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Draxxin Injection

  • 20ml Bottle £97.00
  • 50ml Bottle £220.00
  • 100ml Bottle £421.99

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£97.00 to £421.99

Description

This product is sourced in the United Kingdom and is intended for use in the United Kindgom only.

Draxxin Injection is given to cattle and pigs to control common respiratory diseases. A single injection is given at a dose rate of 1ml per 40kg bodyweight. The response to treatment should be evaluated after 48 hours and if this is poor, the diagnosis should be checked and an alternative treatment considered.

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Medication Datasheets

100ml Bottle

Draxxin 100 mg/ml solution for injection for cattle, pigs & sheep

Draxxin 100 mg/ml solution for injection for cattle, pigs & sheep

Presentation

A clear aqueous ready to use solution containing tulathromycin 100 mg/ml.

Uses

Cattle

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis and Histophilus somni sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.

Pigs

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Draxxin should only be used if pigs are expected to develop the disease within 2-3 days.

Sheep

Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

Dosage and administration

Cattle

A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg body weight). For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.

Pigs

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck. For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site.

For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.

Sheep

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.

Contra-indications, warnings, etc

Do not use in cases of hypersensitivity of the target animals to macrolide antibiotics.

Do not use simultaneously with other macrolides or lincosamides.

In the absence of compatibility studies, do not mix with other veterinary medicinal products.

Withdrawal periods

Cattle (meat and offal): 22 days
Pig (meat and offal): 13 days
Sheep (meat and offal): 16 days

Do not use in lactating animals producing milk for human consumption.

Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.

Subcutaneous administration of Draxxin to cattle very commonly causes transient pain reactions and local swellings at the injection site that can persist for up to 30 days. No such reactions have been observed in pigs and sheep after intramuscular administration. Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs.

In sheep, transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection. These signs resolve within a few minutes.

The frequency of adverse reactions is defined using the following convention:

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. Official, national and regional antimicrobial policies should be taken into account when the product is used. Cross resistance occurs with other macrolides.

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of tulathromycin has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

In cattle at dosages of 3, 5 or 10 times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5-6 times the recommended dose. In young pigs weighing approximately 10 kg given 3 or 5 times the therapeutic dose, transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.

In lambs (approx. 6 weeks old) at dosages of 3 or 5 times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, and bleating.

The efficacy of antimicrobial treatment of foot rot in sheep might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.

Antibiotic treatment of benign foot rot is not considered appropriate. Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot.

For the user

Wash hands after use.

Tulathromycin is irritating to eyes. In case of accidental eye exposure occurs, flush the eyes immediately with clean water.

Tulathromycin may cause sensitisation by skin contact. In case of accidental spillage onto skin, wash the skin immediately with soap and water.

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

Pharmaceutical precautions

No special precautions for storage.

Shelf life after first opening the immediate packaging: 28 days.

Keep out of the sight and reach of children.

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

For animal treatment only.

Legal category

Packaging quantities

Clear glass vials containing 20 ml, 50 ml, 100 ml, 250 ml and 500 ml. The 500 ml vials must not be used for pigs and sheep. Not all pack sizes may be marketed.

Further information

Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product. It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.

Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA. They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process.

Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae, the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively. Increased MIC values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae. In vitro activity against Dichelobacter nodosus (vir), the bacterial pathogen most commonly associated with infectious pododermatitis (foot rot) in sheep has been demonstrated.

Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovin keratoconjunctivitis (IBK).

Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux. MLSB resistance may be constitutive or inducible. Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids.

In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and anti-inflammatory actions in experimental studies. In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of apoptotic cells by macrophages. It lowers the production of the pro-inflammatory mediators leukotriene B4 and CXCL-8 and induces the production of anti-inflammatory and pro-resolving lipid lipoxin A4.

In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg bodyweight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.5 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of 90 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 l/kg. The bioavailability of tulathromycin after subcutaneous administration in cattle was approximately 90%.

In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.6 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of approximately 91 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 l/kg. The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%.

In sheep, the pharmacokinetic profile of tulathromycin, when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, achieved a maximum plasma concentration (Cmax) of 1.19 µg/ml in approximately 15 minutes (Tmax) post-dosing and had an elimination half-life (t1/2) of 69.7 hours. Plasma protein binding was approximately 60-75%. Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg. The bioavailability of tulathromycin after intramuscular administration in sheep was 100%.

Marketing Authorisation Number

EU/2/03/041/001-005

50ml Bottle

Draxxin 100 mg/ml solution for injection for cattle, pigs & sheep

Draxxin 100 mg/ml solution for injection for cattle, pigs & sheep

Presentation

A clear aqueous ready to use solution containing tulathromycin 100 mg/ml.

