PHENOXYPEN WSP, 325 mg/g powder for oral solution for chickens.

QUALITATIVE AND QUANTITATIVE COMPOSITION
Per gram:
Active substance:
Phenoxymethylpenicillin                 293 mg
equivalent to potassium phenoxymethylpenicillin    325 mg

PHARMACEUTICAL FORM
Powder for oral solution.
White to off-white powder.

Target species
Chickens.

Indications for use, specifying the target species
Prevention of mortality at a group level from necrotic enteritis in chickens caused by Clostridium perfringens susceptible to phenoxymethylpenicillin.

Contraindications
Do not use in case of hypersensitivity to the active substance.

Special warnings for each target species
The administration of the product may lead to an increase in medicated water consumption.

Special precautions for use
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from chickens that have already died on the farm.
The product should not be used to compensate for poor hygiene and management of the chicken houses.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Phenoxymethylpenicillin  may cause hypersensitivity reactions after injection, inhalation, oral ingestion,  skin or eye contact. Hypersensitivity to phenoxymethylpenicillin  may lead to cross-sensitivity to other penicillins and cephalosporins, and vice versa. Allergic reactions caused by these substances can sometimes be serious.
In case of accidental ingestion or serious symptoms of hypersensitivity reactions such as skin rash following exposure, swelling of the face, lips or eyes or difficulty with breathing, seek medical advice immediately and show the package leaflet to the physician.
People with known hypersensitivity to penicillins or cephalosporins should avoid contact with the product. In case of development of hypersensitivity symptoms following exposure to the product, all further contact with the product (and other medicines containing other penicillins or cephalosporins) should be avoided.
Handle this product with great care to avoid exposure, taking all recommended precautions. 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 EN 143 when mixing and handling the product. Wash hands immediately after handling the product..

Adverse reactions (frequency and seriousness)
Although no adverse reactions have been seen after the administration of the product, penicillins may cause vomiting, diarrhoea and alter gut flora with selecting resistant bacteria.

Use during pregnancy, lactation or lay
Studies in laboratory animals and humans have not produced any evidence of effects on reproductive function or foetal development.

Interaction with other medicinal products and other forms of interaction
Do not combine with bacteriostatic antibiotics.

Amounts to be administered and administration route
13.5 – 20 mg phenoxymethylpenicillin  per kg of body weight per day,
corresponding with,46 – 68 mg of the product per kg of 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 250 g of the product per litre of drinking water.
The following calculation should be made to determine the quantity in gram of the product to be added in 1000 litres of water:

mg product/ kg body weight/day x mean body weight of individual animals (kg) x number of animals     = mg product/l x 1000 = g product/1000 l water   
                          Total water consumption of the house (litres) at the previous day


In dispensing the weight of the product to be used, 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 underdosing.
No other source of drinking water should be available during the medication period.
In cases of altered drinking water consumption in poultry, the concentration should be adjusted so that the recommended dosage is achieved.

Overdose (symptoms, emergency procedures, antidotes), if necessary
Phenoxymethylpenicillin  has a high therapeutic index. The administration of the 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 period
Meat and offal:    2 days.
Eggs:        zero days.

Incompatibilities
Do not mix with other veterinary medicinal products.
Contact of penicillin containing solutions with metals and the use of metal systems for their administration is known to adversely influence penicillin stability. Therefore such systems should be avoided and they should not be used for the storage of solutions.

Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years.
Shelf life after first opening of the immediate packaging:  3 months.
Shelf life after reconstitution in drinking water according to directions: 12 hours.

Special precautions for storage
Store below 25 °C.
Store in the original package.
Do not refrigerate or freeze.
Protect from frost.

Nature and composition of immediate packaging
-    Securitainer: white PP cylindrical container, with white HDPE/LDPE closure, with thumb-tab for opening. This type of container has two different sizes (650 ml, 1875 ml) with a content of 250 g, 1000 g product respectively.
-    Composite can: three-layered rectangular container, which consists of a cardboard base with an inner lining of aluminium-paper and with label on the outside. This type of container has a content of 1 kg of product .
Not all pack sizes may be marketed

Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.