Excenel Flow 50mg/ml Injection for Pigs & Cattle 100ml

Target species Pigs and cattle. 4.2 Indications for use, specifying the target species Infections associated with bacteria sensitive to ceftiofur: In pigs: For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis. In cattle: For the treatment of bacterial respiratory disease associated with Mannheimia haemolytica (former Pasteurella haemolytica), Pasteurella multocida and Histophilus somni (former Haemophilus somnus). For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica). For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur, were treatment with another antimicrobial has failed. 4.3 Contraindications Do not administer to an animal previously found to be hypersensitive to ceftiofur and other  -lactam antibiotics. Do not inject intravenously. Do not use in cases where resistance to other cephalosporins or beta-lactam antibiotics has occurred. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans. 4.4 Special warnings for each target species None known. 4.5 Special precautions for use Special precautions for use in animals Shake the bottle well before use to bring the product back into suspension. In case of the occurrence of allergic reaction the treatment should be withdrawn. EXCENEL Fluid suspension (or EXCENEL Flow or Evo) selects for resistant strains such as bacteria carrying extended spectrum betalactamases (ESBL) which may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, EXCENEL Fluid suspension (or EXCENEL Flow or Evo) should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly (refers to very acute cases when treatment must be initiated without bacteriological diagnosis), to more narrow spectrum antimicrobials first line treatment. Official, national and regional antimicrobial policies should be taken into account when the product is used. Increased use, including use of the product deviating from the instructions given in the SPC, may increase the prevalence of such resistance bacteria resistant to EXCENEL Fluid suspension (or EXCENEL Flow or Evo). Whenever possible, EXCENEL Fluid suspension (or EXCENEL Flow or Evo) should only be used based on susceptibility testing. Do not use as prophylaxis in case of retained placenta. EXCENEL Fluid suspension (or EXCENEL Flow or Evo) is intended for treatment of individual animals. Do not use for disease prevention or as a part of herd health programmes. Treatment of groups of animals should be strictly limited to ongoing disease outbreaks according to the approved conditions of use. Special precautions to be taken by the person administering the veterinary medicinal product to animals Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross reactions to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. If you develop symptoms following exposure such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention. Wash hands after use. 4.6 Adverse reactions (frequency and seriousness) Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) have been reported in very rare cases (less than 1 animal in 10,000 animals, including isolated reports). In pigs, mild reactions at the injection site, such as discoloration of the fascia or fat, have been observed in very rare cases for up to 20 days after injection. In cattle, firmness and swelling were observed at the injection site after SC injection of the test article. Mild to moderate local chronic inflammation was observed in most animals until 42 days post injection. Injection site reactions have been reported from the field in very rare cases. 4.7 Use during pregnancy, lactation or lay Even though studies in laboratory animals show no evidence of teratogenesis, abortion or influence on reproduction, the reproductive safety of ceftiofur has not been specifically investigated in pregnant sows or cows. Use only according to a benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction The bactericidal properties of Beta-lactams are neutralised by simultaneous use of bacteriostatic antibiotics (macrolides, sulfonamides and tetracyclines). Aminoglycosides may have a potentiating effect on cephalosporins.
Vat Rate: 20%