Solutie injectabilă

Lincodem

100 mg/ml, solution for injection dogs, cats and pigs

Formula

Each ml of Lincodem contains:

Lincomycin (as lincomycin hydrochloride) ………………………… 100 mg

Benzyl alcohol ……………………………………………………………9 mg

Target species

Swine, cattle and sheep.

Indications

Dogs and cats

For the treatment of infections caused by lincomycin-susceptible Gram-positive organisms, particularly Streptococci and Staphylococci, and certain Gram-negative anaerobic organisms e.g. Bacteroides spp. or Fusobacterium spp.

Tonsillitis, laryngitis and other upper respiratory tract infections: The product has proved effective against most causal organisms.

Abscesses, infected wounds and purulent dermatitis: The product has proved useful in clearing dermal infection since it readily penetrates tissues and maintains its action in the presence of purulent material.

Septicaemia: The product has been used successfully to combat septicaemic conditions caused by organisms sensitive to lincomycin.

Pigs

For the treatment of infections caused by lincomycin-susceptible Gram-positive organisms, particularly Streptococci and Staphylococci, and certain Gram-negative anaerobic organisms e.g. Serpulina (treponema) hyodysenteriae, Bacteroides, Fusobacterium spp. and Mycoplasma spp.

Swine dysentery: Lincodem has been found effective in the treatment of swine dysentery. Lincodem may be used in the inappetent pig when 1-2 injections with a 24 hour interval given intramuscularly at a dose of 10 mg/kg will normally be adequate to return the appetite. Follow-up treatment should be provided either in feed or via the drinking water.

Enzootic or mycoplasmal pneumonia: the product has antimycoplasmal activity, and will provide an effective aid in the treatment of primary infective organisms and the secondary Gram-positive pathogens.

Septic arthritis, foot abscesses: Where these conditions are caused by staphylococci, streptococci, erysipelothrix and mycoplasma sensitive to lincomycin, this antibiotic provides useful treatment by the virtue of its ability to penetrate relatively avascular tissue (e.g. joints) and remain active in the presence of purulent material.

Administration

For intramuscular or intravenous administration in dogs and cats. For intramuscular administration only in pigs.

 

Dogs and cats:

Intramuscular: 22 mg/kg bwt once daily or 11 mg/kg bwt.

Intravenous: 11-22 mg/kg bwt once or twice daily by slow injection.

 

Pigs:

Intramuscular: 4.5-11 mg/kg bwt once daily for a maximum of 3 days.

When injecting large volumes, a maximum of 10 ml per injection site should be administered.  It is recommended that no more than two injections per day are given. At the lowest dose rate of 4.5 mg/kg, the maximum recommended weight of animal for treatment is therefore 445 kg and at the higher dose rate of 11 mg/kg, the maximum weight of animal for treatment will be 180 kg.

For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

Contraindications

Not recommended for use in species other than the dog, cat and pig. Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-intestinal disturbance.

Not to be given to animals with known pre-existing monilial infection.

Not effective against E.coli, Salmonella spp., Streptococcus faecalis or yeasts.

Not to be used in animals hypersensitive to lincosamides.

Side effects

None.

Special precautions for storage

Store in original packaging, at temperature below 25oC.

Do not refrigerate. Protect from frost.

Do not use after expiry date which is stated on the label.

Shelf life after first broaching the immediate packaging: 28 days

Advice on correct administration

As the vial should not be broached more than 25 times, the user should select the most appropriate vial size according to the target species to be treated. Use a dry sterile needle and syringe.

Withdrawal period

Meat and offal:

Swine:

3 days

The withdrawal period is calculated from the last administration of the drug. It should be noted that whatever the withdrawal period no food of animal origin can be given to humans during the period of treatment.

Special warnings

The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies. Use of the product deviating from the instructions given by the SPC may increase the prevalence of bacteria resistant to the lincomycin and may decrease the effectiveness of treatment with other antibiotics due to the potential for cross resistance.

Do not use the product in known cases of sensitivity to active ingredient or excipients.

Care should be taken to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician. The direct contact with skin should be avoided due to hypersensitization and contact dermatitis. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product. Do not smoke, drink or eat during administration of the product.

Studies in laboratory animals have not revealed any evidence of embryo- or foeto-toxic potential for florfenicol.

Interactions with other medicinal products and other forms of interaction are not known.

Higher levels of dosage than recommended may cause diarrhoea and loose stools in pigs.

Do not administer concomitant with erythromycin due to antagonism effect.

Special precautions for the disposal of unused product or waste materials

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal prod- ucts should be disposed of in accordance with local requirements.

Other information

PE-HD flasks of 100 ml, 500 ml, and 1000 ml.
PE-HD cans of 5 l, 10 l, and 20 l.
Not all pack sizes may be marketed.
For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.