Package leaflet for
COLIVET quick-pump, 8mg/ml, oral suspension
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder and manufacturer responsible for batch release :
PRODIVET pharmaceuticals sa/nv
NAME OF THE VETERINARY MEDICINAL PRODUCT
COLIVET quick-pump, 8 mg/ml, oral suspension
STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENTS
Active substance: Colistin Sulphate 8.0 mg
Excipients: Methyl p-Hydroxybenzoate 2,0 mg - Propyl p-Hydroxybenzoate 0,2 mg- Mannitol - Kaolin - Dimethicon - Purified water up to 1 ml
Treatment of gastro- intestinal infections caused by non invasive Escherichia coli sensitive to Colistin, subject to obtaining effective concentrations in the infectious site.
In exceptional case of allergy to Polymyxins, administration of this product 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.
In case of allergy to the treatment, it 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 package leaflet, please inform your veterinary surgeon.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Administer 6.4mg/kg BW (corresponding to 1 ml of solution per 1,3 Kg BW), every 24 hours, during maximum 5 days.
In case of severe infection, the treatment might be repeated every 12 hours during a maximum of 5 days.
Way of administration
ADVICE ON CORRECT ADMINISTRATION
If you note an abnormal behaviour of the treated animal, please inform your veterinary surgeon.
Piglets: Meat and offals: 3 days after the end of the treatment.
SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not store above 30 °C, in the original container, tightly closed, protected from light.
Special precautions for use in animals :
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 to be taken by the person administering the veterinary medicinal product to animals :
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
Interaction with other medicinal products and other forms of interaction :
The activity of colistin is decreased in presence of calcium ions. Administration of COLIVET quick-pump simultaneously with solutions or foods rich in calcium ions must be avoided
Overdose (symptoms, emergency procedures, antidotes) :
In case of overdose, polymyxins cause a neuromuscular block, non reversible by neostigmine or calcium
For the doctor
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
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
PRODIVET pharmaceuticals sa
Phone: 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
For veterinary use
Available on prescription only