Dectomax Pour On (Doremectin)

Dectomax Pour-on for Cattle 5 mg/ml is used for the treatment and control of gastro-intestinal nemotades, lungworms, warbles, mange mites, sucking and biting lice and hornfly. Dectomax Pour-On also features 5 week persistent protection against Osteragia and 6 week persistent protection against Lungworm.

​Active Ingredient: Doramectin

Target Species: Cattle

Treats and Controls: Gastro-intestinal roundworms, lungworms, eyeworms, mites and lice

Administration Method: Pour-on

Withdrawal Time: 35 days for animals intended for meat and offal, not permitted for use on animals producing milk for human consumption or in dry cows or pregnant dairy heifers within 60 days prior to calving.

Dosage: 1 ml per 10 kg of bodyweight

Always read the label and all enclosed information for Dectomax Pour-on before administering to animals!

Features of Dectomax Pour-On

• Broad spectrum Doramectin Pour on​
• 5 week persistent activity against osteragia​
• 6 week persistent activity against lungworm
• Aimed at treating cattle
• Treatment of most parisites both internal and external

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

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Health Products Regulatory Authority

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Dectomax 5 mg/ml Pour-On Solution for Cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Doramectin 5.0 mg

Excipients
Trolamine (as an antioxidant) 0.5 mg
For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Pour-on solution Clear,
colourless solution.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle

4.2 Indications for use, specifying the target species
For treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.

Gastrointestinal roundworms (adults and fourth stage larvae)
Ostertagia ostertagi (inc. inhibited larvae)
O. lyrata1
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata1
C. surnabada1 (syn. mcmasteri)
Bunostomum phlebotomum1
Oesophagostomum radiatum T
richuris spp1  1 adults

Lungworms (adults and fourth stage larvae)
Dictyocaulus viviparous

Eyeworms (adults) Thelazia spp

Warbles (parasitic stages)
Hypoderma bovis,
H. lineatum

Biting lice
Damalinia (Bovicola) bovis

Sucking lice
Haematopinus eurystemus
Linognathus vituli
Solenopotes capillatus

Mange mites
Psoroptes bovis
Sarcoptes scabiei
Chorioptes bovis

Horn fly
Haematobia irritans

Duration of activity Following product administration, efficacy against re-infection with the following parasites persists for the period indicated:
Species Days
Ostertagia ostertagi 35
Cooperia oncophora 28
Dictyocaulus viviparus 42
Linognathis vituli 49 
Oesophagostomum radiatum 21
Damalinia (Bovicola) bovis 42
Trichostrongylus axei 28
Solenopotes capillatus 35

The product also controls horn flies (Haematobia irritans) for at least 42 days after treatment.

4.3 Contraindications
The product has been formulated for topical application specifically for cattle.
It should not be administered to other species as severe adverse reactions, including fatalities in dogs, may occur.
Do not use in cases of hypersensitivity to the active substance or any of the excipients.
See section 4.5 i.

4.4 Special warnings for each target species
For external use only.
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.
- under dosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of a 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 a different pharmacological class and having a different mode of action should be used. Do not apply to areas of skin that are contaminated with mud or manure.

Therapeutic efficacy for internal and external parasites is not affected by heavy rainfall (2 cm in 1 hour) either before (20 minutes) or after (20 and 40 minutes) treatment.
The influence of extreme weather conditions on efficacy is unknown.

4.5 Special precautions for use
Special precautions for use in animals
Avermectins may not be well tolerated in all 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/tortoise.
Care should be taken to avoid ingestion of spilled product or access to containers by these other species.
To avoid secondary reactions due to death of Hypoderma larvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of warble fly activity and before the larvae reach their resting sites. Consult your veterinary surgeon on the correct timing of treatment.

Special precautions to be taken by the person administering the veterinary medicinal product to animals. Persons with known hypersensitivity to the active substance should avoid contact with the product.
Do not smoke or eat while handling the product.
Wash hands after use.
The veterinary product may be irritating to human skin and eyes and users should be careful not to apply it to themselves or to other persons.
Operators should wear 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.
Use only in well ventilated areas or outdoors.
Highly Flammable - Keep away from heat, sparks, open flame or other sources of ignition.

Other precautions Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments. The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.
The risk to aquatic ecosystems will be reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.

4.6 Adverse reactions (frequency and seriousness)
In rare cases small skin lesions may occur at the administration site.
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
Do not use in non-lactating dairy cows, including pregnant heifers, within 60 days prior to calving.

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

4.9 Amounts to be administered and administration route
A single treatment of 1 ml (5 mg doramectin) per 10 kg bodyweight, equivalent to 500 μg/kg bodyweight, applied topically along the mid-line of the back in a narrow strip between the withers and tail head.
To ensure administration of a correct dose, bodyweight 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 bodyweight and dosed accordingly, in order to avoid under- and over- dosing.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdoses up to 5 times the label recommended dose resulted in no clinical signs that could be attributed to treatment with Doramectin.

4.11 Withdrawal period(s)
Meat and offal: 35 days.
Not permitted for use in lactating animals producing milk for human consumption.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.


5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:
macrocyclic lactones, avermectins

ATCvet Code:
QP 54AA03

5.1 Pharmacodynamic properties
Doramectin is a fermentation-derived antiparasitic agent, which belongs to the avermectin class, and is closely related structurally to ivermectin. Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Whilst it is not possible to assign a single mode of action to the avermectins, it is likely that the entire series share a common mechanism.
In parasitic organisms the effect is mediated through a specific avermectin-binding site. The physiological response to avermectin binding is an increase in membrane permeability to chloride ions.
In invertebrate nervous tissue an influx of chloride ions into the excitatory motor neurone in nematodes or muscle cell of arthropods results in hyperpolarisation and the elimination of signal transmission with resulting paralysis.

5.2 Pharmacokinetic particulars
Maximum plasma concentration of Doramectin occurs in cattle approximately 9 days after topical administration of the product. An (apparent) elimination half-life of around 10 days results in sustained Doramectin concentrations, which protect animals from parasitic infection and re-infection for extended periods following treatment.

5.3 Pharmacokinetic particulars
Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks. Faeces containing doramectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.

Doramectin is very toxic to aquatic organisms and may accumulate in sediments

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetearyl octanoate
Trolamine Isopropyl alcohol


6.2 Major incompatibilities
None known.

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 4 years
Shelf-life after first opening the immediate packaging: 1 year

6.4 Special precautions for storage
Store below 30 °C.

6.5 Nature and composition of immediate packaging
The product will be supplied in: - 250 ml and 1 L multi-dose high-density polyethylene bottles with screw-top lids and dosing cups in a carton box and - 2.5 L, 3 L and 5 L multi-dose high-density polyethylene bottles with screw-top lids and draw-off adaptor in a carton box.
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

Extremely dangerous for fish and aquatic life.
Do not contaminate ponds, waterways 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 national requirements.

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

8 MARKETING AUTHORISATION NUMBER(S)
VPA10387/020/001 

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 17th August 2012
Date of last renewal: 11th November 2016

10 DATE OF REVISION OF THE TEXT
January 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