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Taurador 10mg/ml Injection is an antiparasitic for cattle, sheep and pigs, containing 10mg/ml doramectin. It provides long-lasting protection against key internal and external parasites and supports sustainable parasite control with fewer doses.
Active Ingredient: Doramectin
Target Species: Cattle, Sheep and Pigs
Administration Method:
Cattle: Subcutaneous injection
Sheep: Intramuscular injection
Pigs: Intramuscular injection
Treats and Controls:
Cattle: Gastrointestinal roundworms, lungworms, warbles, lice, mange mites and eye worms
Sheep: Gastrointestinal roundworms, lungworms, mange mites (scab) and nasal bots
Pigs: Gastrointestinal roundworms, lungworms, kidney worms, sucking lice and mange mites
Withdrawal Time:
Cattle: Meat Withdrawal: 70 days. Do not use in pregnant dairy cows or dairy heifers within 2 months of expected parturition
Sheep: Meat Withdrawal: 70 days. May be used in pregnant ewes Do not use in pregnant ewes intended to produce milk for human consumption within 70 days of expected parturition
Pigs: Meat Withdrawal: 77 days Can be used in lactating sows Can be used in breeding sows and breeding boar
Dosage:
Cattle: 1ml / 50kg bodyweight
Sheep: 1ml / 50kg bodyweight
Pigs: 1ml / 33kg bodyweight
This product is only licensed for sale within the Republic of Ireland
Click to download Brochure here
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Taurador 10 mg/ml Solution for Injection for cattle, sheep & pigs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance: Doramectin 10.0 mg
Excipients: Qualitative composition of excipients and other constituents Quantitative composition if that information is essential for proper administration of the veterinary medicinal product Ethyl oleate Sesame oil, refined Butylhydroxyanisole (E320) 0.026 mg Butylhydroxytoluene (E321) 0.01 mg Clear, colourless to yellow solution. 3. CLINICAL INFORMATION
3.1 Target species Cattle, Sheep and Pigs.
3.2 Indications for use for each target species
Cattle: For the treatment of gastrointestinal roundworms, lungworms, warbles, lice, mange mites and eyeworms, listed below:
Gastrointestinal roundworms
Ostertagia ostertagi (L4, inhibited larvae and adult), O. lyrata (adult), Haemonchus placei (L4, adult), Trichostrongylus axei (L4, adult), T. colubriformis (L4, adult), T. longispicularis (adult), Cooperia oncophora (L4, adult), C. pectinata (adult), C. punctata (L4, adult), C. surnabada (syn. mcmasteri) (L4, adult), Nematodirus spathiger (adult), Bunostomum phlebotomum (adult), Strongyloides papillosus (adult), Oesophagostomum radiatum (L4, adult), Trichuris spp. (adult)
Lungworms
Dictyocaulus viviparous (L4, adult)
Eyeworms
Thelazia spp. (adult)
Warbles (parasitic stages)
Hypoderma bovis, H. lineatum 3
Sucking lice
Haematopinus eurysternus, Linognathus vituli, Solenopotes capillatus
Mange mites
Psoroptes bovis, Sarcoptes scabiei
The veterinary medicinal product also helps to treat:
Gastrointestinal roundworms
Nematodirus helvetianus
Mange mites
Chorioptes bovis
Biting lice
Damalinia bovis
The veterinary medicinal product also helps to combat:
Ticks
Ixodes ricinus
Persistent activity
The veterinary medicinal product protects cattle against infections or re-infections due to the below listed parasites during the indicated periods:
Species Prolonged activity
Ostertagia ostertagia : 28 days
Cooperia oncophora : 21 days
Dictyocaulus viviparus : 35 days
Linognathus vituli : 28 days
Psoroptes bovis : 42 days
Sheep:
For the treatment of gastrointestinal roundworms, lungworms, mange mites and nasal bots listed below:
Gastrointestinal roundworms
(adult, L4 larvae and L3 larvae, unless stated otherwise): Bunostomum trigonocephalum (adult), Chabertia ovina, Cooperia curticei (L4 larvae), C. oncophora (adult, L4 larvae), Gaigeria pachycelis, Haemonchus contortus, Nematodirus filicollis (adult), N. battus (L4 larvae), N. spathiger, Ostertagia (Teladorsagia) circumcincta, Ostertagia (Teladorsagia) trifurcata (adult), Oesophagostomum venulosum (adult), Oesophagostomum columbianum, Strongyloides papillosus, Trichostrongylus axei (adult, L4 larvae), Trichostrongylus colubriformis, Trichostrongylus vitrinus (adult, L4 larvae), Trichuris spp. (adult)
Lungworms
(adults, L4 larvae and L3 larvae, unless stated otherwise): Cystocaulus ocreatus (adult), Dictyocaulus filaria, Muellerius capillaris (adult), Neostrongylus linearis (adult), Protostrongylus rufescens (adult)
Nasal bots
(L1, L2 and L3 larvae) Oestrus ovis
Mange mites
Psoroptes ovis 4
Pigs:
For the treatment of gastrointestinal roundworms, lungworms, kidney worms, sucking lice and mange mites in pigs.
