Closamectin Pour-On (Ivermectin, Closantle)

Closamectin Pour-on for cattle is a ready to use pour-on solution that is used in the treatment and control of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eye worms, warbles, mites and lice. Closamectin Pour-on uses a unique mixture of ivermectin (for the treatment of lice, worms and ticks) and closantel (for the treatment of liver fluke and gastrointestinal roundworm).Closamectin pour-on is highly effective and extremely easy to use compared to injections or drenches. The ease and efficiency of this product will save farmers both time and money.

Active Ingredient: Ivermectin, Closantle

Target Species: Cattle

Administration Method: Pour-On

Treats and Controls: Gastro-intestinal worm, lungworm,eye worms, warbles, lice, mange mites, immature and mature fluke

Withdrawal Time: 58 days for cattle intended for meat and offal, not suitable for cattle producing milk for human consumption.

Dosage for cattle: 1 ml per 10 kg of bodyweight.

Always read the label and all enclosed information for Closamectin before administering to animals!

Key Features of Closamectin pour on

• Ready to use pour-on solution
• helps treat and control mixed trematode (fluke) and nematode or arthropod infestations
• Uses a unique mixture of ivermectin  and closantel
• Highly effective 
• Extremely easy to use compared to injections or drenches. 

Field Tests

Field tests have shown that Closamectin Pour-on is highly effective in the fight against ostertagia ostertagi

• Killed 99.8% of adult fluke aged 12 weeks following infection
• Killed 98.3% of immature fluke aged 7 weeks following infection
• Killed 95.7% of Cooperia oncophora in field tests
• Killed 99.5% of Cooperia surnabada in field tests

Closamectin Treatment Regime

It is recomended that treating beef cattle at least twice a year is the most effective way of controlling the fluke problem on your farm. 

Housing: Cattle should be treated at the time of housing or just after housing. A second treatment may be needed if the cattle are housed early or if the area is highly susceptible to contamination.

Turnout: Cattle should be treated at 8 to 10 weeks after turnout. This treatment will kill fluke that have been picked up by cattle as soon as they were turned out. This treatment will also help reduce the reinfection of pastures. 

Outwintering: For cattle who are outwintered a treatment should be given in the late autumn to early winter, a second treatment may be needed in January/February.

Bought in cattle: All bought in livestock should be treated and quarantined for at least 48 hours, this will help protect your herd from infections introduced from new cattle

"Choose Closamectin Pour on… The easy and effective way to treat  fluke, worms and lice."

This product is only licensed for sale within the Republic of Ireland. 

PLEASE NOTE: Only the 5L variation of this product comes with an application gun.

Click here to Download Data Sheet

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Closamectin Pour-On Solution for Cattle.

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active ingredient(s)
Ivermectin 5 mg/mL
Closantel (as closantel sodium) 200 mg/mL

Excipients
Brilliant Blue FCF (E133) 0.1 mg/mL
For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM
Pour-On solution.
A clear blue/green solution.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle.

Active ingredient(s)
Ivermectin 5 mg/mL
Closantel (as closantel sodium) 200 mg/mL

Excipients
Brilliant Blue FCF (E133) 0.1 mg/mL
For a full list of excipients see section 6.1.

4.2 Indications for use, specifying the target species
For the treatment of mixed trematode (fluke) and nematode or arthropod infestations due to roundworms, lungworms, eyeworms, warbles, mites and lice of cattle.

Gastrointestinal roundworms (adults and fourth stage larvae)
Ostertagia ostertagi (including inhibited O. ostertagi),
Haemonchus placei,
Trichostrongylus axei,
Trichostrongylus colubriformis,
Cooperia spp,
Oesophagostomum radiatum,
Nematodirus helvetianus (adult),
Strongyloides papillosus (adult).

Lungworms (adult and fourth stage larvae)
Dictyocaulus viviparus
Trematodes (adult and late immatures)
Fasciola gigantica
Fasciola hepatica

Treatment of fluke at 12 weeks (mature) >95% efficacy.
Treatment of fluke at 7 weeks (late immature) >95% efficacy.

Eyeworms (adult)
Thelazia spp

Cattle grubs (parasitic stages)
Hypoderma bovis,
Hypoderma lineatum

Lice
Linognathus vituli,
Haematopinus eurysternus,
Damalinia bovis

Mange Mites
Chorioptes bovis,
Sarcoptes scabiei var bovis

4.3 Contraindications
Do not use in cases of known hypersensitivity to the active substances.
Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure.
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).

