1. NAME OF THE VETERINARY MEDICINAL PRODUCT

DILUMAREX

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Aqueous diluents q.s. 1 ml

3. PHARMACEUTICAL FORM

Solution for injection.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens.

4.2 Indications for use, specifying the target species

In chickens:

For the suspension preparation of MERIAL frozen vaccines against Marek’s disease.

4.3 Contraindications

Do not use alone.

4.4 Special warnings

None.

4.5 Special precautions for use

Special precautions for use in animals

Read special precautions for use of MERIAL frozen vaccines against Marek’s disease.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Read corresponding information of MERIAL frozen vaccines against Marek’s disease.

4.8 Interaction with other medicinal products and other forms of interaction

None.

4.9 Amounts to be administered and administration route

Refer to posology and method of administration of MERIAL frozen vaccines against Marek’s disease.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

None.

4.11 Withdrawal period(s)

Zero days.

5. IMMUNOLOGICAL PROPERTIES

Not applicable.

ATCvet code: QV07AB. Solvents and diluting agents, incl. irrigating solutions.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Sucrose

Casein hydrolysate

Dipotassium phosphate

Potassium dihydrogen phosphate

Phenol red sodium salt

Hydrochloric acid concentrated

Sodium hydroxide

Water for injections

6.2 Incompatibilities

Do not mix with any other medicinal products except MERIAL frozen vaccines against Marek’s disease.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years.

Once broached, use immediately.

6.4 Special precautions for storage

Store at a temperature lower than 30°C.

Avoid freezing or excessive temperature.

6.5 Nature and composition of immediate packaging

- 200 ml polyethylene-PVC bag.

- 400 ml polyethylene-PVC bag.

- 800 ml polyethylene-PVC bag.

- 1000 ml polyethylene-PVC bag.

- 1200 ml polyethylene-PVC bag.

- 1600 ml polyethylene-PVC bag.

- 1800 ml polyethylene-PVC bag.

- 2400 ml polyethylene-PVC bag.

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

Any unused product or waste material should be disposed of in accordance with national requirements.

7. MARKETING AUTHORISATION HOLDER

Merial Animal Health Ltd

Sandringham House

Harlow Business Park

Harlow

Essex

CM19 5TG

8. MARKETING AUTHORISATION NUMBER

Vm 08327/4219

9. RENEWAL OF THE AUTHORISATION

23 February 2010

10. DATE OF REVISION OF THE TEXT

24 March 2010

PROHIBITION OF SALE, SUPPLY AND/OR USE

Not applicable.