LINCOMIX 300 INJ.

COMPOSITION

Active substance:

Lincomycin (as lincomycin hydrochloride)  300 mg/ml

Excipients:

Benzyl alcohol                                              9 mg/ml

CONTRAINDICATIONS

Do not use in animals with known hypersensitivity to lincomycin or to any of the excipients.

Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-intestinal disturbance.

ADVERSE REACTIONS

None known.

If you notice any side effects, even those not already listed in this package leaflet, please inform your veterinary surgeon.

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION

The product is administered by intramuscular injection at a daily dose of 11 mg active substance / kg bodyweight (equivalent to 1 ml product / 27 kg bodyweight), for 3 consecutive days.

Depending on the clinical status of the animals, the treatment may be continued by administration of lincomycin via feed or drinking water.

ADVICE ON CORRECT ADMINISTRATION

To ensure a correct dosage, bodyweight should be determined as accurately as possible to avoid underdosing.

WITHDRAWAL PERIOD

Pigs (meat and offal): 4 days.

SPECIAL STORAGE PRECAUTIONS

Do not store above 25°C.

Protect from direct sunlight.

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.

SPECIAL WARNINGS

Special warnings for each target species

None.

Special precautions for use

Special precautions for use in animals

Due to the likely variability (time, geographical) in the occurrence of resistance of bacteria for lincomycin, bacteriological sampling and susceptibility testing are recommended. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Use of the product deviating from the instructions given in the SPC may increase the prevalence of resistant bacteria and may decrease the effectiveness of treatment with other lincosamides due to the potential for cross-resistance.

Official and local antimicrobial policies should be taken into account when the product is used.

Special precautions to be taken by the person administering the medicinal products to animals

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

Avoid splashing on skin or eyes. In case of accidental eye or skin contact wash off the affected area thoroughly with water.

People with known hypersensitivity to lincomycin should avoid contact with the veterinary medicinal product.

Use during pregnancy, lactation or lay

Lincomycin may be used during pregnancy or lactation.

Interaction with other medicinal products and other forms of interaction

Clinical antagonism may exist between lincomycin and erythromycin and concurrent use is therefore not recommended.

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

Higher levels of dosage than recommended may cause diarrhea and loose stools.

Do not exceed the recommended dose.

Incompatibilities

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

PRESENTATION/PACKAGE

Vials of 50 ml, 100 ml, 250 ml and 500 ml.