Each ml contains:

Paracetamol 400 mg

For the full list of excipients, see Pharmaceutical particulars.

Solution for use in drinking water. Clear viscous pink solution

Pigs

In pigs:

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

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not use in animals with severe hepatic impairment,

Do not use in animals with severe renal impairment. See also Interaction with other medicinal products.

Do not use in animals suffering from dehydration or hypovolaemia

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.

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

None

The product can cause hypersensitive reactions (allergy). People with known hypersensitivity to paracetamol or any of the excipients should avoid contact with the product. The product may cause skin and eye irritation. Wear appropriate protective clothing, gloves, goggles and mask when handling the product.

In cases of accidental contact with the skin or eyes, rinse immediately with a large amount of water. If symptoms persist, seek medical advice and show the leaflet to the physician.

The product may be harmful if ingested. In the case of accidental ingestion, seek medical advice. Do not eat, drink or smoke while handling this product. Wash hands after use.

In rare cases, 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.

Laboratory studies in rats have not produced any evidence of 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. The product can be used during pregnancy and lactation.

Concurrent administration of nephrotoxic drugs should be avoided.

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. To avoid under-dosing and to ensure a correct dosage, bodyweight should be determined as accurately as possible.

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 40 ml 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.

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.

N-acetylcysteine can be used in case of accidental overdose.

Excessive overdoses can cause hepatotoxicity.

Meat and offal: zero days.

Pharmacotherapeutic group: Other analgesics and antipyretics. ATCvet code: QN02BE01

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

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.

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.

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.

Dimethyl sulfoxide, Ponceau 4R (E124), Macrogol 300.

The product has been proved to be physically-chemically compatible with the active substances Amoxicillin, Sulfadiazine/Trimethoprim, Doxycycline, Tylosin, Tetracycline, Colistin.

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

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

This veterinary medicinal product does not require any special storage conditions.

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)

Polypropylene screwcap (1-l and 5-l bottle)

Silicone seal (for polypropylene screwcap of 1-l and 5-l bottle)

Not all pack sizes may be marketed.

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

UK: Vm 15052/4130

06 September 2016

October 2022

Nil