SPECTOL INJ.

50/100 mg/ml, injectable solution for pigs, pre-ruminant calves, chickens, turkeys, sheep, goats, dogs and cats

Indications

In pigs, pre-ruminant calves, chickens, turkeys, sheep, goats, dogs and cats, for the treatment of infections caused by organisms sensitive to lincomycin and / or spectinomycin including: Actinobacillus spp., Pasteurella spp., Brachyspira hyodysenteriae, Salmonella spp., Escherichia coli, Campylobacter spp., Bacteroides spp., Clostridium spp., Fusobacterium spp., Actinomyces spp., Staphylococcus spp., Streptococcus spp., Mycoplasma spp.

Pigs: for the treatment of bacterial and mycoplasma pneumonia, dysentery, bacterial enteritis and infectious arthritis.

Pre-ruminant calves: for the treatment of pneumonia and enteritis commonly associated with pneumonia.

Sheep and goats: for the treatment of pneumonia and respiratory diseases caused by Mycoplasma and other microorganisms, including pododermatitis.

Chickens and turkeys: for the treatment of respiratory diseases, aerosaculitis, cholera, staphylococcosis, sinusitis and coryza.

Dogs and cats: for the treatment of urinary and respiratory tract infections, abscesses and wounds due to bites at risk of infection and for the treatment of bacterial infections secondary to viral diseases such as panleukopenia, pneumonia, rhinotracheitis and upper respiratory tract diseases.

COMPOSITION

Active substances:

Lincomycin (as lincomycin hydrochloride)           50 mg/ml

Spectinomycin (as spectinomycin sulphate)    100 mg/ml

 

Excipients:

Benzyl alcohol                                                     9 mg/ml

 

CONTRAINDICATIONS

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

 

ADVERSE REACTIONS

The use of this product may cause occasional local pain upon injection. In pigs, an occasional loss of appetite may also occur.

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

By intramuscular or subcutaneous injections.

Pigs: 1 ml product / 10 kg body weight, intramuscularly, to be repeated daily for 3 days according to clinical response.

Pre-ruminant calves: 1ml product / 10 kg body weight, intramuscularly twice daily for the first day followed by once daily for 2-4 days according to clinical response.

Chickens and turkeys: 0.1 ml product / 0.5 kg body weight / day, subcutaneously for 3 consecutive days, or a single administration followed by administration of veterinary medicinal products containing lincomycin and spectinomycin via drinking water for 3 to 5 consecutive days.

Sheep and goats: 1 ml product / 10 kg body weight, by intramuscular route, to be repeated daily for 3 consecutive days.

Dogs and cats: 1 ml of the product per 5 kg bw, intramuscularly. May be repeated at 12 to 24 hour  intervals for 3-7 days according to clinical response.

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

 

ADVICE ON CORRECT ADMINISTRATION

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

 

WITHDRAWAL PERIOD

Pigs (meat and offal): 14 days.

Pre-ruminant calves (meat and offal): 21 days.

Sheep and goats (meat and offal): 15 days.

Chickens and turkeys (meat and offal): 15 days.

Not authorised for use in animals producing milk for human consumption.

Not for use in birds producing or intended to produce eggs for human consumption.

 

SPECIAL STORAGE PRECAUTIONS

Do not store above 250C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Protect from direct light.

 

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 precautions for use in animals

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local epidemiological (region, farm level) 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 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.

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

Use during pregnancy, lactation or lay

The product may be used during pregnancy or lactation.

Interaction with other medicinal products and other forms of interaction

Do not use concurrently with macrolides.

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

At higher levels than recommended in pigs, the product may give rise to transient diarrhea.

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.


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