COLISTIN SULFAT FP

TARGET SPECIES: Pigs (sows), lambs, hens (laying hens, replacement youth) and turkeys.

Amoxicilina 250ml

INDICATION: The product COLISTIN SULFATE FP - oral solution is indicated for pigs (sows), lambs, hens (laying hens, replacement youth) and turkeys in treatment and metaphylaxis of enteric infections caused by noninvasive E. coli bacteria susceptible to colistin. Before metaphylactic treatment disease in the herd must be confirmed.

COMPOSITION:
1 ml of solution contains:
Active substance:
Colistin sulfate ……...................................................100 mg
(equivalent 2.000.000 U.I.)
Excipients:
Benzyl alcohol .............................................................10 mg
 

CONTRAINDICATIONS:
Do not administer it to animals with serious renal failure.
The product will not be used in cases of hypersensitivity to active substance or any of the excipients. Do not use in horses, especially in foals, because colistin alters the balance of the gastrointestinal tract microflora and could lead to development of colitis associated with antimicrobials administration (colitis X), usually associated with Clostridium difficile, which can be lethal.

ADVERSE REACTIONS:

They were not reported.

ADMINISTRATION:
The product is administered diluted in drinking water, individually or in mass.
Individual administration:
Pigs (sows), lambs: 0,5 ml product/ 10 kg body weight/day (5 mg active substance/ kg weight body/ day respectively 100,000 IU/ kg body weight/ day), for 3-5 consecutive days. The recommended daily dose should be divided into two equal doses if the product will be administered directly into the animal’s mouth.
Mass administration:
Pigs (sows): 0.625 ml product/ liter of water/ day, respectively 62.5 mg of active substance/ liter of water/ day.
Lambs: 0.50 ml product/ liter of water/ day, respectively 50 mg of active substance/ liter of water/ day.
To obtain the most accurate dosage, the following formula may be used:
Product quantity/ 1000 L water = A (mg) x herd weight (kg)/ B(mg) x total water consumption of the herd in 24 hours (L)
Where:
A= recommended dose of active substance/ kg body weight
B= product concentration in active substance/ ml
Hens (laying hens, replacement youth) and turkeys:
18.75 ml product/ 100 liters of water/ day (3.75 mg active substance/ kg body weight/ day respectively 75,000 IU/ kg body weight/ day), for 3 - 5 consecutive days.
Use a freshly prepared solution every day.
The duration of treatment should not exceed 7 days.
The duration of treatment should be limited to a minimum necessary for the treatment of the disease.
To ensure the correct dosing, the body weight of the animals must be accurately determined whenever possible to avoid underdosing.

RECOMMENDATIONS FOR PROPER ADMINISTRATION:
Before administering the product, the animals should be left thirsty for two hours.

USE DURING THE GESTATION, LACTATION OR LAYING PERIOD:
It may be used during the gestation, lactation or laying period.

INTERACTIONS WITH OTHER MEDICINAL PRODUCTS OR OTHER FORMS OF INTERACTION:
It has an effect of further enhancement and synergism with beta-lactam antibiotics and antibiotics with bacteriostatic action.

WITHDRAWAL PERIOD:
Meat and offal:
Lambs: 1 day
Pigs (sows): 1 day
Hens (laying hens, replacement youth), turkeys: 1 day
Eggs: zero days

 

SPECIAL WARNINGS FOR EACH TARGET SPECIES:
Colistin has a concentration-dependent action on Gram-negative bacteria. Following oral administration, high concentrations are obtained in the gastrointestinal tract, i.e. the target site, due to the insufficient absorption of the substance. These factors indicate that a longer duration of treatment than indicated, leading to unnecessary exposure, is not recommended.

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 for the treatment of infections caused by certain multidrug-resistant bacteria. In order to minimize any potential risk associated with the widespread use of colistin, its use should be restricted to the treatment or treatment and metaphylaxis of diseases and should not be used for prophylaxis.
Whenever possible, colistin should only be used on the basis of susceptibility testing.
Using the product without following the instructions in the Summary of Product Characteristics can lead to treatment failure and increased prevalence of colistinresistant bacteria.

STORAGE:
Keep at a temperature not exceeding 25°C.

SHELF LIFE:
Shelf life of the product as packaged for sale: 2 years.
Shelf life after first opening the primary packaging: 3 months.
Shelf life after dilution or reconstitution as instructed: 24 hours.

 
Bottles x 100 ml, 1 L
Canisters x 5 L, 10 L
 
 

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