Injectable Solution. 100ml. Injectable Solution. SEG-CA100 (55,00 x 55,00 x 103,00 mm)

Transcription

1 100 ml NUFLOR LA is indicated for the treatment of cattle with bacterial infections susceptible to florfenicol, especially the causative organisms of pink-eye (Moraxella bovis), bovine respiratory disease (including Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus) and footrot of cattle (Fusobacterium necrophorum and Bacteroides melaninogenicus), and for the treatment of pigs with swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma spp. and Streptococcus suis Type. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. Restraints: DO NOT USE in female cattle which are producing or may in the future produce milk or milk products for human consumption. DO NOT USE in calves to be processed for veal. DO NOT exceed 10mL at any one injection site (subcutaneous or intramuscular). Contra-indications and Special Precautions for Use: Not for use in cattle and pigs intended for breeding. Clinical improvement should be evident in most treated subjects within 4 hours of initiation of therapy. If a positive response is not seen within 4 hours after the second injection, the diagnosis should be reconfirmed. Susceptibility discs containing 30 μg of florfenicol are available for sensitivity testing. Mild, transient inappetence, decreased water consumption or diarrhoea may occur in cattle following treatment. Transient diarrhoea and/or perianal erythema/swelling may occur in pigs following treatment. These symptoms should return to normal shortly after treatment. The effect of florfenicol on bovine and porcine reproductive performance and pregnancy has not been assessed. As seen with many antibiotics high dosage and/or prolonged administration may lead to superinfections by non-sensitive organisms such as yeasts and fungi. Intramuscular injection at sites other than the neck can cause local reaction which may result in trim loss of edible tissue at slaughter. CATTLE: Intramuscular - 0 mg/kg of bodyweight (1 ml per 15 kg). A second dose should be given 48 hours later. Do not exceed 10mL at any one injection site. Inject into muscle tissue on the side of the neck. Intramuscular injection may result in local tissue reaction which persists beyond 35 days and may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck are likely to more severe. Subcutaneous - 40 mg/kg of bodyweight (ml per 15 kg). One subcutaneous dose ONLY. For doses that exceed 10mL, more than one injection site will be required. Inject under the skin high on the neck behind the ear. PIGS: Intramuscular - 15 mg/kg of bodyweight (0.75 ml per 15 kg). Two injections are given 48 hours apart. Do not exceed 10mL at any one injection site. Inject into muscle tissue on side of the neck. Intramuscular injection may result in local tissue reaction which persists for up to 1 days and may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck are likely to more severe. Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may require extending the approved withholding period. WITHHOLDING PERIODS CATTLE: MILK: DO NOT USE in female cattle which are producing or may in the future produce milk or milk products for human consumption. MEAT: DO NOT USE less than 4 days before slaughter for human consumption. PIGS: MEAT: DO NOT USE less than 1 days before slaughter for human consumption. TRADE ADVICE EXPORT SLAUGHTER INTERVAL (ESI): CATTLE: DO NOT USE less than 4 days before slaughter for export. PIGS: DO NOT USE less than 1 days before slaughter for export. The ESI on this label was correct at the time of label approval. Before using this product, confirm the current ESI from the manufacturer on or the APVMA website. ( FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre (Phone 13116). For further information contact Animal Health Customer Service on Warranty Pty Ltd (SPPL) warrants that this product is of merchantable quality and fit for its intended purpose. SPPL s liability for any loss, including consequential losses or injury caused by any act or omission, including negligent acts or omissions, by SPPL or its agent, is limited to replacing or repairing the product at the option of SPPL. If possible, a sample of any product causing concern should be retained or delivered to SPPL within 30 days for a scientific examination. DISPOSE of empty container by wrapping with paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labelled sharps container. STORE below 5 C (Air Conditioning). BATCH/EXPIRY FOR BATCH AND EXPIRY SEE BOTTOM PANEL APVMA Approval No. 501/100mL/0908 Manufactured by: Bray, Ireland for Corporation Registered Trademark Pty Ltd 008 PRESCRIPTION ANIMAL REMEDY 100mL S198B 1_008 SEG-CA100 BATCH: EXPIRY: S198B 1_008.indd 1 1/19/09 1:06:30 PM SEG-CA100 (55,00 x 55,00 x 103,00 mm) NEW CODE S198B 1_008 SUBMISSION.1 100ml PANTONE 01 C BLACK REPLACES OLD CODE DATE OF START UP 0dec008 PROFILE SEG-CA100 SIZE (mm) A55,00 x B55,00 x H103,00

