ANTIBIOTIC

Toltcoxin B

Toltrazuril 25 mg /ml.
Oral solution for chickens and turkeys poults

Formula

Each ml of product contains:

Toltrazuril (active substance) 25 mg

Target species

Chickens and turkey poults.

Indications

For the treatment of coccidiosis in chickens and turkey poults.

The product is effective against:

In chickens: Eimeria acervulina, Eimeria brunetti, Eimeria maxima, Eimeria mivati, Eimeria necatrix, Eimeria tenella.

In turkey poults: Eimeria adenoides and Eimeria meleagrimitis.

Administration

For oral administration via the drinking water.

The dose is 7 mg toltrazuril per kg body weight (bw) per day (= 0.28 ml Toltcoxin B per

kg bw per day). Treatment is carried out on two consecutive days. The medicinal product should be administered continuously over 24 hours continuously or 8 hours/day, everyday, for 2 consecutive days.

Calculate the weight of the flock. Estimate the water consumption of the flock to ensure that the birds are receiving the required dose and that Toltcoxin B is mixed into the amount of water that will be consumed daily. It will be mixed gently.


Toltcoxin B is a therapeutic product in contrast to the usual anticoccidial products. Treatment in the initial stages of infestation is most effective and therefore early diagnosis is useful. Treatment will be started at the appearance of the first signs of the disease. Two days of treatment are usually effective.

For any information regarding this veterinary medicinal product, please contact the local representative of the marketing authorization holder.

Contraindications

Do not use in animals with hypersensitivity to the active substance or to any of the excipients.

Side effects

Not known.

Special precautions for storage

Keep away from reach and sight of children!

Store in original packaging, at temperature below 25oC, protected from direct sunlight and freeze.

Shelf life after dilution in drinking water, according to directions: 24 hours.

Shelf-life after first opening of package: 3 months.

Advice on correct administration

The uptake of medicated water is dependant on the clinical condition of animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.

Underdosing can lead to ineffective use and promote the development of resistance.

The dosage should be based on the current, actual drinking water intake of the animals, because this varies depending on the animal species, on the age, state of health and intended use of the animals and depending on the housing conditions (e.g. temperature, lighting regime)

Thus, to achieve the correct dose, appropriate adjustment of the toltrazuril concentration may be necessary. The use of properly calibrated measuring equipment is recommended.

Withdrawal period

Meat and offal:

Chickens: 16 days.
Turkey poults: 16 days.

Special warnings

Special warnings for each target species

Colistin exerts concentration-dependent activity against Gram-negative bacteria. Following oral administration high concentrations are achieved in the gastrointestinal tract, i.e. the target site, due to the poor absorption of the substance. These factors indicate that a longer duration of treatment than the one indicated, leading to unnecessary exposure, is not recommended.

Special precautions for use

Special precautions for use in animals

Do not use colistin as a substitute for good management practices. Colistin is a last resort drug in human medicine for treatment of infections caused by certain multi-drug resistant bacteria. In order to minimise any potential risk associated with widespread use of colistin, its use should be limited to treatment or treatment and metaphylaxis of diseases, and should not be used for prophylaxis. Whenever possible, colistin should only be used based on susceptibility testing. Use of the product deviating from the instructions given may lead to treatment failures and increase the prevalence of bacteria resistant to colistin.

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

People with known hypersensitivity to any of the product ingredients should avoid contact with the veterinary medicinal product. To prevent any unpleasant effects, personal protective equipment consisting in rubber gloves, goggles and protective masks should be worn when administering the product. In case of accidental ingestion or the occurrence of symptoms characterized by skin rash, seek medical advice. Serious symptoms such as swelling of face, lips or eye lids, accompanied by breath difficulties, need immediate medical attention.

Use during pregnancy, lactation or lay

Following the studies made on laboratory animals, colistin sulphate, administered orally, due to low absorption from digestive tract, has not impaired the reproductive functions nor offsprings evolutions the product can be used safely.

Interactions with other medicinal products

Colistin has synergism with beta-lactams and bacteriostatic antibiotics (tetracyclines, macrolides).

Incompatibilities

Being an oral veterinary medicinal product that is not absorbed from the gastrointestinal tract, the administration with other medicinal products for oral use containing divalent metal ions (e.g. calcium, iron or magnesium). will be avoided.

Incompatibility with ampicilin.

Special precautions for the disposal of unused product or waste materials

For the environmental protection, medicines should not be disposed of via wastewater or household waste. Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Other information

PE-HD flasks of 100 ml, 250 ml, 500 ml, and 1000 ml.

PE-HD cans of 5 l, 20 l.

Not all pack sizes may be marketed.

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