Uses

Cattle

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis and Histophilus somni sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.

Pigs

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Draxxin should only be used if pigs are expected to develop the disease within 2-3 days.

Sheep

Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

Dosage and administration

Cattle

A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg body weight). For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.

Pigs

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck. For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site.

For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.

Sheep

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.

Contra-indications, warnings, etc

Do not use in cases of hypersensitivity of the target animals to macrolide antibiotics.

Do not use simultaneously with other macrolides or lincosamides.

In the absence of compatibility studies, do not mix with other veterinary medicinal products.

Withdrawal periods

Cattle (meat and offal): 22 days
Pig (meat and offal): 13 days
Sheep (meat and offal): 16 days

Do not use in lactating animals producing milk for human consumption.

Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.

Subcutaneous administration of Draxxin to cattle very commonly causes transient pain reactions and local swellings at the injection site that can persist for up to 30 days. No such reactions have been observed in pigs and sheep after intramuscular administration. Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs.

In sheep, transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection. These signs resolve within a few minutes.

The frequency of adverse reactions is defined using the following convention:

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. Official, national and regional antimicrobial policies should be taken into account when the product is used. Cross resistance occurs with other macrolides.

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of tulathromycin has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

In cattle at dosages of 3, 5 or 10 times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5-6 times the recommended dose. In young pigs weighing approximately 10 kg given 3 or 5 times the therapeutic dose, transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.

In lambs (approx. 6 weeks old) at dosages of 3 or 5 times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, and bleating.

The efficacy of antimicrobial treatment of foot rot in sheep might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.

Antibiotic treatment of benign foot rot is not considered appropriate. Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot.

For the user

Wash hands after use.

Tulathromycin is irritating to eyes. In case of accidental eye exposure occurs, flush the eyes immediately with clean water.

Tulathromycin may cause sensitisation by skin contact. In case of accidental spillage onto skin, wash the skin immediately with soap and water.

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

Pharmaceutical precautions

No special precautions for storage.

Shelf life after first opening the immediate packaging: 28 days.

Keep out of the sight and reach of children.

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

For animal treatment only.

Legal category

Packaging quantities

Clear glass vials containing 20 ml, 50 ml, 100 ml, 250 ml and 500 ml. The 500 ml vials must not be used for pigs and sheep. Not all pack sizes may be marketed.

Further information

Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product. It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.

Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA. They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process.

Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae, the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively. Increased MIC values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae. In vitro activity against Dichelobacter nodosus (vir), the bacterial pathogen most commonly associated with infectious pododermatitis (foot rot) in sheep has been demonstrated.

Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovin keratoconjunctivitis (IBK).

Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux. MLSB resistance may be constitutive or inducible. Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids.

In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and anti-inflammatory actions in experimental studies. In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of apoptotic cells by macrophages. It lowers the production of the pro-inflammatory mediators leukotriene B4 and CXCL-8 and induces the production of anti-inflammatory and pro-resolving lipid lipoxin A4.

In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg bodyweight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.5 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of 90 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 l/kg. The bioavailability of tulathromycin after subcutaneous administration in cattle was approximately 90%.

In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.6 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of approximately 91 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 l/kg. The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%.

In sheep, the pharmacokinetic profile of tulathromycin, when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, achieved a maximum plasma concentration (Cmax) of 1.19 µg/ml in approximately 15 minutes (Tmax) post-dosing and had an elimination half-life (t1/2) of 69.7 hours. Plasma protein binding was approximately 60-75%. Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg. The bioavailability of tulathromycin after intramuscular administration in sheep was 100%.

Marketing Authorisation Number

EU/2/03/041/001-005

20ml Bottle

Draxxin 100 mg/ml solution for injection for cattle, pigs & sheep

Draxxin 100 mg/ml solution for injection for cattle, pigs & sheep

Presentation

A clear aqueous ready to use solution containing tulathromycin 100 mg/ml.

Uses

Cattle

Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis and Histophilus somni sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.

Pigs

Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and Bordetella bronchiseptica sensitive to tulathromycin. The presence of the disease in the herd should be established before metaphylactic treatment. Draxxin should only be used if pigs are expected to develop the disease within 2-3 days.

Sheep

Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

Dosage and administration

Cattle

A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg body weight). For treatment of cattle over 300 kg bodyweight, divide the dose so that no more than 7.5 ml are injected at one site.

Pigs

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck. For treatment of pigs over 80 kg bodyweight, divide the dose so that no more than 2 ml are injected at one site.

For any respiratory disease, it is recommended to treat animals in the early stages of the disease and to evaluate the response to treatment within 48 hours after injection. If clinical signs of respiratory disease persist or increase, or if relapse occurs, treatment should be changed, using another antibiotic, and continued until clinical signs have resolved.

