Cydectin Pour-On (Moxidectin)

Cydectin is a high-quality pour-on, and is designed for treating worms, lice and mange in all cattle. Dosing is essential for the maintenance of good animal health, as worms, lice and mange compromise the animal's immune system and ability to fight diseases. Parasites are a leading cause of revenue loss on Irish farms. Dosing with Cydectin will help to prevent this outcome. Cydectin has a persistency of 5 weeks for Ostertagia and and 6 weeks for lungworm. 

Active Ingredient: Moxidectin

Target Species: Cattle

Treats and Controls: Infections of cattle with parasites sensitive to moxidectin.
For the treatment of infections caused by: Adult and larval gastro-intestinal nematodes, Adult respiratory tract nematode, Warbles (migrating larvae), Lice, Mange Mites, Horn Flies

Administration Method: Pour on solution

Withdrawal Time: Meat and offal : 14 days.     Milk : 6 days (144 hours).

Dosage: Cydectin should be administered at a dosage rate of 1ml/10kg body weight. This product has a short meat withdrawal period of just 14 days. For milk, the withdrawal period is 6 days.

Key features of Cydectin Pour-On

• For treatment of worms, lice and mange
• Pour-on
• Short withdrawal for meat and milk
• Essential for cattle health

​Information sheet

Click here to Download Data Sheet

Health Products Regulatory Authority

1 NAME OF THE VETERINARY MEDICINAL PRODUCT CYDECTIN
0.5% w/v Pour-On for cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance:
Moxidectin 5.00  mg  

Excipients:
Butylated hydroxyanisole E320 0.10 mg
Tert butyl hydroquinone 0.03  mg q.s. to 1 ml
For full list of excipients, see Section 6.1.

3 PHARMACEUTICAL FORM
Pour-on solution.
Pale yellow oily solution.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle.

4.2 Indications for use, specifying the target species
Infections of cattle with parasites sensitive to moxidectin.
For the treatment of infections caused by:

- Adult and larval gastro-intestinal nematodes: Haemonchus placei Ostertagia ostertagi (including inhibited larvae) Trichostrongylus axei Nematodirus helvetianus Cooperia oncophora Cooperia punctata (adults) Oesophagostomum radiatum (adults) Bunostomum phlebotomum (adults)

- Adult respiratory tract nematode Dictyocaulus viviparus

- Warbles (migrating larvae) Hypoderma bovis  Hypoderma lineatum

- Lice Linognathus vituli Haematopinus eurysternus Solenopotes capillatus Bovicola bovis (Damalinia bovis)

- Mange Mites Sarcoptes scabiei Psoroptes ovis Chorioptes bovis

- Horn Flies Haematobia irritans CYDECTIN 0.5% W/V POUR-ON for cattle has a persistent effect in preventing against reinfection by: Ostertagia ostertagi for 5 weeks Dictyocaulus viviparus for 6 weeks.

4.3 Contraindications
None known.
See Section 4.11.

4.4 Special warnings for each target species
None.

4.5 Special precautions for use
Special precautions for use in animals
For topical application only.
All animals in a group should be treated.
To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of fly activity and before the larvae reach their resting sites: consult the veterinarian to know the correct treatment period.

Special precautions to be taken by the person administering the veterinary medicinal  product to animals
- Do not smoke, eat or drink while handling the product.
- Avoid direct contact with skin and eyes.
- Wash hands after use.
-Protective clothes and gloves are recommended when using the product.
-If splashed in the eye or on the skin, wash with plenty of clean, running water immediately.

Other precautions regarding impact on the environment 
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance; therefore, exposure of the environment to moxidectin must be limited to the extent possible.
Treatments should be administered only when necessary and should be based on faecal egg counts or evaluation of the risk of infestation at the animal and/or herd level.

Like other macrocyclic lactones, moxidectin has the potential to adversely affect non-target organisms:

 Faeces containing moxidectin excreted onto pasture by treated animals may temporarily reduce the abundance of dung feeding organisms.
Following treatment of cattle with the product, levels of moxidectin that are potentially toxic to dung fly species may be excreted over a period more than 2 weeks and may decrease dung fly abundance during that period.
It has been established in laboratory tests that moxidectin may temporarily affect dung beetle reproduction; however, field studies indicate no-long term effects.
Nevertheless, in case of repeated treatments with moxidectin (as with products of the same anthelmintic class) it is advisable not to treat animals every time on the same pasture to allow dung fauna populations to recover.

