SPC - Vpa22664-150-001
SPC - Vpa22664-150-001
SPC - Vpa22664-150-001
1 ml of solution contains:
Active substance:
Closantel 200 mg
(as Closantel Sodium Dihydrate 217.5 mg)
Excipients:
Brilliant Blue FCF (E133) 0.1 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Pour-On solution.
A clear blue/green solution.
4 CLINICAL PARTICULARS
Cattle
For the treatment of late immature (> 7 weeks) and adult Fasciola hepatica (fluke) infestations of cattle.
4.3 Contraindications
Do not use in known cases of hypersensitivity to the active substance or to any of the excipients.
Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure.
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 bodyweight, misadministration of the product, or lack of calibration of
the dosing device.
The effect of rain on the pour-on formulation at the time of and after application has not been investigated. For maximum
effect animals should be kept indoors or undercover following treatment, when there is rain or an imminent risk of rain.
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 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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This product may be toxic after accidental ingestion. Avoid ingestion by hand-to-mouth contact. In case of accidental
ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.
This product may cause irritation to human skin and eyes.
This product may cause hypersensitivity (allergic) reactions in those known to be sensitised to polyethylene glycols (PEGs),
povidones, isopropyl alcohol, triethanolamine, ethanol, and/or closantel.
Do not use in cases of known hypersensitivity to the active substance or to any of these excipients.
Avoid skin or eye contact with product.
Users should wear nitrile rubber gloves and boots with a waterproof coat when applying the product.
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 seek medical attention. Wash any exposed skin after use. Protective clothing
should be washed after use.
This product is flammable.
Keep away from heat, sparks, open flame or other sources of ignition.
Store in a closed cabinet. Do not smoke or eat while handling the product.
This product contains volatile organic solvents, which may be accidentally inhaled.
Use only in well ventilated areas or outdoors.
Other precautions:
This product is very toxic to aquatic organisms and dung insects.
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.
In very rare cases, 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.
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. See Section 4.11.
4.8 Interaction with other medicinal products and other forms of interactions
None known.
At doses of three times the recommended dose, no significant clinical signs were recorded.
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. 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. Treatment of overdosage is symptomatic
as no antidote has been identified.
Closantel is a member of the salicylanilide class of anthelmintics. Salicylanilides are hydrogen (proton) ionophores (referred to
as oxidative phosphorylase uncouplers.)
The chemical structure of salicylanilides illustrate the possession of a detachable proton. This type of molecule is lipophilic and
is known to shuttle protons across membranes, in particular the inner mitochondrial membrane. Closantel acts by uncoupling
oxidative phosphorylation.
Closantel is a parasiticide with activity against fluke.
After topical administration of the product to cattle at a dose rate of 20 mg closantel per kg the following parameters were
observed: Closantel – Cmax of 57 (SD ± 52) µg/mL, AUC of 34690 (SD ± 29922) µg/hr/mL, Tmax of 223 (SD ± 327) hours
(median value) and t½ of 385 (SD ± 95) hours (harmonic mean).
Salicylanilides are poorly metabolised and are excreted mainly unchanged. About 90% of closantel is excreted unchanged in
the faeces and urine in cattle.
6 PHARMACEUTICAL PARTICULARS
None known.
6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 16 months.
Shelf life after first opening the immediate packaging: 6 months.
White 1L, 2.5L and 5L HDPE backpacks for use with a suitable dosing device and white polypropylene screw caps.
Not all packs sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the
use of such products
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used
container. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should
be disposed of in accordance with local requirements.
VPA22664/150/001