FLOROMED 30%

FLOROMED 30%

injectable Solution

Product description

Composition

Each 100 ml contains:
Florfenicol                       30 gm

Properties

  • Florfenicol is a synthetic broad spectrum antibiotic effective against most Gram-positive and Gram-negative isolated from domestic animals. Florfenicol acts by inhibiting protein synthesis at ribosomal level and is bacteriostatic. Laboratory tests have shown that florfenicol is active against the most commonly isolated bacterial pathogens involved in ovine and bovine respiratory disease which include Mannheimia haemolytica, Pasteurella multocida, and for cattle Histophilus somni.
    Florfenicol is considered to be a bacteriostatic agent, but in vitro studies of florfenicol demonstrate bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni

Indications

Cattle:

  • Diseases caused by florfenicol susceptible bacteria: Treatment of respiratory tract infections in cattle due to Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

Sheep:

  • Treatment of ovine respiratory tract infections due to Mannheimia haemolytica and Pasteurella multocida susceptible to florfenicol.

Pigs:

  • Treatment of acute outbreaks of swine respiratory disease caused by strains of Actinobacillus pleuropneumoniae and Pasteurella multocida susceptible to florfenicol.

Target species

Cattle, sheep and pigs.

Dosage & Administration

Route of administration: For subcutaneous and intramuscular injection.

For active Ingredient:

Cattle:

  • By subcutaneous injection, 40 mg of florfenicol/kg bodyweight as a single dose.
  • By intramuscular injection, 20 mg of florfenicol/kg bodyweight. Repeat after 2 days.

Sheep:

  • By intramuscular injection, 20 mg of florfenicol/kg bodyweight daily for three consecutive days.

Pigs:

  • By intramuscular injection, 15 mg of florfenicol/kg bodyweight daily for three consecutive days.

For whole product:

Cattle:

  • By subcutaneous injection, 6.5 ml Florfenicol /50kg body weight as a single dose.
  • By intramuscular injection, 3.5 ml Florfenicol /50 kg body weight. Repeat after 2 days.

Sheep:

  • By intramuscular injection, 3.5 ml Florfenicol /50 kg body weight daily for three consecutive days.

Pigs:

  • By intramuscular injection, 2.5 ml Florfenicol /50 kg body weight daily for three consecutive days.

Warnings

Do not exceed the recommended treatment dose or the recommended duration of treatment.

Precautions

Precautions for humans:

  • This product may cause hypersensitivity (allergy).
  • People with known hypersensitivity to florfenicol or propylene glycol should avoid contact with the product.
  • Take care to avoid accidental self-injection. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
  • Avoid skin or eye contact with the product. In case of contact with the skin or eyes, rinse the affected area immediately with plenty of clean water.
  • If you develop symptoms following exposure such as skin rash, seek medical advice and take the package leaflet or the label with you.
  • Wash hands after use.

Precautions for animals:

  • The safety of the product has not been established in sheep under 7 weeks of age.
  • Do not use in piglets of less than 2 kg.
  • The product should be used in conjunction with susceptibility testing and take into account official and local antimicrobial policies.

Precautions during pregnancy, lactation and laying:

Studies in laboratory animals have not revealed any evidence of embryo- or foetotoxic potential for florfenicol.

Cattle and Sheep:

  • The effect of florfenicol on bovine and ovine reproductive performance and pregnancy has not been assessed. Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

Pigs:

  • The safety of the product in sows during pregnancy and lactation has not been demonstrated. Do not use the product during pregnancy and lactation.

Contra Indications

  • Do not use in adult bulls and rams intended for breeding purposes.
  • Do not administer to boars intended for breeding.
  • Do not use in case of hypersensitivity to the active substance or to any of the excipients.
  • It should not be used in newly born domestic animals.

Drug-drug interaction:

None known.

Side Effects

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 product by the intramuscular and subcutaneous routes may cause inflammatory lesions at injection site which persist for 14 days.
  • In very rare cases, anaphylactic shocks have been reported in bovines.

Sheep:

  • A decrease in food consumption may occur during the treatment period. The treated animals recover quickly and completely upon termination of the treatment.
  • Administration of the product by the intramuscular route may cause inflammatory lesions at the injection site which may persist up to 28 days. Typically, these are mild and transient.

Pigs:

  • 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.
  • Under field conditions approximately 30% of treated pigs presented with pyrexia (40ºC) associated with either moderate depression or moderate dyspnoea a week or more after administration of the second dose.
  • Transient swelling lasting up to 5 days may be observed at the site of injection. Inflammatory lesions at the injection site may be seen up to 28 days.

Poisoning:

  • In 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.
  • In sheep after administration of 3 times the recommended dose or more, a transient reduction in feed and water consumption has been observed. Additional secondary effects that were noted included an increased incidence of lethargy, emaciation and loose faeces.
  • Head tilt was seen after administration of 5 times the recommended dose and was considered most likely a result of irritation at the injection site.
  • 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 time

Cattle:

  • Meat and offal:
    • by IM route: 30 days
    • by SC route: 44 days

Sheep:

  • Meat and offal:
    • by IM route: 39 days

Pigs:

  • Meat and offal:
    • by IM route: 18 days

Storage Condition

Store at temperature not exceeding 30ºC and used after opening for 45 days at temperature not exceeding 30ºC away from light.

Packaging

Carton box containing amber glass (type II) vials of 10, 20, 30, 50, 100 & 250 ml with inner & outer label.