Norofas Pour-on Solution for Cattle

recommendation may lead to residues violations (see section
4.11) or in very rare cases, it can lead to adverse events (see
section 4.6) in non-treated animals.
It is not advisable to administer the product when
lineatum 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.
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. Do not allow these species to
come in contact with this product.
It is recommended to treat all animals within a herd or group.
ii. 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. Operators should wear nitrile rubber

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gloves and boots with a waterproof coat 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, get
medical attention 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.
iii. Other Precautions
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.
4.6 Adverse Reactions (Frequency and Seriousness)
In very rare cases (less than 1 animal in 10,000 animals, including
isolated reports), neurological signs such as blindness, ataxia, and
recumbency may occur after administration of the product. These cases
may also be associated with gastrointestinal signs such as anorexia,
diarrhoea and in extreme cases signs may persist and may result in
death of the animal.
Even though the overall incidence of adverse events is very rare, it has
been noted that, when there is an adverse event in a herd, several
animals may be affected. Therefore, should neurological signs be
observed in one animal, it is recommended to reinforce surveillance, at
the herd level, of all treated animals.
4.7 Use During Pregnancy, Lactation or Lay
The 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.

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4.8 Interactions with Other Medicinal Products and Other Forms of
Interaction
Do not combine ivermectin treatment with vaccination against lungworms.
If vaccinated animals are to be treated, treatment should not be carried
out within a period of 28 days before or after vaccination.
4.9 Amounts to be Administered and Administration Route
The veterinary medicinal product should be administered topically at a
dosage rate of 500
per kg bodyweight (1 mL per 10 kg).
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 PACKBODYWEIGHTDOSE
VOLUME
250ml500ml1 litre2.5 litre5 litre100kg*10ml2550100250500150kg15ml163366166333200kg20ml122550125250250kg25ml102040100200300kg30ml8163383166350kg35ml7142871142400kg40ml6122562125450kg45ml5112255111500kg50ml5102050100550kg55ml49184590600kg60ml48164183
* Dose rate 1ml per 10kg bodyweight
4.10 Overdose (Symptoms, Emergency Procedures and Antidotes) (if
necessary)
At doses of three times the recommended dose, no significant clinical
signs were recorded.

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Ivermectin
No antidote has been identified. 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 in co-ordination, hyperthermia,
convulsions, tachycardia and in extreme cases death. Treatment of
overdosage is symptomatic as no antidote has been identified.
4.11 Withdrawal Periods
Meat and offal: 58 days.
Milk: 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.
5.