COLIVET<sup>®</sup> SF 500

COLIVET® SF 500

  • Colistin sulphate
  • 500 000 IU/ml, Injectable solution
  • Vials of 100 ml
Pigs
Cattle

PACKAGE LEAFLET

COLIVET SF 500, 500 000 IU/ml, Injectable solution

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

NAME OF THE VETERINARY MEDICINAL PRODUCT

COLIVET SF 500, 500 000 IU/ml, injectable solution
Colistin sulphate

STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT

Per ml:
Active substance: Colistin sulphate equivalent to 500 000 IU.
Excipients: Manitol - Sodium Chloride - Methyl p-Hydroxybenzoate 2,0 mg - Propyl p-hydroxybenzoate  0.2 mg - Propylene Glycol - Purified water up to 1 ml.

INDICATIONS

Treatment of systemic infections caused by strains sensitive to Colistin, especially Escherichia coli and Salmonella subject to obtaining effective concentrations in the infectious site.

CONTRA INDICATIONS

In exceptional case of allergy  to polymyxins, administration of COLIVET SF 500 is contraindicated.

ADVERSE REACTIONS

Rare cases of nephrological and neurological accidents have been reported. Other incidences  (local irritation or digestive symptoms) are never of a serious nature.
In case of allergy to the treatment, this 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

COLIVET SF 500 is intended for calves (non -ruminating and ruminating) and for pigs.

DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

Calves and pigs: 50 000 IU of Colistin sulphate per Kg BW  every 24 hours, means 1 ml per 10 Kg BW every 24h, during 3 days. The treatment must not exceed 5 days.
To ensure correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

Way of administration

IM injection

ADVICES ON CORRECT ADMINISTRATION

Special precautions for use in animals

  • Respect the usual asepsis rules of an intramuscular injection.
  • The susceptibility of the colistin against the sensitive germs, can vary after a time; an antibiogram may be necessary before starting the treatment.

Interaction with other medicinal products and other forms of interaction

The activity of colistin is decreased in presence of calcium ions. Avoid to mix COLIVET SF 500 with solutions containing calcium ions.

Overdose (symptoms, emergency procedures, antidotes), if necessary

In case of overdose, polymyxins cause a neuromuscular block, non reversible by neostigmine or calcium.

Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Use in gravidity or lactation

Colistin being deprived of teratogenic action, its administration during gestation is authorized

WITHDRAWAL PERIOD

Calves: Meat and offal: 26 days after the end of the treatment.
Pigs: Meat and offal: 21 days after the end of the treatment.

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.
Protect from light.
Do not use this veterinary medicinal product after the expiry date which is stated on the bottle after EXP.
The expiry date refers to the last day of that month.
Shelf life after first opening the container: 14 days, protect from light.

SPECIAL WARNINGS

Special precautions to be taken by the person administering the veterinary medicinal product to
animals

All necessary precautions must be taken to avoid self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
The misuse of the product may increase the prevalence of bacteria resistant to colistin and decrease, due to the potential risk of cross-resistance, treatment efficacy by polymyxins.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
MATERIALS, IF ANY

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

April 2016

OTHER INFORMATION

BE-V496577
Available on prescription only.
Pack sizes: bottles of 100ml.
 
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder:
 
PRODIVET Pharmaceuticals sa/nv
 Hagbenden 39c
B - 4731 EYNATTEN
Phone : 00 32 (0)87 85 20 25
Fax : 00 32 (0)87 86 68 20
e-mail : info@prodivet.com
 
Colivet SF 500-not-GB- V5-20160420