2 PRESCRIPTION ANIMAL REMEDY 100mL READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. CATTLE: IM - 0 mg/kg of BW (1 ml per 15 kg). nd dose - 48 hours later. SC - 40 mg/kg of BW (ml per 15 kg). One subcutaneous dose ONLY. PIGS: IM - 15 mg/kg of BW (0.75 ml per 15 kg). nd dose - 48 hours later. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre (Phone 13116). DISPOSE of empty container by wrapping with paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labelled sharps container. APVMA Approval No. 501/100mL/0908 S00B 1_008 STORE below 5 C (Air Conditioning). S00B 1_008.indd :49:5 SEG-LA100 (W40 x L1 mm) NEW CODE S00B 1_008 SUBMISSION ml PANTONE 01 C BLACK REPLACES OLD CODE S.00A DATE OF START UP 0dec008 PROFILE SEG-LA100 SIZE (mm) W40,00 x L1,00 SEG-LA100 (W40 x L1 mm)

3 NUFLOR LA is indicated for the treatment of cattle with bacterial infections susceptible to florfenicol, especially the causative organisms of pink-eye (Moraxella bovis), bovine respiratory disease (including Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus) and footrot of cattle (Fusobacterium necrophorum and Bacteroides melaninogenicus), and for the treatment of pigs with swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma spp. and Streptococcus suis Type. READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. Restraints: DO NOT USE in female cattle which are producing or may in the future produce milk or milk products for human consumption. DO NOT USE in calves to be processed for veal. DO NOT exceed 10mL at any one injection site (subcutaneous or intramuscular). Contra-indications and Special Precautions for Use: Not for use in cattle and pigs intended for breeding. Clinical improvement should be evident in most treated subjects within 4 hours of initiation of therapy. If a positive response is not seen within 4 hours after the second injection, the diagnosis should be reconfirmed. Susceptibility discs containing 30 μg of florfenicol are available for sensitivity testing. Mild, transient inappetence, decreased water consumption or diarrhoea may occur in cattle following treatment. Transient diarrhoea and/or perianal erythema/swelling may occur in pigs following treatment. These symptoms should return to normal shortly after treatment. The effect of florfenicol on bovine and porcine reproductive performance and pregnancy has not been assessed. As seen with many antibiotics high dosage and/or prolonged administration may lead to superinfections by non-sensitive organisms such as yeasts and fungi. Intramuscular injection at sites other than the neck can cause local reaction which may result in trim loss of edible tissue at slaughter. CATTLE: Intramuscular - 0 mg/kg of bodyweight (1 ml per 15 kg). A second dose should be given 48 hours later. Do not exceed 10mL at any one injection site. Inject into muscle tissue on the side of the neck. Intramuscular injection may result in local tissue reaction which persists beyond 35 days and may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck are likely to more severe. Subcutaneous - 40 mg/kg of bodyweight (ml per 15 kg). One subcutaneous dose ONLY. For doses that exceed 10mL, more than one injection site will be required. Inject under the skin high on the neck behind the ear. PRESCRIPTION ANIMAL REMEDY PIGS: Intramuscular - 15 mg/kg of bodyweight (0.75 ml per 15 kg). Two injections are given 48 hours apart. Do not exceed 10mL at any one injection site. Inject into muscle tissue on side of the neck. Intramuscular injection may result in local tissue reaction which persists for up to 1 days and may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck are likely to more severe. Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may require extending the approved withholding period. WITHHOLDING PERIODS CATTLE: MILK: DO NOT USE in female cattle which are producing or may in the future produce milk or milk products for human consumption. MEAT: DO NOT USE less than 4 days before slaughter for human consumption. PIGS: MEAT: DO NOT USE less than 1 days before slaughter for human consumption. TRADE ADVICE EXPORT SLAUGHTER INTERVAL (ESI): CATTLE: DO NOT USE less than 4 days before slaughter for export. PIGS: DO NOT USE less than 1 days before slaughter for export. The ESI on this label was correct at the time of label approval. Before using this product, confirm the current ESI from the manufacturer on or the APVMA website. ( FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre (Phone 13116). For further information contact Customer Service on Warranty Pty Ltd (SPPL) warrants that this product is of merchantable quality and fit for its intended purpose. SPPL s liability for any loss, including consequential losses or injury caused by any act or omission, including negligent acts or omissions, by SPPL or its agent, is limited to replacing or repairing the product at the option of SPPL. If possible, a sample of any product causing concern should be retained or delivered to SPPL within 30 days for a scientific examination. DISPOSE of empty container by wrapping with paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labelled sharps container. STORE below 5 C (Air Conditioning). BATCH/EXPIRY FOR BATCH AND EXPIRY SEE BOTTOM PANEL APVMA Approval No. 501//0908 Manufactured by: Bray, Ireland for Corporation Registered Trademark Pty Ltd 008 PRESCRIPTION ANIMAL REMEDY S01B 1_008 SEG-CA50B BATCH: EXPIRY: S01B 1_008.indd 1 1/16/09 1:36:51 PM SEG-CA50B (71 x 71 x 137 mm) NEW CODE S01B 1_008 SUBMISSION.1 50ml PANTONE 01 C BLACK REPLACES OLD CODE S.01A DATE OF START UP 03dec008 PROFILE SEG-CA50B SIZE (mm) A71,00 x B71,00 x H137,00

