Package Leaflet
COLIVET Bolus 150 mg
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder
PRODIVET PHARMACEUTICALS SA/NV
Hagbenden, 39c
B-4731 EYNATTEN
Manufacturer for the batch release
Laboratoria Wolfs NV
Westpoort, 50
B-2070 ZWIJNDRECHT
NAME OF THE VETERINARY MEDICINAL PRODUCT
COLIVET Bolus 150mg tablets, colistin sulphate
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
per bolus:
Active substance: Colistin Sulphate 150 mg
Excipients: Microcristalline Cellulose - Mannitol – Anhydorus Colloidal Silicon - Magnesium Stearate - Maize Starch q.s.ad.
Oblong, white, scored tablets.
INDICATIONS
Treatment of gastro- intestinal infections in non ruminant calves caused by non invasive Escherichia coli sensitive to Colistin subject to obtaining effective concentrations in the infectious site.
CONTRA INDICATIONS
In exceptional case of allergy to Polymyxins, COLIVET Bolus administration is contra-indicated.
Do not use in horses, especially in foals, as colistin, due to the change in the balance of intestinal microflora, could lead to the development of antimicrobial-associated colitis (colitis X), generally associated to Clostridium difficile, which can be fatal.
ADVERSE REACTIONS
In case of allergy to the treatment, this one $ must be stopped and a symptomatic treatment (oxygen, epinephrine, anti-histaminic) must be initiated.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
TARGET SPECIES
COLIVET Bolus is intended for non- ruminant calves.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Posology
Administer 2.5 mg/Kg BW (that is to say one bolus for 60 Kg BW or half a bolus for 30 Kg BW), twice a day with 12 hours between the administrations, during 3 days. The period of treatment must not exceed 5 days.
Way of administration
Oral administration
ADVICES FOR A CORRECT ADMINISTRATION
Special precautions of use in the animals
The susceptibility of the colistin against the sensitive germs, can vary after a time; an antibiogram may be necessary before starting the treatment.
The activity of colistin is decreased in presence of calcium ions. Administration of COLIVET Bolus simultaneously with solutions or foods rich in calcium ions must be avoided.
In case of overdose, polymyxins cause a neuromuscular block, non reversible by neostigmine or calcium.
If you note an abnormal behaviour of the treated animal, please inform your veterinary surgeon.
WITHDRAWAL PERIOD
Calves : Meat and offals : 3 days after the end of the treatment.
SPECIAL STORAGE PRECAUTIONS
Keep out of the reach and sight of children.
Store in the original packaging.
SPECIAL WARNINGS
For the user :
This drug contains an antibiotic, colistin sulphate. In case of accidental ingestion, even of small amounts, seek medical advice immediately and show the package leaflet or the label
For the animal :
Do not use colistin as a substitute for good management practices.
Colistin is a drug of last resort in human medicine in the treatment of infections due to certain multi-resistant bacteria. To minimize any potential risks associated with widespread use of colistin, its use should be limited to treatment and to metaphylaxis of diseases, and it should not be used for prophylaxis.
The use of colistin should be based as far as possible, on susceptibility testing.
Any use of this product other than the one recommended in the SPC may cause the failure of treatment and the increase of prevalence of bacteria resistant to colistin.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Medicines should not be disposed of via wastewater or household waste
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
June 2015
OTHER INFORMATIONS
Boxes of 20 or 100 boli.
Not all pack sizes may be marketed.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
PRODIVET Pharmaceuticals sa
Hagbenden 39c
B-4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
E-mail :Info@prodivet.com
For veterinary use.
Available on prescription only.
COLIVET BOL 150_NOT_GB_V4_20150615