Closamectin 5 mg/ml + 200 mg/ml Pour-on Solution for Cattle

this recommendation may lead to residues violations (see section 3.12) or in
very rare cases, it can lead to adverse events (see section 3.6) in non-treated
animals.
It is not advisable to administer the product when larvae
are localised in the periaesophagic region, or when larvae
are situated in the spinal canal. Seek professional veterinary advice to
determine the best period of use.
Care should be taken to ensure animals are not overdosed by the application
volume, accidental spillage or oral ingestion, as overdosage may result in signs
of toxicity such as inco-ordination and blindness. It is recommended that
animals are not clipped prior to treatment to reduce the risk of increased drug
absorption and hence bioavailability, or oral ingestion through mutual grooming.
Care should be taken when treating animals which may be of low nutritional
status as this may increase susceptibility of adverse events occurring.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals:
This product may be irritating to human skin and eyes or cause hypersensitivity.
Avoid skin and/or eye contact with the product during treatment, when handling
recently treated animals or when cleaning the used equipment. Personal
protective clothing consisting of nitrile rubber gloves and boots with a
waterproof coat should be worn when applying the product. Protective clothing
should be washed after use. If accidental skin contact occurs, wash the
affected area immediately with soap and water. If accidental eye exposure
occurs, flush the eyes immediately with water and get medical attention.
This product may be toxic after accidental ingestion. Avoid ingestion by hand-
to-mouth contact. Do not eat, drink or smoke whilst handling the product. If
accidental ingestion occurs, seek medical advice immediately and show the
package leaflet to the physician. Wash hands after use.
This product is flammable. Keep away from sources of ignition. Use only in well
ventilated areas or outdoors.
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Special precautions for the protection of the environment:
The product is very toxic to aquatic organisms and dung insects.
Treated cattle should not have direct access to ponds, streams or ditches for 14
days after treatment.
Long term effects on dung insects caused by continuous or repeated use
cannot be excluded therefore repeat treatments on a pasture within a season
should only be given on the advice of a veterinarian.
Other precautions:
Avermectins may not be well tolerated in non-target species (cases of
intolerance with fatal outcome are reported in dogs – especially Collies, Old
English Sheepdogs and related breeds or crosses, and also in turtles/tortoises).
3.6 Adverse events
Very rare
(<1 animal / 10,000 animals treated,
including isolated reports):
Neurological disorders
(e.g. Ataxia,
Blindness, Recumbency)
Gastrointestinal signs (e.g. Anorexia,
Diarrhoea)
Death
1
When there is an adverse event in a herd, several animals may be affected.
Should neurological signs be observed in one animal, it is recommended to
reinforce surveillance, at the herd level, of all treated animals.
In extreme cases.
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:
The veterinary medicinal product can be administered to cattle (including dairy,
beef/suckler cattle) at any stage of pregnancy or lactation provided that the milk
is not intended for human consumption. See section 3.12.
3.8 Interactions with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
The veterinary medicinal product should be administered topically at a dosage
rate of 500 g ivermectin per kg bodyweight and 20 mg closantel per kg
bodyweight (1 mL per 10 kg).
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The formulation should be applied along the midline of the back in a narrow
strip between the withers and the tail head.
Assess bodyweight carefully prior to administration.
The timing for treatment should be based on epidemiological factors and should
be customised for each individual farm. A dosing programme should be
established by a veterinary professional.
HANDY DOSING GUIDEANIMALS SHOULD BE WEIGHED AND
GROUPED ACCORDING TO BODYWEIGHT TO
AVOID UNDER OR OVER-DOSING*
NUMBER OF FULL DOSES PER PACKBODYWEIG
HT
DOSE
VOLUME
250 mL500
mL
1 litre2.5 litre5 litre100kg*10 mL2550100250500150kg15 mL163366166333200kg20 mL122550125250250kg25 mL102040100200300kg30 mL8163383166350kg35 mL7142871142400kg40 mL6122562125450kg45 mL5112255111500kg50 mL5102050100550kg55 mL49184590600kg60 mL48164183
* Dose rate 1 mL per 10 kg bodyweight
Avoid introduction of contamination.
If stored at temperatures below 0
o
C, the veterinary medicinal product may
appear cloudy. Allowing to warm to room temperature will restore the normal
appearance without affecting efficacy.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
At doses of three times the recommended dose, no significant clinical signs
were recorded. No antidote has been identified for ivermectin or closantel
overdose. Symptomatic treatment may be beneficial.
Closantel like other salicylanilides is a potent uncoupler of oxidative
phosphorylation and the safety index is not as high as is the case of many other
anthelmintics. However where used as directed there are unlikely to be any
untoward effects. Signs of overdosage can include slight loss of appetite, loose
faeces, decreased vision and increased frequency of defecation. High doses
may cause blindness, hyperventilation, general weakness and inco-ordination,
hyperthermia, convulsions, tachycardia and in extreme cases death.
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3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Meat and offal: 58 days.
Not authorised for use in cattle producing milk for human consumption including
during the dry period. Do not use during the second half of pregnancy in
heifers which are intended to produce milk for human consumption.
Due to the significant likelihood of cross-contamination of non-treated animals
with this product due to grooming (licking), all animals in a group should be
treated at the same time and treated animals should be kept separately from
non-treated animals throughout the withdrawal period. Non-compliance with
this recommendation may lead to residues violations in non-treated animals.