Sheep

A single intramuscular injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight) in the neck.

To ensure correct dosage bodyweight should be determined as accurately as possible to avoid underdosing. For multiple vial entry, an aspirating needle or multi-dose syringe is recommended to avoid excessive broaching of the stopper.

Contra-indications, warnings, etc

Do not use in cases of hypersensitivity of the target animals to macrolide antibiotics.

Do not use simultaneously with other macrolides or lincosamides.

In the absence of compatibility studies, do not mix with other veterinary medicinal products.

Withdrawal periods

Cattle (meat and offal): 22 days
Pig (meat and offal): 13 days
Sheep (meat and offal): 16 days

Do not use in lactating animals producing milk for human consumption.

Do not use in pregnant animals, which are intended to produce milk for human consumption, within 2 months of expected parturition.

Subcutaneous administration of Draxxin to cattle very commonly causes transient pain reactions and local swellings at the injection site that can persist for up to 30 days. No such reactions have been observed in pigs and sheep after intramuscular administration. Pathomorphological injection site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage) are very common for approximately 30 days after injection in cattle and pigs.

In sheep, transient signs of discomfort (head shaking, rubbing injection site, backing away) are very common after intramuscular injection. These signs resolve within a few minutes.

The frequency of adverse reactions is defined using the following convention:

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. Official, national and regional antimicrobial policies should be taken into account when the product is used. Cross resistance occurs with other macrolides.

Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. The safety of tulathromycin has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.

In cattle at dosages of 3, 5 or 10 times the recommended dose, transient signs attributed to injection site discomfort were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Mild myocardial degeneration has been observed in cattle receiving 5-6 times the recommended dose. In young pigs weighing approximately 10 kg given 3 or 5 times the therapeutic dose, transient signs attributed to injection site discomfort were observed and included excessive vocalisation and restlessness. Lameness was also observed when the hind leg was used as the injection site.

In lambs (approx. 6 weeks old) at dosages of 3 or 5 times the recommended dose, transient signs attributed to injection site discomfort were observed, and included walking backwards, head shaking, rubbing the injection site, lying down and getting up, and bleating.

The efficacy of antimicrobial treatment of foot rot in sheep might be reduced by others factors, such as wet environmental conditions, as well as inappropriate farm management. Treatment of foot rot should therefore be undertaken along with other flock management tools, for example providing dry environment.

Antibiotic treatment of benign foot rot is not considered appropriate. Draxxin showed limited efficacy in sheep with severe clinical signs or chronic foot rot, and should therefore only be given at an early stage of foot rot.

For the user

Wash hands after use.

Tulathromycin is irritating to eyes. In case of accidental eye exposure occurs, flush the eyes immediately with clean water.

Tulathromycin may cause sensitisation by skin contact. In case of accidental spillage onto skin, wash the skin immediately with soap and water.

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

Pharmaceutical precautions

No special precautions for storage.

Shelf life after first opening the immediate packaging: 28 days.

Keep out of the sight and reach of children.

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

For animal treatment only.

Legal category

Packaging quantities

Clear glass vials containing 20 ml, 50 ml, 100 ml, 250 ml and 500 ml. The 500 ml vials must not be used for pigs and sheep. Not all pack sizes may be marketed.

Further information

Tulathromycin is a semi-synthetic macrolide antimicrobial agent, which originates from a fermentation product. It differs from many other macrolides in that it has a long duration of action that is, in part, due to its three amine groups; therefore it has been given the chemical subclass designation of triamilide.

Macrolides are bacteriostatic acting antibiotics and inhibit essential protein biosynthesis by virtue of their selective binding to bacterial ribosomal RNA. They act by stimulating the dissociation of peptidyl-tRNA from the ribosome during the translocation process.

Tulathromycin possesses in vitro activity against Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis, and Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae, the bacterial pathogens most commonly associated with bovine and swine respiratory disease, respectively. Increased MIC values have been found in some isolates of Histophilus somni and Actinobacillus pleuropneumoniae. In vitro activity against Dichelobacter nodosus (vir), the bacterial pathogen most commonly associated with infectious pododermatitis (foot rot) in sheep has been demonstrated.

Tulathromycin also possesses in vitro activity against Moraxella bovis, the bacterial pathogen most commonly associated with infectious bovin keratoconjunctivitis (IBK).

Resistance to macrolides can develop by mutations in genes encoding ribosomal RNA (rRNA) or some ribosomal proteins; by enzymatic modification (methylation) of the 23S rRNA target site, generally giving rise to cross-resistance with lincosamides and group B streptogramins (MLSB resistance); by enzymatic inactivation; or by macrolide efflux. MLSB resistance may be constitutive or inducible. Resistance may be chromosomal or plasmid-encoded and may be transferable if associated with transposons or plasmids.

