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Adverse event report

If you become aware of adverse reactions resulting from administration of drug products manufactured by Avexima, please, fill in the adverse event report form provided below or inform us via e-mail: pharmakonadzor@avexima.ru or by phone: +7 (495) 258 45 28.

Health provider or the other person reporting about AR

Surname, First name, Patronymic *

Position and place of employment

Institution address

Phone number

Message

Initial
Follow-up

Дата первичного обращения

Date of information receipt

Information about the patient

Initials (e.g. CAY)

Treatment

Inpatient
Ambulatory
Self-treatment
Unknown

Number of case record or medical history

Sex

Male
Female

Age

Weight (kg)

Pregnancy

Yes
No
Gestational age in weeks

Hepatic impairment

Renal disorders

Allergy (specify)

Drug product (DP) that potentially caused AR

Brand name (BN)

International nonproprietary name (INN)

Manufacturer

Country

Batch number

Indication for use

Single dose (mg, mL)

Daily dose (mg, mL)

Therapy start date

Route of administration

Therapy end date

Dose which caused AR (mg, mL)

AR potentially associated with administration of drug product

AR description

Date of AR onset

Date of AR resolution

DP withdrawal was followed by AR resolution

AR reoccurrence after DP rechallenge

Actions taken

No treatment
Lowering of suspected drug dose
Drug therapy
Suspected drug withdrawal
Concomitant treatment withdrawal
Drug-free therapy
Other

AR drug therapy (where appropriate)

Outcome

Последствия

Seriousness criterion

Death
Life threat
Hospitalization or its prolongation
Disability/incapacity
Congenital anomaly
Not applicable

Significant add. information ¹

Other drug products

Patient received no other drug products

Yes

International non-proprietary name

Trade name

Route of administration

Therapy start date

Therapy end date

Indication

Significant additional information

Additional files

Add file

¹ The data will be treated as confidential and will be used for the sole purpose to ensure drug safety.

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