Tulaven 100 mg/ml Solution for Injection

Target species
Cattle, pigs and sheep.
Indications for use, specifying the target species
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 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 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.
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
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 product is used.
Use of the 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, 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. Tulathromycin may cause sensitisation by skin contact resulting in e.g. reddening of the skin (erythema) and/or dermatitis. 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 physician.
If there is suspicion of a hypersensitivity reaction following accidental exposure (recognised by e.g. itching, difficulty in breathing, hives, swelling on the face, nausea, vomiting) appropriate treatment should be administered. Seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions (frequency and seriousness)
Subcutaneous administration of the 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.
Use during pregnancy, lactation or lay
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.
Amounts to be administered and administration route
Cattle:
Subcutaneous use.
A single subcutaneous injection of 2.5 mg tulathromycin/kg bodyweight (equivalent to 1 ml/40 kg bodyweight). 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:
Intramuscular use.
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:
Intramuscular use.
A single intramuscular injection of 2.5 mg tulathromycin/kg body weight (equivalent to 1 ml/40 kg body weight) 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. The stopper may be safely punctured up to 20 times.
Overdose (symptoms, emergency procedures, antidotes), if necessary
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 5 to 6 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.
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.

Pharmaceutical particulars
List of excipients
Monothioglycerol, Propylene glycol, Citric acid, Hydrochloric acid dilute(for pH adjustment), Sodium hydroxide (for pH adjustment), Water for injections
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with otherveterinary medicinal products.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf-life after first broaching the vial: 28 days.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Nature and composition of immediate packaging
Colourless type I glass vial closed with a bromobutyl rubber stopper coated with fluoropolymer and aluminium and plastic flip capsule.
Translucent multi layer (plastic) vial closed with a bromobutyl rubber stopper coated with fluoropolymer and aluminium and plastic flip capsule.
Pack sizes:
Cardboard box containing 1 glass vial of 20 ml
Cardboard box containing 1 plastic vial of 50 ml
Cardboard box containing 1 plastic vial of 100 ml
Cardboard box containing 1 plastic vial of 250 ml
Cardboard box containing 1 plastic vial of 500 ml
The 500 ml vials must not be used for pigs or sheep.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.