SHANUR I REPORTING OF ADVERSE EVENTS

SHANUR I REPORTING OF ADVERSE EVENTS

Kindly provide as much information as possible. For assistance contact Pharmacovigilance Officer Tel: +27 87 405 9660 or medsafety@shanur.co.za

I. EVENT INFORMATION

1. Suspect Medicine*

Select or enter value

1.a. Suspect Medicine Batch/ Lot Number

1.b. Suspect Medicine(s) Expiry Date

1.c. Product Strength

e.g. 100mg or 5mg/ml

1.d. Product Dosage Form

e.g. Syrup/ Tablet/Capsule

2. Patient Name

Patient Name and Surname

3. Country

Identification of the country where the reaction/event occurred

4. Date of Birth (YYYY/MM/DD)*

5. Age (Years)*

6. Sex

Select

7. Patient Height (cm)

8. Patient Weight (kg)

9. Pregnant

Select or enter value

9.a. Provide Gestational Age

How many weeks pregnant at time of event

10. Adverse Event*

Please describe the symptoms in as much detail as possible.

11. Include Relevant Test Lab Data

Provide results of tests and procedures relevant to the investigation - if available

II. SUSPECT MEDICINE INFORMATION

12. Daily Dose(s)*

Dosage taken i.e. One tablet every 12 hours after meals

13. Route(s) of Administration*

Select

14. Indication(s) for Use (reason for use)*

Provide the reasons for starting the medicine.

15. Suspect Medicine Start Date (YYYY/MM/DD)*

Date of first administration of medicine.

16. Suspect Medicine End Date (YYYY/MM/DD)

Date of last administration if medicine was stopped.

17. Therapy Duration

How long was the suspect medicine used for.

18. Event Onset (YYYY/MM/DD)*

Date the adverse event started.

19. Did the Event Stop When the Medicine Was Stopped?

Select

20. Did the Event Reappear if the Medicine Was Readministered?

Did the event recur on readministration?

Select

21.Corrective Treatment

Specify treatments used to alleviate the symptoms of the event.

21. a. Corrective Treatment 1

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

21.b. Corrective Treatment 2

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

21.c. Corrective Treatment 3

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

21.d. Corrective Treatment 4

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

21.e. Corrective Treatment 5

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administrationof Medicine

21.f. Corrective Treatment 6

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

III. CONCOMITANT MEDICINE(S) AND HISTORY

Concomitant : Any other medicines or treatment used by the patient at the same time as the suspected medicine.

22.a. Concomitant Medicine 1

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

22.b. Concomitant Medicine 2

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

22.c. Concomitant Medicine 3

Please include the below :

Name of Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

22.d. Concomitant Medicine 4

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

22.e. Concomitant Medicine 5

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

22.f. Concomitant Medicine 6

Please include the below :

Name of Medicine
Purpose of the Medicine
Date of Start of Medicine
Date of Last Administration of Medicine

23. Medical History

Additional information available e.g Co-morbidity (chronic disease), diagnostics, pregnancy with last month of period, etc.

Relevant medical history and concurrent conditions (not including the event)

24. Patient Allergies

25. Date of this Report (YYYY/MM/DD)

26. File Upload (where required)

Drag and drop files here or

27. Reporter Name*

28. Reporter Contact Number*

Phone

29. Reporter Email Address*

Send me a copy of my responses

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