Date: 1 November 2011 Page 1 of 9 Injectable Solution - Nov 11 (highlighted).doc IMMEDIATE CONTAINER- Main Panel PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Linco-Spectin Antibiotic Injectable Solution RLP APPROVED LINCOMYCIN.......... 50 mg/ml (as lincomycin hydrochloride) SPECTINOMYCIN... 1 00 mg/ml (as spectinomycin sulphate) 100 ml IMMEDIATE CONTAINER- Right Panel READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT DIRECTIONS FOR USE Dosage and Administration Use the contents within 28 days of first broaching of the vial. Discard the unused portion. WITHHOLDING PERIODS: MEAT: DO NOT USE less than the following periods before slaughter for human consumption. Pigs Broiler chickens 21 days 10 days TRADE ADVICE: ESI not established. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126. APVMA Approval No. 38692/53703 Pfizer Animal Health A division of Pfizer Australia Pty Ltd 38-42 Wharf Road West Ryde NSW 2114 Store below 30 C (Room Temperature) Batch: Ex ir : PRIMARY PACK- Front Panel
Date: 1 November 2011 Page 2 of 9 Injectable Solution- Nov 11 (highlighted).doc PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Linco-Spectin Antibiotic Injectable Solution LINCOMYCIN... 50 mg/ml (as lincomycin hydrochloride) SPECTINOMYCIN... 1 00 mg/ml (as spectinomycin sulphate) For the treatment of infections in pigs, broiler chickens, dogs and cats caused by organisms sensitive to the action of lincomycin and/or spectinomycin. 100 ml PRIMARY PACK- Right Panel READ THE ENCLOSED INSERT BEFORE USING THIS PRODUCT DIRECTIONS FOR USE: This product is contraindicated for use in animals previously found to be hypersensitive to either antibiotic or the combination. This product is contraindicated for use in animals with known pre-existing monilial infections. Use in species other than those indicated may result in adverse gastrointestinal effects. At dose levels higher than those recommended, intramuscular administration to swine may cause transient diarrhoea or loose stools. This effect rarely has been reported at the recommended therapeutic dose level. An occasional report of pain on injection has been received; however, serious inflammatory reactions following injection have not been reported. Pfizer Animal Health A division of Pfizer Australia Ply Ltd 38-42 Wharf Road West Ryde NSW 2114 PRIMARY PACK- Left Panel DOSAGE AND ADMINISTRATION: Use the contents within 28 days of first broaching of the vial. Discard the unused portion. Pigs: 15mg/kg (1 ml/1 Okg) of body weight, intramuscularly. May be repeated at 24 hour intervals for 3 to 7 days as needed.
Date: 1 November 2011 Page 3 of 9 File number: LAB0807 - Linco-Spectin Antibiotic Version : 2 Injectable Solution - Nov 11 (highlighted).doc Broiler Chickens: 30mg/kg (0.1 mu0.5kg) of body weight, subcutaneously once daily for 3 consecutive days, or inject once and follow with Linco-Spectin Antibiotic Soluble Powder water medication for 3 to 5 days. Dogs and Cats: 30mg/kg (1 mu5kg) of body weight intramuscularly. May be repeated at 12 or 24 hour intervals for up to 21 days. Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may result in the need to extend the approved withholding period. WITHHOLDING PERIODS MEAT: DO NOT USE less than the following periods before slaughter for human consumption: Pigs Broiler chickens 21 Days 10 Days TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufacturer on 1800 814 883 before using this product. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131126. Pfizer Animal Health A division of Pfizer Australia Pty Ltd 38-42 Wharf Road West Ryde NSW 2114
Date: 1 November 2011 Page 4 of 9 Injectable Solution- Nov 11 (highlighted).doc PRIMARY PACK- Back Panel Practice aseptic techniques in withdrawing each dose. Adequately clean and disinfect the vial closure before entry with a sterile needle and syringe. CAUTION -AVOID CARCASE DAMAGE 1. Sterilise all injection apparatus by boiling before use. Avoid the use of strong disinfectants on the apparatus. 2. Maintain cleanliness at all times. 3. Keep needles sharp and clean; replace frequently. 4. Use needles of appropriate gauge and length. For subcutaneous administration use the shortest needle possible, certainly not exceeding 15mm. 5. Avoid injection of animals in wet weather or under dusty conditions as far as possible. Disposal: Dispose of container by wrapping with paper and putting in garbage. APVMA Approval No. 38692/53703 BARCODE PRIMARY PACK- Top Panel 100 ml Linco-Spectin Antibiotic Injectable Solution PRIMARY PACK- Base Panel Store below 30 C (Room Temperature) Batch Expiry Disposal: Dispose of empty container by wrapping with paper and putting in garbage.
