Leaflet
NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER AND OF THE MANUFACTURING AUTHORIZATION HOLDER THAT IS RESPONSIBLE FOR THE BATCH RELEASE, IF DIFFERENT
Registration holder and the manufacturer responsible for release:
Prodivet pharmaceuticals sa/nv
Hagbenden 39C
4731 Eynatten
Belgium
Tel : 0032 (0)87 85 20 25
Email : info@prodivet.com
NAME OF THE VETERINARY MEDICINAL PRODUCT
COLIVET S, 50.000 UI/ml, solution for injection.
Colistin sulphate
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
Per ml :
Active substance : Colistin sulphate equivalent to 50,000 IU.
Excipients : Mannitol – sodium chloride – methylparahydroxybenzoate 1.0 mg – propylparahydroxybenzoate 0.1 mg – propylene glycol – eau pour préparations injectables.
INDICATIONS
Treatment of systemic infections caused by colistin-sensitive germs, and more specifically, Escherichia coli and Salmonella spp., subject to obtaining effective concentrations at the site of infection
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
Rare nephrological and neurological accidents have been reported. Other manifestations (digestion and local irritation) are never of a serious nature. If the treatment causes an allergic reaction, then the treatment should be discontinued and a symptomatic treatment should be given (oxygen, adrenaline, antihistaminic). As colistin is nephrotoxic, subsequent disorders may occur in animals suffering from renal insufficiency.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports
If there are any serious side effects or other reactions that are not listed in this leaflet, or if you think the medicinal product has not been efficient, your veterinarian should be informed.
TARGET SPECIES
Piglets.
DOSAGE FOR EACH TARGET SPECIES, METHOD AND ROUTE
Intramuscular injection.
Piglets: 50,000 IU of colistin sulphate per kg of body weight (equating to 1 ml per kg of body weight) per 24 hours, during 3 days. The treatment period shall not exceed 5 days.
In order to ensure a correct dose, the body weight should be as accurate as possible so as to avoid under dosing.
ADVICE ON CORRECT ADMINISTRATION
A use of this veterinary medicinal product other than that specified in the package leaflet may increase the prevalence of colistin-resistant bacteria and decrease treatment efficacy of other polymyxins following the potential risk for cross-resistance.
WITHDRAWAL PERIOD
Meat and offal : 21 days.
SPECIAL STORAGE PRECAUTIONS
Keep out of reach and sight of children. Store below 25°C. Protect from light.
Shelf life after first opening the container: 28 days, under 25°C, protected from light, after the date of first opening.
Do not use after the expiry date stated on the bottle after EXP. The expiration date refers to the last day of the month.
SPECIAL WARNINGS
Special precautions for use in animals
Apply usual hygiene measures for intramuscular injection. Susceptibility to colistin of sensitive germs may vary with time: an antibiogram may be necessary before initiating treatment. .
Special precautions to be taken by the person administering the veterinary medicinal product to animals
All necessary precautions should be taken to avoid self-injection.
In case of an accidental self-injection, consult a doctor immediately and show the package leaflet or label.
Gestation and lactation
The veterinary medicinal product is only for piglets.
Interactions with other drugs and other forms of interaction
The efficacy of colistin decreases in the presence of calcium. The mixing of the veterinary medicinal product with solutions containing calcium is to be avoided.
Overdose (symptoms, emergency procedures, antidotes)
In case of an overdose, polymyxins provoke a neuromuscular block that cannot be eliminated either with neostigmine or calcium.
Incompatibilities
As no incompatibility studies have been done, the drug should not be mixed with other veterinary medicinal products.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Ask your veterinary surgeon or pharmacist 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
March 2021
OTHER INFORMATION
Delivery on veterinary prescription.
BE-V111483
Packaging : vials of 100, 250 and 500ml. 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/nv
Hagbenden 39C
4731 Eynatten
Belgium
Tel : 0032 (0)87 85 20 25
Email : info@prodivet.com
COLIVET S-NOT-BE-FR-V7-20210323