On-line form for adverse drug reactions reporting

Do not hesitate to send a message even when you do not have all data required in the form on your disposal! This document is confidential! The information from your message is managed under strict confidentiality. The identity of the patient is never disclosed. Please report all adverse drug reactions that occurred during treatment with Sopharma products using this form.
Information about adverse drug reactions can be also reported to:

Phone: +359 2 8177 413;

Fax: +359 2 9743759;

E-mail: safety@sopharma.bg

Data about the reporter
Health-care professional?
  • Yes
  • No
Name: (required field)
Address:
Contact phone number: (required field)
E-mail:
Data about the patient
Initials:
Sex: (required field)
  • Male
  • Female
Age:
Suspected drug product
Product name: (required field)
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Indications:
Was administration of the suspected drug discontinued?
  • Yes
  • No
  • Dose was reduced
Did the patient use the suspected drug before?
  • Yes
  • No
  • Unknown
Product name:
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Indications:
Was administration of the suspected drug discontinued?
  • Yes
  • No
  • Dose was reduced
Did the patient use the suspected drug before?
  • Yes
  • No
  • Unknown
Product name:
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Incidactions:
Was administration of the suspected drug discontinued?
  • Yes
  • No
  • Dose was reduced
Did the patient use the suspected drug before?
  • Yes
  • No
  • Unknown
Concomitant drugs
Product name:
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Indications:
Product name:
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Indications:
Product name:
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Indications:
Product name:
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Indications:
Product name:
Pharmaceutical formulation:
Daily dose:
Start date:
Stop date:
Route of administration:
Показания:
Adverse drug reaction
Description of the adverse drug reaction: (required field)
Start date:
Stop date:
Result:
  • Recovered
  • Recovered with sequelae
  • Improved
  • Worsened
  • No change
  • Fatal outcome
  • Unknown
Causal relationship:
  • Certain
  • Probable
  • Possible
  • Unlikely
  • Conditional
  • Unclassified
Did the adverse reaction abate after
drug use stopped ?
  • Yes
  • No
  • Unknown
Did the adverse reaction reappear after
the drug reintroduction?
  • Yes
  • No
  • Unknown
Did the adverse reaction cause:
  • Hospitalization or prolonged hospitalization?
  • Life-threatening condition?
  • Disability?
  • Congenital anomaly or birth defect?
  • Medically significant reaction?
  • Death?
Description of the adverse reaction:
Start date:
Stop date:
Result:
  • Recovered
  • Recovered with sequelae
  • Improved
  • Worsened
  • No change
  • Fatal outcome
  • Unknown
Causal relationship:
  • Certain
  • Probable
  • Possible
  • Unlikely
  • Conditional
  • Unclassified
Did the adverse reaction abate after
drug use stopped?
  • Yes
  • No
  • Unknown
Did the adverse reaction reappear after
the drug reintroduction?
  • Yes
  • No
  • Unknown
Did the adverse reaction cause:
  • Hospitalization or prolonged hospitalization?
  • Life-threatening condition?
  • Disability?
  • Congenital anomaly or birth defect?
  • Medically significant reaction?
  • Death?
Description of the adverse drug rection:
Start date:
Stop date:
Result:
  • Recovered
  • Recovered with sequelae
  • Improved
  • Worsened
  • No change
  • Fatal outcome
  • Unknown
Causal relationship:
  • Certain
  • Probable
  • Possible
  • Unlikely
  • Conditional
  • Unclassified
Did the adverse reaction abate after
drug use stopped?
  • Yes
  • No
  • Unknown
Did the adverse reaction reappiar after
the drug reintroduction?
  • Yes
  • No
  • Unknown
Did the adverse reaction cause:
  • Hospitalization or prolonged hospitalization?
  • Life-threatening condition?
  • Disability?
  • НCongenital anomaly or birth defect?
  • Medically significant reaction?
  • Death?
Additional information:

(treatment details, diagnostic procedures, concomitant diseases, pregnancy, abuses, allergy, concomitant treatment, medical history etc.)

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