Cydectin TriclaMox Drench for Sheep 1 Litre€10 OFF€10 OFF

Cydectin Triclamox 1mg drench for Sheep is a flukicide used for the treatment and control gastro-intestinal roundworm, lungworm and all three stages of fluke.

Active Ingredient: Moxidectin, Triclabendazole

Target Species: Sheep

Treats and Controls: gastro-intestinal roundworm, lungworm and all three stages of fluke.

Administration Method: Oral drench

Withdrawal Time: 31 days for sheep intended for meat and offal,Not permitted for use on sheep producing milk for human consumption

Dosage for sheep: 2 ml per 10 kg of bodyweight

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

• Acute or untreated chronic infections which can lead to death
• Reduced lambing percentages and ewe fertility
• Reduced weight in new born lambs
• Infected lambs take longer to reach finish weight
• Reduced and lower quality wool yields
• Heightened susceptibility to clostridial infections

Cydectin Triclamox 1mg drench for Sheep should be used strategically against fluke

• Sheep should be treated in early spring to make sure all adult fluke are eliminated and that the egg shedding is reduced. This should be done before the population of snails increases. 
• The infective challenge of fluke begins to gain momentum in July and reaches it's peak in the autumn.
• It is important to make sure that that fluke does not make it onto your farm through new livestock that is introduced to your farm. New livestock must be quarantined and treated with a suitable flukicide.
• Wet areas should not be used for grazing at times of high risk from fluke.
• If your livestock persists to show signs of fluke infection after treatment you should seek professional help.

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cydectin TriclaMox 1mg/ml + 50 mg/ml Oral Solution for sheep

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substances
Moxidectin 1.0 mg
Triclabendazole 50.0 mg
Excipients
Benzyl Alcohol 40.0 mg
Butylhyroxytoluene 1.0 mg
For a full list of excipients see section 6.1

3 PHARMACEUTICAL FORM
Oral solution
A clear yellow to brown liquid

4 CLINICAL PARTICULARS

4.1 Target Species
Sheep
Each ml contains:
Active substances
Moxidectin 1.0 mg
Triclabendazole 50.0 mg
Excipients
Benzyl Alcohol 40.0 mg
Butylhyroxytoluene 1.0 mg
For a full list of excipients see section 6.1

4.2 Indications for use, specifying the target species
For the treatment of mixed nematode and fluke infections in sheep, caused by moxidectin and triclabendazole
sensitive strains of:
The product has a persistent efficacy and protects sheep against infection or re-infection with the following parasites for the period
indicated:
Clinical trials, after experimental and natural infection, have shown that the product is effective against certain benzimidazole
resistant strains of:
.Haemonchus contortus
.Teladorsagia circumcincta
.Trichostrongylus colubriformis
.Cooperia curticei

4.3 Contraindications
Do not use in cases of hypersensitivity to the active substance(s) or to any of the excipient(s).
Parasite Adult stage L4 Inhibited stages
Gastro-intestinal nematodes:
Haemonchus contortus



Teladorsagia circumcincta



Ostertagia trifurcata


Trichostrongylus axei



Trichostrongylus colubriformis


Trichostrongylus vitrinus


Nematodirus battus


Nematodirus spathiger


Nematodirus filicolis

Strongyloides papillosus

Cooperia curticei

Cooperia oncophora


Oesophagostomum columbianum


Oesophagostomum venulosum

Chabertia ovina


Trichuris ovis

Respiratory tract nematode:
Dictyocaulus filaria

Liver fluke: Adult stage Early Immature
stages
Late Immature
stages
Fasciola hepatica



Species Protection period
(days)
Teladorsagia circumcincta 35
Haemonchus contortus 35

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 effective therapy:

Too frequent and repeated use of anthelmintics from the same class, over an extended period of time.

Underdosing, which may be due to an 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 macrocyclic lactones has been reported in Teladorsagia in sheep in a number of countries. In 2008,
throughout Europe, moxidectin resistance is very rare; it has been reported in a single case involving a levamisole-,
benzimidazole and ivermectin-resistant strain of Teladorsagia circumcinta. Resistance to trilabendazole has been reported
in Fasciola hepatica in sheep in some European countries. Therefore the use of this product should be based on local
(regional, farm) epidemiological information about susceptibility of parasites, local history of treatments and
recommendations on how to use the product under sustainable conditions to limit further selection for resistance to
antiparasitic compounds. These precautions are especially important when moxidectin is being used to control resistant
strains.