Gastrointestinal roundworms
(adults and fourth stage larvae) Hyostrongylus rubidus, Ascaris suum, Strongyloides ransomi (adults only), Oesophagostomum dentatum, Oesophagostomum quadrispinulatum
Lungworms
Metastrongylus spp. (adults only)
Kidney worms
Stephanurus dentatus (adults only)
Sucking lice
Haematopinus suis
Mange mites
Sarcoptes scabiei var. suis
The veterinary medicinal product protects pigs against infection or reinfection with Sarcoptes scabiei for 18 days.
3.3 Contraindications
Do not use in dogs, as severe adverse reactions may occur. In common with other avermectins, certain breeds of dogs, such as collies, and also tortoises, are especially sensitive to doramectin and particular care should be taken to avoid accidental consumption of the veterinary medicinal product.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
3.4 Special warnings
Unnecessary use of antiparasitics or use deviating from the instructions given in the SPC may increase the resistance selection pressure and lead to reduced efficacy. The decision to use the product should be based on confirmation of the parasitic species and burden, or of the risk of infestation based on its epidemiological features, for each herd/flock.
Repeated use for an extended period, particularly when using the same class of substances, increases the risk of resistance development. Within a herd/flock, maintenance of susceptible refugia is essential to reduce that risk. Systemically applied interval-based treatment and treatment of the whole herd/flock should be avoided. Instead, if feasible, only selected individual animals or subgroups should be treated (targeted selective treatment). This should be combined with appropriate husbandry and pasture management measures. Guidance for each specific herd/flock should be sought from the responsible veterinarian.
Resistance to doramectin and other avermectins has been reported in Psoroptes ovis in cattle and sheep and in gastro-intestinal nematodes, especially T. longispicularis, Haemonchus spp., Cooperia spp. and Ostertagia ostertagi in cattle and Teladorsagia spp., Trichostrongylus spp. and Haemonchus spp. in sheep.
The veterinary medicinal product can be used for the treatment of Ostertagia (Teladorsagia) circumcincta in sheep, including the inhibited L4 larval stages, especially strains resistant to benzimidazoles.
The use of this veterinary medicinal product should take into account local information about susceptibility of the target parasites, where available. It is recommended to further investigate cases of 5 suspected resistance using an appropriate diagnostic method (e.g. FECRT). Confirmed resistance should be reported to the marketing authorisation holder or to the competent authorities.
3.5 Special precautions for use
Special precautions for safe use in the target species:
To avoid secondary reactions due to the death of Hypoderma larvae in the oesophagus or in the spine, it is recommended to administer the veterinary medicinal product at the end of the period of warble fly activity and before the larvae reach their resting site. Consult your veterinary surgeon on the correct timing of this treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Take care to avoid accidental self-administration – seek medical attention should any specific signs be noticed. Advice to medical practitioners: In case of accidental self-injection specific symptoms have rarely been observed and therefore any cases should be treated symptomatically. This veterinary medicinal product can be irritating to eyes. Avoid accidental contact with the eyes, including hand-to eye contact. In the case of accidental contact with the eyes rinse with plenty of water. The veterinary medicinal product may cause embryotoxicity and toxic effects to newborns via breastfeeding. Pregnant and breastfeeding woman should therefore take special care when handling this veterinary medicinal product. Wash hands after use.
Special precautions for the protection of the environment:
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). The risk to aquatic ecosystems will be reduced by keeping treated animals away from water bodies for two to five weeks after treatment.
3.6 Adverse events
None known.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay Pregnancy and lactation:
Cattle and Sheep:
May be used in pregnant cows and ewes.
Pigs:
Can be used in lactating sows.
Fertility:
Pigs: Can be used in breeding sows and in breeding boars.
3.8 Interaction with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
Subcutaneous use (cattle).
Intramuscular use (sheep and pig).
Cattle
A single treatment of 1 ml (10 mg doramectin) per 50 kg bodyweight, equivalent to 200 μg/kg bodyweight, administered in the region of the neck by subcutaneous injection.
Treatment schedule in regions where hypodermosis occurs Cattle with hypodermosis should be treated at the end of the period of warble fly activity and before the larvae reach their resting site.
Sheep
A single treatment of 1 ml (10 mg doramectin) per 50 kg bodyweight, equivalent to 200 μg/kg bodyweight, administered by intramuscular injection in the neck region.
Pigs
A single treatment of 0.3 ml (3 mg doramectin) per 10 kg bodyweight (1.0 ml per 33.0 kg) corresponding to 300 μg/kg bodyweight, administered by intramuscular injection.
