Brand: RAFAZOLE ® Oral Suspension
CHEMICAL CLASS of the active ingredient(s):
INDICATIONS: SHEEP & CATTLE
PARASITES CONTROLLED* (spectrum of activity)
* Country-specific differences may apply: read the product label.
- Liver flukes (Fasciola spp, mature stages).
* Country-specific differences may apply: read the product label.
- 7.5 mg levamisole hydrochloride and 7.5 mg oxyclozanide per kg bodyweight; This represents 12.5 ml product per 504 kg bodyweight.
Read the product label for further details on dosing
- LD50 (acute oral) in rats:
- LD50 (acute dermal) in rats: n.a.
Withholding periods (=withdrawal times) for meat & milk (country-specific differences may apply: read the product label)
- Meat: Ireland Cattle & Sheep: 60 days
- Milk for human consumption: Ireland
- Not authorised for use in cattle producing milk for human consumption, including pregnant cattle intended to produce milk for human consumption.
- Not authorised for use in ewes producing milk for human consumption including during the dry period. Do not use within 1 year prior to the first lambing in ewes intended to produce milk for human consumption.
WARNING !!!: Never use on humans, dogs or cats
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Risk of resistance? YES, resistance of gastrointestinal roundworms to levamisole in ruminants is a serious and increasing problem, particularly in sheep and goats, but also in cattle. Levamisole resistance is usually less strong and widespread than resistance to benzimidazoles, but nevertheless a serious problem. The most affected worm species in sheep are:
- Sheep & goats: Haemonchus spp, Ostertagia spp /Teladorsagia spp, Trichostrongylus spp, Nematodirus spp, Chabertia ovina.
- Cattle: Cooperia spp, Haemonchus spp, Ostertagia spp, Trichostrongylus spp, Oesophagostomum spp.
This means that if this product does not achieve the expected efficacy against the mentioned parasites, it can be due to resistance and not to incorrect use, which is usually the most frequent cause of product failure.
- Benzimidazoles, e.g. albendazole, febantel, fenbendazole, oxfendazole, etc. Even worse resistance problems than levamisole.
- Derquantel: available so far only for sheep in combination with abamectin.
- Macrocyclic lactones (e.g. abamectin, doramectin, eprinomectin, ivermectin, moxidectin, etc.). Resistance to macrocyclic lactones is also increasing and strengthening quickly in many countries.
- Monepantel: available only for sheep & goats in some countries (e.g. Australia, UK & EU, New Zealand). First cases of resistance reported in New Zealand in 2013.
- Salicylanilides (e.g. closantel): effective only against certain gastrointestinal roundworms. Not available in some countries. Resistance to closantel has been reported in some countries.
- Tetrahydropyrimidines (e.g. morantel, pyrantel): effective only against certain gastrointestinal roundworms. Not available in some countries. Resistance to morantel has been reported in some countries.
- Nitroxinil: effective only against certain gastrointestinal roundworms (e.g. Bunostomum spp, Haemonchus spp, Oesophagostomum spp). Not available in some countries.
These alternative products may not be available in all countries, or may not be available as drenches, or may not be effective against all the concerned parasites.
It is highly recommended to periodically check the resistance status of each property performing appropriate tests (e.g. fecal egg counts) under supervision of a veterinary doctor. Such tests are now routinely available for most producers in developed countries.
Are the active ingredients of this product ORIGINAL* or GENERICS**?
- Levamisole: GENERIC (introduced in the 1960s by JANSSEN)
- Oxyclozanide: GENERIC (introduced in the 1960s by ICI)
*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: UK, Ireland and other EU countries.
GENERIC BRANDS available? Rather few, if at all, with this particular composition: oxyclozanide is rarely used in livestock. This product itself contains generic active ingredients.
Click here to learn more about GENERIC vs. ORIGINAL drugs.
For an overview on the most used drench brands for livestock click here.
Levamisole is a veteran anthelmintic. It was introduced by JANSSEN already in the 1960s (NILVERM, RIPERCOL). It has a broad-spectrum of activity against roundworms (gastrointestinal and pulmonary) but no efficacy whatsoever against tapeworms and flukes. It is also completely ineffective against external parasites of livestock (ticks, flies, lice, mites, etc). Levamisole has been used massively worldwide in countless generic formulations. It still remains one of the most preferred low-cost anthelmintics for livestock worldwide. It is scarcely used in horses and pets. It is not used in agriculture.
Oxyclozanide is another veteran, narrow spectrum flukicide (introduced by ICI in the 1960s). It is effective against adult liver flukes, without efficacy against roundworms, tapeworms or any external parasites. It kills only the adult flukes in the bile ducts, but not those immature stages migrating through the liver that are responsible for acute fasciolosis, which are the most harmful ones, particularly for sheep. It is only marginally used in livestock or pets. It is not used in agriculture.
As many other anthelmintics (e.g. benzimidazoles, monepantel, and tetrahydropyrimidines) levamisole administered as a drench has no residual effect, i.e. it kills the parasites shortly after administration, but does not significantly protect the animals against re-infestation by infective stages in their environment.
Unfortunately, resistance of several gastrointestinal roundworms to levamisole is already very high and very frequent worldwide in sheep and goats, slightly lower in cattle, which has significantly reduced its usage in livestock. Nowadays more convenient pour-ons and injectables containing macrocyclic lactones (e.g. abamectin, doramectin, eprinomectin, ivermectin, moxidectin) are often preferred over drenches with levamisole or benzimidazoles. Macrocyclic lactones (ML) also ensure several weeks protection against re-infestation by several worm species, in contrast with levamisole or benzimidazole drenches that lack any residual effect. However, resistance of gastrontestinal worms to ML is alredy quite frequent in sheep and goats, less common in cattle but increaising.
In ruminants, reducing the amount of feed slows down the exit flow of the rumen and prolongs the time during which the active ingredient remains there and is absorbed. Consequently it is advisable to reduce the access of animals to feed (especially to fresh pasture, not to water) 24 hours before administration. For the same reason, it is better to keep the animals away from food for about 6 hours after drenching. However sick or weak animals should not be kept away from food and fasting animals should have access to water.
Click here for general information on good practices for the prevention and control of gastrointestinal worms in livestock.
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.
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