Taurador 10 mg/ml Solution for Injection for Cattle & Sheep

Unnecessary use of antiparasitics or use deviating from the instructions given in the
SPC may increase the resistance selection pressure and lead to reduced efficacy.
The decision to use the product should be based on confirmation of the parasitic
species and burden, or of the risk of infection/infestation based on its epidemiological
features, for each individual herd/flock.
Repeated use for an extended period, particularly when using the same class of
substances, increases the risk of resistance development. Within a herd/flock,
maintenance of susceptible refugia is essential to reduce that risk. Systematically
applied interval-based treatment and treatment of a whole herd/flock should be
avoided. Instead, if feasible, only selected individual animals or subgroups should be
treated (targeted selective treatment). This should be combined with appropriate
husbandry and pasture management measures. Guidance for each specific
herd/flock should be sought from the responsible veterinarian.
In the absence of risk of co-infection, a narrow spectrum product should be used
where available.
Resistance to doramectin and other avermectins has been reported in Psoroptes
ovis in cattle (Europe) and sheep (UK) and in gastro-intestinal nematodes, especially
Haemonchus spp (outside Europe/UK)., Cooperia spp. and Ostertagia ostertagi in
cattle (Europe including the UK) and Teladorsagia spp., Trichostrongylus spp. and
Haemonchus spp. in sheep (Europe including the UK).
The use of this product should take into account local information about susceptibility
of the target parasites, where available.
Care should be taken to avoid the following practices because they increase the risk
of development of resistance and could ultimately result in ineffective therapy:
•
over an extended period of time.
•
misadministration of the product, or lack of calibration of the dosing
device (if any).
It is recommended to further investigate cases of suspected resistance, using an
appropriate diagnostic method (e.g. Faecal Egg Count Reduction Test). Where the
results of the test(s) strongly suggest resistance to a particular anthelmintic, an
anthelmintic belonging to another pharmacological class and having a different mode
of action should be used.
Confirmed resistance should be reported to the marketing authorisation holder or to
the competent authorities.

Special precautions for safe use in the target species:
This veterinary medicinal product does not contain an antimicrobial preservative.
Swab septum before removing each dose.
Use sterile equipment and follow aseptic procedures.
When treating groups of animals, use a suitable automatic dosing device and vented
draw-off apparatus.
For the treatment of individual sheep, a disposable 2 ml syringe calibrated in
increments of 0.1 ml should be used.
In young lambs of less than 16 kg bodyweight seek veterinary advice regarding the
use of appropriately sized needles and of 1 ml disposable syringes graduated in
increments of 0.1 ml or less.
Syringes must be filled from the vial through a dry, sterile draw-off needle that has
been placed in the vial stopper.
100 ml: The veterinary medicinal product is to be administered using a draw-off
needle.
250 ml and 500ml: Vial stoppers must not be broached more than 10 times with an
18G needle.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
Take care to avoid accidental self-administration. If any adverse effects are noticed
following accidental self-administration, seek medical advice and show the package
leaflet or the label to the physician.
This veterinary medicinal product can be irritating to eyes. Avoid accidental contact
with the eyes, including hand-to-eye contact. In the case of accidental contact with
the eyes rinse with plenty of water.
The veterinary medicinal product may cause embryotoxicity and toxic effects to
newborns via breastfeeding. Pregnant and breastfeeding women should therefore
take special care when handling this veterinary medicinal product.
Do not eat, drink or smoke while handling the product.
Wash hands after use.
Advice to medical practitioners: In case of accidental self-injection specific symptoms
have rarely been observed and therefore any cases should be treated
symptomatically.
Special precautions for the protection of the environment:
Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate
in sediments.
The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too
frequent and repeated use of doramectin (and products of the same anthelmintic
class) in cattle and sheep.
The risk to aquatic ecosystems will be reduced by keeping treated cattle away from
water bodies for five weeks after treatment.