Ivomec solution for injection for pigs 500 ml
Pig wormer for the treatment and control of gastro-intestinal roundworms, lungworms, lice and mange mites
IVOMEC Injection for Pigs (ivermectin)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION OF IVOMEC Injection for Pigs
Ivermectin 10 mg
For full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM IVOMEC Injection for Pigs
Solution for injection.
4. CLINICAL PARTICULARS IVOMEC Injection for Pigs
4.1 Target species
4.2 Indications for use, specifying the target species
Indicated for the treatment and control of the following parasites of pigs:
PARASITE Adult L4
Strongyloides ransomi *
Sarcoptes scabei var. suis
* Includes somatic larval stages
The product may also be used as an aid in the control of adult whipworm (Trichuris suis).
This product is not to be used intramuscularly or intravenously.
The product is formulated specifically for use in pigs only.
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
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. Use a sterile needle and syringe.
When treating groups of animals use only an automatic dosing device.
(ii) Special precautions to be taken by the person administering the medicinal product to the animals
Do not smoke, drink or eat 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)
Mild and transient discomfort has occasionally been observed in pigs following subcutaneous administration.
4.7 Use during pregnancy, lactation or lay
Pregnancy: Studies have demonstrated a wide safety margin. At the recommended use level, no adverse effects on fertility or gestation in breeding animals were observed.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
At the recommended dosage level of 300 mcg ivermectin per kg of bodyweight, administer only subcutaneously in the neck in pigs. Each ml contains 10 mg of ivermectin sufficient to treat 33 kg of bodyweight of pigs.
Use the following dosage table:
Bodyweight (kg): Dose Volume (ml); Doses Per Pack
8: 0.25; 800 (200ml) 2000 (500 ml)
8-16: 0.5; 400 (200ml) 1000 (500 ml)
17-33: 1.0; 200 (200ml) 500 (500 ml)
34-50: 1.5; 133 (200ml) 330 (500 ml)
51-66: 2.0; 100 (200ml) 250 (500 ml)
67-99: 3.0; 66 (200ml) 166 (500 ml)
100-133: 4.0; 50 (200ml) 125 (500 ml)
134-166: 5.0; 40 (200ml) 100 (500 ml)
167-200: 6.0; 32 (200ml) 83 (500 ml)
Over 200 kg bodyweight, give 1.0 ml per 33 kg bodyweight.
The injection may be given with any standard automatic or single-dose or hypodermic syringe. Use of 17 gauge x 1/2 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. 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. In young pigs, especially those weighing under 16kg for which less than 0.5ml of the product is indicated, dosing accuracy is important. The use of a syringe that can accurately deliver increments of 0.1ml is recommended. For piglets weighing less than 16kg give 0.1ml/3kg.
When treating pigs of less than 16kg seek veterinary advice regarding the use of 1ml disposable syringes graduated in increments of 0.1ml.
Recommended Treatment Programme
At the time of initiating any parasite control programme, it is important to treat all breeding animals in the herd. After the initial treatment use regularly as follows;
Treat 7-14 days prior to farrowing.
Treat 7-14 days prior to service. Treat 7-14 days prior to farrowing.
Boars are an important source of infestation of mange. Treat at least twice a year.
Arrivals and transfers.
Treat on arrival and isolate for 7 - 10 days before mixing with the rest of the herd.
The above programme is a guide for effective parasite control. Alternatively, control can be achieved by treating the whole herd at six monthly intervals.
Treat before placement in clean quarters.
Note (1) For effective mange control, care must be taken to prevent re-infestation from exposure to untreated animals or contaminated facilities.
Note (2) Since louse eggs are unaffected by ivermectin and may take up to three weeks to hatch, retreatment may be necessary.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
A dose of 30 mg ivermectin per kg (100 x the recommended dose of 0.3 mg per kg) injected subcutaneously to pigs caused lethargy, ataxia, bilateral mydriasis, intermittent tremors, labored breathing and lateral recumbency. No antidote has been identified; however, symptomatic therapy may be beneficial.
4.11 Withdrawal periods
Pigs. Meat: 19 days.
5. PHARMACOLOGICAL PROPERTIES IVOMEC Injection for Pigs
ATC Vet Code:
5.1 Pharmacodynamic properties
Mechanism of Action
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.
5.2 Pharmacokinetic properties
Maximum plasma concentration
During trials carried out at a dose rate of 0.2 mg/kg ivermectin, a plasma concentration of 10-20 ng/ml was reached in about 2 days and half-life in plasma was 0.5 days.
Excretion: length of time and route
A liquid chromatographic method with fluorescence detection allows the determination of ivermectin residues in tissues. After an injection of 0.4 mg/kg ivermectin the liver (target tissue) contained average residues ranging from 69 ppb at 3 days post dose to 13 ppb at 14 days post dose. No liver residue (< 2 ppb) was found at 28 days post dose. Swine receiving a single dose of tritium-labelled ivermectin (0.3-0.4 mg/kg) were slaughtered at 1, 7, 14 and 28 days after dosing. Composites of faeces collected during the first 7 days after dosing contained only about 36% of the dosed radioactivity. Less than 1% of the dosed radioactivity was found in the urine. Analysis of the faeces showed that about 40% of the excreted radioactivity was unaltered drug.
6. PHARMACEUTICAL PARTICULARS IVOMEC Injection for Pigs
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
Do not store above 300C. Protect from direct sunlight. Following withdrawal of the first dose, use the product within 6 months. Discard unused material.