorder, migraine headache and in doses above the maximum recommended by the FDA, I am of the opinion that, based on the evidence reviewed and detailed in my report, this campaign was effectuated by dissemination of inaccurate, incomplete or misleading scientific evidence ...
M P D U
M P D U

... defines the drug name and the amount of drug represented by the code but does not specify manufacturer or package size information. ...
FDA Regulation: 21 – CFR – 314 New Drug Application
FDA Regulation: 21 – CFR – 314 New Drug Application

... the traditional approval of a product originally approved under subpart H of part 314; or (8) Incorporate other information based on at least one adequate and well-controlled clinical study. FDA means the Food and Drug Administration. Listed drug means a new drug product that has an effective approv ...
November 2015 PBAC Meeting Agenda
November 2015 PBAC Meeting Agenda

... circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters. Pharmaceu ...
GPAT-2012 PAPER
GPAT-2012 PAPER

... (A) P, Q and S are treated while R is NOT (B) P, R and S are treated while Q is NOT (C) Q, R and S are treated while P is NOT (D) P, Q and R are treated while S is NOT Q.26 Which one of the following statements is FALSE for fluoroquinolones? (A) These are highly effective by oral and parenteral rout ...
GPAT-2012 PAPER
GPAT-2012 PAPER

... (A) P, Q and S are treated while R is NOT (B) P, R and S are treated while Q is NOT (C) Q, R and S are treated while P is NOT (D) P, Q and R are treated while S is NOT Q.26 Which one of the following statements is FALSE for fluoroquinolones? (A) These are highly effective by oral and parenteral rout ...
Examination of the Evidence for Off
Examination of the Evidence for Off

... OBJECTIVES: (1) Describe the relevance of off-label use of gabapentin to managed care pharmacy; (2) summarize recent FDA warnings and media reports related to off-label gabapentin use; (3) review medical information pertaining to the off-label use of gabapentin; (4) outline alternatives to off-label ...
The PBAC agenda primarily consists of applications relating
The PBAC agenda primarily consists of applications relating

... circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters. Pharmaceu ...
March 2016 PBAC Meeting Agenda
March 2016 PBAC Meeting Agenda

... circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters. Pharmaceu ...
E - Morgan Joseph
E - Morgan Joseph

... Trexima approval. Pozen’s lead development program, Trexima, is a unique formulation of Imitrex and naproxen (Aleve), two already approved drugs that are widely used to treat migraines. As such, we believe safety concerns for the drug are largely mitigated relative to more traditional development pr ...
MHRA recommendations on simvastatin interactions: What are the
MHRA recommendations on simvastatin interactions: What are the

...  Atorvastatin (20mg or 40mg daily) is an option if a more potent statin is needed. The risk of an interaction with amlodipine is much lower with atorvastatin than simvastatin. 4. Change to an alternative calcium channel blocker- do not change therapy in patients who are well controlled with amlodip ...
PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE (PBAC
PHARMACEUTICAL BENEFITS ADVISORY COMMITTEE (PBAC

... circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters. Pharmaceu ...
November 2016 PBAC Meeting Agenda
November 2016 PBAC Meeting Agenda

... circumstances, consumers will be able to comment on items in other sections of the agenda. The submissions for which input is sought will be listed in alphabetical order by drug name. There is no provision for consumer comments to the PBAC on agenda item 8 which relates to pricing matters. Pharmaceu ...
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List of off-label promotion pharmaceutical settlements

The following are settlements reached against pharmaceutical companies to resolve allegations of off-label promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may be subject to civil liability under the False Claims Act as well as criminal penalties.
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