|

 

Bela-pharm.de

250 mg/g powder for oral administration
with the drinking water or milk /milk substitute
Target species: cattle (calves) and pigs Statement of the active substance(s) and other ingredient(s):
1.0 g powder contains:
Pharmacological active substance:
Tetracycline hydrochloride 250 mg
Excipients:
Glucose monohydrate.
Indications:
Cattle (calves) and pigs:
For therapy and metaphylaxis of infectious diseases of the respiratory- and gastro-intestinal
tract and infections of the urinary tract in calves and pigs (with the exception of systemic
E. coli and Salmonella infections), caused by bacteria sensitive to tetracycline.
Contraindications:
Hypersensitivity to tetracyclines.
Severe disturbances of hepatic or renal function.
Do not use in ruminating cattle (calves older than 6 weeks).
Resistance to tetracyclines.
Adverse reactions:
On corresponding disposition, allergical or anaphylactic reactions may occur. In this case
withdraw tetracycline hydrochloride immediately and initiate appropriate countermasures
(parenteral administration of glucocorticoids and antihistaminics). Gastro-intestinal
disturbances with vomiting and diarrhoea may be observed in rare cases when the product
is administered to fasting animals. In long-term treatment pay attention to superinfections
e.g. with Candida spp.
In animals with disturbed fluid balance, the danger of functional disturbance of the kidneys
is increased. Tetracycline may cause liver damage. During therapy intensive light insolation
on skin with poor pigmentation often causes photodermatitis.
Target species:
Cattle (calves) and pigs.
Dosage for each species, route(s) and method of administration:
Pigs:
for administration with the drinking water.
for administration with the milk/milk substitute or the drinking water.
80 mg tetracycline hydrochloride per kg body weight (b.w.) per day, 320 mg Tetracyclinhydrochlorid 25% per kg b.w. per day or 8 g Tetracyclinhydrochlorid 25% per 25 kg b.w. per day.
20 mg tetracycline hydrochloride per kg body weight (b.w.) per day, 2 g Tetracyclinhydrochlorid 25% per 25 kg b.w. per day or 1 g Tetracyclinhydrochlorid 25% per 25 kg b.w. twice daily. For to solve 15 g Tetracyclinhydrochlorid 25% in the drinking water completely, a minimum amount of 100 ml is necessary. To solve 1 g Tetracyclinhydrochlorid 25% in the milk replacer, a minimum of 100 ml milk replacer ready to be given is necessary. The prepared solution is to be used immediately. It has to be ensured that the intended dose is taken up completely. In animals with clearly disturbed general state of health and/or in animals with inappetence, a preparation which can be given parenterally should be preferred. Treatment of single animals:The powder is to be mixed for each application fresh into a part of the drinking, or in the ready to use milk replacer, respectively, that a complete mixing is achieved. The prepared solution is to be given prior to the regular feeding. If administration with the drinking water is intended, the required amount of the powder is to be solved completely in a small part of the drinking water, and to be given immediately.
Treatment of a part of the stock:The required amount of the powder is to be solved completely and fresh daily in a small part of the drinking water, and to be given to the drinking water immediately. To ensure an even water uptake by all animals, sufficient watering places have to be provided. In case of pasture keeping, the animals should be kept in stables during the treatment. The dosage has to be adjusted to the actual, real daily intake of drinking water by the animals as this varies in dependence on the age, state of health, purpose of the animals and the way of rearing (e.g. varying ambient temperature, different light patterns).
For the above mentioned dose, the amount of Tetracyclinhydrochlorid 25% to be mixed into the drinking for the animals to be treated is calculated according to the following formula: 320 mg Tetracyclinhydro- x average body weight (kg) chlorid 25% per kg b.w./day of animals to be treated = . mg Tetracyclinhydro- average daily intake of drinking water (l) per animal chlorid 25% per l of Upon completion of the treatment, the watering trough is to be cleaned in a suitable manner
to avoid the intake of subtherapeutic, especially resistance-promoting residues of the
applied antibiotic.
Duration of treatment: 5 days. After cessation of clinical symptoms, the therapy should be
continued for 2 more days. Should there be no significant improvement of the state of health
after 3 days of treatment, review diagnosis and change therapy, if necessary.
Advice on correct administration:
Special warnings for each target species:
None.
Special precautions for use in animals:
The solubility of tetracycline hydrochloride is influenced by the quality of the water.
This must be observed during application.
Because of the high incidence of bacteria resistant to tetracyclines, especially of E. coli in
pigs and turkeys, but as well as in other farm animals, and Salmonella typhimurium in cattle
and pigs, if such germ is under suspect, a treatment with tetracycline shall only be executed
based on the clear susceptibility of the germ given as a result of a susceptibility testing.
Special safety precautions to be taken by the person administering the medicinal product to
animals:
Avoid direct skin contact and inhalation during handling and application due to the risk
of sensitisation or contact dermatitis. Wear a dust mask and gloves when handling the
veterinary medicinal product.
Use during pregnancy, lactation or lay:
The treatment of pregnant and newborn animals requires strict indications, as disturbances
of dental and skeletal development in the foetus and the newborn, on the basis of the
binding of tetracycline in dental and bone tissue of growing animals can not be excluded.
Interaction with other medicinal products and other forms of interaction:
The concomitant administration of products containing bi- or trivalent cations (e.g. Ca2+,
Fe2+, Fe3+) has to be avoided, as antibacterial inactive chelates may be formed, which
hinders the absorption, just as oral adsorbents do. There is a potential antagonism between
tetracyclines and bactericidal antibiotics.
Overdose (symptoms, emergency procedures, antidotes):
Following overdosage gastro-intestinal symptoms, as vomiting or tympany, may appear.
Overdoses may cause liver damage. Withdraw the pharmaceutical immediately. On
the occurrence of symptoms indicating hepatic or renal damage, stop therapy with
Tetracyclinhydrochlorid 25% immediately and initiate therapeutic measures as rehydration
and providing electrolytes.
Administration of calcium- or magnesium salts or adsorbants may prevent enteral absorption
of tetracycline. Allergic reactions may be treated parenterally with glucocorticoids and
antihistaminics.
Withdrawal period(s):
Calf, pig:
Special storage precautions:
Keep container tightly closed.
Protect from moisture and do not store at temperatures exceeding 20 °C.
Keep out of reach and sight of children.
Do not use after the expiration date stated on the label.
Shelf life after first opening of the container: not indicated
Shelf life after dilution or reconstitution according to directions: The medicated drinking
water or milk replacer must be used up immediately.
Special warnings:
None.
Special precautions for the disposal of unused product or waste materials:
Remaining quantities shall be preferably given to pollutant collecting points. When wasted
together with the general household waste, it has to be ensured that no misuse of the
pharmaceutical is possible. Veterinary pharmaceuticals must not be wasted with waste
water or sewage systems. Local regulations for the disposal of pharmaceuticals have to be
observed.
Date on which the package leaflet was last approved: 30.08.2012
For Veterinary use only.
Available on prescription only!

Source: http://www.bela-pharm.de/nc/en/produkte/schweine.html?download=Tetracyclinhydrochlorid_25__08-12_03.pdf&did=1636