Merial
Ivomec solution for injection for cattle 1 l

For the treatment of gastro-intestinal nematodes, lung-worms, liver fluke, eye-worms, mange mites and lice in cattle

Prescription required* (Exceptions apply)

IVOMEC Super Injection for Cattle (ivermectin and clorsulon)

2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF IVOMEC Super Injection for Cattle

Per ml:
Ivermectin  10 mg
Clorsulon    100 mg 

For full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM OF IVOMEC Super Injection for Cattle

Solution for injection.

4. CLINICAL PARTICULARS OF IVOMEC Super Injection for Cattle

4.1 Target species

Cattle.

4.2 Indications for use, specifying the target species

IVOMEC Super Injection for Cattle is indicated for the treatment and control of the following parasites:

Gastrointestinal roundworms (adult and fourth-stage larvae):
Ostertagia ostertagi (including inhibited larval stages) O. lyrata Haemonchus placei Trichostrongylus axei T. colubriformis Cooperia oncophora C. punctata C. pectinata Bunostomum phlebotomum Oesophagostomum radiatum Strongyloides papillosus (adult) Nematodirus helvetianus (adult) N. spathiger (adult) Trichuris spp. (adult)

Lungworms (adult and fourth-stage larvae):
Dictyocaulus viviparus

Liver fluke (adult):
Fasciola hepatica

Eye worms (adult):
Thelazia spp.

Mange mites:
Psoroptes bovis Sarcoptes scabiei var. bovis

Sucking lice:
Linognathus vituli Haematopinus eurysternus Solenopotes capillatus

IVOMEC Super Injection for Cattle 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
IVOMEC Super Injection for Cattle given at the recommended dosage of 0.2 mg per kg bodyweight controls re-infection with Haemonchus placei, Cooperia spp. and Trichostrongylus axei acquired up to 14 days after treatment; Ostertagia ostertagi and Oesophagostomum radiatum acquired up to 21 days after treatment and Dictyocaulus viviparus acquired up to 28 days after treatment.
To obtain optimal benefit from the persistent activity of IVOMEC Super Injection for Cattle for grazing animals, it is recommended that calves which are set stocked in the first grazing season should be treated 3, 8 and 13 weeks after the day of turn-out. This can protect the animals from parasitic gastro-enteritis and lungworm disease throughout the grazing season, provided they are set-stocked, all the calves included in the programme and that no untreated cattle are added to the pasture. Treated animals should always be monitored according to good husbandry practices.

4.3 Contra-indications

This product is not to be used intramuscularly or intravenously. IVOMEC Super Injection for Cattle is a low-volume product registered for use in cattle. It should not be used in other species as severe adverse reactions, including fatalities in dogs, may occur.

4.4 Special warnings for each target species

For use only in beef cattle and non-lactating dairy cattle.
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.
4.5 Special precautions for use

(i) Special precautions for use in animals
This product does not contain any antimicrobial preservative. Swab septum before removing each dose.

(ii) Special precautions to be taken by the person administering the medicinal product to the animals
Do not smoke, eat or drink while handling the product. Wash hands after use. Take care to avoid self injection: the product may cause local irritation and/or pain at the injection site.

4.6 Adverse reactions (frequency and seriousness)

Transitory discomfort has been observed in some cattle following subcutaneous administration. A low incidence of soft tissue swelling at the injection site has been observed. These reactions disappeared without treatment.

4.7 Use during pregnancy, lactation or lay

IVOMEC Super Injection for Cattle can be administered to beef cows at any stage of pregnancy or lactation provided that the milk is not intended for human consumption. IVOMEC Super Injection for Cattle 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 point 4.11.


4.8 Interaction with other medicinal products and other forms of interaction

No interactions have been identified with other products.

4.9 Amounts to be administered and administration route

IVOMEC Super should be administered only by subcutaneous injection at the recommended dosage level of 1 ml/50 kg bodyweight (based on a dosage level of 200 mcg ivermectin plus 2 mg clorsulon per kg bodyweight) under the loose skin in front of, or behind, the shoulder. Divide doses greater than 10 ml between two injection sites. A sterile 17 gauge 1/2 inch (15-20 mm) needle is recommended. Replace with a fresh sterile needle after every 10-12 animals or sooner if the needle becomes soiled. To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked. When the temperature of the product is below 5°C, difficulty in administration may be encountered due to increased viscosity. 

Warming the product and injection equipment to about 15°C will greatly increase the ease with which the product can be injected. Different injection sites should be used for other parenteral products administered concurrently. When using the 200 ml, 500 ml and 1000 ml pack sizes, use only automatic syringe equipment. For the 50 ml pack sizes, use of a multidose syringe is recommended.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

The administration of 25 ml IVOMEC Super per 50 kg bodyweight (25 x 
the use level) resulted in an injection site lesion (including tissue necrosis, oedema, fibrosis and inflammation). No other drug-related adverse reactions could be determined.

4.11 Withdrawal periods

Animals must not be slaughtered for human consumption during treatment. Cattle (meat & offal) – 66 days. Do not use in cattle producing milk for human consumption. Do not use in non-lactating dairy cows including pregnant heifers within 60 days of calving.

5. PHARMACOLOGICAL PROPERTIES OF IVOMEC Super Injection for Cattle

Pharmacotherapeutic group:

Endectocides, macrocyclic lactones, avermectins

ATCVet code: QP54AA51

5.1 Pharmacodynamic properties

Mechanism of Action

Ivermectin
Ivermectin is a member of the macrocyclic lactone class of endectocides which have a unique mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have glutamate-gated chloride channels, the macrocyclic lactones have a low affinity for other mammalian ligand gated chloride channels and they do not readily cross the blood-brain barrier.

Clorsulon
Clorsulon is rapidly absorbed into the circulating blood. Erythrocytes with bound drug as well as plasma are ingested by Fasciola spp. Adult Fasciola spp. are killed by clorsulon because of inhibition of enzymes in the glycolytic pathway, which is their primary source of energy.

5.2 Pharmacokinetic Particulars

Maximum plasma concentration
After subcutaneous administration of 2 mg clorsulon and 0.2 mg ivermectin per kg bodyweight, the plasma profile demonstrated the slow, steady absorption of ivermectin with peak plasma levels averaging 23 
ng/ml around day 7 post dose. In contrast, clorsulon appeared rapidly absorbed since the first sampling point, 8 hours post dose, had the highest average residues, approximately 2µg/ml.

6. PHARMACEUTICAL PARTICULARS OF IVOMEC Super Injection for Cattle

6.1 List of excipients

Glycerol Formal Propylene Glycol

6.2 Major incompatibilities

No major incompatibility has been identified.

6.3 Shelf-life, when necessary after reconstitution of the medicinal product or when the immediate packaging is opened for the first time

Shelf-life of the veterinary medicinal product as packaged for sale: 5 years. Shelf-life after first opening the immediate packaging: 6 months.

6.4 Special precautions for storage

Protect from direct sunlight. Following withdrawal of the first dose, use the product within 6 months. Discard unused material.


1207.00
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on Thursday 21 November
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