Target species
Cattle, sheep and pigs.
Indications for use
The veterinary medicinal product is indicated for the effective treatment and control of the following harmful parasites of cattle, sheep and pigs:
Cattle
Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)
Ostertagia ostertagi
Gastrointestinal Roundworms (Adult and L4)
Ostertagia lyrata
Cooperia oncophora
C. pectinata
C. punctata
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Bunostomum phlebotomum
Oesophagostomum radiatum
Gastrointestinal Roundworms (Adult)
Strongyloides papillosus
Nematodirus helvetianus
Nematodirus spathiger
Trichuris spp.
Lungworms (Adult and L4)
Dictyocaulus viviparus
Eye Worms (Adult)
Thelazia spp.
Warbles
Hypoderma bovis
H. lineatum
Mange Mites
Psoroptes ovis
Sarcoptes scabiei var. bovis
Sucking Lice
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
The veterinary medicinal product may also be used as an aid in the control of biting lice (Damalinia bovis) and the mange mite (Chorioptes bovis), but complete elimination may not occur.
Persistent Activity
The veterinary medicinal product given at the recommended dosage of 0.2 mg per kg bodyweight controls re-infection with Barbers pole worm (Haemonchus placei), Small intestinal worm (Cooperia spp.) and Hairworm (Trichostrongylus axei) for 14 days, Brown stomach worm (Ostertagia ostertagi) and Nodular worm (Oesophagostomum radiatum) for 21 days, and Lungworm (Dictyocaulus viviparus) for 28 days after treatment.
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing programme should be established by a qualified professional person.
Sheep
Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)
Ostertagia circumcincta
Haemonchus contortus
Gastrointestinal Roundworms (Adult and L4)
Ostertagia trifurcata
Trichostrongylus colubriformis
Cooperia curticei
Oesophagostomum columbianum
Nematodirus filicollis
Chabertia ovina
Gastrointestinal Roundworms (Adult)
Trichostrongylus axei
T. vitrinus
Oesophagostomum venulosum
Trichuris ovis
Lungworms (Adult and L4)
Dictyocaulus filaria
Lungworms (Adult)
Protostrongylus rufescens
Nasal Bots
Oestrus ovis
Mange Mites
Psoroptes ovis*
*For the treatment and control of sheep scab, two injections with a seven-day interval are required to treat clinical signs of scab and to eliminate mites.
Pigs
Gastrointestinal Roundworms (Adult and L4)
Ascaris suum
Hyostrongylus rubidus
Oesophagostomum spp.
Gastrointestinal Roundworms (Adult and somatic larval stages)
Strongyloides ransomi
Lungworms (Adult)
Metastrongylus spp.
Lice
Haematopinus suis
Mange Mites
Sarcoptes scabei var. suis
Contra-indications
The veterinary medicinal product is not for intramuscular or intravenous use. Do not use in cases of hypersensitivity to the active substance or any of the excipients.
Special warnings
In sheep treatment of psoroptic mange (sheep scab) with one injection is not recommended because, although a clinical improvement may be seen, elimination of all mites may not occur.
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.
- underdosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of the dosing device.
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 (which includes ivermectin) has been reported in Teladorsagia spp. in sheep and in Cooperia spp. in cattle within the EU. Therefore, the use of this product should be based on local (regional, farm) epidemiological information about susceptibility of nematodes and recommendations on how to limit further selection for resistance to anthelmintics.
Special precautions for safe use in the target species
The veterinary medicinal product has been formulated specifically for use in these target species. It should not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.
Sheep scab (Psoroptes ovis) is an extremely contagious external parasites of sheep. Following treatment of infected sheep, great care must be taken to avoid re-infestation, as mites may be viable for up to 15 days off the sheep. It is important to ensure all sheep which have been in contact with infected sheep are treated. Contact between treated infected and non-treated, non-infected flocks must be avoided until at least 7 days after the last treatment.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not smoke, eat or drink while handling the veterinary medicinal product. Wash hands after use. Take care to avoid self-injection as the veterinary medicinal product may cause local irritation and/or pain at the injection site. In case of accidental self-injection, seek medical advice and show the label or package leaflet to the physician.
Adverse events
Cattle
Rare (1 to 10 animals / 10,000 animals treated): Injection site swelling (soft tissue)1
Very rare (<1 animal / 10,000 animals treated, including isolated cases): Discomfort2
1 disappears without treatment 2 transient after subcutaneous administration
Sheep
Very rare (<1 animal / 10,000 animals treated, including isolated cases): Pain1
1 sometimes intense but usually transient; disappears without treatment
Pigs
Very rare (<1 animal / 10,000 animals treated, including isolated cases): Pain1
1 mild and transient; disappears without treatment
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 the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
The veterinary medicinal product can be administered to beef cows and ewes at any stage of pregnancy or lactation provided that the milk is not intended for human consumption, and to sows at any stage of pregnancy or lactation. The veterinary medicinal product will not affect the fertility of breeding ewes, rams, sows and boars. The veterinary medicinal product can be given to all ages of animals including young calves, lambs and piglets.
