Pharmacovigilance - Lamyra-Pharmacare

Form for specialists

Medical or pharmaceutical professional notifying of an adverse reaction

Last name, first name, patronymic name

Telephone

Job title and place of work

Address of organization

Patient information

Name

Medical record number

Sex

Age

Weight

Impairment of liver function

Impairment of kidney function

Allergy (indicate allergen)

Suspected drug

International Nonproprietary Name

Trade name

Manufacturer

Batch number

Indications for use

Administration way

Single dose

Frequency of administration

Start date of therapy

End date of therapy

Other drugs concurrently administered

International nonproprietary name or trade name of the drug

Indications for use

Administration way

Single dose

Frequency of administration

Start date of therapy

End date of therapy

- +

Description of suspected adverse reaction

Start date of therapy

End date of therapy

Result of the end of therapy
of the suspected drug

Causal Relationship
Assessment

Concurrent diseases, other states or risk factors

Outcome of the adverse reaction

Measures taken

Drugs used to reverse adverse effects (if needed)

Criteria for serious adverse reactions (please, mark if appropriate)

Death

Threat to life

Admission for treatment or its extension

Congenital abnormalities

Disability or incapacity for work

Necessity for medical intervention to prevent the above states

Non-applicable

Was the adverse reaction
observed after the repeated
administration of the drug?

Suspected drug is used in

Important additional information

Data from the clinical, laboratory and roentgenological studies and autopsies including the determination of the drug concentration in blood (tissue), if any or if associated with adverse reactions (please, provide the dates)

Concurrent diseases, anamnestic data

Suspected drug interactions

If having any congenital abnormalities, please, indicate all drugs taken during the pregnancy and the last menstrual period.

Please, attach the additional information, if needed.

Form for patients

Patient information

Name

Medical record number

Sex

Age

Weight

Impairment of liver function

Impairment of kidney function

Allergy (indicate allergen)

Suspected drug

International Nonproprietary Name

Trade name

Manufacturer

Batch number

Indications for use

Administration way

Single dose

Frequency of administration

Start date of therapy

End date of therapy

Other drugs concurrently administered

International nonproprietary name or trade name of the drug

Indications for use

Administration way

Single dose

Frequency of administration

Start date of therapy

End date of therapy

- +

Description of suspected adverse reaction

Start date of therapy

End date of therapy

Result of the end of therapy
of the suspected drug

Causal Relationship
Assessment

Concurrent diseases, other states or risk factors

Outcome of the adverse reaction

Measures taken

Drugs used to reverse adverse effects (if needed)

Criteria for serious adverse reactions (please, mark if appropriate)

Death

Threat to life

Admission for treatment or its extension

Congenital abnormalities

Disability or incapacity for work

Necessity for medical intervention to prevent the above states

Non-applicable

Was the adverse reaction
observed after the repeated
administration of the drug?

Suspected drug is used in

Important additional information

Concurrent diseases, anamnestic data

Suspected drug interactions

If having any congenital abnormalities, please, indicate all drugs taken during the pregnancy and the last menstrual period.

Please, attach the additional information, if needed.

Report of adverse reaction to the drug

Medical or pharmaceutical professional notifying of an adverse reaction

Patient information

Suspected drug

Other drugs concurrently administered

Important additional information

Patient information

Suspected drug

Other drugs concurrently administered

Important additional information