1

Name of the veterinary medicinal product, including its strength and pharmaceutical form.

2

The name and proportion of each active substance, and of any excipient if knowledge of the excipient is needed for safety reasons.

3

Pharmaceutical form.

4

Clinical particulars—

4.1

• target species;

4.2

• indications for use, specifying the target species;

4.3

• contra-indications;

4.4

• special warnings for each target species;

4.5

• special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals;

4.6

• adverse reactions (frequency and seriousness);

4.7

• use during pregnancy, lactation or lay;

4.8

• interaction with other medicinal products and other forms of interaction;

4.9

• amounts to be administered and administration route;

4.10

• overdose (symptoms, emergency procedures, antidotes) if necessary;

4.11

• withdrawal periods for the various foodstuffs, including those for which the withdrawal period is zero.

5

Pharmacological properties—

5.1

• pharmacodynamic properties;

5.2

• pharmacokinetic particulars.

6

Pharmaceutical particulars—

6.1

• list of excipients;

6.2

• major incompatibilities;

6.3

• shelf life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time;

6.4

• special precautions for storage;

6.5

• nature and contents of immediate packaging;

6.6

• special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate.

7

Marketing authorisation holder.

8

Marketing authorisation number.

9

Date of the first authorisation or date of renewal of the authorisation.

10

Date of any revision of the text.

11

Any other information required by the Secretary of State.