VETDRAX 100 mg/ml solution for injection for cattle, pigs and sheep tulathromycin
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Each ml contains:
Active substance:
Tulathromycin 100 mg
Excipients:
Monothioglycerol 5 mg
Clear colourless to slightly yellow solution, free from visible particles.
INDICATION(S)
Cattle
Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia
haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis susceptible to
tulathromycin. The presence of the disease in the group must be established before the veterinary
medicinal product is used.
Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella
bovis susceptible to tulathromycin.
Pigs
Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus
pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis and
Bordetella bronchiseptica susceptible to tulathromycin. The presence of the disease in the group
must be established before the veterinary medicinal product is used. The veterinary medicinal
product 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.
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to macrolide antibiotics or to any of the excipients.
ADVERSE REACTIONS
Subcutaneous administration of the veterinary medicinal product to cattle causes very commonly
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
pig.
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:
- 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}.
TARGET SPECIES
Cattle, pigs and sheep
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Cattle
2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
A single subcutaneous injection. 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
2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
A single intramuscular injection 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.
Sheep
2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight).
A single intramuscular injection in the neck.
The cap may be safely punctured up to 25 times in 100 ml-vials and 50 times in 250- ml vials.
ADVICE ON CORRECT ADMINISTRATION
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.
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.
WITHDRAWAL PERIOD(S)
Cattle (meat and offal): 22 days. Pigs (meat and offal): 13 days. Sheep (meat and offal): 16 days.
Not authorised for use in 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.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
This veterinary medicinal product does not require any special storage conditions.
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: 28 days.
SPECIAL WARNING(S)
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.
Sheep:
The efficacy of antimicrobial treatment of foot rot might be reduced by other 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. Tulathromycin 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.
Special precautions for use in animals:
Use of the veterinary medicinal product should be based on susceptibility testing of the bacteria
isolated from the animal. If this is not possible, therapy should be based on local (regional, farm
level) epidemiological information about susceptibility of the target bacteria.
Official, national and regional antimicrobial policies should be taken into account when the
veterinary medicinal product is used.
Use of the veterinary medicinal product deviating from the instructions given in the SPC 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.
If a hypersensitivity reaction occurs appropriate treatment should be administered without delay.
Special precautions to be taken by the person administering the veterinary medicinal product to
animals:
Tulathromycin is irritating to eyes. In case of accidental eye exposure, 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.
Wash hands after use.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet
or the label to the physician.
Pregnancy and lactation:
Laboratory studies in rats and rabbits have not produced any evidence of teratogenic, foetotoxic
or maternotoxic effects. The safety of the veterinary medicinal product 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:
None known.
Overdose (symptoms, emergency procedures, antidotes):
In cattle at dosages of three, five or ten 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 five to six times the recommended dose.
In young pigs weighing approximately 10 kg given three or five 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 three or five 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, bleating.
Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with
other veterinary medicinal products.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Medicines should not be disposed of via wastewater or household waste. Ask your veterinary surgeon
or pharmacist how to dispose of medicines no longer required. These measures should help to protect
the environment.
OTHER INFORMATION
Pack sizes:
Cardboard box with 1 vial of 100 ml Cardboard box with 1 vial of 250 ml Not all pack sizes may be
marketed.
For any information about this veterinary medicinal p oduct, please contact the local
representative of the marketing authorisation holder.
Reg.Numb.: 73693 / 03-08-2021
