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ARGUSPRODUCT SCREEN
1
05/03/23Katalyst Healthcares & Life
Sciences
Product Information:
Spontaneous/Literature: At least one Novartis drug should be entered as
suspect Two or more Novartis drugs can be entered as co-
suspect Only one case will be created Concomitant Novartis drugs are coded with WHO drug
dictionary
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05/03/23
Katalyst Healthcares & Life Sciences
Concomitant Medication & Treatments
All co-medications should be entered in the Products screen and marked concomitant
All drugs used to treat the adverse event should be entered in the Products screen and marked treatment
Use the WHO Drug Coding List to select product name - using the encode button for both concomitant and treatment medication
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05/03/23
Katalyst Healthcares & Life Sciences
Coding Medication:
Product Name and Generic Name fields are automatically populated from data entered in the book-in screen
Indication will also be automatically populated as derived from book-in coding if the drug is coded to an indication
Therefore, ensure information is correct prior to product selection
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05/03/23
Katalyst Healthcares & Life Sciences
Trade Name Lookup
The most critical fields are:
• Product
• Ingredient
• Formulation
• Indication
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05/03/23
Katalyst Healthcares & Life Sciences
Trade Name Lookup
The most critical fields are:
• Product
• Ingredient
• Formulation
• Indication
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05/03/23
Katalyst Healthcares & Life Sciences
Coding of Novartis Drugs:
Under country delete the country name and type in
- World1 to look for the local trade name
- World to look for the international trade name
- NH (for Novartis Pharma Headquarters) to look for the generic name
- NCH (Novartis Consumer Health) to look for products ‘owned’ by Consumer Health.
- NVO (Novartis Ophthalmics) or ‘o-‘ to look for Ophtha products.
- NGX (Novartis Generics) to look for products ‘owned’ by Novartis Generics.
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05/03/23
Katalyst Healthcares & Life Sciences
Coding of Novartis Drugs8
05/03/23
Katalyst Healthcares & Life Sciences
Co-meds and Treatment meds
Therapy Details:
Enter for concomitant and treatment medications Do not enter procedures, surgery, and non-drug
therapy as treatment
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05/03/23
Katalyst Healthcares & Life Sciences
Product Information:
Concentration Units: should be used to capture strength of suspect formulation, if
provided Do not use this field for products which have an indication
linked to the product selection ie. NeoralFormulation: should be left unchanged
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05/03/23
Katalyst Healthcares & Life Sciences
Dosage Information:
Suspect/Concomitant Medication: For all cases enter all dosage information up until the onset
of the event
Treatment Medication: For all cases enter all known dosage information relevant to
the treatment of the event
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05/03/23
Katalyst Healthcares & Life Sciences
Dosage Information:
Multiple dosage regimens: Enter in chronological order Relevant dosage changes leading up to an event/episode
(recurrent events) and during an event/episode can be added up until the final resolution of the event/episode
Dosage range: when citing a range, use the minus key, not a dash (dashes
do not print out on the MedWatch form)
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05/03/23
Katalyst Healthcares & Life Sciences
Dosage Regimens:
Stop dates: should not be entered where the patient has died
while on drug therapy
Dose Description: should always be filled in, if appropriate, as it
maps to regulatory forms
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05/03/23
Katalyst Healthcares & Life Sciences
Dosage Regimens:
Patient Route of Administration: select the appropriate value from the drop down list, which
reflects the patient’s route of administration i.e. oral or type o several times.
Parent Route of Administration: used in Baby cases to enter mother information of route of
administration
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05/03/23
Katalyst Healthcares & Life Sciences
Action Taken
Specifically refers to the suspect product, not the event as a whole
Only one action item can be entered
If more than one action, use most relevant term- the discontinued option should have higher priority
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05/03/23
Katalyst Healthcares & Life Sciences
Dechallenge:
Tick the appropriate checkbox:• Positive: drug was stopped and the event/symptoms
improved/disappeared• Negative: drug was stopped and the event/symptoms
did not improve/go away or patient has sequelae
• N/A: drug was not stopped • Unknown: the result of the dechallenge is unknown
Definition: when the drug has been interrupted because of the event...
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05/03/23
Katalyst Healthcares & Life Sciences
Rechallenge:
Tick the appropriate checkbox:• Positive: drug was re-introduced and symptoms
reappeared• Negative: drug was re-introduced and symptoms did not
reappear• N/A: drug was not re-introduced• Unknown: The result of the rechallenge is unknown
Definition: …if drug is then re-introduced
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05/03/23
Katalyst Healthcares & Life Sciences
Thank YouThank You&&
QuestionsQuestions
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Contact:Katalyst Healthcare’s & Life SciencesSouth Plainfield, NJ, USA 07080.E-Mail: [email protected]