Product Name: LINCO-SPECTIN 1111 ANTIBIOTIC INJECTABLE SOLUTION Date: 1 November 2011 Page 5 of 9 Injectable Solution - Nov 11 (hiqhliqhted).doc Reason: Category 14- Addition of In use shelf life, ESI statement and other updates to comply with current LEAFLET PRESCRIPTION ANIMAL REMEDY KEEP OUT OF REACH OF CHILDREN FOR ANIMAL TREATMENT ONLY Linco-Spectin Antibiotic Injectable Solution For use in pigs, broiler chickens, dogs and cats. Each ml contains: Lincomycin hydrochloride equivalent to lincomycin base, 50 mg; spectinomycin sulphate equivalent to spectinomycin base, 100 mg: benzyl alcohol, 9 mg; water for injection, q.s. When necessary, ph was adjusted with sodium hydroxide and/or hydrochloric acid. The appearance of a slight haze in an unopened vial of LINCO-SPECTIN Antibiotic Injectable Solution may occur, but does not affect the potency or therapeutic efficacy of the product. Lincomycin is produced by Streptomyces lincolnensis and is chemically distinct from all other clinically available antibiotics. It is readily soluble in water. It is effective in vitro against most of the common gram-positive pathogens. It is also effective against certain mycoplasma, spirochete and anaerobic organisms. Spectinomycin is produced by Streptomyces flavopersicus. Spectinomycin free base is weakly basic and readily soluble in water. It has in vivo and in vitro activity against many gram-positive, gram-negative and mycoplasma organisms but like lincomycin, is inactive against yeasts, moulds and viruses. ACTIONS Animal Toxicology Lincomycin: The acute LDSO intraperitoneally in mice is 1,000 mg/kg and orally in rats is 15,645 mg/kg. It was well tolerated when administered orally to rats and dogs at doses up to 300 mg/kg/day for one year. Parenteral administration of 60 mg/kg/day for 30 days produced no evidence of toxicosis detectable at necropsy. Daily administration of lincomycin parenterally to pregnant rats and dogs did not produce teratogenic effects. Lincomycin was subcutaneously injected into mature male and female rats at a daily dose level of 75 mg/kg during a pre-breeding period of 60 days and throughout two mating cycles (84 days). No evidence was obtained that lincomycin antibiotic injectable solution exerted any effect on the embryos. The subcutaneous LDSO value in the newborn rat was determined to be 783 mg/kg. Newborn rats and canine pups have tolerated multiple doses of 39-90 mg/kg/day of the drug without evidence of ill effects.
