PACKAGE LEAFLET FOR
BAXYL LONG ACTING® Oxytetracyclinum 20%, injectable solution.
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
PRODIVET Pharmaceuticals S.A./N.V.
B – 4731 EYNATTEN
Tel : 00 32 (0)87 85 20 25
Fax : 00 32 (0)86 86 68 20
NAME OF THE VETERINARY MEDICINAL PRODUCT
BAXYL Long Acting®, Oxytetracyclinum 20%, injectable solution.
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Active substance: Oxytetracycline dihydrate 216 mg (= 200 mg oxytetracycline) per ml.
Excipients: sodium formaldehyde sulphoxylate – magnesium oxide– Dimethylacetamide – Sodium edetate –
Ethanolamine - Water for injection up to 1 ml.
Treatment of infections due to micro-organisms sensitive to Oxytetracycline in tissues where the distribution of the antibiotic in the infectious site is in effective concentration, within the limits of its pharmacokinetic characteristics.
- Do not administer BAXYL Long Acting® in cats, dogs and horses
- Do not administer BAXYL Long Acting® in lactating cows
- Liver or renal failure
- Hypersensitivity to Tetracyclines
A local transient reaction that can last 21 days may occur at the injection site.
A transitory rise of the creatine kinase rates can appear during 72 hours (bovines).
The reactions are more marked in case of injection in the croup. A weak/moderate lameness can appear during a maximum of 10 days.
The treated animals, particularly those having little cutaneous pigmentation, can develop a photodermatitis when intensively exposed to solar light.
Tetracyclines can bind calcium and settle on bones and teeth, which can modify the color of those.
The administration of Tetracyclines can induce hypocalcemia and cardiovascular disorders.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
BAXYL Long Acting® is intended for bovines (calves and adults) and for porcines.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Intramuscular injection of 20 mg/kg BW, that is to say 1 ml/10 kg.
In case of severe infections the injection can be repeated after 48 hours.
To prevent an under-dose, the body weight must be determined as exactly as possible.
Way of administration
For intramuscular injection.
ADVICE ON CORRECT ADMINISTRATION
- Respect the usual rules of asepsis during an intramuscular injection
- Do not exceed 10 ml BAXYL Long Acting® per injection site, for animals of more than 100Kg, distribute the amount to be injected over several sites of injection
- Do not administer BAXYL Long Acting® simultaneously with penicillins or cephalosporins
- It is recommended to proceed to a antibiogram before beginning the treatment if a resistance to the Tetracyclines is suspected
- It is recommended to evaluate the response to the treatment 2 days after the last injection. If antibiotherapy seems still necessary, another antibiotic should be used.
Bovine: Meat and offal: 35 days after the end of the treatment.
Do not use in cows whose milk is destined to human consumption.
Porcine: Meat and offal: 14 days after the end of the treatment.
SPECIAL STORAGE PRECAUTIONS
Do not store above 25 °C in the original packaging, tightly closed, protected from light.
Do not use after the expiration date reproduced on the package, behind the abbreviation EXP (month/year). It refers to the last day of that month
Shelf-life after first opening of the container: 28 days.
For the user
This drug contains an antibiotic, Oxytetracycline. In case of accidental self-injection, do immediately ask advice by a doctor and show him the instructions.
People who are hypersensitive to Tetracycline should not handle the product.
Keep out of the reach and sight of children.
For the doctor
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Adequate measures of precaution must be taken to ensure that the product gets not in the environment
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact:
PRODIVET Pharmaceuticals S.A./N.V.
B - 4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
e-mail : firstname.lastname@example.org
Available on prescription only.