Paragraph 3 Summary of product characteristics

The summary of product characteristics required under the preceding paragraph must include the following information, set out in the same format—

Summary of product characteristics

1	Name of the veterinary medicinal product, followed by 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.