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Date: Wednesday, September 30, 2020 8:01

Description: 2015-Elanco-logo
Telephone: 01256 353131 (24 hr response) Veterinary Technical Services
Release 2.49
Dectomax 5 mg/ml Pour-On Solution for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, For cattle, For cattle
Active ingredient: Doramectin
Product:Dectomax 5 mg/ml Pour-On Solution for Cattle
Product index: Dectomax 5 mg/ml Pour-On Solution for Cattle
Cattle - milk: Not permitted for use in lactating animals producing milk for human consumption.
Cattle - meat: 35 days
Qualitative and quantitative composition
1 ml Dectomax Pour-On Solution 5 mg/ml contains the following:
Active substance:
Doramectin 5 mg
Excipients:
Cetearyl octanoate 160.00 mg
Triethanolamine 0.5 mg
Isopropanol to 1 ml
For a full list of excipients, see section Pharmaceutical Particulars
Pharmaceutical form
Pour-on solution.
Clear, colourless solution.
Clinical particulars
Target species
Cattle.
Indications for use, specifying the target species
For treatment 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
Trichuris spp1
1 adults
Lungworms (adults and fourth stage larvae)
Dictyocaulus viviparus
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
Dectomax Pour-On protects cattle against infection or re-infection with the following parasites for the periods indicated.
Species
Days
Ostertagia ostertagi
35
Cooperia oncophora
28
Dictyocaulus viviparous
42
Linognathis vituli
49
Oesophagostomum radiatum
21
Damalinia (Bovicola) bovis
42
Trichostrongylus axei
28
Solenopotes capillatus
35
Dectomax Pour-On also controls horn flies (Haematobia irritans) for at least 42 days after treatment.
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 dog, may occur.
Do not use in lactating cows used to produce milk for human consumption, or in dry cows or pregnant dairy heifers within 60 days prior to calving.
Do not use in cases of hypersensitivity to the active substance or any of the excipients.
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.
Special precautions for use
i) 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 Dectomax Pour-on 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.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke or eat while handling the product. Wash hands after use.
Dectomax Pour-on 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.
Highly Flammable - Keep away from heat, sparks, open flame or other sources of ignition.
iii) 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.
Adverse reactions (frequency and seriousness)
In rare cases small skin lesions may occur at the administration site.
Use during pregnancy, lactation or lay
Do not use in non-lactating dairy cows, including pregnant heifers, within 60 days prior to calving.
Interaction with other medicinal products and other forms of interaction
None known.
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 tailhead.
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.
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.
Withdrawal periods
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.
Pharmacological particulars
Pharmacotherapeutic group: Antiparasitic Products Insecticides and Repellents/Endectocides
ATCvet Code: QP 54AA03
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.
Pharmacokinetic particulars
Maximum plasma concentration of doramectin occurs in cattle approximately 9 days after topical administration of Dectomax Pour-On. 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.
Environmental properties
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.
Pharmaceutical particulars
List of excipients
Cetearyl octanoate
Triethanolamine
Isopropanol
Incompatibilities
None known.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 4 years.
Special precautions for storage
Store at temperatures below 30 °C. Do not refrigerate.
Protect from light.
Nature and composition of immediate packaging
Dectomax Pour-On will be supplied in:
250 ml and 1 L multi-dose high-density polyethylene bottles with screw-top lids and dosing cups
and
2.5 L, 3 L and 5 L multi-dose high-density polyethylene bottles with screw-top lids and draw-off adaptor.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product 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 product or waste materials should be disposed of in accordance with national requirements.
Marketing Authorisation Holder (if different from distributor)
N/A
Marketing Authorisation Number
Vm: 00006/4122
Significant changes
Date of the first authorisation or date of renewal
19 February 1997
Date of revision of the text
December 2013
Any other information
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Dectomax 5 mg/ml Pour-On Solution for Cattle 1L
GTIN:05014602800239
GTIN description:Dectomax 5 mg/ml Pour-On Solution for Cattle 2.5L
GTIN:05014602800246
GTIN description:Dectomax 5 mg/ml Pour-On Solution for Cattle 5L
GTIN:05014602801298