Bovimox LA 100 mg/ml Solution for Injection for Cattle

The use of this product should take into account local information about susceptibility
of the target parasites, where available.
It is recommended to further investigate cases of suspected resistance, using an
appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test). Confirmed
resistance should be reported to the marketing authorisation holder or to the
competent authority.
Where the results of tests strongly suggest resistance to a particular anthelmintic, an
anthelmintic belonging to another pharmacological class and having a different mode
of action should be used.
In the absence of risk of co-infection, a narrow spectrum product should be used.
3.5 Special precautions for use
Special precautions for safe use in the target species:
In order to prevent abscesses, a strict aseptic technique is recommended. The
veterinary medicinal product has been formulated specifically for subcutaneous
injection in dorsal surface of the ear of cattle and must not be given by any other route
of administration or to any other species.
To avoid possible secondary reactions by the death of larvae in the spine
or the oesophagus of animals, it is recommended to administer a veterinary medicinal
product effective against
larvae reach their resting sites. Consult your veterinary surgeon on the correct timing
of this treatment.
Immunity to nematodes depends on adequate exposure to infection. Although not
normally the case, circumstances could occur in which anthelmintic control measures
might increase the vulnerability of cattle to re-infection. Animals may be at risk towards
the end of their first grazing season, particularly if the season is long, or in the following
year if they move onto heavily contaminated pasture. In such instances, further control
measures may be necessary.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
This product can cause skin and eye irritation.
Avoid direct contact with skin and eyes.
Do not smoke, drink, or eat while handling the product.
Wash hands after use.
If accidental skin contact occurs, wash the affected area with soap and water.
If accidental eye exposure occurs, immediately rinse the eyes thoroughly with water
If skin or eye irritation persists, seek medical attention.
Take care to avoid self-injection.
In case of accidental self-injection, seek medical advice immediately and show the
package leaflet or the label to the physician.
Advice to medical practitioners: In case of accidental self-injection: Treat
symptomatically.
Special precautions for the protection of the environment:
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT)
substance; therefore, exposure of the environment to moxidectin must be limited to
the extent possible. Treatments should be administered only when necessary and
should be based on faecal egg counts or evaluation of the risk of infestation at the
animal and/or herd level.
Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-
target organisms:
Faeces containing moxidectin excreted onto pasture by treated animals may
temporarily reduce the abundance of dung feeding organisms. Following treatment of
cattle with the veterinary medicinal product, levels of moxidectin that are potentially
toxic to dung fly species may be excreted over a period more than 4 weeks and may
decrease dung fly abundance during that period. It has been established in laboratory
tests that moxidectin may temporarily affect dung beetle reproduction; however, field
studies indicate no long-term effects. Nevertheless, in case of repeated treatments
with moxidectin (as with veterinary medicinal products of the same anthelmintic class)
it is advisable not to treat animals every time on the same pasture to allow dung fauna
populations to recover.
Moxidectin is inherently toxic to aquatic organisms including fish. The veterinary
medicinal product should be used only according to the label instructions. Based on
the excretion profile of moxidectin when administered as the injectable formulation,
treated animals should not have access to watercourses during the 10 days after
treatment.
3.6 Adverse events
Cattle:
Rare
(1 to 10 animals / 10,000 animals treated):
Injection site swelling
1,2
Depression and ataxia
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Injection site abscess
1
immediate or delayed, may further develop into injection site abscesses, frequency
tends to be higher in heavier animals.
generally disappear without treatment within 14 days after administration, although
may persist up to 5 weeks (<5% of cases) or longer (very rare occasions). In case of
hypersensitivity reactions, a symptomatic treatment should be applied.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy and lactation:
Can be used during pregnancy. Note section 3.3. Contraindications and section 3.12
Withdrawal periods.
3.8 Interaction with other medicinal products and other forms of interaction
The effects of GABA agonists are increased by moxidectin.
3.9 Administration routes and dosage
For subcutaneous use.
Dosage is 0.5 ml/50 kg bodyweight, equivalent to 1.0 mg moxidectin/kg bodyweight,
given by a single subcutaneous injection in the ear using an 18 gauge, 25 – 40 mm
hypodermic needle. The 50 ml vial stoppers must not be broached more than 20 times.
Use automatic syringe equipment for the 250 ml vial, no more than five piercings
should be made.
Shake well before use.
Underdosing could result in ineffective use and may favour resistance development.
To ensure that the correct dosage is used, an animal’s bodyweight should be
determined as accurately as possible. If animals are to be treated collectively,
reasonably homogeneous groups should be set up, and all animals in a group should
be dosed at a rate corresponding to the heaviest one.
Accuracy of the dosing device should be thoroughly checked.
The injection should be given subcutaneously in the loose tissues on the dorsal
surface of the ear, just distal to the distal edge of the auricular cartilage.
The dorsal (outer) surface of the ear should first be cleansed with antiseptic and
allowed to briefly air dry. Palpate the edge of the auricular cartilage closest to the head,
on the dorsal (hairy) surface of the ear. From this landmark, taking care to avoid blood
vessels (artery, vein), the needle should be inserted subcutaneously starting at a point
approximately 3 to 3.5 cm distal to this edge (away from the head), and directed
towards the base of the ear, and the needle advanced to the hub. At this point, gently
aspirate the syringe to confirm that the needle is not in a blood vessel.
Upon injection, the resulting depot should reside just distal to the edge of the auricular
cartilage.
Following administration, the needle is withdrawn from the skin as pressure is applied
for several seconds with the thumb at the point of insertion.
Due to the long-lasting protection against and the stomach
worms, and , a single treatment with the
formulation at turn-out helps control parasitic bronchitis (lungworm) and parasitic
gastro-enteritis throughout the grazing season by reducing the build-up of infective
larvae on pasture associated with these parasites.
For best results the injection should be given to each calf of target weight to be grazed
together immediately prior to being turned out to pasture. Animals should be set
stocked throughout the grazing season or moved to a pasture which has not been
grazed by other cattle earlier in the season.
Diagram
•
inches) distal to the distal edge of the auricular
cartilage.
•
•
needle.
•
distal edge of the auricular cartilage.
•
needle is withdrawn from the skin to help seal the
opening.