COLIVET<sup>®</sup> S

COLIVET® S

  • Colistin Sulphate 2,5 mg/ml
  • Injectable solution
  • Vials of 100 ml
Pigs

Leaflet

NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

PRODIVET Pharmaceuticals sa/nv
Hagbenden 39C
B -4731 EYNATTEN

NAME OF THE VETERINARY MEDICINAL PRODUCT

COLIVET S 2,5 mg/ml injectable solution

STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Per ml:
Active substance: Colistin Sulphate 2,5 mg (equivalent to 50.000 IU of colistin)
Excipients: Manitol - Sodium Chloride - Methyl para-Hydroxybenzoate 1,0 mg - Propyl para-Hydroxybenzoate  0,1 mg - Propylene Glycol - Purified water.

INDICATIONS

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

CONTRA INDICATIONS

Do not use in case of hypersensibility  to polymyxins.

ADVERSE REACTIONS

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

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

Piglets: 1 ml per kg BW (50.000 IU/Kg) every 24 hours, during 3 days. The treatment must not exceed 5 days.

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 colistine 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 S with solutions containing calcium ions.

Overdose (symptoms, emergency procedures, antidotes)

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 pregnancy or lactation

The product is intended only for piglets.

WITHDRAWAL PERIOD

Meat and offals: 21 days after the end of the treatment

SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.
Store below 25° C, protect from light.
Shelf life after first opening: 28 days, under 25°C and protect from light

SPECIAL WARNINGS

Special precautions for use in animals

The misuse of the product may increase the prevalence of bacteria resistant to colistin and decrease, due to the potential risk of cross-resistance, the effectiveness of treatment with polymyxins.

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

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

Any unutilised veterinary medicinal product or waste derived from such veterinary medicinal product must be eliminated in accordance with the local requirements.

DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

04/2013

OTHER INFORMATION

Packaging: Bottle of 100, 250 and 500 ml
 
Not all pack sizes may be marketed.
 
For any information about this veterinary medicinal product, please contact:
PRODIVET Pharmaceuticals S.A./N.V.
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
 
BE-V111483
 
On prescription only.



COLIVET S-NOT-GB-V5-20130426