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Cefenil RTU 100 ml

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Cefenil RTU is a ready-to-use antimicrobial solution for injection containing 50mg/ml ceftiofur. Indication for the treatment of bacterial respiratory disease in pigs in cattle. Also indicated for treating acute interdigital necrobacillosis (foot rot) and acute post-partum (puerperal) metritis where treatment with another antimicrobial has failed.

Cefenil RTU 100 ml

 

 

Cefenil RTU is a ready-to-use antimicrobial solution for injection containing 50mg/ml ceftiofur. Indication for the treatment of bacterial respiratory disease in pigs in cattle. Also indicated for treating acute interdigital necrobacillosis (foot rot) and acute post-partum (puerperal) metritis where treatment with another antimicrobial has failed.

 

 

Active Ingredient: Each ml contains: Ceftiofur (as hydrochloride) 50 mg

Pharmaceutical Form: Suspension for injection. A white to yellowish coloured oily suspension.

Indications: Infections associated with bacteria sensitive to Ceftiofur: Swine: For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis sensitive to ceftiofur. Cattle: For the treatment of bacterial respiratory disease associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni sensitive to ceftiofur. For the treatment of acute interdigital necrobacillosis (panaritium, foot rot), associated with Fusobacterium necrophorum and Bacteroides melaninogenicus (Porphyromonas asaccharolytica) sensitive to ceftiofur. For treatment of the bacterial component of acute post-partum (puerperal) metritis within 10 days after calving associated with, Arcanobacterium pyogenes and Fusobacterium necrophorum, sensitive to ceftiofur. The indication is restricted to cases where treatment with another antimicrobial has failed.

Dosage: Swine: 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.

Contraindications: Do not administer to an animal previously found to be hypersensitive to Ceftiofur and other beta-lactam antibiotics or to any of the excipient(s). Do not use in cases of known resistance to other cephalosporins or beta-lactam antibiotics Do not use intravenously. Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.

Special Warnings: This product selects for resistant strains such as bacteria carrying extended spectrum betalactamases (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 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. 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.

Adverse Reactions: 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 discoloration 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.

Withdrawal Period: Cattle: Meat and offal: 5 days. Milk: zero days. Swine: Meat and offal: 5 days.

Packaging Size: 100ml type 1 clear glass vials or high density polyethylene (HDPE) vials. Each vial is closed with a nitryl bung and sealed with an aluminium cap.

Shelf Life: Shelf life of the veterinary medicinal product as packaged for sale: 2 years. 28 days once broached.

 

 

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