Target species
Chickens.
Indications for use for each target species
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 warnings
None
Special precautions for use
Special precautions for safe use in the target species:
Use of the veterinary medicinal 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 veterinary medicinal product should not be used to compensate for poor hygiene and management of the farm houses.
Use of the veterinary medicinal product deviating from the instructions given in the SPC 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 veterinary medicinal 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. People with known hypersensitivity to the active substance or to any of the excipients should avoid contact with the veterinary medicinal product.
2. Handle this veterinary medicinal 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 immediately and show the package leaflet or the label to the physician. Swelling of the face, lips or eyes or difficulty with breathing, are more serious symptoms and require urgent medical attention.
Persons handling this veterinary medicinal product should avoid inhalation of any dust and contact with skin. Personal protective equipment consisting of 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 should be worn when mixing and handling the veterinary medicinal product.
Hands and exposed skin should be washed thoroughly after use.
Special precautions for the protection of the environment:
Not applicable.
Adverse reactions
Chickens:
Undetermined frequency (cannot be estimated from the available data): | Diarrhoea, Disorder of gastrointestinal floraa, Vomiting |
aAlter gut flora by selecting resistant bacterial
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Studies in laboratory animals and humans have not produced any evidence of effects on reproductive function or foetal development.
Interactions with other medicinal products and other forms of interaction
This veterinary medicinal product should not be combined with bacteriostatic antibiotics.
Administration route an dosage
In drinking water use.
Dissolve in drinking water and use within 12 hours. The maximum solubility is 100 g product per litre drinking water.
13.5 – 20 mg phenoxymethylpenicillin per kg body weight per day, corresponding to 17 – 25 mg of the veterinary medicinal product per kg body weight per day, for 5 days.
Based on the recommended dose and the number and weight of animals to be treated, the exact daily concentration of the veterinary medicinal product should be calculated according to the following formula:
mg veterinary medicinal product/kg body weight per day | X average body weight (kg) of animals to be treated | = mg veterinary medicinal product per litre of drinking water | = g veterinary medicinal product/ 1000 l water |
----------------------------- |
average daily water intake (l/animal) | |
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.
Symptoms of overdose (and where applicable, emergency procedures and antidotes)
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.
Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Withdrawal periods
Meat and offal: 2 days.
Eggs: zero days.