Cefenil RTU 50 mg/ml Suspension for Injection 100ml

   Product Ref: NBCEF03 Category: C

Temporarily Out of Stock



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, Pasteurella multocida and Histophilus somni . For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Porphyromonas asaccharolytica (previously Bacteroides melaninogenicus) . For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with, Trueperella pyogenes (previously Arcanobacterium pyogenes) and Fusobacterium necrophorum. . The indication is restricted to cases where treatment with another antimicrobial has failed. 4.3 Contraindications Do not use in known cases of hypersensitivity to the active substance, to other β-lactam antibiotics or to any of the excipients. Do not inject intravenously. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans. Do not use in cases where resistance to ceftiofur or to other cephalosporins or β-lactam antibiotics has occurred. 4.4 Special warnings for each target species None known 4.5 Special precautions for use Special precautions for use in animals This product selects for resistant strains such as bacteria carrying extended spectrum β-lactamases (ESBL) and may constitute a risk to human health if these strains disseminate to humans e.g. via food. For this reason, the product 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 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. Whenever possible, the product should only be used based on susceptibility testing. This product is intended for treatment of individual animals. Do not use for disease prevention or as a part of heard health programmes. Treatment of groups of animals should be strictly restricted to ongoing disease outbreaks according to the approved conditions of use. Do not use as prophylaxis in case of retained placenta. Special precautions to be taken by the person administering the medicinal products 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. 1. Do not handle this product if you know you are sensitised, or if you have been advised not to work with such preparations. 2. Handle this product with great care to avoid exposure, taking all recommended precautions. 3. 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) In cattle, mild inflammatory reactions such as hardness at the injection site have been observed in some animals. Clinical resolution is reached in most animals by 21 days after injection. In pigs, mild reactions at the injection site, such as discolouration of the fascia or fat, have been observed in some animals for up to 20 days after injection. Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxis) may occasionally occur. If an allergic reaction occurs, the treatment should be withdrawn. 4.7 Use during pregnancy and lactation Studies in laboratory species have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects or of abortion. Safety of the product has not been investigated in the target species during pregnancy. Use only according to the benefit/risk assessment by the responsible veterinarian. 4.8 Interaction with other medicinal products and other forms of interaction The bactericidal properties of β-lactams are neutralised by simultaneous use of bacteriostatic antibiotics (macrolides, sulphonamides and tetracyclines).
Vat Rate: 20%

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Category POM-V
Temperature Ambient
MA/VM/EU No: 02000/4330
Species
  • cattle
  • pig
VMD Link Product Information Database (defra.gov.uk)
NOAH Link
Dosage Pigs: 3 mg ceftiofur /kg bw/day for 3 days via intramuscular route, i.e. 1 ml/16 kg bw at each injection. Cattle: Respiratory disease: 1 mg ceftiofur /kg bw/day for 3 to 5 days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection. Acute interdigital necrobacillosis: 1 mg/kg bw/day for 3 days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection. Acute post-partum metritis within 10 days after calving: 1 mg/kg bw/day for 5 consecutive days by subcutaneous injection, i.e. 1 ml/50 kg bw at each injection. Subsequent injections must be given at different sites. In case of acute post-partum metritis, additional supportive therapy might be required in some cases. Before use, shake the bottle vigorously until the product appears adequately resuspended. The colour of the glass vial may not be uniform making it difficult to determine when the product is in suspension. Following shaking the absence of sediment can be confirmed most readily by inverting the vial and viewing the contents through the base of the vial. To ensure a correct dosage body weight should be determined as accurately as possible to avoid underdosing. The recommended maximum volume to be administered at a single injection site is 10 ml. 50 ml and 100 ml vials can only be broached a maximum of 50 times. 250 ml vials can only be broached a maximum of 85 times 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary The low toxicity of ceftiofur has been demonstrated in Pigs using ceftiofur sodium at doses in excess of 8 times the recommended daily dose of ceftiofur intramuscularly administered for 15 consecutive days. In cattle, no signs of systemic toxicity have been observed following substantial parenteral overdosages.
Withdrawals Cattle: Meat and offal: 5 days. Milk: zero hours. Pigs: Meat and offal: 5 days.