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Date: Friday, November 8, 2024 7:17

Description: 2021 logo_HIPRA
Release 3.54
Selectan
 
Species: Pigs, Cattle
Therapeutic indication: Pharmaceuticals: Antimicrobials: Injections
Active ingredient: Florfenicol
Product:Selectan
Product index: Selectan
Cattle - milk: See note
Cattle - meat: 30 days
Pig - meat: 18 days
Withdrawal notes: Not permitted for use in lactating animals producing milk for human consumption
Incorporating:
Qualitative and quantitative composition
Each ml contains
Active Substance:
Florfenicol 300 mg
Excipients:
N-methyl pyrrolidone 308 mg
Pharmaceutical form
Solution for injection.
A slightly yellowish clear solution.
Clinical particulars
Target species
Cattle and Pigs
Indications for use
Diseases caused by florfenicol susceptible bacteria:
Cattle:
Therapeutic treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni.
Swine:
Treatment of acute outbreaks of respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida.
Contra-indications
Do not administer to adult bulls or boars intended for breeding purposes.
Do not administer to cattle producing milk for human consumption.
Do not administer to animals with known hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
Use of the veterinary medicinal product should be based on susceptibility testing and take into account official and local antimicrobial policies.
Do not use in piglets of less than 2 kg.
Swab the septum before removing each dose.
Use a dry, sterile syringe and needle.
Special precaution to be taken by the person administering the medicinal product to animals.
Care should be taken to avoid accidental self-injection.
Avoid contact with eyes and skin.
If eye exposure occurs, flush eyes immediately with clean water.
If skin exposure occurs, wash the affected area with clean water.
Wash hands after use.
People with known hypersensitivity to florfenicol should avoid contact with the veterinary medicinal product.
Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women, or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self injection.
Other Precautions
The use of this veterinary medicinal product may pose a risk for terrestrial plants, cyanobacteria and groundwater organisms.
Adverse reactions
Cattle
A decrease in food consumption and transient softening of the faeces may occur during the treatment period. The treated animals recover quickly and completely upon termination of treatment.
Administration of the veterinary medicinal product may cause inflammatory lesions at injection site which persist for up to 14 days.
Swine
Commonly observed adverse effects are transient diarrhoea and/or peri-anal and rectal erythema/oedema which may affect 50% of the animals. These effects can be observed for one week.
Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen for up to 28 days.
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established in cattle and swine during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only accordingly to the benefit/risk assessment by the responsible veterinarian
Interactions
None known
Amounts to be administered and administration route
Cattle:
20 mg/kg body weight (1 ml of SELECTAN per 15 kg) by intramuscular route to be administered twice 48 hours apart.
The volume administered per injection site should not exceed 10 ml.
Swine:
15 mg/kg body weight (1 ml of SELECTAN per 20 kg) by intramuscular injection into the neck muscle twice at 48 hours intervals.
The volume administered per injection site should not exceed 3 ml.
Overdose
In swine, after administration of 3 times the recommended dose or more a reduction in feeding, hydration and weight gain has been observed. After administration of 5 times the recommended dose or more vomiting has also been noted.
Withdrawal periods
Cattle: Meat and offal: 30 days.
Not permitted for use in lactating animals producing milk for human consumption.
Swine: Meat and offal: 18 days.
Pharmacological particulars
Pharmacoterapeutic group: Antibacterials for systemic use
ATCvet code: QJ01BA90.
Pharmacodynamic properties
Florfenicol is a systemic broad spectrum antibiotic effective against most Gram-positive and Gram-negative bacteria isolated from domestic animals. Florfenicol acts by inhibiting protein synthesis at the ribosomal level and is bacteriostatic. However, in vitro studies of florfenicol demonstrate bactericidal activity against Mannheimia haemolytica, Pasteurella multocida, Actinobacillus pleuropneumoniae, and Histophilus somni.
In vitro testing has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory diseases in cattle (including Pasteurella multocida, Mannheimia haemolytica, Histophilus somni and Arcanobacterium pyogenes) and in pigs (including Actinobacillus pleuropneumoniae and Pasteurella multocida).
Pharmacokinetic properties
Cattle:
In cattle, intramuscular administration at the recommended dose of 20 mg/kg maintains efficacious blood levels for 48 hours. Maximum mean serum concentration (Cmax) of 2.55 μg/ml occurs at 4.7 hours (Tmax) after dosing. The mean serum concentration 24 hours after dosing was 1.4 μg/ml. The harmonic mean elimination half life was 26.2 hours.
Pigs:
After initial intramuscular administration of florfenicol, maximum serum concentrations of between 1.9 and 3.1 μg/ml are reached after 2.2 hours and the concentrations deplete with a terminal mean half-life of 35.5 hours. After a second intramuscular administration, maximum serum concentrations of between 2.0 and 8.1 μg/ml are reached after 1.7 hours. Florfenicol concentrations achieved in lung tissue reflect plasma concentrations, with a lung:plasma concentration ratio of approximately 1.
After administration to pigs by intramuscular route, florfenicol is rapidly excreted, primarily in urine. The florfenicol is extensively metabolised.
Pharmaceutical particulars
Excipients
N-methylpyrrolidone.
Glycerol formal.
Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
Immediate packaging
The veterinary medicinal product is bottled in 100 ml colourless Type II glass bottles and 250 ml plastic bottles, closed with Type I polymeric elastomer stopper with aluminium cap.
One bottle of 100 ml or one bottle of 250 ml is available in a cardboard box.
Also clinical pack sizes are available:
10 x 100, 10 x 250, 12 x 100, and 12 x 250.
Not all pack sizes may be marketed.
Disposal
Any unused veterinary medicinal product or waste material should be disposed of in Accordance with national requirements. The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.
Marketing Authorisation Holder (if different from distributor)
LABORATORIOS HIPRA, S.A.
Avda. La Selva, 135
17170- AMER (Girona) SPAIN
Tel. +34 972 430660
Fax. +34 972 430661
E-mail: hipra@hipra.com
Marketing Authorisation Number
Vm17533/4006
Significant changes
Date of the first authorisation or date of renewal
19.12.2007
Date of revision of the text
December 2012.
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:SELECTAN PP 100ml
GTIN:08427711133216
GTIN description:SELECTAN PP 50ml
GTIN:08427711133230
GTIN description:SELECTAN 250ml
GTIN:08427711115595