ANTIBIOTICS
NEW DRAXXIN KP 500ML
SKU: DRAXXINKP
STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS
Each ml contains:
Active substances:
Tulathromycin 100 mg
Ketoprofen 120 mg
Excipients:
Monothioglycerol 5 mg
Clear colourless to yellow / green-yellow solution for injection. Free from visible particles.
4. INDICATION(S)
Treatment of bovine respiratory disease (BRD) associated with pyrexia due to Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to tulathromycin.
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5. CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to any of the excipients.
Do not use simultaneously with other macrolides or lincosamides.
Do not administer to animals suffering from gastrointestinal lesions, haemorrhagic diathesis,
blood dyscrasia or hepatic, renal or cardiac conditions.
6. ADVERSE REACTIONS
Subcutaneous administration very commonly causes transient pain reactions and local
swellings at the injection site that can persist for up to 32 days. Pathomorphological injection
site reactions (including reversible changes of congestion, oedema, fibrosis and haemorrhage)
are present for approximately 32 days after injection.
In common with all NSAIDs, due to their action of inhibition of prostaglandin synthesis, there
can be the possibility in certain individuals of gastric or renal intolerance.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
If you notice any side effects, even those not already listed in this package leaflet or you think
that the medicine has not worked, please inform your veterinary surgeon.
Alternatively you can report via your national reporting system {national system details}. For
details regarding the national system please contact National Competent Authority.
7. TARGET SPECIES
Cattle
8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF
ADMINISTRATION
Subcutaneous use.
A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight and 3 mg
ketoprofen/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). For treatment of cattle over
400 kg bodyweight, divide the dose so that no more than. 10 ml are injected at one site.
9. ADVICE ON CORRECT ADMINISTRATION
To ensure correct dosage bodyweight should be determined as accurately as possible to avoid
underdosing.
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.
If there is persistent elevated body temperature 24 hours after treatment initiation, the
responsible veterinarian must evaluate the necessity of further anti-pyretic treatment.
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When treating groups of animals in one run, use a draw-off needle that has been placed in the vial stopper or an automatic syringe to avoid excessive broaching of the stopper. The draw-off needle should be removed after treatment.
The stopper may be safely punctured up to 20 times.
10. WITHDRAWAL PERIOD(S)
Meat and offal: 50 days.
Not authorised for use in cattle 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.
11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. The expiry date refers to the last day of that month.
Shelf life after first opening the container: 56 days.
12. SPECIAL WARNING(S)
This product does not contain any antimicrobial preservative.
Special warnings for each target species:
Cross resistance occurs with other macrolides. Do not administer simultaneously with antimicrobials with a similar mode of action such as other macrolides or lincosamides.
Special precautions for use in animals:
Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target bacteria at farm level, or at local/regional level.
Use of the product should be in accordance with official, national and regional antimicrobial
policies. Use of the product deviating from the instructions given in the package leaflet may increase the prevalence of bacteria resistant to tulathromycin and may decrease the effectiveness of treatment with other macrolides, lincosamides and group B streptogramins due to the potential for cross resistance (MLSB resistance).
Since many NSAIDs possess the potential to induce gastrointestinal ulceration, especially in aged cattle and young calves, concomitant use of the product with other anti-inflammatory drugs (NSAIDs) or steroidal anti-inflammatory drugs (e.g., corticosteroids) should be avoided within the first 24 hours of treatment. Afterwards concurrent treatment with NSAIDs and steroidal anti-inflammatory drugs should be closely monitored. The use of the product (that contains ketoprofen) in aged animals or animals less than 6 weeks should be based on a benefit/risk assessment of the responsible veterinarian.
Avoid use in dehydrated, hypovolaemic or hypotensive animals which require parenteral rehydration, as there may be a potential risk of renal toxicity.
Intra-arterial and intra-venous injection should be avoided.
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Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This veterinary medicinal product may cause hypersensitivity (allergy). People with known hypersensitivity to tulathromycin, ketoprofen, or to non-steroidal anti-inflammatory drugs (NSAIDs) should avoid contact with the veterinary medicinal product. In case of accidental spillage onto skin, wash the skin immediately with soap and water.
This veterinary medicinal product may cause adverse effects after dermal exposure and self-injection. Take care to avoid skin contact and accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
NSAIDs, such as ketoprofen, may affect fertility and be harmful for the unborn child. Pregnant women, women intending to conceive and men planning to have children should use extreme caution while handling this veterinary medicinal product.
This veterinary medicinal product is irritating to eyes. Avoid contact with the eyes. In case of accidental eye exposure, flush the eyes immediately with clean water. If irritation persists, seek medical advice and show the package leaflet to the physician.
Wash hands after use.
Pregnancy and lactation:
Laboratory studies with tulathromycin in rats and rabbits have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. Studies with ketoprofen in laboratory species (rats, mice and rabbits) have not produced any evidence of teratogenic effects, but effects on fertility, maternal toxicity and embryotoxicity has been observed. There are known adverse class-effects of NSAIDS and other prostaglandin inhibitors on pregnancy and/or embryofoetal development. The safety of tulathromycin and ketoprofen combination in the target species has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction:
Do not use concurrently with other diuretics, nephrotoxic veterinary medicinal products or anticoagulants.
Overdose (symptoms, emergency procedures, antidotes):
At dosages of 3 and 5 times the recommended dose transient signs of injection site pain and/or swelling which in some instances lasted until day 32. Additionally, transient signs attributed to injection site discomfort (pain) were observed and included restlessness, head-shaking, pawing the ground, and brief decrease in feed intake. Microscopic mucosal erosions of the pylorus of the abomasum were observed at 3 and 5 times the recommended dose. Repeated administration can result in gastric toxicity. Mild myocardial degeneration has been observed in cattle receiving 5 to 6 times the recommended dose.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Ask your veterinary surgeon or pharmacist how to dispose of medicines no longer required. These measures should help to protect the environment.
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