Roleno

Clorsantel Solution for Subcutaneous or Intramuscular Injection Sterilized for Use in Animals

Composition: Clorsantel - 50 mg/mL

Pharmacological Action: Roleno belongs to broad-spectrum anti-parasitic medications. It contains clorsantel, which is active against sexually mature nematodes and their larval stages, including species such as Bunostomum spp., Haemonchus spp., Oesophagostomum radiatum, Chabertia ovis, as well as sexually mature trematodes like Fasciola gigantica, and also against warble flies like Hypoderma bovis, Hypoderma lineatum, Oestrus ovis. These are parasites of cattle and sheep.

The mechanism of action of clorsantel involves the alteration of phosphorylation processes and electron transfer, leading to a disturbance of energy metabolism in helminths and ultimately causing their death. After parenteral administration, clorsantel is rapidly absorbed at the injection site, reaches most organs and tissues, and attains peak concentration within 24 hours. The therapeutic concentration of clorsantel is maintained in the body for 10 hours, and it is mainly excreted unchanged through bile. In lactating animals, a small portion is excreted through milk.

Roleno is classified as moderately hazardous to animals (hazardous substance group 3 according to the state standard 12/01/2007-76).

Indications: It is indicated for both therapeutic and prophylactic use in cattle for the treatment of fascioliasis, bunostomiasis, haemonchosis, oesophagostomiasis, trichostrongylosis, ostertagiosis, and hypodermatosis. It is also used in sheep and goats for treating haemonchosis, oesophagostomiasis, trichostrongylosis, nematodiriasis, chabertiosis, bunostomiasis, fascioliasis, and myiasis.

Dosage and Administration: The drug is administered to animals via subcutaneous or intramuscular injection under sterile conditions:

• For cattle with nematodiasis and fascioliasis, administer 0.5 mL per 10 kg body weight (2.5 mg/kg).
• For cattle with hypodermatosis, administer 1 mL per 10 kg body weight (5 mg/kg).
• For sheep and goats with nematodiasis and myiasis, administer 0.5 mL per 10 kg body weight (2.5 mg/kg), and for chronic fascioliasis, administer 1 mL per 10 kg body weight (5 mg/kg).

Prior to mass application, test the drug on a small group (5-7 animals) and observe for 3 days. If no adverse reactions are observed, apply it to the rest of the animals.

Helminthic treatments for therapeutic purposes should be conducted according to indications, while prophylactic treatments are performed before animal transportation or during spring pasture grazing.

Before use, shake the bottle well.

Contraindications: The use of this product is contraindicated in animals with individual hypersensitivity to any of its components. It is not recommended for use in debilitated, exhausted, or infected animals.

Side Effects: When used according to the instructions, no side effects or complications have been observed. In rare cases, subcutaneous injection may cause swelling at the injection site, which usually resolves within 2-3 days. If allergic reactions occur, discontinue use and administer antihistamines.

Drug Interactions: The use of Roleno is not recommended in combination with chlororganophosphorus or organophosphorus drugs.

Overdose: Overdose may lead to decreased appetite, lethargy, or inflammatory reactions at the injection site.

Withdrawal Period:

• Meat: The animal can be slaughtered after 28 days from the last dose of Roleno. Meat from animals slaughtered before this period should only be used in the diets of fur-bearing animals.
• Milk: Milk from treated cows or sheep should not be used for human consumption.

Storage Conditions: Store in the manufacturer's original packaging in a dry, cool place away from sunlight, and separately from food and animal feed, at temperatures between 5°C and 25°C.

Packaging: Available in 10, 50, 100, or 250 mL dark glass vials. Keep out of reach of children.

Manufacturer: Invesa, Spain.