In addition to its antimicrobial properties, tulathromycin demonstrates immune-modulating and anti-inflammatory actions in experimental studies. In both bovine and porcine polymorphonuclear cells (PMNs; neutrophils), tulathromycin promotes apoptosis (programmed cell death) and the clearance of apoptotic cells by macrophages. It lowers the production of the pro-inflammatory mediators leukotriene B4 and CXCL-8 and induces the production of anti-inflammatory and pro-resolving lipid lipoxin A4.

In cattle, the pharmacokinetic profile of tulathromycin when administered as a single subcutaneous dose of 2.5 mg/kg bodyweight, was characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.5 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of 90 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 11 l/kg. The bioavailability of tulathromycin after subcutaneous administration in cattle was approximately 90%.

In pigs, the pharmacokinetic profile of tulathromycin when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, was also characterised by rapid and extensive absorption followed by high distribution and slow elimination. The maximum concentration (Cmax) in plasma was approximately 0.6 μg/ml; this was achieved approximately 30 minutes post-dosing (Tmax). Tulathromycin concentrations in lung homogenate were considerably higher than those in plasma. There is strong evidence of substantial accumulation of tulathromycin in neutrophils and alveolar macrophages. However, the in vivo concentration of tulathromycin at the infection site of the lung is not known. Peak concentrations were followed by a slow decline in systemic exposure with an apparent elimination half-life (t1/2) of approximately 91 hours in plasma. Plasma protein binding was low, approximately 40%. The volume of distribution at steady-state (Vss) determined after intravenous administration was 13.2 l/kg. The bioavailability of tulathromycin after intramuscular administration in pigs was approximately 88%.

In sheep, the pharmacokinetic profile of tulathromycin, when administered as a single intramuscular dose of 2.5 mg/kg bodyweight, achieved a maximum plasma concentration (Cmax) of 1.19 µg/ml in approximately 15 minutes (Tmax) post-dosing and had an elimination half-life (t1/2) of 69.7 hours. Plasma protein binding was approximately 60-75%. Following intravenous dosing the volume of distribution at steady-state (Vss) was 31.7 l/kg. The bioavailability of tulathromycin after intramuscular administration in sheep was 100%.

Marketing Authorisation Number

EU/2/03/041/001-005

Delivery Information

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Under almost all products on our website is an Estimated dispatch time, check this for a delivery prediction specific to the item you are looking to purchase. These badges are updated live based on the stock levels we have and also those of our suppliers - so are usually very accurate, but cannot be guaranteed. In more general terms, we aim to dispatch all orders within 1 working day of receiving payment (and a prescription if required). If we cannot do so within 3 working days we will contact you by email.

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For UK delivery, we charge the following:

Order Total Weight Delivery
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2kg+ £4.99
£29-£38.99 Under 2kg Free
2kg+ £4.99
£39+ Under 2kg Free
2kg+ Free

Prices quoted are for delivery to all parts of mainland UK except certain Scottish postcodes (where the price is higher for items sent by courier. Delivery of food abroad (including Channel Islands, N. Ireland and other islands around the UK) is charged at a higher price and free delivery is not available. Temperature controlled products, such as Insulin, are also not always subject to the standard and/or free delivery options.

For full information on our delivery charges, including prices on heavy deliveries to Scotland and abroad, see our delivery information page.

We can deliver most items to all around the world, but prices do vary. The majority of light weight orders (less than 1.5kg) can be delivered for a flat rate of £10. For an accurate estimate of the delivery charge, please put the items you require in your basket and use the "Estimate Delivery" system on the shopping basket page (you only need to enter your country and postal/zip code) for a quick quote. For deliveries to the USA you may need to go to the checkout page and enter your full address to get a quote (as some services need your state in order to quote too). For more information on international deliveries, please see our delivery information page.

Delivery of aerosols

Due to air freight restrictions aerosols cannot ever be sent abroad by Royal Mail. We appreciate your understanding.

Delivery of temperature controlled items

Some products, such as insulin and frozen food, need to be delivered in insulated packaging to prevent them from getting too warm (or too cold) during transit from us to you. Purchasing any of these items in your order will result in a £1.99 charge being added to the total to cover the high cost of the insulated packaging materials. You only pay the £1.99 once per order, regardless of how many temperature controlled items you purchase in that order.

How do I cancel or return an order?

Please call us as soon as possible if you need to amend or cancel an order on 01582 842096. If your order has been processed for dispatch we will be unable to cancel or amend the order. You will however be able to return your product for a full refund*.

To return an item, you must contact us by phone or email to arrange this BEFORE posting any product back to us. We will explain the process at this stage for you.

*For full details on returns, see our terms and conditions page.

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