SPECTOL inj

COMPOSITION

Each ml of product contains Lincomycin (as Lincomycin hydrochloride) 50 mg and Spectinomycin (as Spectinomycin sulphate) 100 mg

TARGET SPECIES

Pigs, calves up to weaning, chickens, turkeys, sheep, goats, dogs and cats

INDICATIONS

Spectol inj is indicated for the treatment of infections caused by microorganisms susceptible to action of lincomycin and/or spectinomycin, including: Actinobacillus spp., Pasteurella spp., Brachyspira hyodysenterie, Escherichia coli, Campylobacter spp., Bacteroides spp., Salmonella spp., Clostridium spp., Fusobacterium spp., Actinomyces spp., Staphylococcus spp., Streptococcus spp., Mycoplasma spp. in pigs, calves up to weaning, chickens, turkeys, sheep, goats, dogs and cats.

Pigs - For the treatment of bacterial and mycoplasmic pneumonia, dysentery, bacterial enteritis and infectious arthritis.

Calves up to weaning - 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, air sacculitis, cholera, staphylococcus infections, sinusitis and rhinitis.

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

CONTRAINDICATIONS

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

ADVERSE REACTIONS 

Sometimes pain may occur at the injection site. Another side effect occasionally observed in pigs is loss of appetite.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

In the form of intramuscular or subcutaneous injections.

Pigs - 15 mg active substance per kg body weight/day (1 mL/10 kg body weight) intramuscularly.

Repeat for 3 days, depending on the clinical response observed.

Calves up to weaning - 15 mg active substance per kg body weight/day (1 mL/10 kg body weight) intramuscularly, twice a day on the first day, then a single administration for 2-4 days, depending on their clinical response.

Chickens and turkeys - 0.1 mL/0.5 kg body weight/day by subcutaneous route, for 3 days or a single administration followed by administration in drinking water of medicinal products containing lincomycin and spectinomycin for 3 to 5 days.

Sheep and goats - 15 mg active substance per kg body weight/day (1 mL/10 kg body weight) intramuscularly, for 3 days.

Dogs and cats - 30 mg active substance per kg body weight/day (1 mL/5 kg body weight) intramuscularly. 

It can be repeated every 12 or 24 hours and can be administered for up to 21 days. 

To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing.

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

The recommended doses should be observed.

WITHDRAWAL PERIOD(S)

Meat and offal

Pigs - 14 days after last treatment.

Calves before weaning - 21 days after last treatment.

Sheep and goats - 15 days after last treatment.

Chickens and turkeys - 15 days after last treatment.

Do not administer to animals producing milk for human consumption.

Do not administer to hens laying eggs for human consumption.

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 PRECAUTIONS FOR STORAGE

Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on antimicrobial susceptibility testing of bacteria isolated from animals.

National and regional antimicrobial policies shall be observed when using the product.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

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

Those with known hypersensitivity to the active substance should avoid contact with the veterinary medicinal product.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

It can be used during gestation and lactation.

Do not use in animals producing milk for human consumption.

Do not use in hens laying eggs for human consumption.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

Do not use concomitantly with macrolide antibiotics.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

If a higher than recommended dose is administered to pigs, the product may cause transient diarrhoea.

INCOMPATIBILITIES

Do not dilute or mix with other veterinary medicinal products.

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

Any unused veterinary medicinal product or waste materials derived from such products should be disposed of in accordance with local requirements.

Medicines should not be disposed of via waste water or household waste.

Ask your vet for information on how to dispose of medicines no longer required.

These measures contribute to environmental protection.

PRESENTATION/PACKAGE

100 mL and 250 mL polypropylene vials sealed with bromobutyl rubber stopper and aluminium cap.