Contraindications
Extra-label use in dogs should be avoided, as severe adverse reactions may
occur. In common with other avermectins, certain breeds of dog, such as
collies, are especially sensitive to doramectin and particular care should be
taken to avoid accidental consumption of the product.
Special warnings for each target species
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:
• Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
• Underdosing, which may be due to underestimation of body weight,
misadministration of the product, or lack of calibration of the dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further
investigated using appropriate tests (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.
Resistance to doramectin (an avermectin) has been reported in Teladorsagia
and Haemonchus in sheep within the EU. Therefore, the use of this product
should be based on local (regional, farm) epidemiological information about
susceptibility of nematodes and recommendations on how to limit further
selection for resistance to anthelmintics.
Special precautions for use
Special precautions for use in animals
This 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 only the Doramax 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 appropriate 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. Vial stoppers must not be broached more than 20 times.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not eat, drink or smoke while handling the product.
Wash hands after use.
Take care to avoid accidental self-administration - seek medical attention should any specific signs be noticed.
Advice to Medical Practitioners: In cases 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.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
None known
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 also the last section of the package leaflet for contact details.
Use during pregnancy, lactation or lay
May be used in pregnant cows and ewes.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.
Do not use in pregnant ewes, which are intended to produce milk for human
consumption, within 70 days of expected parturition.
Interaction with other medicinal products and other forms of interaction
None known
Overdose (symptoms, emergency procedures, antidotes), if necessary
In cattle (SC route only) and sheep (IM route only) overdoses up to 25 and 10 times respectively the maximum label recommended dose resulted in no
adverse clinical signs.