4.4 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 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.

Resistance to ivermectin has been reported in Cooperia spp in cattle.
Therefore the use of this product should be based on local epidemiological information about the susceptibility of the Cooperia spp and recommendations on how to limit further selection for resistance to anthelmintics.

4.5 Special precautions for use
(i)Special precautions for use in animals:
None
(ii)Special precautions to be taken by the person administering the veterinary medicinal product to animals:
The veterinary medicinal product may be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons.
Operators should wear nitrile rubber 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.
Do not smoke or eat whilst handling the product. Wash hands after use. Use only in well ventilated areas or outdoors.

(iii)Other Precautions Regarding the Environment.
Treated cattle should not have direct access to ponds, streams or ditches for 14 days after treatment.

4.6 Adverse reactions (frequency and seriousness)
Undesirable effects are not expected when the product is used at the recommended dose rate

4.7 Use during pregnancy, lactation or lay
The product is safe for use during pregnancy and lactation.
However, the product is not permitted for use in animals
producing milk for human consumption, including pregnant animals intended to produce milk for human consumption.

4.8 Interaction with other medicinal products and other forms of interaction
None known.

4.9 Amounts to be administered and administration route
The veterinary medicinal product should be administered topically at a dosage rate of 500μg ivermectin per kg bodyweight and 20 mg closantel 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.
* Dose rate 1 ml per 10 kg bodyweight

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
At doses of three times the recommended dose, no significant clinical signs were recorded.

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 inco-ordination,
hyperthermia,
convulsions,
tachycardia and
in extreme cases death.
Treatment of overdosage is symptomatic as no antidote has been identified.

4.11 Withdrawal Period(s)
Cattle must not be treated within 28 days of slaughter for human consumption.
Not permitted for use in animals producing milk for human consumption, including pregnant animals intended to
produce milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vet Code:
QP54AA51

Pharmacotherapeutic Group:
Ivermectin, combinations.
 

5.1 Pharmacodynamic properties
Ivermectin is an endectocide with activity against a wide range of internal and external parasites.
Ivermectin is a macrocylic lactone and acts by inhibiting nerve impulses.
It binds selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells.
This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the relevant parasites.
Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gammaaminobutyric acid (GABA).
The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels.
The macrocylic lactones have a low affinity for other mammalian ligand-gated chloride channels and they do not readily cross the blood-brain barrier.

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 flukicide activity and efficacy against certain other helminths and arthropods.

5.2 Pharmacokinetic properties
After topical administration of Closamectin Pour-On to cattle at a dose rate of 500 microgram ivermectin per kg and 20 mg closantel per kg the following parameters were observed:

Ivermectin – Cmax of 19.13 ng/mL and AUC of 2440 ng.hr/mL;
Closantel – Cmax of 68.5 microgram/mL and AUC of 35207 microgram.hr/mL.

Ivermectin is only partially metabolised. In cattle, only about 1 to 2% is excreted in the urine the remainder is excreted in the faeces, approximately 60% of which is excreted as unaltered drug. The remainder is excreted as metabolites or degradation products. 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
6.1 List of excipients
Brilliant Blue FCF (E133) Dye
Anhydrous Ethanol
Macrogol,
Cetearyl Ethylhexanoate
Isopropyl Myristate
Povidone
Denatonium Benzoate
Trolamine
Isopropylalcohol

6.2 Incompatibilities
None known.

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 1 year.

6.4 Special precautions for storage
Do not store above 25°C.
Store upright in original container.
Protect from light.
Discard unused material. Avoid introduction of contamination.
If stored at temperatures below 0°C, Closamectin Pour-On Solution for Cattle may appear cloudy. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.
Flammable – keep away from heat, sparks, open flame or other sources of ignition.

6.5 Nature and composition of immediate packaging
Translucent 250 mL and 1L HDPE containers with white HDPE caps and
white 1L, 2.5L and 5L HDPE backpacks with 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
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with
the product or used container.
Any unused product or waste material should be disposed of in accordance with national requirements.

7 MARKETING AUTHORISATION HOLDER
Norbrook Laboratories Limited
Station Works
Camlough Road
Newry
Co Down,
BT35 6JP
Northern Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA 10999/124/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
7th August 2009

10 DATE OF REVISION OF THE TEXT
5th May 2010