SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Pracetam 400 mg/ml solution for use in drinking water for pigs

Pracetam Vet 400 mg/ml solution for use in drinking water for pigs (DK)

Pracetam 40% solution buvable pour porc (FR)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Paracetamol 400 mg

Excipients:

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Solution for use in drinking water.

Clear viscous pink solution

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

In pigs:

Symptomatic treatment of fever in the context of respiratory diseases in combination with an appropriate anti infective therapy, if necessary.

4.3 Contraindications

- Do not use in animals with known hypersensitivity to paracetamol and to any other ingredients of the product,

- Do not use in animals with severe hepatic impairment,

- Do not use in animals with severe renal impairment. See also section 4.8

- Do not use in animals suffering from dehydration or hypovolaemia

4.4 Special warnings for each target species

Animals with reduced water intake and/or disturbed general condition have to be treated parenterally.

In case of combined viral and bacterial aetiology of the disease, an appropriate anti infective therapy should be given concomitantly.

4.5 Special precautions for use

Special precautions for use in animals

The anti-pyretic effect of the product is expected at 12 - 24 hours after the onset of treatment.

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

Do not handle the product if you know you are hypersensitive to paracetamol.

Wear appropriate protective clothing, gloves, goggles and mask when handling the product.

To rule out any risk of ingestion it is recommended not to eat or drink while using the product and to wash hands after use.

If the product comes in contact with the skin or eyes, rinse immediately with a large amount of water. If symptoms persist, seek medical advice.

In the case of accidental ingestion, seek medical advice.

4.6 Adverse reactions (frequency and seriousness)

In rare cases, at therapeutic doses, transient soft faeces can occur and can persist for up to 8 days after the withdrawal of treatment. This does not have any effect on the general condition of animals, and resolves without any specific treatment.

4.7 Use during pregnancy, lactation or lay

Studies in laboratory animals have not detected any teratogenic or foetotoxic effects at therapeutic doses. The administration of the product up to three times the recommended dose, during pregnancy or lactation, did not result in adverse effects. As such the product may be administered during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Concurrent administration of nephrotoxic drugs should be avoided.

4.9 Amounts to be administered and administration route

In drinking water use

30 mg of paracetamol per kg body weight per day, for 5 days, orally, administered in the drinking water, equivalent to 0.75 ml of oral solution per 10 kg body weight per day for 5 days.

The intake of medicated drinking water depends on the clinical condition of the animals. In order to obtain a correct dosage, the concentration in the drinking water must be adjusted accordingly.

Recommendation for dissolution:

First add, the necessary quantity of water for the preparation of the final solution in the container.

Then add the product while stirring the solution.

Preferably prepare, the solution in water at ambient temperature (20°C – 25°C).

For water at 25°C, there is an upper concentration limit of 40ml of product per litre of drinking solution.

When using the product with a water proportioner, adjust the setting to 3% - 5%. Do not set proportioners below 3%.

The solution should be prepared freshly every 24 hours. No other source of drinking water should be available during the medication period.

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

After administration of 5 times the recommended dose of paracetamol, liquid faeces with solid particles may occasionally occur. It does not have any effect on general body condition of animals.

Acetylcysteine can be used in case of accidental overdose.

4.11 Withdrawal period(s)

Meat and offal:zero days.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Other Analgesics and Antipyretics

ATCvet code: QN02BE01

5.1 Pharmacodynamic properties

Paracetamol or acetaminophen or N-acetyl-p-aminophenol is a paraminophenol derivative with analgesic and antipyretic properties.

5.2 Pharmacokinetic particulars

Absorption:Paracetamol is rapidly and almost completely absorbed after oral administration (bioavailability of about 90% after administration in the drinking water).Peak concentrations are reached in a little less than 2 hours after ingestion.

Metabolism:Paracetamol is mainly metabolised in the liver.The two major metabolic pathways are conjugation to glucuronate and conjugation to sulphate.The latter route is rapidly saturable at dosages higher than therapeutic doses.A minor pathway, catalysed by cytochrome P450 (CYP), leads to the formation of the intermediary reagent, N-acetyl-benzoquinoneimine which, under normal conditions of use, is rapidly detoxified by reduced glutathione and removed in urine after conjugation with cystein and mercapturic acid.On the contrary, after massive intoxication, the quantity of this toxic metabolite is increased.

Elimination:Paracetamol is mainly eliminated in the urine.In the pig, 63% of the ingested dose is eliminated by the kidneys in 24 hours mainly conjugated to glucuronate and suphate.Less than 5% is eliminated in unchanged form.The elimination half-life is approximately 5 hours.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Dimethyl sulfoxide

Ponceau 4R (E124)

Macrogol 300.

6.2 Incompatibilities

The product has been proved to be physically-chemically compatible with the actives substances Amoxicillin, Sulfadiazine/Trimethoprime, Doxycycline, Tylosine, Tetracycline, Colistin.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

6.3 Shelf life

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

Shelf life after first opening the immediate packaging: 3 months

Shelf life after dilution to directions: 24 hours

6.4 Special precautions for storage

This veterinary medicinal product does not require any special storage conditions

6.5 Nature and composition of immediate packaging

- High density polyethylene bottle

- High density polyethylene screwcap

- Polyethylene – Polyethylene – Polyethylene – seal (500 ml bottle)

- Polyethylene-aluminium-wax-paper-low density polyethylene seal (1-l bottle)

- Polyethylene-PET-aluminium-wax-cardboard seal (2.5-l and 5-l bottles)

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 veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

United Kingdom

8. MARKETING AUTHORISATION NUMBER

Vm 15052/4130

9. DATE OF FIRST AUTHORISATION

06 September 2016

10. DATE OF REVISION OF THE TEXT

September 2016

06 September 2016