Underdosing could result in ineffective use and may favour resistance development. To ensure a correct dosage, body weight should be determined as accurately as possible. If animals are to be treated collectively, reasonable homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one.
When treating groups of animals, use a suitable automatic dosing device and vented draw-off apparatus. Accuracy of the dosing device should be thoroughly checked.
For treatment of individual sheep or pigs, the use of appropriately sized needles and disposable syringes should be advised by a veterinarian. For the treatment of young lambs or piglets weighing 16kg or less, a 1mL disposable syringe graduated in increments of 0.1mL or less should be used.
Use dry, sterile equipment and follow aseptic procedures. Avoid introduction of contamination. Vial stoppers must not be broached more than 40 times with a 16G needle. Swab the septum before removing each dose.
Under cold conditions the veterinary medicinal product may be warmed to room temperature in a warm environment, to aid syringeability.
3.10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
Overdoses of up to 25 times the recommended dose in cattle, up to 15 times in sheep and up to 10 times in pigs have produced no particular clinical signs that could be attributed to treatment with doramectin.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Cattle
Meat and offal: 70 days.
Not authorised for use in 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.
Sheep
Meat and offal: 70 days.
Not authorised for use in animals producing milk for human consumption.
Do not use in pregnant ewes which are intended to produce milk for human consumption within 70 days of expected parturition.
Pigs
Meat and offal: 77 days.
4. PHARMACOLOGICAL INFORMATION
4.1 ATCvet code: QP54AA03
4.2 Pharmacodynamics
Doramectin is an antiparasitic agent, isolated from fermentation of selected strains derived from the soil organism Streptomyces avermitilis. It is a macrocyclic lactone and is closely related to ivermectin. Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods. Macrocyclic lactones activate glutamate gated chloride channels (GluCl) found on muscle membranes of the pharynx and particular neurones of invertebrate parasites. Entry of chloride ions into roundworm excitatory motor neurons or arthropod muscle cells results in hyperpolarization and elimination of the transmission signal which results in paralysis. The selective toxicity of the macrocyclic lactones as antiparasitics is attributed to this action on channels that are not present in the host animal. There is evidence that the membranes of the muscle cells of the invertebrate female reproductive tract may be more sensitive to macrocyclic lactones than receptors on nerve or other muscle and this may explain the dramatic but temporary reduction in egg production in parasites not killed or eliminated by drug therapy. Several resistance mechanisms to macrocyclic lactones have been proposed, for example polymorphisms or changes in expression of the GluCls target and transport protein genes, and to the increased expression of encoding drug-metabolizing enzymes. In addition, decreased expression of drug target genes may lead to a reduction of drug-binding sites and thus reduced drug effectiveness.
4.3 Pharmacokinetics
In cattle, maximum plasma concentration of Doramectin occurs 3 days after subcutaneous administration. The elimination half-life is around 6 days,
In sheep, maximum plasma concentration of Doramectin occurs 2 days after intramuscular administration. The elimination half-life is 4.5 days in sheep,
In pigs, maximum plasma concentration of Doramectin occurs 3 days after intramuscular administration of the veterinary medicinal product. The elimination half-life is around 6 days.
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. Doramectin is very persistent in soils.
5. PHARMACEUTICAL PARTICULARS
5.1 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
5.2 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years
Shelf life after first opening the immediate packaging: 28 days
5.3 Special precautions for storage
Store in the original package.
5.4 Nature and composition of immediate packaging Multi-dose amber glass vials (Type II) closed a with a nitrile rubber stopper and sealed with an aluminium cap in a protective plastic container.
Package Sizes:
Protective plastic container with 1 x 100 ml vial.
Protective plastic container with 1 x 250 ml vial.
Protective plastic container with 1 x 500 ml vial. Not all pack sizes may be marketed.
5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste. The veterinary medicinal product should not enter water courses as doramectin is extremely dangerous for fish and other aquatic organisms. Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned
6. NAME OF THE MARKETING AUTHORISATION HOLDER
Norbrook Laboratories (Ireland) Limited
7. MARKETING AUTHORISATION NUMBER(S)
8. DATE OF FIRST AUTHORISATION
‘Date of first authorisation: DD/MM/YYYY’
9. DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS
‘MM/YYYY’
10. CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Detailed information on this veterinary medicinal product is available in the Union Product Database (https://medicines.health.europa.eu/veterinary).
Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately.
Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.
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All purchases can be returned to us within 14 days of delivery and returned goods must be received within 14 days from the date you informed us of the return.
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1) All returns must be accompanied with a fully filled out returns form which can be downloaded here.
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If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.
For the return of bulk products please contact us at sales@agridirect.ie
First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.
How do I begin the returns process?
If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.
Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.
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