 Moxidectin is inherently toxic to aquatic organisms including fish.
The product should be used only according to the label instructions.
Based on the excretion profile of moxidectin when administered as the pour-on formulation, treated animals should not have access to watercourses during the first week after treatment.

4.6 Adverse reactions (frequency and seriousness)
Reactions at the site of application may occur after application in very rare occasions.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

4.7 Use during pregnancy, lactation or lay
Moxidectin has been shown to be safe for use in pregnant and lactating animals and breeding bulls.
See 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
500 µg moxidectin/kg body weight (1 ml for 10 kg) as a single topical application.
To be administered along the midline of the back of the animal from the withers to the tailhead.
Apply to clean healthy skin.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
No symptoms of overdose have been observed with the product given at ten times the recommended dose.
They are manifested as transient salivation, depression, drowsiness and ataxia.
There is no specific antidote.

4.11 Withdrawal period(s)
Meat and offal : 14 days.
Milk : 6 days (144 hours).

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

ATC Vet Code:
QP54AB02

Therapeutic group:  
endectocide (milbemycin family)

5.1 Pharmacodynamic properties
Moxidectin is a parasiticide active against a wide range of important internal and external parasites.
It is a second generation macrocyclic lactone of the milbemycin family.
Its principal mode of action is interference with the GABA (gamma amino butyric acid) receptors involved with neuromuscular transmission.
Moxidectin stimulates the release of GABA and increases its binding to the postsynaptic receptors.
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.

5.2 Pharmacokinetic particulars
Following pour-on application, the drug is distributed throughout the body tissues (except muscle) but due to its lipophilicity the concentrations in fat are 5-15 times those in other tissues.

Moxidectin undergoes partial biotransformation by hydroxylation in the body and the only significant route of excretion is the faeces, where the parent compound accounts for approximately 50%.

5.3 Environmental properties
Moxidectin fulfils the criteria for a (very) persistent, bioaccumulative and toxic (PBT) substance.
In particular, in acute and chronic toxicity studies with algae, crustaceans and fish, moxidectin showed toxicity to these organisms, yielding the following endpoints:

EC50: the concentration which results in 50% of the test species individuals being adversely affected, i.e. both mortality and sub-lethal effects.
NOEC: the concentration in the study at which no effects are observed.
This implies that when allowing moxidectin to enter water bodies, this may have a severe and lasting impact on aquatic life.
To mitigate this risk, all precautions for use and disposal must be adhered to.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Aromatic Solvent
Myristal Propoxylate Propionic Ester
Polybutene Polymer
Propylene Glycol
Butylated hydroxyanisole (E320)
Tertiary Butylhydroquinone
Citric Acid Monohydrate (E330)
Fractionated coconut oil

6.2 Major incompatibilities
Not to be mixed with other Veterinary Medicinal Products before administration.

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
Keep the container in the outer carton to protect from light.
Do not store above 25°C.
If accidentally frozen, shake vigorously before use.

6.5 Nature and composition of immediate packaging
500, 1000, 2500 and 5000 ml fluorinatedhigh-density polyethylene containers.
Not all pack 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
Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Do not contaminate watercourses with the product.
The product can be toxic for fish and aquatic organisms.

7 MARKETING AUTHORISATION HOLDER
Zoetis Belgium S.A.
2nd Floor,
Building 10
Cherrywood Business Park
Loughlinstown
Co Dublin
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA10387/012/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7th February 1997
Date of last renewal: 9th January 2006


10 DATE OF REVISION OF THE TEXT
April 2018

Cattle Pour-ons

These should be applied along the length of the flattest part of the animal’s back, from the withers to the tail head.
In general, animals should not be treated when the hair is wet or if rain is anticipated within two hours of treatment. However, some products are waterproof and can be used on wet animals.
Areas of damaged skin should be avoided, as should areas contaminated with mud or manure