Target species
Cattle.
Indications for use, specifying the target species
Supply of trace minerals to correct concurrent clinical or subclinical deficiencies of selenium, copper, manganese and zinc which can arise during critical phases of the production or breeding life cycle.
Contraindications
Do not administer intramuscularly.
Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Additional copper, zinc, manganese or selenium should not be administered at the same time.
Use standard aseptic procedures during administration of injections. Strict adherence to correct subcutaneous injection technique should be employed. Ensure that animals are properly restrained, including those in the vicinity.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
- This product is HIGHLY concentrated in Selenium.
- Due to a potential risk of Selenium toxicity, care should be taken when handling the product to avoid accidental self-injection.
- The most common manifestations of accidental exposure to selenium in humans are gastrointestinal and neurological symptoms, such as nausea, vomiting, tenderness, fatigue and irritability.
- When treating a large number of animals, a safe injection system should be used.
- Do not work alone when using the product.-
In the event of accidental self-injection, SEEK IMMEDIATE MEDICAL ATTENTION and take the vial or package leaflet with you.
- Wash hands after use.
Adverse reactions (frequency and seriousness)
Mild pain is commonly observed during injection and can persist for the first hour after injection
Local reactions at the injection site are very common and consist of transient moderate to severe swelling that resolves within 48 hours and evolves into induration estimated at less than 5 cm at palpation after 14 days.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports
Use during pregnancy, lactation or lay
Pregnancy:
Can be used during pregnancy.
Lactation:
Can be used during lactation.
Interaction with other medicinal products and other forms of interaction
None known.
Amounts to be administered and administration route
Strictly for subcutaneous administration only.
Dose:
•Cattle - Up to 1 year: 1ml per 50kg
•Cattle - From 1-2 years: 1ml per 75kg
•Cattle - Over 2 years: 1ml per 100kg
Schedule of administration:
To be administered as a single administration during, or in advance of, periods of stress in the production and breeding life cycle likely to result in concurrent clinical or subclinical deficiencies of the four trace minerals (for example, transport/shipping, calving, breeding).
Maximal volume per injection site: 7ml
The 500ml vial can be broached a maximum of 90 times.
Overdose (symptoms, emergency procedures, antidotes), if necessary:
Repeated overdosing (3 consecutive administrations) at one to three times the recommended dose (i.e. 3x – 9x recommended dose) is well tolerated systemically in cattle.
Repeated overdosing (3 consecutive administrations) at five times the recommended dose (i.e. 15x recommended dose) is associated with elevation of liver enzymes and centrilobular hepatocellular degeneration limited to two animals out of eight.
Withdrawal period(s)
Meat and offal: 28 days
Milk: zero hours.