e-Obrazac za prijavu sumnji na štetne događaje – veterinarski lijekovi

Adverse event report

Required fields are marked in RED. The form cannot be submitted unless all required fields are completed. Please provide as much information as possible.

Reporter details

An email address of the reporter is required to submit this report. We may contact you to obtain additional information about the reported adverse event.

Who is reporting the adverse event

Veterinarian

Other

Name of the veterinary organisation

Full name

Address

Telephone number

Details about the animal in which the adverse event occurred

Species

Breed

Sex

Male

Female

Unknown

Male

Neutered

Unknown

Female

Neutered

Unknown

Gravid

Lactating

Body weight

Age

Animal ID (tag, microchip…)

Number of animals treated with the veterinary medicinal product

Number of animals in which the adverse event occurred

Number of animals that died

Health status prior to treatment / previous medical conditions

Veterinary medicinal product details

Name of the veterinary medicinal product

Strength and the pharmaceutical form of the veterinary medicinal product

Batch number

Lot

Was the veterinary medicinal product used in accordance with the leaflet

Yes

Reason for administration of the veterinary medicinal product

Route of administration of the veterinary medicinal product

Administered dose

Duration/frequency of treatment

Who administered the veterinary medicinal product

Has the Marketing authorisation holder/manufacturer been informed

Yes

Is the animal being treated with any other veterinary medicinal products

Yes

Unknown

Please specify which ones

Add another veterinary medicinal product

Veterinary medicinal product details 2

Name of the veterinary medicinal product

Strength and the pharmaceutical form of the veterinary medicinal product

Batch number

Lot

Was the veterinary medicinal product used in accordance with the leaflet

Yes

Reason for administration of the veterinary medicinal product

Route of administration of the veterinary medicinal product

Administered dose

Duration/frequency of treatment

Who administered the veterinary medicinal product

Has the Marketing authorisation holder/manufacturer been informed

Yes

Is the animal being treated with any other veterinary medicinal products

Yes

Unknown

Please specify which ones

Add another veterinary medicinal product

Veterinary medicinal product details 3

Name of the veterinary medicinal product

Strength and the pharmaceutical form of the veterinary medicinal product

Batch number

Lot

Was the veterinary medicinal product used in accordance with the leaflet

Yes

Reason for administration of the veterinary medicinal product

Route of administration of the veterinary medicinal product

Administered dose

Duration/frequency of treatment

Who administered the veterinary medicinal product

Has the Marketing authorisation holder/manufacturer been informed

Yes

Is the animal being treated with any other veterinary medicinal products

Yes

Unknown

Please specify which ones

Add another veterinary medicinal product

Veterinary medicinal product details 4

Name of the veterinary medicinal product

Strength and the pharmaceutical form of the veterinary medicinal product

Batch number

Lot

Was the veterinary medicinal product used in accordance with the leaflet

Yes

Reason for administration of the veterinary medicinal product

Route of administration of the veterinary medicinal product

Administered dose

Duration/frequency of treatment

Who administered the veterinary medicinal product

Has the Marketing authorisation holder/manufacturer been informed

Yes

Is the animal being treated with any other veterinary medicinal products

Yes

Unknown

Please specify which ones

Add another veterinary medicinal product

Veterinary medicinal product details 5

Name of the veterinary medicinal product

Strength and the pharmaceutical form of the veterinary medicinal product

Batch number

Lot

Was the veterinary medicinal product used in accordance with the leaflet

Yes

Reason for administration of the veterinary medicinal product

Route of administration of the veterinary medicinal product

Administered dose

Duration/frequency of treatment

Who administered the veterinary medicinal product

Has the Marketing authorisation holder/manufacturer been informed

Yes

Is the animal being treated with any other veterinary medicinal products

Yes

Unknown

Please specify which ones

Limit reached (max. 5)

Adverse event details

When was the veterinary medicinal product administered?

Date of onset of the adverse event

Duration of the adverse event

Time interval between administration of the veterinary medicinal product and the onset of the adverse event

Has the veterinary medicinal product been administered to the animal before

Yes

Veterinary medicinal product has been administered to the animal before

Adverse event occurred

No adverse event occurred

Unknown

Other medicinal products administered concurrently:

Measures taken following the adverse event

Outcome of the adverse event

DESCRIPTION OF THE REPORTED ADVERSE EVENT (chronological sequence of events, clinical manifestation, description, severity and duration of symptoms, outcome, concurrent diseases, information on other administered medicinal products)

Attach Documents (laboratory report, copy of medical records, necropsy findings, etc.)

Drag documents here (or click to upload). Maximum file size: 50 MB

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e-Form for reporting suspected adverse events for veterinary medicinal products

Reporter details

Details about the animal in which the adverse event occurred

Details about the person in whom the adverse reaction occurred

Veterinary medicinal product details

Veterinary medicinal product details 2

Veterinary medicinal product details 3

Veterinary medicinal product details 4

Veterinary medicinal product details 5

Adverse event details