NOAH Compendium

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Date: Sunday, October 20, 2019 3:04

Release 5.12
Ivomec Classic Pour-On for Cattle
 
Species: Cattle
Therapeutic indication: Pharmaceuticals: Endoparasiticides: Anthelmintics for cattle, For cattle, For cattle
Active ingredient: Ivermectin
Product:Ivomec Classic Pour-On for Cattle
Product index: Ivomec Classic Pour-On
Cattle - milk: See note
Cattle - meat: 15 days
Withdrawal notes: Do not use in cows producing milk for human consumption and in non-lactating dairy cows including pregnant heifers within 60 days of calving
Qualitative and quantitative composition
Each ml contains:
Active substance: Ivermectin: 5 mg
Excipients: For the full list of excipients, see below.
Pharmaceutical form
Pour-on solution.
Clinical particulars
Target species
Cattle.
Indications for use
For the treatment and control of gastrointestinal nematodes, lungworms, eyeworms, warbles, chorioptic and sarcoptic mange and sucking and biting lice in beef and non-lactating dairy cattle.
The product at the recommended dosage level of 500 μg ivermectin per kg bodyweight effectively controls the following parasites of cattle:
Gastrointestinal Roundworms (Adult, L4 and Inhibited L4)
Ostertagia ostertagi
Gastrointestinal Roundworms (Adult and L4)
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia spp.
Oesophagostomum radiatum
Gastrointestinal Roundworms (Adult)
Strongyloides papillosus
Trichuris spp.
Lungworms (Adult and L4)
Dictyocaulus viviparus
Eye Worms (Adult)
Thelazia spp.
Warbles (parasitic stages)
Hypoderma bovis
H. lineatum
Mange Mites
Sarcoptes scabiei var. bovis
Chorioptes bovis
Lice
Linognathus vituli
Haematopinus eurysternus
Solenopotes capillatus
Damalinia bovis
The product given at the recommended dosage of 500 μg/kg bodyweight, controls infections with Trichostrongylus axei and Cooperia spp. acquired up to 14 days after treatment, Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment, and Dictyocaulus viviparus (lungworm) acquired up to 28 days after treatment. It also controls horn fly (Haematobia irritans) for up to 35 days after treatment.
The timing of treatment should be based on epidemiological factors and should be customised for each individual farm. A dosing program should be established by a qualified professional person.
Contra-indications
Do not use in animals with known hypersensitivity to the active ingredient or any of the excipients.
The product has been formulated for topical application specifically in cattle. Do not apply or administer to other species as severe adverse reactions, including fatalities in dogs, may occur.
Do not apply to areas of skin which have mange, scabs or other lesions or to areas contaminated with mud or manure.
Special warnings for each target species
Rainfall before or after treatment will not affect the efficacy of the product. 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 (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 another pharmacological class and having a different mode of action should be used.
Resistance to macrocyclic lactones (which includes ivermectin) has been reported in Cooperia spp. in cattle within the EU. Therefore, the use of this and other similar macrocyclic lactone products 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 use in animals
For external use only.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
HIGHLY FLAMMABLE – KEEP AWAY FROM HEAT, SPARKS, OPEN FLAME OR OTHER SOURCES OF IGNITION.
May be irritating to human skin and eyes and the user should be careful not to apply it to himself or other persons. Operators should wear nitrile rubber gloves and boots with a waterproof coat when applying the product. Wash all protective clothing after use.
If accidental skin contact occurs, wash the affected area immediately with soap and water. If irritation persists, seek medical advice and show the package leaflet or label to the doctor. If accidental eye exposure occurs, flush the eyes immediately with plenty of water and get medical attention.
Do not smoke or eat while handling the product. Wash hands after use. Use only in well-ventilated areas or outdoors.
Adverse reactions
Undesirable effects are not expected when the product is used at the recommended dose rate.
Use during pregnancy, lactation or lay
The product can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. It will not affect the fertility of cows and bulls and can be given to all ages of animals including young calves. Please also refer to ‘Special warnings for each target species’.
Interactions
Not known. May be used concurrently with foot and mouth disease vaccine or clostridial vaccine.
Amounts to be administered and administration route
Dosage: 1 ml per 10 kg bodyweight (based on a recommended dosage level of 500 μg/kg bodyweight).
Administration: The formulation should be applied 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.
Dosing cup with Measure-Squeeze-Pour System (250 ml bottle and 1 litre pack)
The 250 ml pack contains one 25 ml dosing cup and one dip tube. The 1 litre pack contains one 60 ml dosing cup and one dip tube. Insert the dip tube into base of the dosing cup. Leave the "slotted end" of the dip tube exposed in the bottom of the bottle. Unscrew bottle cap from the top of the bottle. Screw the dosing cup onto the top of the bottle.
Measure: To select the correct dose rate, rotate the adjuster cap at the top of the cup in either direction to position the dose indicator to the weight of the animal you want to treat. When body weight is between markings, use the higher setting.
Squeeze the bottle gently to fill the dosing cup to the required dose. Release your grip and any excess will return to the bottle.
Pour: Apply the full dose by tipping and pouring along the back line of the animal until the dosing cup is empty. The dosing cup should not remain attached to the bottle when not in use. Detach the dosing cup after each use and replace the bottle cap.
Collapsible Pack (2.5 litre pack x 2 in a carton)
If the carton is opened for purpose of sale in single 2.5 L units, a package insert must be provided with each transaction. Connect the pour-on applicator to the collapsible pack as follows:
Attach the open end of the draw-off tubing to the pour-on applicator.**
Attach draw-off tubing to the cap with the stem. Replace the shipping cap with the cap that has the draw-off tubing. Tighten this draw-off cap.
Gently prime the pour-on applicator, checking for leaks.
Follow manufacturer’s directions for correct use and care of the equipment.
** An applicator compatible with the formulation is available for use with the 2.5 litre pack of IVOMEC Pour-On. Other applicators may be incompatible with the formulation, resulting in locking, incorrect dosage and leakage.
Overdose
No sign of toxicity appeared in trials up to 5 mg/kg (10 times the recommended dose rate). No antidote has been identified.
Withdrawal periods
Meat and offal: 15 days.
Do not use in cows producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.
Pharmaceutical particulars
Excipients
Triethanolamine, Isopropyl alcohol, Crodamol Cap.
Incompatibilities
None known
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Special precautions for storage
Avoid extremes of temperature. Protect from light. Store in tightly closed original container. Store upright. The dosing cup should not be stored attached to the bottle when not in use. Remove the cup after each use and replace with the bottle cap.
If stored at temperatures below 0°C, IVOMEC CLASSIC Pour-On may appear cloudy. Allowing the product to warm at room temperature will restore the normal appearance without affecting efficacy.
Immediate packaging
1 litre measure-squeeze-pour bottle, 2.5 litre high density collapsible backpacks.
Disposal
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE. Do not contaminate surface waters or ditches with the product or used container.
Marketing Authorisation Number
Vm 08327/4169
Significant changes
Legal category
Legal category: POM-VPS
GTIN
GTIN description:Ivomec Classic Pour-On for Cattle 1 litre
GTIN:03661103025740
GTIN description:Ivomec Classic Pour-On for Cattle 2.5 litre
GTIN:03661103025757
GTIN description:Ivomec Classic Pour-On for Cattle 2.5 litre x 2
GTIN:03661103025764