Product Name: LINCO-SPECTIN'"' ANTIBIOTIC INJECTABLE SOLUTION Date: 1 November 2011 Page 6 of 9 Injectable Solution - Nov 11 (highlighted).doc Reason: Category 14- Addition of In use shelf life, ESI statement and other updates to comply with current Pigs receiving lincomycin hydrochloride antibiotic injectable solution injection intramuscularly at 22, 55 and 110 mg/kg {4, 10 and 20 times overdose) for 14 days tolerated all injections well, gained weight normally and showed normal haematology, urinalysis and blood chemistry values. Diarrhoea was noted in the 110 mg/kg group with a lessening gradation of soft stools seen in the 22 and 55 mg/kg groups. These changes in stool consistency did not adversely affect performance of blood electrolyte values. By the tenth day of the trial period, all stools were again normal. Spectinomycin: The oral LD50 for spectinomycin in the rat was 13,685 mg/kg. The dog has tolerated single oral doses of 1,000 mg/kg and single intravenous doses of 500 and 1,000 mg/kg. Intravenous administration to dogs at doses up to 300 mg/kg/day for 5 days was nontoxic. Continuous oral doses up to 500 mg/kg for four weeks did not produce signs of toxicosis in the dog. LINCO-SPECT/1\P Antibiotic Injectable Solution: Studies conducted in rats demonstrated that there was no potentiation or antagonistic effect shown by the combination of the two compounds administered orally. LINCO-SPECTIN Antibiotic Injectable Solution was administered intramuscularly to dogs twice daily for 21 days at doses of 15, 50 or 150 mg spectinomycin/kg and 7.5, 25 or 75 mg lincomycin/kg. No evidence of toxicosis was detected either grossly or by clinical chemistry during treatment. Only moderate irritation was noted at the first injection sites and two dogs on the higher levels showed transient signs of pain following injection. In a similar study, LINCO-SPECTIN Antibiotic Injectable Solution was administered intramuscularly to cats for 21 days to provide 5 or 25 mg lincomycin/kg and 10 or 50 mg spectinomycin/kg twice daily. All injections were well tolerated. No signs of toxicosis were detected clinically during administration or by gross examination. Only mild to moderate signs of muscular and subcutaneous irritation were observed grossly. Biological Studies Lincomycin: In vitro studies have shown that the spectrum of lincomycin is primarily against gram-positive organisms, including Staphylococcus aureus, Staph. a/bus, beta-haemolytic streptococci, Strep. viridans, Clostridium tetani and Ct. perfringens. Lincomycin is not active against Strep. faecalis, gram-negative bacteria, yeasts or fungi. It has shown in vitro activity against certain strains of Mycoplasma spirochetes and anaerobic organisms. In vivo studies have demonstrated the effectiveness of lincomycin in protecting animals infected with Streptococcus viridans, beta-haemolytic streptococci, Staphylococcus aureus and Leptospira pomona. It was ineffective in Klebsiella, Pasteurella, Pseudomonas and Salmonella infections. Clinically, it was proved effective in the treatment of upper respiratory tract infections, septicaemia, and in infections of the skin and adjoining tissues. Lincomycin has not shown cross-resistance with penicillin, triacetyloleandomycin, chloramphenicol, novobiocin, streptomycin or the tetracyclines. Staphylococci develop resistance to lincomycin in a slow, step-wise manner as shown in in vitro serial subculture experiments. Spectinomycin: Spectinomycin demonstrates activity in vitro against a variety of gram-positive, gram-negative and mycoplasmal organisms. It is primarily bacteriostatic in nature.
Date: 1 November 2011 Page 7 of 9 Injectable Solution -Nov 11 (highlighted). doc Spectinomycin has been found effective in vivo against infections caused by Escherichia, Salmonella, Staphylococcus, Streptococcus and certain mycoplasmal organisms. Against systemic infections, spectinomycin is most effective when given parenterally. Although resistance development of organisms to spectinomycin has been demonstrated in vitro (serial passage under laboratory conditions) and in vivo (susceptibility testing of field isolates) significant resistance problems have not been reported. Clinical Absorption and Excretion: When LINCO-SPECTIN Antibiotic Injectable Solution was administered intramuscularly to dogs, peak levels of both antibiotics were obtained in one hour. At doses of 15 mg spectinomycin and 7.5 mg lincomycin/kg, the peak serum level for spectinomycin was 42 mcg/ml and lincomycin 4.50 meg/mi. These levels are in excess of the minimum inhibitory concentrations of the two antibiotics for many bacteria. Studies indicate that bile is an important route of excretion of lincomycin. Significant levels of lincomycin have been demonstrated in the majority of body tissues. After a single oral administration of lincomycin antibiotic injectable solution to a dog, faecal excretion amounted to 77 percent of the dose; urinary excretion 14 percent. After a single, intramuscular injection, faecal excretion equalled 38 percent of the dose; and urinary excretion, 49 percent. Urinary excretion was essentially complete in less than 24 hours and faecal excretion by 48 hours after administration by either route. Lincomycin has also been shown to be excreted in the milk of lactating cows, goats, rats and women. Following intramuscular administration, spectinomycin is rapidly excreted in the urine. INDICATIONS LINCO-SPECTIN Antibiotic Injectable Solution is indicated for the treatment of infections in pigs, broiler chickens, dogs and cats caused by organisms sensitive to the action of lincomycin and/or spectinomycin. Pigs: LINCO-SPECTIN Antibiotic Injectable Solution is indicated for treatment and control of swine dysentery (S. hyodysenteriae) and enteritis associated with E. coli. Aids in the control of mycoplasma pneumonia. Broiler chickens: Ll NCO-SPECTI N Antibiotic Injectable Solution is indicated for the prevention and treatment of chronic respiratory disease in broiler chickens associated with Mycoplasma gallisepticum and E. coli. Dogs: LINCO-SPECTIN Antibiotic Injectable Solution is indicated for treatment of respiratory infections, skin infections, urinary tract infections and secondary bacterial infections, due to susceptible organisms, associated with virus diseases. Cats: LINCO-SPECTIN Antibiotic Injectable Solution is indicated for treatment of urinary tract and upper respiratory tract infections, localised infections and secondary bacterial infections due to susceptible organisms, associated with virus diseases.
