FLUMIGAL 50 mg/ mL oral solution

Composition:

1 mL of the veterinary medicinal product contains:

Active substance:
Flumequine     50.0 mg

Excipients: Propylene glycol, sodium hydroxide, purified water .

Yellowish solution.

Indications: 

Diseases of respiratory, gastrointestinal and urinary tract, sepsis, osteomyelitis, bacterial dermatitis caused by pathogens susceptible to flumequine:
Chickens: E.coli, Pasteurella spp., Salmonella spp., Staphylococcus aureus
Calves: E.coli, Pasteurella spp. (P. multocida, P. haemolytica), Salmonella spp. (S. Typhimurium, S. Dublin), Proteus spp., Klebsiella spp., Pseudomonas spp., Haemophilus spp., Staphylococcus aureus, Streptococus pyogenes
Rabbits: Salmonella spp. (S. Typhimurium), E.coli, Pasteurella spp. (P. multocida), Mycoplasma spp., Staphylococcus aureus, Klebsiela pneumoniae, Proteus spp., Pseudomonas spp.
Lambs, kids: Pasteurella spp. (P. multocida), E.coli, Staphylococcus aureus, Streptococus pyogenes, Klebsiela pneumoniae. 

Dose for each species, method and route of administration:

Chickens:
12 mg flumequine (0.24 mL product) per kg bodyweight and day, via drinking water for 3 – 5 days.
Broilers:
younger than 2 weeks: 1 mL product per 1 litre of drinking water
older than 2 weeks: 2 mL product per 1 litre of drinking water
Chickens for further breeding:
younger than 6 weeks: 1 mL product per 1 litre of drinking water
older than 6 weeks: 2 mL product per 1 litre of drinking water
Rabbits:
20-25 mg flumequine (0.40-0.50 mL product) per kg bodyweight and day, for 3 – 5 days via drinking water.
Calves, lambs, kids:
12-15 mg flumequine (0.24 – 0.30 mL product) per kg bodyweight and day, split in half in the morning and in the evening, for 5 – 7 days.
In practice: 4 mL product per 15 kg bodyweight, daily, for 5 – 7 days.

Based on the recommended dose, number and weight of animals treated, the exact daily amount of FLUMIGAL 50 mg / ml oral solution should be calculated according to the following formula:

(... mL product per kg bodyweight and day   x   Average bodyweight (kg) animals to be treated) / Average daily water consumption (L) per animal and day = …. mL product per litre of drinking water

Advice on correct administration:

Always prepare only as much medicated water as is needed for daily consumption.

To ensure correct dosing and to avoid underdosing, determine the body weight of the animals as accurately as possible and monitor water consumption. The required amount of drug should be measured using a suitably calibrated weighing device.
Medicated water intake depends on several factors, including age, clinical condition of the animals, and local conditions such as temperature and humidity.
If adequate medicated water intake cannot be achieved, animals should be treated parenterally.

Withdrawal period:

Meat and offal of calves, lambs, kids: 5 days.
Meat and offal of chickens: 2 days.
Meat and offal of rabbits: 5 days.  
Do not use in therapy of layers producing eggs for human consumption.

Contraindications:

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Adverse reactions:

Side effects after flumequine administration are relatively low, however the gastrointestinal disorders such as diarrhoea, vomiting, nausea may occur. Their course is relatively mild and usually it is not necessary to interrupt the therapy. The unfavourable influence of fluorochinolones on development of the cartilaginous bones in young animals was not determined. Due to this statement, flumequine is the safest product of all fluoroquinolones.

The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one
treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals )
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports)

Special precautions for storage:

Keep out of the reach and sight of children. 
Store below 25°C. Protect from light. Store in a dry place. 
Do not use this veterinary medicinal product after the expiry date which is stated on the label.
Shelf life after reconstitution according to directions: 24 hours.

For more information please read the package leaflet.