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Enter the actual dose administered most recently before the adverse event started, such as number of tablets or quantity of solution. For multiple animals or where multiple different dosages were used, add details in the 鈥楧etails of adverse event鈥�/鈥橬arrative of adverse event鈥� field located in the Adverse Event section of this form. Enter the actual dose administered, not the dose prescribed.

For medicinal products administered in food or water, and where dose units are best represented by concentrations, enter the number of mg/g/kg or ml/l in the 鈥楧ose鈥� field with the appropriate unit in the 鈥楧ose (units)鈥� field, the total amount of food or water administered in the 鈥楶er鈥� field and the appropriate unit for this total amount in the 鈥楶er (units)鈥� field.

Enter the number of units, such as, 10 in the 鈥楧ose鈥� field, Milligram in the 鈥楧ose (units)鈥� field, 1 in the 鈥楶er鈥� field and Kilogram or Millilitre (or other unit as applicable) as appropriate in the Per 鈥楿nit鈥� field.

An example would be a 6% premix, where the dose is 1 mg of the product per kilogram bodyweight daily. You would enter 1 in the 鈥楧ose鈥� field, milligram in the 鈥楧ose (units)鈥� field, 1 in the 鈥楶er鈥� field and 鈥楰ilogram鈥� in the Per 鈥楿nit鈥� field.

For dairy cow teat medicinal products select Teat or Quarter as appropriate for the 鈥楶er (units)鈥� field.

Complex situations, such as premixes for multiple animals, should be detailed in the 鈥楧etails of adverse event鈥�/鈥橬arrative of adverse event鈥� field located in the 鈥楢dverse event details鈥� section below.

Describe the event(s) in chronological order, including any important details or explanations that could not be entered in specific fields in the form. Please note that the text box has a 2,000鈥慶haracter limit, and you will not be able to continue typing once this limit is reached.

Do not include any confidential details, such as the names of individuals, veterinary practices, or any offensive language. Avoid using abbreviations or acronyms. Although every effort is made to prevent the sharing of confidential information or inappropriate language, we cannot guarantee that this material will not be shared with third parties -such as Marketing Authorisation Holders (pharmaceutical companies, MAHs), other VMD teams, or other government organisations - as part of our routine data-sharing processes.

List all signs (symptoms) that occurred following administration of the product(s) or explain why lack of efficacy is suspected.

List the date each sign started, and ended if applicable, and their severity:

• if signs occurred at a particular body location, include this information, and specifically state if signs occurred at the site of administration of the product

• if multiple affected animals are included within the same report, provide clear details as to which signs relate to which animal or group of animals.

Estimates can be used if necessary, however, the total number of animals affected by a single sign should not exceed the number entered into the 鈥楴umber of animals affected鈥� field located within the Patient section of this form.

List test or investigation results.

Explain when different events started or ended on different dates.

Describe with numbers when multiple animals experienced different outcomes.

Include details of any relevant medical history.

Include details of the treatment received by the animal(s) for the adverse event(s), if any, including details of treatment products that were administered and whether they had a positive effect.

Express your opinion as to whether the product(s) caused the events and specify a particular product if applicable.

If you select 鈥極ther鈥� for the field 鈥楻eporter category鈥�, provide additional details about your involvement, for example, if you are an Suitably Qualified Person (SQP), identify which category you are.

Where there is more than one animal affected and there are differences in breed, age, weight, reproductive status or sex of the animals, provide this information here.

If the current status of any of the animals treated or affected is not recorded in the form fields, that information can be added in this section.

Other relevant information such as medical history or post-mortem findings can also be noted here.

If multiple batches/lots of a specific product were involved in the adverse event, record the additional numbers here, including expiry dates, if known, and periods of use.

Record specially formulated (extemporaneous products) administered, with details of the active substance(s), amount and manufacturer in this section. Extemporaneous preparations (also be known as 鈥渧eterinary specials鈥�) are products that do not hold a Marketing Authorisation. These products have not been assessed against the same standards of quality, safety (for the target animal, user, consumer and environment) and efficacy as authorised veterinary medicines. They can legally be prescribed, supplied and used under the last step of the GB cascade. They may be, for example, a compounded medicine prepared for an individual patient at the time of prescription.

Include any additional information about how the products were administered, if this has not already been captured elsewhere in the form. If any products were used off-label, that is, in a manner not specified on the product鈥檚 label, provide full details, including whether this was intentional or occurred in error.

Include the dates on which the products were administered, for example, where multiple animals were involved and administration occurred on different dates, or where multiple or interrupted treatment courses were given.

Include information about how often the product was administered and the intervals between administrations, if this has not already been captured elsewhere in the form. If the administration differed from what was prescribed, record how the product was actually given. Provide further details where multiple administration frequencies or intervals were used for the same dose.

Include any additional details relating to events that occurred during previous administrations of any of the products, such as whether the events resolved, how quickly they resolved, and whether treatment was required.

If an animal previously experienced an adverse event following administration of a product, but the product was given alongside other products at that time, provide details of those circumstances.