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Tilmovet

Main information

  • Trade name:
  • Tilmovet 100 mg/g Oral Granules for Pigs
  • Available from:
  • Huvepharma N.V.
  • Pharmaceutical form:
  • Granules
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Tilmovet 100 mg/g Oral Granules for Pigs
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Pigs
  • Therapeutic area:
  • Antimicrobial

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 30282/4015
  • Authorization date:
  • 14-10-2009
  • Last update:
  • 24-06-2017

Summary of Product characteristics

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Revised: July 2014

AN: 01175/2013

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

TILMOVET 100 mg/g oral granules for pigs

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each gram contains

Active substance:

Tilmicosin: 100 mg

Excipients

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Oral granules.

A brown granulated powder.

4.

CLINICAL PARTICULARS

4.1

Target species

Pigs (weaned piglets and fattening pigs)

4.2

Indications for use (specifying the target species)

The product is indicated for the treatment of pneumonia in weaned piglets

and fattening pigs, caused by Actinobacillus pleuropneumoniae, Mycoplasma

hyopneumoniae, Pasteurella multocida sensitive to tilmicosin.

4.3

Contraindications

Do not use in animals hypersensitive to tilmicosin and when there is

resistance to tilmicosin or cross resistance to other macrolides like tylosin,

erythromycin or lincomycin.

Tilmicosin is known to be toxic for horses. Do not allow horses or other

equines access to feeds containing tilmicosin.

4.4

Special warnings (for each target species)

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If for an individual animal, feed intake is such that the recommended dosage

is not realized, medication should be carried out by parenteral treatment.

4.5

Special precautions for use

4.5i)

Special precautions for use in animals

Cross-resistance between tilmicosin and other macrolide antibiotic has

been observed. Use of the product should be based on susceptibility

testing and take into account official and local antimicrobial policies.

Due to likely variability (time, geographical) in the occurrence of the

resistance of bacteria for tilmicosin, bacteriological sampling and

susceptibility testing are recommended. Inappropriate use of the

product may increase the prevalence of bacteria resistant to tilmicosin

and may decrease the effectiveness of treatment with tilmicosin related

substances.

4.5ii)

Special precautions to be taken by the person administering the

veterinary medicinal product to animals

Accidental ingestion should be avoided by humans.

People with known hypersensitivity to macrolide antibiotics should

avoid contact with the veterinary medicinal product.

May cause sensitisation by skin contact. May cause skin and eye

irritation. Avoid direct skin contact. Wear overalls, safety glasses and

impervious gloves when mixing and handling the product. Wash

affected parts if skin contact occurs. If accidental eye contact occurs,

immediately rinse thoroughly with water. In case of accidental

ingestion, or if you develop symptoms following exposure such as skin

rash, seek medical advice immediately and show the package leaflet

or the label to the physician

Swelling of the face, lips or eyes or difficulty with breathing are more

serious symptoms and require urgent medical attention.

If the operations involve the risk of exposure to dust, wear either a

disposable filter and half mask respirator conforming to European

Standard EN149 or a non-disposable respirator to European Standard

EN140 fitted with a filter to EN143. This warning is particularly relevant

to on-farm mixing, where the risk of exposure to dust is likely to be

enhanced.

This warning is particularly relevant to on-farm mixing, where the risk

of exposure to dust is likely to be enhanced.

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