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FLORFENICOL INJECTION 30%

 

DESCRIPTION

 

Generic Name: Florfenicol Injection

Appearance: A clear, colorless to slightly yellow liquid.

Active Ingredient: Florfenicol.

 

Specification

 

100 mL : 30 g Florfenicol

 

COMPOSITION

 

Active Substance: Florfenicol 30 g

Excipients: q.s. to 100 mL

 

PHARMACOLOGICAL PROPERTIES

 

Pharmacodynamics

Florfenicol is a broad-spectrum, bacteriostatic antibiotic belonging to the amphenicol class. It exerts its antibacterial effect by binding to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting bacterial protein synthesis.

It demonstrates strong activity against a wide range of Gram-positive and Gram-negative bacteria. Pasteurella haemolytica, Pasteurella multocida, and Actinobacillus pleuropneumoniae are highly sensitive to Florfenicol.

In vitro studies indicate that Florfenicol possesses antimicrobial activity similar to or greater than Thiamphenicol. Notably, bacteria that have developed resistance to amphenicols due to acetylation (e.g., Escherichia coli, Klebsiella pneumoniae) may still remain susceptible to Florfenicol.

Pharmacokinetics

Florfenicol is rapidly absorbed after intramuscular administration. Therapeutic concentrations are reached in the blood within approximately 1 hour, with peak plasma concentrations ( Cmax) achieved within 1–3 hours. Bioavailability exceeds 80%.

The drug is widely distributed throughout the animal body and can cross the blood-brain barrier. It is primarily excreted in urine as the parent compound, with a small amount excreted in feces.

 

INDICATIONS

 

This product is indicated for the treatment of bacterial diseases in swine, poultry, and fish caused by Florfenicol-sensitive organisms:

Swine & Cattle: Respiratory diseases caused by Pasteurella haemolytica, Pasteurella multocida, and Actinobacillus pleuropneumoniae.

Poultry:

Typhoid and Paratyphoid caused by Salmonella spp.

Fowl Cholera and Pullorum disease.

Colibacillosis caused by Escherichia coli.

Fish: Bacterial septicemia, enteritis, and red-skin disease caused by Pasteurella, Vibrio, Staphylococcus aureus, Aeromonas hydrophila, and enteric bacteria.

 

DOSAGE AND ADMINISTRATION

Species

Dosage (per kg Body Weight)

Frequency & Duration

Swine

0.05 – 0.067 mL

Repeat every 48 hours for 2 injections.

Chicken

0.067 mL

Repeat every 48 hours for 2 injections.

Fish

0.0017 – 0.0034 mL

Once daily.

 

Route of Administration: Intramuscular (IM) injection only.

Species Dosage (per kg Body Weight) Frequency & Duration

Swine 0.05 – 0.067 mL Repeat every 48 hours for 2 injections.

Chicken 0.067 mL Repeat every 48 hours for 2 injections.

Fish 0.0017 – 0.0034 mL Once daily.

 

DRUG INTERACTIONS

 

Antagonism: Macrolides and Lincosamides share the same mechanism of action (binding to the 50S ribosomal subunit). Concurrent use with Florfenicol may result in mutual antagonism.

Potential Interference: Florfenicol may theoretically antagonize the bactericidal activity of Penicillins or Aminoglycosides, although this has not been definitively proven in vivo in animals.

 

ADVERSE REACTIONS

 

Immunosuppression: Administration at doses higher than recommended may cause a degree of immunosuppression.

 

CONTRAINDICATIONS & WARNINGS

 

Poultry: Do not use in laying hens producing eggs for human consumption. Use with caution in breeder chickens.

Reproductive Safety: This drug has embryotoxicity. Use with caution in pregnant and lactating livestock.

Vaccination: Do not use in animals during vaccination periods or in animals with severely compromised immune function.

Renal Impairment: Dosage reduction or extended dosing intervals are recommended for animals with renal insufficiency.

 

WITHDRAWAL PERIODS

 

Swine: 14 days

Chicken: 28 days

Fish: 375 Degree-Days (°C·days)

 

STORAGE

 

Store in a tightly closed container.

Protect from light and moisture.

 

PACKAGE SIZE

 

100 mL / bottle

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R&A Technology Co., Limited

Address: Office 3A-9, 12/F.,Kaiser centre, No.18 CTR Street, Sai,Ying Pun, Hong Kong

Eastern Along Pharmaceutical Co., Ltd.

Address: No. 66, Taoyuan East Road, Songxia Industrial Park, Shilin Town, Nanhai District, Foshan City、

Ramical Pet Health Technology Com.,Ltd

Address: No.10, Hengbao Road, Datang Industrial Park, Sanshui District, Foshan City, Guangdong Province, P.R.C.

 

E-mail:

export@easternalong.com    shirley@ramicalhk.com 

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