Month: December 2019
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Fentanyl Counterfeiting – Global threat
Counterfeit medicine is fake medicine. It may be contaminated or contain the wrong or no active ingredient. They could have the right active ingredient but at the wrong dose. Counterfeit drugs are illegal and may be harmful to your health. Counterfeit fentanyl pills are showing up on the streets and Drug Enforcement Administration (DEA) considers fentanyl-containing…
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Paracetamol: Dangerous When Not Used Correctly
Paracetamol, also known as acetaminophen and APAP, is a medication used to treat pain and fever. It is typically used for mild to moderate pain relief. It is often sold in combination with other medications, such as in many cold medications. Paracetamol is an effective, simple analgesic that is well tolerated by adults and children…
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28. Periodic Safety Update Reports (PSURs)/Periodic Benefit-risk Evaluation Reports (PBRER) and Periodic Adverse Drug Experience Report (PADER) – Introduction
What is PSUR/PBRER? A Periodic Safety Update Report or Periodic Benefit-risk Evaluation Reports are pharmacovigilance documents intended to provide an evaluation of the risk-benefit balance of a medicinal product at defined time points after its authorisation. The objective of the PSUR is to present a comprehensive and critical analysis of the risk-benefit balance of the…