Interactions
The veterinary medicinal product has been used concurrently without adverse effects with foot and mouth disease vaccine or clostridial vaccine, given at separate injection sites. Adequate vaccination of sheep against clostridial infections is strongly recommended.
Administration routes and dosage
The veterinary medicinal product should be given only by subcutaneous injection at the recommended dosage level of 200 mcg ivermectin per kg bodyweight under the loose skin in front of, or behind, the shoulder in cattle and in the neck in sheep. At the recommended dosage level of 300 mcg ivermectin per kg bodyweight, the veterinary medicinal product should be given only subcutaneously in the neck in pigs.
Syringes must be filled from the vial through a dry sterile draw-off needle that has been placed in the vial stopper. Vial stoppers must not be broached more than 20 times.
This product does not contain an antimicrobial preservative. Swab septum before removing each dose. Use sterile needle and syringe. When treating groups of animals use only an automatic dosing device (with vented draw-off apparatus when using the 50 ml vial). To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
Use this chart as a guide in working out the appropriate dose rate:
Cattle (1 ml/50 kg) | Sheep (0.5 ml/25 kg) | Pigs (1 ml/33 kg) |
Bodyweight (kg) | Dose volume (ml) | Bodyweight (kg) | Dose volume (ml) | Bodyweight (kg) | Dose volume (ml) |
Up to 50 | 1.0 | Up to 5 | 0.1 | Less than 4 | 0.1 |
51-100 | 2.0 | 5.1-10 | 0.2 | 5-7 | 0.2 |
101-150 | 3.0 | 10.1-15 | 0.3 | 8-10 | 0.3 |
151-200 | 4.0 | 15.1-25 | 0.5 | 11-13 | 0.4 |
201-250 | 5.0 | 25.1-50 | 1.0 | 14-16 | 0.5 |
251-300 | 6.0 | 50.1-75 | 1.5 | 17-33 | 1.0 |
301-350 | 7.0 | 75.1-100 | 2.0 | 34-50 | 1.5 |
351-400 | 8.0 | | | 51-66 | 2.0 |
| | | | 67 - 99 | 3.0 |
| | | | 100 - 133 | 4.0 |
| | | | 134 - 166 | 5.0 |
| | | | 167 - 200 | 6.0 |
For cattle weighing over 400 kg calculate the dose at the rate of 1 ml per 50 kg bodyweight. | For sheep weighing over 100 kg calculate the dose at the rate of 0.5 ml per 25 kg bodyweight. | For pigs weighing over 200 kg calculate the dose at the rate of 1 ml per 33 kg bodyweight. |
When treating pigs and sheep of less than 16 kg, seek veterinary advice regarding the use of 1 ml disposable syringes graduated in increments of 0.1 ml. When treating individual sheep, a syringe, not exceeding 2 ml and calibrated in increments of 0.1 ml, should be used.
Each ml contains 10 mg of ivermectin sufficient to treat 50 kg of bodyweight of cattle and sheep and 33 kg of bodyweight of pigs. The injection may be given with any standard automatic or single-dose or hypodermic syringe. Use of 17-gauge x ½ inch needle is suggested.
Replace with a fresh sterile needle after every 10 to 12 animals. Injection of wet or dirty animals is not recommended. For the treatment and control of sheep scab (Psoroptes ovis), two injections with a seven-day interval are required to treat clinical signs of scab and to eliminate mites.
Overdose
Cattle: Single doses of 4 mg ivermectin per kg (20x the recommended use level) given subcutaneously resulted in ataxia and depression.
Sheep: At oral dose levels up to 4 mg ivermectin per kg (20x the recommended use level) given subcutaneously resulted in ataxia and depression.
Pigs: A dose of 30 mg ivermectin per kg (100x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, laboured breathing and lateral recumbency.
No antidote has been identified; however, symptomatic therapy may be beneficial.
Withdrawal periods
Cattle (meat and offal): 49 days
Cattle (milk): Do not use in lactating cows producing milk for human consumption. Do not use in non-lactating dairy cows, including pregnant heifers, within 60 days of calving.
Sheep (meat and offal): 37 days
Sheep (milk): Do not use in lactating sheep producing milk for human consumption.
Pigs (meat and offal): 19 days.