4.5 Special precautions for use
Special precautions for use in animals
This product should not be used for the treatment of single infections.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Avoid direct contact with skin and eyes.
Wash hands after use.
Do not smoke, drink or eat when using this product.
Wear impermeable rubber gloves during use.

4.6 Adverse reactions (frequency and seriousness)
None known.

4.7 Use during pregnancy, lactation or lay
This product is safe for use in breeding animals. See also Section 4.11.

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

4.9 Amounts to be administered and administration route
Should be given as a single oral drench of 1 ml/5 kg bodyweight, equivalent to 0.2 mg moxidectin/kg bodyweight and 10 mg
triclabendazole/kg bodyweight, using any standard drenching equipment.
To ensure a correct dosage, body weight should be determined as accurately as possible; accuracy of the dosing device should be
checked. If animals are to be treated collectively rather than individually, they should be grouped according to their body weight
and dosed accordingly, in order to avoid under- or overdosing.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Signs of overdoses have not been seen at 3 and 5 times the recommended dose. However, if they do occur they should
be consistent with the mode of action of moxidectin and/or triclabendazole and would be manifested as transient salivation,
depression, drowsiness, ataxia and reduced food intake 8 to 12 hours post-treatment. Treatment is not generally necessary and
recovery is generally complete within 1 to 5 days. There is no specific antidote.

4.11 Withdrawal Period(s)
Meat and offal: 31 days
Milk: not authorised for use in ewes producing milk intended for human consumption including during the dry period. Do not use
within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group: antiparasitic product, endectocide
ATC vet code : QP 54 AB 52, moxidectin combination

5.1 Pharmacodynamic properties
Moxidectin is an endectocide active against a wide range of internal and external parasites and is a second generation macrocyclic
lactone of the milbemycin family. Its principal mode of action is interfering with neuromuscular transmission of the GABA
(gamma amino butyric acid)-gated or glutamate-gated chloride channels. Moxidectin stimulates the release of GABA and
increases its binding to the postsynaptic receptors, and binds to the glutamate-gated chloride channels. The net effect is to open the
chloride channels on the postsynaptic junction to allow the inflow of chloride ions and induce an irreversible resting state. This
results in flaccid paralysis and eventual death of parasites exposed to the drug.
Triclabendazole is a flukicide belonging to the benzimidazole group of anthelmintics. It is well established that benzimidazole
anthelmintics selectively bind to -tubulin, thus causing the depolymerisation of microtubules and the subsequent disruption of
microtubule-based processes in helminths.

5.2 Pharmacokinetic properties
Moxidectin is distributed throughout the body tissues but due to its lipophilicity the highest drug concentrations are obtained in fat
tissue. Moxidectin undergoes biotransformation by hydroxylation. The only significant route of excretion is the faeces. The main
pharmacokinetic parameters of moxidectin when administered in the final formulation were the following:
AUCtot 58 ng.day.mL-1, Cmax 12 ng.mL-1 , T max : 6 hours and plasma half-life 3.5 days.
The majority of the oral dose of triclabendazole in rats, sheep, goats and rabbits is eliminated in faeces after 6-10 days, as
unchanged drug or products of biliary excretion. Urinary excretion is minimal. Sulphone, sulphoxide, ketone and 4-hydroxy
triclabendazole derivatives are the main metabolites identified in plasma. The main pharmacokinetic parameters of the active
metabolite triclabendazole sulfoxide when triclabendazone was administered in the final combined formulation were:
AUCtot 608 μg.h.mL-1, Cmax 10 μg.mL-1, Tmax 21 h and plasma half-life 20 h.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Benzyl alcohol
Polysorbate 80
Sorbitan oleate
Propylene glycol, dicaprylocaprate
Butylhydroxytoluene

6.2 Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal
products.

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale:24 months.
Shelf-life after first opening the immediate packaging: 6 months

6.4 Special precautions for storage
Do not store above 25°C.
Protect from light.
Do not freeze.

6.5 Nature and composition of immediate packaging
1 litre, 2.5 litre and 5 litre polyethylene containers with polypropylene screw-cap.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials
The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed
of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER
Zoetis Ireland Limited
25/28 North Wall Quay
Dublin 1
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA: 10438/018/001

9 DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
18th December 2009

10 DATE OF REVISION OF THE TEXT
January 2014

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