Neocell

Doxylin 100%, powder for  use  in drinking water/ milk for calves and pigs.

Active substance:
Doxycycline hyclate     1000 mg/g
(equivalent to doxycycline   867 mg/g)

Yellow, crystalline powder.

INDICATION
Calves:
- Bronchopneumonia and pleuropneumonia caused by Pasteurella spp, Streptococcus spp, Arcanobacterium pyogenes, Haemophilus somnus and Mycoplasma spp.
Pigs:
- Atrophic rhinitis caused by Pasteurella multocida and Bordetella bronchiseptica;
- Bronchopneumonia caused by Pasteurella multocida, Streptococcus suis and Mycoplasma hyorhinis;
- Pleuropneumonia caused by Actinobacillus pleuropneumoniae.

CONTRAINDICATIONS
Do not use in animals with an active microbiological digestion in the rumen.
Do not use in case of hypersensitivity to tetracyclines.
Do not administer to animals with severe liver- or kidney insufficiency.

ADVERSE REACTIONS
In calves acute, sometimes fatal myocardial degeneration can occur following single or multiple dosages. Since mostly this is caused by overdosage, it is important to measure the dosage accurately.
Tetracyclines may - in rare cases - induce photosensitivity and allergic reactions. If suspected adverse reactions occur, treatment should be discontinued.

If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.

TARGET SPECIES
Calf and pig.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD(S) OF ADMINISTRATION
Calves         10 mg of doxycycline hyclate/kg of body weight/day,
        for 3-5 consecutive days,
divided over 2 administrations.

Pigs:    10 mg of doxycycline hyclate/kg of body weight/day,
        for 3-5 consecutive days.

Mode of administration:
Calves: orally, dissolve in  the milk(replacer)
Pigs:    orally, dissolve in  the drinking water

ADVICE ON CORRECT ADMINISTRATION
For the administration through the drinking water, the exact daily amount of product should be calculated, based on the recommended dose, and the number and weight of the animals to be treated, according to the following formula:

mg of product / kg of body weight / day    X    Mean body weight (kg) of animals to be treated    
                                                                                                                                       = .... mg of product per litre of drinking water
                               Mean daily water consumption (litre) per animal
    

To ensure a correct dosage body weight should be determined as accurately as possible.
The uptake of medicated water is dependant on the clinical conditions of the animals. In order to obtain the correct dosage, the concentration in drinking water may have to be adjusted.
The use of suitably calibrated weighing equipment is recommended if part packs are used. The daily amount is to be added to the drinking water such that all medication will be consumed in 24 hours. Medicated drinking water should be freshly prepared every 12 hours. It is recommended to     prepare a concentrated pre-solution – max. 400 grams of product per 10 litres of drinking water - and to dilute this further to therapeutic concentrations if required. Alternatively, the concentrated solution can be used in a proportional water medicator.
Solubility of the product is pH dependent and in areas with hard alkaline water formation of complexes may occur in the drinking water.
The product should not be used in very hard water above 16°d and pH more than 8.
The medicated milk replacer should be used within 6 hours.

WITHDRAWAL PERIOD
Meat and offal:    
Calves:      14 days.
Pigs:       8 days.

SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach  of children.

Keep the container tightly closed in order to protect from light and moisture.

Do not use after the expiry date stated on the label after exp.
Shelf life after first opening of the container: 3 months.
Shelf life after reconstitution in drinking water: 12 hours.
Shelf life after reconstitution in milk replacer: 6 hours.

SPECIAL WARNINGS
Special warnings for each target species
Seriously sick animals have a changed drinking pattern and therefore have to be medicated parenterally.

Special precautions for use in animals
It is necessary that the medicated milk is administered to each calf individually. Also the separation of doxycycline in the milk replacer has to be taken into account. In order to prevent this, leave the mixer on during the tapping of the milk.

Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, bacteriological sampling and susceptibility testing of micro-organisms from diseased animals on farm are highly recommended. If this is not possible, therapy should be based on local (regional and farm level) epidemiological information about susceptibility of the target bacteria as well as by taking into account official national antimicrobial policies.
Inappropriate use of the product may increase the prevalence of bacteria resistant to doxycycline and may decrease the effectiveness of treatment with other tetracyclines due to the potential for cross-resistance.
Avoid administration in oxidised drinking equipment
Resistance to tetracyclines has been reported in pig respiratory pathogens (A. pleuropneumoniae, S. suis,) and calf pathogens (Pasteurella spp) in some EU countries.

As eradication of the target pathogens may not be achieved, medication should therefore be combined with good management practices, e.g. good hygiene, proper ventilation, no overstocking.

Operator warnings
If you know you are allergic to the tetracycline class of antibiotics, special care should be taken when handling this product or the medicated solution.
To prevent sensitization and contact dermatitis during preparation and administration of the medicated drinking water, skin and eye contact with the product and inhalation of dust particles should be avoided. Wear impermeable gloves (e.g. rubber or latex) and an appropriate dust mask (e.g. disposable half-mask respirator conforming to European Standard EN149) when applying the product.
In the event of eye or skin contact, rinse the affected area with large amounts of clean water and if irritation occurs, seek medical attention. Wash hands and contaminated skin immediately after handling the product.
If you develop symptoms following exposure such as skin rash, you should seek medical advice and show this warning to the physician. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.
Do not smoke, eat or drink while handling the product.

Use during pregnancy and lactation
Due to deposit of doxycycline in young bone tissue, use of the product should be limited during pregnancy and lactation.

Interactions with other medicinal products and other forms of interaction
Do not use in conjunction with bactericidal antibiotics, such as penicillins and cephalosporins.
Absorption of doxycycline can be decreased in the presence of high quantities of calcium, iron, magnesium or aluminium in the diet. Do not administered together with antacids, kaolin and iron preparations.
It is advised that the interval between the administration of other products containing polyvalent cations should be 1-2 hours because they limit the absorption of tetracyclines.
Doxycycline increases the action of anticoagulants.
The solubility of the product is pH dependent and will precipitate if mixed in alkaline solution.
Do not store the drinking water in metallic containers.

Overdose (symptoms, emergency procedures, antidotes)
In calves an acute, sometimes fatal myocardial degeneration can occur following overdose. (See also the section Adverse reactions).

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

OTHER INFORMATION
List of pack sizes:
- Container: 1 kg.
- Bucket: 1, 2, 5 kg.
Not all pack sizes may be marketed.