4 PRESCRIPTION ANIMAL REMEDY READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT. CATTLE: IM - 0 mg/kg of BW (1 ml per 15 kg). nd dose - 48 hours later. SC - 40 mg/kg of BW (ml per 15 kg). One subcutaneous dose ONLY. PIGS: IM - 15 mg/kg of BW (0.75 ml per 15 kg). nd dose - 48 hours later. FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre (Phone 13116). DISPOSE of empty container by wrapping with paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labelled sharps container. APVMA Approval No. 501//0908 Level 4, 66 Waterloo Road, North Ryde NSW 113 S0B 1_008 STORE below 5 C (Air Conditioning). S0B 1_008.indd 1 1/19/09 11:17:03 AM SEG-LA50 (W60 x L130 mm) NEW CODE S0B 1_008 SUBMISSION.1 50ml PANTONE 01 C BLACK REPLACES OLD CODE DATE OF START UP 0dec008 PROFILE SEG-LA50 SIZE (mm) W60,00 x L130,00 SEG-LA50 (W60 x L130 mm)

5 PRESCRIPTION ANIMAL REMEDY. Pharmacology: Florfenicol is a synthetic, broad spectrum antibiotic active against many gram-negative and gram-positive bacteria isolated from domestic animals. Florfenicol acts by inhibiting bacterial protein synthesis at the ribosomal level. Indications: NUFLOR LA is indicated for the treatment of cattle with bacterial infections susceptible to florfenicol, especially the causative organisms of pink-eye (Moraxella bovis), bovine respiratory disease (including Mannheimia haemolytica, Pasteurella multocida and Haemophilus somnus) and footrot of cattle (Fusobacterium necrophorum and Bacteroides melaninogenicus), and for the treatment of pigs with swine respiratory disease associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma spp. and Streptococcus suis Type. Restraints: DO NOT USE in female cattle which are producing or may in the future produce milk or milk products for human consumption. DO NOT USE in calves to be processed for veal. DO NOT exceed 10mL at any one injection site (subcutaneous or intramuscular). Contra-indications and Special Precautions for Use: Not for use in cattle and pigs intended for breeding. Clinical improvement should be evident in most treated subjects within 4 hours of initiation of therapy. If a positive response is not seen within 4 hours after the second injection, the diagnosis should be reconfirmed. Susceptibility discs containing 30 μg of florfenicol are available for sensitivity testing. Mild, transient inappetence, decreased water consumption or diarrhoea may occur in cattle following treatment. Transient diarrhoea and/or perianal erythema/swelling may occur in pigs following treatment. These symptoms should return to normal shortly after treatment. The effects of florfenicol on bovine or porcine reproductive performance, pregnancy and lactation have not been determined. As seen with many antibiotics high dosage and/or prolonged administration may lead to superinfections by non-sensitive organisms such as yeasts and fungi. Intramuscular injection at sites other than the neck can cause local reaction which may result in trim loss of edible tissue at slaughter. Safety Studies Cattle: A 10X safety study was conducted in feeder calves. Two intramuscular injections of 00 mg/kg were administered at a 48-hour interval. The calves were monitored for 14 days after the second dose. Marked anorexia, decreased water consumption, decreased body weight and increased serum enzymes were observed following dose administration. These effects resolved by the end of the study. A 1X, 3X and 5X (0, 60 and 100 mg/kg) safety study was conducted in calves for 3X the duration of treatment (6 injections at 48-hour intervals). Slight decrease in feed and water consumption was observed in the 1X dose group. Decreased feed and water consumption, body weight, urine ph and increased serum enzymes were observed in the 3X and 5X dose groups. Depression, soft stool consistency and dehydration were also observed in some animals (most frequently at the 3X and 5X dose levels), primarily near the end of dosing. A 43-day controlled study was conducted in healthy cattle to evaluate the effects of Nuflor administered at the recommended dose on feed consumption. Although a transient decrease in feed consumption was observed, Nuflor administration had no long-term effect on body weight, rate of gain or feed consumption. Pigs: A safety study was conducted in which cross-bred pigs were administered intramuscular injections of Nuflor at 1X, 3X and 5X the clinical dose (15, 45 and 75 mg/kg, respectively) for 3X the recommended clinical duration of treatment (6 injections at 48-hour intervals). An additional group of animals received 10X the clinical dose (150 mg/kg) administered at the recommended clinical duration of 1 injection every 48 hours for a total of injections. S199B 1_008 S199B 1_008.indd 1 1/16/09 1:50:46 PM SEG-IN-8PLIS (130 x 10 mm) NEW CODE S199B 1_008 SUBMISSION ml / 50 ml 1 BLACK REPLACES OLD CODE S.199A DATE OF START UP 0dec008 PROFILE SEG-IN-8PLIS SIZE (mm) W130,00 x L10,00

