COLIVET<sup>®</sup> quick-pump

COLIVET® quick-pump

  • Colistin Sulphate 8,0 mg
  • Drinkable suspension
  • Vials of 100 ml
Pigs

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
Hagbenden, 39c
B-4731 EYNATTEN
Belgium

NAME OF THE VETERINARY MEDICINAL PRODUCT

COLIVET quick-pump, 8 mg/ml, oral suspension
Colistin Sulphate

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

INDICATIONS

Treatment of gastro- intestinal infections 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, 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.

ADVERSE REACTIONS

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.

TARGET SPECIES

Piglets.

DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Posology

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

Oral administration

ADVICE ON CORRECT ADMINISTRATION

If you note an abnormal behaviour of the treated animal, please inform your veterinary surgeon.

WITHDRAWAL PERIOD

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 WARNINGS

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

None

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 INFORMATION

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
Belgium
Phone: 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
e-mail :Info@prodivet.com
 
For veterinary use
Available on prescription only

COLIVET QP_NOT_GB_V4_20150615