PARACETAM PLUS

200 mg/100 mg/ml, solution for use in drinking water for pigs

Indications

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

COMPOSITION

Active substances:

Paracetamol          200 mg/ml

Vitamin C             100 mg/ml

 

Excipients:

Sodium benzoate   1 mg/ml

 

CONTRAINDICATIONS

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

Do not use in animals suffering from dehydration or hypovolaemia.

 

ADVERSE REACTIONS

Sometimes paracetamol can increase blood urea levels and lower creatinine levels.

In rare cases, at therapeutic doses, transient soft stools have been observed, which may persist for up to 8 days after stopping the treatment.

Other side effects that may occur are: drowsiness, anxiety, irritability, vomiting, redness of the skin, tachycardia, low blood pressure and abdominal pain.

 

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Oral administration, in drinking water.

30 mg of paracetamol per kg body weight per day, for 5 consecutive days equivalent to 1,5 ml oral solution / 10 kg body weight/ day.

 

ADVICE ON CORRECT ADMINISTRATION

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

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

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

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

 

WITHDRAWAL PERIOD

Pigs (meat and offal):  zero days.

 

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place.

Protect from direct sunlight. Do not use this veterinary medicinal product after the expiry date which is stated on the label.

 

SHELF-LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after first opening the immediate packaging: 28 days.

Shelf life after reconstitution into drinking water: 24 hours.             

 

SPECIAL WARNINGS

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 etiology of the disease, an appropriate antiinfective therapy should be given concomitantly.

Special precautions for use in animals

None.

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

People with known hypersensitivity to paracetamol or any of the excipients should avoid contact with the product.

To avoid exposure during the preparation of the medicated water wear appropriate protective clothing, gloves, goggles and mask when handling the product.

Do not eat, drink or smoke while handling this product. Wash hands after use.

The product may be harmful if ingested. In the case of accidental ingestion, seek medical advice.

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

Swelling of the face, lips or eyes or respiratory difficulties are the most serious signs which require urgent medical attention.

Use during pregnancy, lactation or lay

The product can be used during pregnancy and lactation.

Interaction with other medicinal products and other forms of interaction

Concurrent administration of nephrotoxic drugs should be avoided.

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

Major incompatibilities

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

 

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements. Veterinary medicinal product must not be disposed of via waste water or the drainage systems. 

 

PRESENTATION/PACKAGE

White HDPE vials x 50 ml, 100 ml.  HDPE canisters  x 1 L, 5 L, 10 L, 20 L.


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