Форма рапорта о неблагоприятной лекарственной реакции

Не раздумывайте, послать ли сообщение, даже в случае, если не располагаете всеми необходимыми данными для заполнения формуляра!

Это доверительный документ!

Информация, полученная на основе Ваших сообщений, обрабатывается при строгом соблюдении принципа конфиденциальности. Идентичность пациента не раскрывается никогда.

Просим Вас при помощи этого формуляра сообщать обо всех подозреваемых НЛР, замеченных при употреблении лекарственных продуктов фирмы «Софарма» АО.

Мы с благодарностью примем любые сообщения, посланные нам врачами, стоматологами, фармацевтами и другими медицинскими специалистами. Пациенты, которые считают, что у них появились нежеланные реакции на предписанные им лекарства, могут сообщить об этом при помощи своего лечащего врача. Сообщение по поводу лекарственной реакции следует доложить в рамках 24 часов, считая с момента его получения, по:

Телефон: +359 2 8177 413;

Факс: (02) 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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