Date: 1 November 2011 Page 8 of 9 Injectable Solution -Nov 11 (highlighted). doc DIRECTIONS FOR USE This product is contraindicated for use in animals previously found to be hypersensitive to either antibiotic or the combination. This product is contraindicated for use in animals with known pre-existing monilial infections. Use in species other than those indicated on the label may result in adverse gastrointestinal effects. An occasional report of pain on injection has been received; however, serious inflammatory reactions following injection have not been reported. At dose levels higher than those recommended, the intramuscular administration to pigs may cause a transient diarrhoea or loose stools. Although this effect rarely has been reported at the therapeutic dose level, one must be alert to the possibility that it may occur. DOSAGE AND ADMINISTRATION Use the contents within 28 days of first broaching of the vial. Discard the unused portion. As with any multi-dose vial, practice aseptic techniques in withdrawing each dose. Adequately clean and disinfect the vial closure prior to entry with a sterile needle and syringe. Pigs: 15 mg per kg (1 ml/1 0 kg) of body weight intramuscularly. May be repeated at 24 hour intervals for 3 to 7 days as needed. Broiler Chickens: 30 mg per kg (0.1 ml/0.5 kg) of body weight subcutaneously once daily for 3 consecutive days or inject once and follow with LINCO-SPECTIN Antibiotic Soluble Powder water medication for 3 to 5 days. Dogs and cats: 30 mg per kg (1 ml/5 kg) of body weight intramuscularly. May be repeated at 12 or 24 hour intervals for up to 21 days.
Date: 1 November 2011 Page 9 of 9 Injectable Solution - Nov 11 (highlighted).doc labelling reguirements. SHORT SUMMARY- READ ALL INFORMATION Animals Pigs Broiler Chickens Dogs Cats Indications Swine dysentery (S. hyodysenteriae), enteritis associated with E. coli mycoplasma pneumonia. Chronic respiratory disease associated with Mycoplasma gallisepticum and E. coli. Respiratory infections, skin infections, urinary tract infections and secondary bacterial infections, due to susceptible organisms, associated with virus diseases. Urinary tract and upper respiratory tract Infections. Localised infections and secondary bacterial infections, due to susceptible organisms, associated with virus diseases. Dosage 15 mg per kg (1 ml/10 kg) of body weight intramuscularly. May be repeated at 24 hour intervals for 3 to 7 days as needed. 30 mg per kg (0.1 ml/0.5 kg) of body weight subcutaneously once daily for 3 consecutive days or inject once and follow with LINCO-SPECTIN Antibiotic Soluble Powder water medication for 3 to 5 days. 30 mg per kg (1 ml/5 kg) of body weight intramuscularly. May be repeated for up to 21 days. 30 mg per kg (1 ml/5 kg) of body weight intramuscularly. May be repeated at 12 or 24 hours intervals for up to 21 days. WITHHOLDING PERIODS MEAT: DO NOT USE less than the following periods before slaughter for human consumption: Pigs 21 Days Broiler chickens 10 Days TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an ESI established. For advice on the ESI, contact the manufacturer on 1800 814 883 before using this product. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre. Phone Australia 131 126. LINCO-SPECTIN Antibiotic Injectable Solution is available in 100mL vials. Store below 30 C (Room Temperature) Dispose of container by wrapping with paper and putting in garbage. APVMA Approval No. 38692/53703 Pfizer Animal Health A division of Pfizer Australia Pty Ltd 38-42 Wharf Road West Ryde NSW 2114