Brand: SOVEREIGN ® Pour-on

Company: COOPERS


FORMULATION: «pour-on» for topical administration. To be applied along the back line of the animal in a strip starting between the shoulder blades.

ACTIVE INGREDIENT(S):

CHEMICAL CLASS of the active ingredient(s):


INDICATIONS: CATTLE

PARASITES CONTROLLED (spectrum of activity)


RECOMMENDED DOSE


SAFETY

  • LD50 (acute oral) in rats:
    • ivermectin: 50 mg/kg
    • triclabendazole: >5000 mg/kg
  • LD50 (acute dermal) in rats: formulation: low toxicity (according to MSDS)
    • ivermectin: >600 mg/kg
    • triclabendazole: >4000 mg/kg 
  • Estimated hazard class according to the WHO: not applicable for veterinary medicines

Suspected poisoning? Read the articles on ivermectin safety and triclabendazole safety in this site.

Withholding periods (=withdrawal times) in days for meat & milk (country-specific differences may apply: read the product label)

  • Meat: Australia 28 days (ESI 70 days)
  • Milk for human consumption: DO NOT USE in dairy cows except replacing heifers, but not within 70 days of calving.

WARNING !!!: Never use on humans, dogs or cats

You may be interested in the following articles in this site dealing with the general safety of veterinary products:


RESISTANCE PREVENTION

Risk of resistance of gastrointestinal roundworms to macrocyclic lactones (incl. ivermectin): YES, reported in cattle in numerous countries particularly in the following worm species: Cooperia spp and Ostertagia spp.

Resistance of gastrointestinal roundworms to macrocyclic lactones (incl. ivermectin) in sheep, goats and cattle has been reported almost worldwide, including the USA, UK, Australia and New Zealand. Based on the very abundant and frequent use of ivermectin and other macrocyclic lactones (with cross-resistance to ivermectin) in livestock it must be assumed that resistance of these roundworms to this chemical class will continue spreading and strengthening in the future.

Alternative chemical classes/active ingredients to prevent resistance of gastrointestinal roundworms through product rotation:

These alternative products may not be available in all countries, or may not be available as pour-ons.

Risk of resistance of liver flukes to triclabendazole: YES. Resistance of liver flukes to triclabendazole (and albendazole) in sheep was already discovered in the mid 1990's in Australia. Since then it has been reported in several other countries (e.g. New Zealand, UK, Ireland, Spain, Argentina), also in cattle (e.g. Australia, The Netherlands, Argentina). However, the incidence so far is not that serious as for roundworm resistance to benzimidazoles and other nematicides. Nevertheless, in certain regions products with triclabendazole may not protect livestock adequately against liver flukes.

Alternative chemical classes/active ingredients to prevent resistance of liver flukes through product rotation:

These alternative products may not be available in all countries, may not be available as pour-ons, or may not have the same spectrum of efficacy.

This means that if this product does not achieve the expected efficacy against the mentioned parasites, it may be due to resistance and not to incorrect use, which is usually the most frequent cause of product failure.

Learn more about resistance and how it develops.


MARKETING

Are the active ingredients of this product ORIGINAL* or GENERICS**?

*Meaning that they are still patent protected and generics are not yet available
**Meaning that they have lost patent protection and may be acquired from manufacturers of generic active ingredients other than the holder of the original patent.

COUNTRIES where this brand/product is marketed: Australia.
GENERIC BRANDS available? Yes, a few ones, but not in all countries in this particular composition and as a pour-on. Similar combinations of triclabendazole with other macrocyclic lactones are also available as drenches.

Click here to learn more about GENERIC vs. ORIGINAL drugs.

For an overview on the most used antiparasitic pour-on brands click here.


COMMENTS

SOVEREIGN Pour-on for Cattle from COOPERS is one of the numerous combinations of "endectocide + flukicide" for simultaneously controlling roundworms, flukes and external parasites in cattle.

Ivermectin was the first macrocyclic lactone introduced in the market in the early 1980s (by MSD Agvet, later MERIAL). It was a milestone and a tremendous progress that revolutionized the control of veterinary parasites. Nowadays there are thousands of brands with generic ivermectin worldwide. It is effective against most species of roundworms that affect cattle and against many external parasites (mainly lice, mites, buffalo flies, etc.), but not against tapeworms or flukes. It has a systemic mode of action, i.e. it is absorbed into the blood of the treated animals (through the skin but also after licking). However its effect against external parasites is mainly a contact effect of the active ingredient that impregnates the hair coat after topical administration. It is massively used in livestock and horses, moderatily in pets. It is also used in human medicines. It is also used against agricultural pests.

Triclabendazole is a narrow-spectrum benzimidazole introduced in the 1970s (by CIBA-GEIGY). It has no efficacy against roundworms or tapeworms. However it was and remains the only flukicide effective against adults as well as all immature stages of liver flukes, which are the most damaging stages due to their destructive migration through the liver tissues. For this reason it has been for decades and still remains the most widely used livestock flukicide worldwide. It is ineffectivy against any external parasites (ticksflies, lice, mites, etc) of livestock. It is abundantly used in ruminants, but not in other livestock, horses or pets. It is also used in human medicines. It is not used in agriculture.

The combination of ivermectin and triclabendazole makes sense because it extends the spectrum of activity of both active ingredients.

It is useful to know that pour-on administration of parasiticides has some disadvantages when compared with injectables and drenches. In several scientific studies it has been shown that ivermectin administered as a pour-on is not "automatically" absorbed through the skin. Licking (self licking or licking of other treated animals) may account for >50% of the total intake, compared with only about 10% absorbed directly through the skin. This is the reason why a dose of 500 mcg/kg bw is needed after pour-on treatment, compared with only 200 mcg/kg bw after injection. And it has been also shown that intake of topically administered active ingredient in some cattle may be twice as high as in other ones, all treated at the same rate. The reason is that individual cattle show a different licking behavior. An important practical consequence is that the quantity that is finally ingested and is therefore available for the control of gastrointestinal worms depends on the licking behavior of the treated animals. "High lickers" can be overdosed, whereas "low lickers" can be underdosed. And chronic underdosing of animals in a herd may enhance development of resistance to ivermectin and other macrocyclic lactone in gastrointestinal roundworms.

It is likely that licking and grooming also plays an important role in the intake of triclabendazole administered as a pour-on to cattle. The higher dose of 24 mg triclabendazole/kg bw after pour-on administration when compared with the usual dose of 12 mg/kg bw after oral administration (drench) reflects the fact that absorption of triclabendazole through the skin is also significantly lower than after oral administration.

Absorption through the skin is also negatively affected by the thickness of the skin and the hair coat, by dust and mud on the coat, by product lost on fences and yards, etc, factors that don't play a role after injection. The pour-on formulation should not be administered to wet animals, and rain shortly before (up to 6 hours) or after administration can cause product run-off and thus under-dosing. The pour-on shouldn't be administered by strong winds that may blow away part of the product and/or contaminate the workers.

For these reasons efficacy after pour-on administration is usually less reliable than after injection or oral administration (drench).

Click here for general information on good practices for the prevention and control of gastrointestinal worms in livestock.


DISCLAIMER

This article IS NOT A PRODUCT LABEL. It offers complementary information that may be useful to veterinary professionals and users that are not familiar with veterinary antiparasitics. 

Information offered in this article has been extracted from publications issued by manufacturers, government agencies (e.g. EMEA, FDA, USDA, etc.) or in the scientific literature. No guarantee is given on its accuracy, integrity, sufficiency, actuality and opportunity, and any liability is denied. Read the site's DISCLAIMER.

In case of doubt contact the manufacturer or a veterinary professional.