Report adverse reaction

Form for reporting a suspected case of an adverse reaction to a veterinary medicinal product

According to Art. 13 of the General Regulation on the Protection of Personal Data of April 27, 2016 (Journal of Laws UE L 119 of 04/05/2016) we would like to inform you that: 1. The administrator of your data is Vet-Agro Multi-Trade Company Sp. z o.o. Gliniana 32, 20-616 Lublin, Poland.

CONTACT DETAILS OF REPORTER

First and last name

Phone number

E-mail

Address

REPORTER’S QUALIFICATION:

Application concerns:

Species

Breed

Gender

Age of the animal

Body weight (kg)

Health status before treatment

Reason of treatment

Number of treated animals

Number of affected animals

Number of dead animals

VETERINARY MEDICINAL PRODUCT

Name and strength

Lot number

Expiry date

Storage conditions

Treatment start date

End date od treatment

Who administered the product

Has the product been used according to label?

DETAILED DESCRIPTION OF THE OBSERVED ADVERSE EVENTS:

Date of onset of the adverse event

Duration of the adverse event

Actions taken after the onset of the adverse event

Was any other treatment being administered concurrently? If so, what are they?

How did the animal's condition change after the drug was discontinued?

BEFORE ADMINISTRATION OF THE MEDICINAL PRODUCT, WERE DIAGNOSED OTHER DISEASES, ALLERGIC REACTIONS OR GIVEN OTHER MEDICINES (IF YES, WHICH?)

VETERINARY MEDICINAL PRODUCT

Name and strength

Lot number

Expiry date

Storage conditions

Name and surname of the exposed person

The exposed person’s home address

Telephone of the exposed person

E-mail address of the exposed person

DETAILED DESCRIPTION OF THE OBSERVED ADVERSE EFFECTS AND THE WAY OF HUMAN EXPOSURE TO THE VETERINARY MEDICINAL PRODUCT

Date of exposure

Date of onset of the adverse event

Duration of the adverse event

Actions taken after the onset of the adverse event

Was any other treatment being administered concurrently? If so, what are they?

How did the exposed person’s condition change after the drug was discontinued?

BEFORE ADMINISTRATION OF THE MEDICINAL PRODUCT, WERE DIAGNOSED OTHER DISEASES, ALLERGIC REACTIONS OR GIVEN OTHER MEDICINES (IF YES, WHICH?)

Species

Breed

Gender

Age of the animal

Body weight (kg)

Health status before treatment

Reason of treatment

Number of treated animals

Number of animals in which a lack of efficacy was observed

VETERINARY MEDICINAL PRODUCT

Name and strength

Lot number

Expiry date

Storage conditions

Treatment start date

End date od treatment

Who administered the product

Has the product been used according to label?

BEFORE ADMINISTRATION OF THE MEDICINAL PRODUCT, WERE DIAGNOSED OTHER DISEASES, ALLERGIC REACTIONS OR GIVEN OTHER MEDICINES (IF YES, WHICH?)

DETAILED DESCRIPTION:

At what time after the start of therapy, a lack of efficacy was observed?

Actions taken after the onset of the adverse event

Was any other treatment being administered concurrently? If so, what are they?

VETERINARY MEDICINAL PRODUCT

Name and strength

Lot number

Expiry date

Storage conditions

Treatment start date

End date od treatment

Product of animal origin

DETAILED DESCRIPTION:

VETERINARY MEDICINAL PRODUCT

Name and strength

Lot number

Expiry date

Storage conditions

DETAILED DESCRIPTION:

Attachments

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I declare that I have read the content of the information clause regarding the processing of personal data in connection with the obligation to monitor the safety of pharmacotherapy by Vet-Agro Sp. z o.o.