ΠΑΡΑΡΤΗΜΑ 1: ΠΕΡΙΛΗΨΗ ΤΩΝ ΧΑΡΑΚΤΗΡΙΣΤΙΚΩΝ ΤΟΥ ΠΡΟΪΟΝΤΟΣ
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
OXTRA10%, 92.7mg/ml, solution for injection for cattle, horses, swine, sheep.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains:
Active substance:
oxytetracycline……………………………………92.7 mg
(equivalent to oxytetracycline hydrochloride……100 mg)
Excipients:
sodium formaldehyde sulphoxylate………….……….4 mg
For a full list of the excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1.
Target species
Cattle, horses, swine, sheep.
4.2.
Indications for use, specifying the target species
In cattle, horses, swine and sheep ,infections caused by Gram-positive
bacteria (Actinomyces spp., Arcanobacterium pyogenes,Bacillus
anthracis, Clostridium spp,Corynebacterium spp., Staphylococcus spp.,
Streptococcus spp., ) Gram-negative bacteria (Aerobacter aerogenes,
Bortedella spp, Brucella spp. , E.coli, Haemophilus spp., Klebsiella spp.,
Pasteurella spp., Proteus spp., Pseudomonas spp., Salmonella spp.,
Shigella spp., ) Spirochetes, Chlamydiae,Mycoplasmas, Rickettsiae,
Protozoa and Leptospirae sensitive to oxytetracycline.
More specifically:
 bronchopulmonary infections (bronchitis, bronchopneumonia);
 gastro-intestinal infections (enteritis, gastroenteritis);
 mammary infections (acute parenchymatous mastitis);
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
4.3.
breeding
traumatic reticuloperitonitis, metritis and metroperitonitis, phlegmons,
infected wounds, purulent lesions.
Contraindications
Do not use in case of known hypersensitivity to oxytetracycline or any of
the excipients.
Do not use if resistance to the tetracyclines has been found in the
establishment, owing to potential cross-resistance.
4.4.
Special warnings for each target species
Use is not permitted in horses producing milk for human consumption.
Owing to possible variations, over time and geographically, in the
sensitivity of the microbial target species to oxytertracycline, it is
recommended that bacteriological and sensitivity tests be performed.
Repeated or prolonged use should be avoided, improving management
procedures and with cleanliness and disinfection.
4.5.
Special precautions for use
Special precautions for use in animals
Use of the product should be based on sensitivity testing against bacteria
isolated from the animals to be treated .If this should not be possible
,should be based on local epidemiological information ( regional or from
breeding establishments) regarding the susceptibility of the target
bacteria.
Use of the product in ways not complying with the instructions supplied
may increase the prevalence of bacteria resistant to the tetracyclines and
may decrease the efficacy of treatment with other antibiotics of the same
class or different classes, owing to potential cross resistance.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
People with known hypersensitivity to oxytetracycline, to the other
tetracyclines or to any of the excipients must avoid contact with the
veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and
show the package leaflet or the label.
4.6.
Adverse reactions (frequency and seriousness)
The use of tetracycline may result in allergic or anaphylactic phenomena
(which resolve with the use of adrenaline, cortisone agents, etc.),
intestinal dismicrobism (with colic pain, severe diarrhoea, which in some
subject can even be lethal), local intolerance (with irritative and histolesive
phenomena) and alteration of the liver function (with steatosis and
alterations in function tests).The tetracyclines are deposited in bone
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tissue and in developing teeth, with the possibility of deformation and
bone fragility. The tetracyclines may cause photosensitivity.
4.7.
Use during pregnancy or lactation
As the tetracyclines are deposited in bone tissue and in developing teeth,
with possible may result in bone fragility and deformation, use on the
basis of an assessment of the risk/benefit ratio carried out by the
veterinarian in charge.
4.8.
Interaction with other medicinal products and other forms of
interaction
None known.
4.9.
Amounts to be administered and administration route
Administer by the deep intramuscular or intravenous route.
Cattle, horses, swine, sheep: 2-4-8 ml/100 kg b.w./day (equivalent to 24-8 mg of active substance/kg b.w.) for 3 consecutive days.
4.10. Overdose
necessary
(symptoms,
emergency
procedures,
antidotes)
if
Data not available.
Do not exceed the recommended dosage.
4.11. Withdrawal periods
MEAT and OFFAL
Cattle: 15 days.
Swine: 8 days.
Sheep: 20 days.
Horses: 23 days.
MILK
Cattle: 144 hours (12 milkings).
Sheep: 216 hours (18 milkings).
Use is not permitted in horses producing milk for human
consumption.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: antibacterial for systemic use. Tetracyclines.
ATCVet Code: QJ01AA06.
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5.1.
Pharmacodynamic particulars
Oxtra 10% is a solution for injection based on oxytetracycline . The ready
to use preparation permits maximum ease of treatment. The special
formulation permits the perfect rapid absorption of the active substance
,minimising any undesirable effects of the tetracyclines due to poor local
tolerance.
Oxytetracycline is a bacteriostatic antibiotic which acts by inhibiting
bacterial protein synthesis through irreversible binding with ribosomal
subunit 30S.It shows a very broad spectrum of action , against Grampositive( Actinomyces spp.,Arcanobacterium pyogenes, Bacillus
Anthracis, Clostridium spp, Corynobacterium spp., Staphylococcus spp.,
Streptococcus spp.,) Gram-negative bacteria ( Aerobacter aerogenes,
Bordetella spp., Shigella spp.,)Spirochetes, Clamydiae, Mycoplasmas,
Rickettsiae, Protozoa and Leptospirae.
Resistance is usually plasmid-mediated.
Its low toxicity and its lower tendency, compared to other antibiotics, to
produce sensitisation phenomena, have made oxytetracycline one of the
safest and easiest antibiotics to use.
5.2.
Pharmacokinetic particulars
Deep intramuscular or intravenous injection of suitable dosages permits
efficacious blood concentrations to be obtained in a very short time
(immediately with the intravenous route), these persist for almost 24
hours, making a single daily treatment sufficient to keep the infections
under antibiotic control.
6.
PHARMACEUTICAL PARTICULARS
6.1.
List of excipients
Sodium formaldehyde sulphoxylate
Hexahydrate magnesium chloride
Povidone
Monoethanolamine
Water for injections
6.2.
Incompatibilities
The product must not be diluted or mixed with solutions of calcium salts.In
the absence of compatibility studies, this veterinary medicinal product
must not be mixed with other veterinary medicinal products.
6.3.
Shelf life
Shelf life of the veterinary medicinal product packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.
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6.4.
Special precautions for storage
Store protected from light and sources of heat.
6.5.
Nature and composition of immediate packaging
Cardboard box containing one 50 ml, 100 ml or 250 ml Type I glass bottle,
closed with an elastomer closure and sealed with an aluminium collar.
Not all packaging sizes may be marketed.
6.6.
Special precautions for the disposal of unused veterinary medicinal
product or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials deriving from
such veterinary medicinal products should be disposed of in accordance
with local requirements.
7.
MARKETING AUTHORISATION HOLDER
FATRO S.p.A. - Via Emilia, 285 - Ozzano Emilia (Bologna), Italy.
8.
MARKETING AUTHORISATION NUMBER(S)
10460
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 7/5/1986
Date of renewal: 31/5/2012
10.
DATE OF REVISION OF THE TEXT
31/5/2012
PROHIBITION OF SALE, SUPPLY AND/OR USE
Not applicable.
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