Target species
Chickens.
Indications for use
For the treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens. The disease must have been currently diagnosed in the flock before metaphylactic use.
Contraindications
Do not use in known cases of hypersensitivity to the active substance, other substances of the beta-lactam group or to any of the excipients.
Special precautions for use in animals
Use of the product should be based on susceptibility testing of bacteria isolated from the animals on the farm. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria. The product should not be used to compensate for poor hygiene and management of the farm houses.
Use of the product deviating from the instructions given in this datasheet may increase the prevalence of bacteria resistant to phenoxymethylpenicillin and may decrease the effectiveness of treatment with other penicillins, due to the potential for cross-resistance. Official, national and regional antimicrobial policies should be taken into account when the product is used.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins, such as phenoxymethylpenicillin may cause hypersensitivity (allergy) following inhalation, ingestion or skin contact. Hypersensitivity to phenoxymethylpenicillin may lead to cross-sensitivity to other penicillins and cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.
1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations.
2. Handle this product with great care to avoid exposure, taking all recommended precautions.
3. If you develop symptoms following exposure such as a skin rash you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
Persons handling this product should avoid inhalation of any dust and contact with skin. Wear protective clothing, impervious gloves and either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with a filter to EN143 when mixing and handling the product.
Hands and exposed skin should be washed thoroughly after use.
Adverse reactions
Although no adverse reactions have been observed after the administration of the product, penicillins may cause vomiting, diarrhoea and alter gut flora by selecting resistant bacteria.
Use during pregnancy and lactation
Studies in laboratory animals and humans have not produced any evidence of effects on reproductive function or foetal development.
Interactions
This veterinary medicinal product should not be combined with bacteriostatic antibiotics.
Amounts to be administered and administration route
13.5-20 mg phenoxymethylpenicillin per kg body weight per day, corresponding to 17-25 mg of the product per kg body weight per day, for 5 days.
Method of administration: oral use, dissolve in drinking water and use within 12 hours. The maximum solubility is 100 g product per litre drinking water.
The following calculation may be used to determine the quantity in grams of the product to be added to 1000 litres of water:
___ mg product/kg body weight/day x mean body weight of individual animals (kg) x number of animals | | | | |
________________________________________________ | = | ___ mg product/litre | = | ___ g product/ 1000 litre water |
Total water consumption (litre) of the group to be treated on the previous day | | | | |
To calculate correctly the amount of powder required, the use of calibrated weighing equipment is recommended. Taking into account that sick animals may drink less, it is recommended to start therapy with the higher dose, to compensate for a possible lower intake of medicated water.
To ensure correct dosage, the body weight of the animals should be determined as accurately as possible to avoid under dosing.
No other source of drinking water should be available during the medication period. In cases of altered drinking water consumption in chickens, the concentration should be adjusted so that the recommended dosage is achieved. After the end of the treatment period, the water supply system should be cleaned to avoid subsequent intake of sub-therapeutic amounts of the active substance.
Overdose
Phenoxymethylpenicillin has a high therapeutic ratio. The administration of medicated drinking water at two and five times the recommended therapeutic dose for twice the recommended duration of treatment, did not reveal any adverse effects. In some individuals, administration of five times the recommended therapeutic dose for twice the recommended duration of treatment led to an increase in water consumption, a decrease in feed intake and watery faeces.
Withdrawal periods
Meat and offal: 2 days.
Eggs: zero days.