Oxyveto-50 S 1KG

SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
OXYVETo-50 S
2. Qualitative and quantitative composition
One g contains:
Active substance(s):
Oxytetracycline 0.5 g
(as hydrochloride)
For the full list of excipients, see section “List of excipients”.
3. Pharmaceutical form
Powder for drinkable solution
4. Clinical particulars
4.1 Target species
Calves, lambs, kids, pigs, rabbits and poultry.
4.2 Indications for use, specifying the target species
In calves, lambs, kids, pigs, rabbits and poultry:
– Treatment and metaphylaxis of septicaemia, respiratory and digestive tract infections caused by bacteria sensitive to oxytetracycline.
The presence of the disease must be established in the farm before starting treatment or metaphylaxis.
4.3 Contraindications
Do not use in case of known allergy to oxytetracycline or any other substance of the tetracycline group.
Do not use in case of known resistance to tetracyclines.
4.4 Special warnings for each target species
None
4.5 Special precautions for use
i) Special precautions for use in animals
This powder for oral solution is intended to be dissolved in milk, liquid food or water and can not be used as it is.
ii) Special precautions to be taken by the person administering the veterinary medicinal product to animals
Do not handle this product if you are allergic to tetracyclines.
Do not smoke, drink or eat while using the product.
In case of reaction after exposure to the product (rash for example), consult a doctor.
iii) Other precautions
None
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4.6 Adverse reactions (frequency and seriousness)
As with all tetracyclines, adverse effects have been noted such as gastrointestinal disturbances and less frequently allergic reactions and photosensitivity.
4.7 Use during pregnancy, lactation or lay
Oxytetracycline showed no evidence of embryotoxicity or teratogenicity in laboratory animals.
In mammals, oxytetracycline passes the placental barrier, causing staining of teeth and slowing of fetal growth.
Tetracyclines are found in breast milk. Product safety has not been evaluated in pregnant or lactating animals. The use of the product in pregnant or lactating animals should be subject to a benefit-risk assessment by the veterinarian.
4.8 Interaction with other medicinal products and other forms of interaction
Dival or trivalent cations (Mg, Fe, Al, Ca) can chelate tetracyclines. Tetracylines should not be administered with antacids, aluminium-based gels, vitamin or mineral preparations as insoluble complexes are formed, which decreases the absorption of the antibiotic.
4.9 Amounts to be administered and administration route
Orally, via drinking water, milk replacer or feed.
– Calves, pigs, foals, lambs:
Prevention: 20 – 30 mg/kg bodyweight daily.
Treatment: 40 – 60 mg/ kg bodyweight daily.
– Poultry: 600 – 1200 g/ton of feed or 200 – 600 g/1000 litres of drinking water.
Duration of treatment: 5 – 7 days.
Medicated water should be consumed within 24 hours.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
See section “Adverse reactions (frequency and seriousness)”.
4.11 Withdrawal period(s)
Meat and offal: 7 days
Eggs: 0 days
5. Pharmacological properties
Pharmacotherapeutical group: tetracycline antibiotic
ATC-vet code: QJ01AA06
5.1 Pharmacodynamic properties
Oxytetracycline reversibly binds to the 30S ribosomal fraction receptors, leading to blocking of the aminoacyl-tRNA binding at the corresponding site of the ribosome-messenger RNA complex. This results in an inhibition of the protein synthesis and therefore a stop of the growth of the bacterial culture. Oxytetracycline has a predominantly bacteriostatic activity. The bacteriostatic activity of oxytetracycline involves penetration of the substance into the bacterial cell. The penetration of oxytetracycline is exerted by both passive and active diffusion. The main mode of possible resistance is related to the possible presence of an R factor responsible for a decrease in the active transport of oxytetracycline.
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Oxytetracycline is a broad-spectrum antibiotic. It is mainly active against gram-positive and negative microorganisms, aerobic and anaerobic, as well as against mycoplasmas, chlamidiae and Rickettsiae.
Acquired resistance to oxytetracycline has been reported. Such resistance is usually of plasmid origin. Cross resistance to other tetracyclines is possible. Continuous treatment with low doses of oxytetracycline may also result in increased resistance to other antibiotics.
5.2 Pharmacokinetic particulars
For most species, oxytetracycline is rapidly (2-4 h) absorbed after oral administration in fasting animals and has a bioavailability of 60% to 80%. This bioavailability can be reduced in the presence of food in the stomach because oxytetracycline forms insoluble chelates with the divalent or trivalent cations (Mg, Fe, Al, Ca) that they contain. In pigs, the influence of food is negligible on the bioavailability of oxytetracycline which is less than 5%
Oxytetracycline binds to plasma proteins in a variable manner depending on the species (20-40%). Its distribution is wide. Oxytetracycline diffuses throughout the body, with the highest concentrations found in the kidneys, liver, spleen and lungs. Oxytetracycline crosses the placental barrier.
Oxytetracycline is eliminated unchanged, mainly by the urinary tract. It is also excreted by the bile duct but a high proportion of oxytetracycline is reabsorbed by the small intestine (enterohepatic cycle).
6. Pharmaceutical particulars
6.1 List of excipients
Lactose monohydrate
6.2 Major incompatibilities
None known
6.3 Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 30 months.
Shelf life after first opening the immediate packaging: 3 months.
Shelf life after dissolution in water: 24 hours.
6.4. Special precautions for storage
Store dry, in a well-closed packaging, below 25°C and protect from light.
6.5 Nature and composition of immediate packaging
Jars of 100 g and 1 kg
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
The empty packaging and any remaining product should be disposed of following the practices governed by the regulations on waste.
7. MARKETING AUTHORISATION HOLDER
VMD n.v.
HOGE MAUW 900
2370 ARENDONK
BELGIUM
Prescription only medicine.