6 The 1X group showed a minimally increased incidence of diarrhoea and injection site lesions. In the 3X and 5X groups, pigs showed a dose and time-dependent increased incidence and/or severity of diarrhoea, injection site lesions, anal erythema/swelling, decreased body weight, decreased food and water consumption, alterations in some serum electrolytes and proteins and decreased numbers of white blood cells, spleen weights and kidney weights. Most changes in drug-related, in-life parameters did not become apparent until after dosing was extended beyond the normal clinical duration of injections, 48 hours apart. Findings in pigs in the 10X group were limited to minimally increased diarrhoea and serum creatinine, and slight to moderately increased injection site lesions. CATTLE: Intramuscular - 0 mg/kg of bodyweight (1 ml per 15 kg). A second dose should be given 48 hours later. Do not exceed 10mL at any one injection site. Inject into muscle tissue on the side of the neck. Intramuscular injection may result in local tissue reaction which persists beyond 35 days and may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck are likely to more severe. Subcutaneous - 40 mg/kg of bodyweight (ml per 15 kg). One subcutaneous dose ONLY. For doses that exceed 10mL, more than one injection site will be required. Inject under the skin high on the neck behind the ear. PIGS: Intramuscular - 15 mg/kg of bodyweight (0.75 ml per 15 kg). Two injections are given 48 hours apart. Do not exceed 10mL at any one injection site. Inject into muscle tissue on side of the neck. Intramuscular injection may result in local tissue reaction which persists for up to 1 days and may result in trim loss of edible tissue at slaughter. Tissue reaction at injection sites other than the neck are likely to more severe. Any variation by the prescribing veterinarian to the approved dose, frequency, duration, route, disease or target species may require extending the approved withholding period. WITHHOLDING PERIODS CATTLE: MILK: DO NOT USE in female cattle which are producing or may in the future produce milk or milk products for human consumption. MEAT: DO NOT USE less than 4 days before slaughter for human consumption. PIGS: MEAT: DO NOT USE less than 1 days before slaughter for human consumption. TRADE ADVICE EXPORT SLAUGHTER INTERVAL (ESI): CATTLE: DO NOT USE less than 4 days before slaughter for export. PIGS: DO NOT USE less than 1 days before slaughter for export. The ESI on this label was correct at the time of label approval. Before using this product, confirm the current ESI from the manufacturer on or the APVMA website. ( FIRST AID: If poisoning occurs, contact a doctor or Poisons Information Centre (Phone 13116). For further information contact Customer Service on Warranty Pty Ltd (SPPL) warrants that this product is of merchantable quality and fit for its intended purpose. SPPL s liability for any loss, including consequential losses or injury caused by any act or omission, including negligent acts or omissions, by SPPL or its agent, is limited to replacing or repairing the product at the option of SPPL. If possible, a sample of any product causing concern should be retained or delivered to SPPL within 30 days for a scientific examination. Presentation NUFLOR LA is packaged in 0 ml, 50 ml, 100 ml, 50 ml and 500 ml glass sterile multi-dose vials. Disposal Dispose of empty container by wrapping with paper and putting in garbage. Discarded needles should immediately be placed in a designated and appropriately labelled sharps container. Storage Store below 5 C (Air Conditioning). APVMA Approval No. 501/0908 Manufactured by: Bray, Ireland for Corporation Registered Trademark Pty Ltd 008 S199B 1_008 S199B 1_008.indd 1/16/09 1:50:46 PM SEG-IN-8PLIS (130 x 10 mm) NEW CODE S199B 1_008 SUBMISSION ml / 50 ml 1 BLACK REPLACES OLD CODE S.199A DATE OF START UP 0dec008 PROFILE SEG-IN-8PLIS SIZE (mm) W130,00 x L10,00