Chemisole 20% 200 mg/ml

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Chemisole 200 mg/ml, oral solution for administration in drinking water to broilers and turkeys.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

1 ml contains: Active substance: levamisole 200 mg

Excipients:

Sodium metabisulphite 2 mg
propylene
Purified water

Clear colorless or slightly yellowish solution.

3.         CLINICAL INFORMATION

3.1        Target species

Broilers and turkeys

3.2        Directions for use for each target species

Infestations caused by adult and larval forms of Heterakis gallinarum, Capillaria spp., Syngamus trachea and Ascaridia galli.

3.3        Contraindications

Do not use in birds with known hypersensitivity to levamisole or any of the excipients.

Do not administer to animals with severe liver failure.

3.4        Special Notices

Parasite resistance to any class of anthelmintic can develop after frequent and repeated use of an anthelmintic of that class.

Use of anthelmintics when not required or use deviating from the instructions provided in the Summary of Product Characteristics may result in an increased risk of resistance development and reduced efficacy. The decision to use the product must be based on the confirmation of the parasite species and the degree or risk of infestation according to the epidemiological characteristics of the latter for each group.

3.5        Special precautions for use

Special precautions for safe use in target species:

When administered to animals with diarrhea, efficacy against tapeworms may decrease.

The product may have an unpleasant taste for animals.

Avoid too frequent and repeated use of anthelmintics of the same class over a long period of time, as this increases the risk of developing resistance and may cause the treatment to be ineffective; also avoid underdosing, which can be caused by underestimation of body weight or incorrect administration of the product.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:

Avoid direct contact with the product during handling.

People with known hypersensitivity to levamisole should avoid contact with the veterinary medicinal product. When handling the veterinary medicinal product, wear protective clothing, gloves and a protective mask. Do not swallow, avoid contact with skin, eyes and mucous membranes. In case of accidental contact or ingestion, seek medical advice immediately and show the label to the doctor.

Do not eat, drink or smoke during handling; wash hands after use.

This product may cause agranulocytosis, especially in people with immune system abnormalities. These persons must avoid contact with the veterinary medicinal product.

Special precautions for environmental protection:

This is not the case.

3.6        Adverse Events

Broilers and turkeys: Frequency not known (frequency cannot be estimated from available data)
Birds suffering from severe bronchopulmonary nematode infestation may exhibit rales and coughing, caused by the removal of worms from the lungs, which may persist for several hours.

Reporting of adverse events is important. It allows continuous monitoring of the safety of the veterinary medicinal product. Reports are sent, preferably through the veterinarian, either to the marketing authorization holder or to the competent national authority through the national reporting system. See also the combined label and leaflet for the respective contact details.

3.7        Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product during laying has not been established.

Gestation and lactation

This is not the case.

Egg-laying birds

Do not use in birds producing eggs or intended to produce eggs for human consumption.

3.8        Interaction with other medicinal products and other forms of interaction

Avoid concomitant administration of anthelmintics with a similar action to that of nicotine (eg pyrantel tartrate). Levamisole should not be used together with organophosphorus esters and carbamates.

3.9        Routes of Administration and Dosages

To ensure the correct dosage, body weight must be determined as accurately as possible.

Underdosing can be ineffective and favors the development of drug resistance. If animals are to be treated collectively rather than individually, they should be grouped by body weight and dosed accordingly to avoid underdosing.

The product is administered orally, diluted in drinking water.

Doses: 1 ml of veterinary medicinal product/8-10 kg of body weight (ie 20-25 mg of levamisole/kg of body weight), equivalent to approximately 50.0 – 100.0 ml/100 liters of water; the duration of the treatment is one day (12 hours).

It is recommended to repeat the treatment 14-21 days after the first administration, to attack all evolutionary forms that were not attacked by the first treatment.

3.10 Symptoms of overdose (and, where appropriate, emergency procedures and antidotes)

No data available. Do not exceed recommended doses.

3.11 Special restrictions of use and special conditions of use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products, to limit the risk of development of resistance

This is not the case.

3.12      Waiting Periods

Broilers and turkeys:

meat and offal: 7 days.

Do not use in birds producing eggs or intended to produce eggs for human consumption.

4.2        Pharmacodynamics

Chemisole 200 mg/ml is a veterinary medicinal product based on levamisole, a levorotatory, biologically active enantiomer of tetramysol. Levamisole is a broad-spectrum anthelmintic active against the most common nematodes of the digestive and respiratory systems in various animal species. It acts against adult and larval forms of strongyles and adult forms of roundworms.

Levamisole has a similar mechanism of action to that of nicotine. Therefore, it can cause an increase in blood pressure and intestinal motility. It has a ganglionic stimulating effect (acetylcholinemimetic) and causes tonic muscle contractions resulting in paralysis and expulsion of parasites.

4.3 Pharmacokinetics

Levamisole administered orally is rapidly absorbed, with maximum plasma concentrations being reached after 1-2 hours. It is distributed in all tissues of the body, and in the liver it is transformed into less active metabolites. In the following 12 hours after administration approximately 40% is eliminated through urine, during the following 8 days after administration approximately 40% is eliminated through feces.

Levamisole does not cause photosensitisation, nor does it require a special diet before and/or after treatment. It has half the toxicity of tetramysol.

5.         PHARMACEUTICAL INFORMATION

5.1 Major Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

5.2        Term of validity

Shelf life of the veterinary medicinal product as packaged for sale: 24 months.

The period of validity after the first opening of the primary packaging: 3 months.

Shelf life after diluting as directed: 12 hours.

5.3        Special precautions for storage

Store in a cool, dry place below 25°C.

5.4        Nature and composition of primary packaging

White high density polyethylene 5 liter canisters, closed with a cap provided with a seal, which breaks when opened, and with a sub-cap glued to the package.

Not all pack sizes may be marketed.

5.5 Special precautions for the disposal of unused veterinary medicinal products or waste products derived from the use of such products

Use the return systems for unused veterinary medicinal products or waste products derived from them in accordance with local requirements and national collection systems applicable to the respective veterinary medicinal product.

6.         NAME OF THE MARKETING AUTHORIZATION HOLDER

Chemifarma S.p.A.

CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS

Prescription veterinary medicinal product.