Pv Flashcards

1
Q

Banned drugs in india

A

Anal-gin, pi-oglita-zone,dextropropoxyphene

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2
Q

Labelling for the patient/caregiver(USA)

A

Medication guides,patient package inserts,instructions for use

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3
Q

In Europe, document for end users is called

A

Patient information leaflet, package leaflet

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4
Q

In Europe the technical document is called

A

Summary of product characteristics

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5
Q

In the US, labelling for the HCP is called

A

Prescribing information

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6
Q

Recently banned drugs

A

Kavakava,vio-xx,bextra

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7
Q

CIOMS

A

Founded by WHO,UNESCO,United nations educational, scientific, and cultural organization in 1949

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8
Q

Triage

A

Perform preliminary assessment of safety report WRT reportability

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9
Q

Signal

A

Reported info on a possible causal relationship between an adverse event and the drug relationship being previously unknown or incompletely documented previously

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10
Q

medDRA hierarchy

A

The five levels of the dictionary are System Organ Class (SOC), High Level Group Term (HLGT), High Level Term (HLT), Preferred Term (PT), and Lowest Level Term (LLT).

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