Ceftiocyl 50mg/ml suspension for injection for cattle and pigs 100ml.
Suspension for injection.
Slightly yellow to slightly pink, milky suspension.
Each ml contains Ceftiofur (as hydrochloride) 50.0 mg
Infections associated with bacteria sensitive to ceftiofur:
For the treatment of bacterial respiratory disease associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.
For the treatment of bacterial respiratory disease associated with Pasteurella haemolytica (Mannheimia spp.), Pasteurella multocida and 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.
Dosage and administration
3 mg ceftiofur /kg bw/day for 3 days via intramuscular route, i.e. 1 ml/16 kg bw at each injection.
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. For the injections, the neck should be preferred in cattle.
In case of acute post-partum metritis, additional supportive therapy might be required in some cases.
Contra-indications, warnings, etc
Do not administer to an animal previously found to be hypersensitive to ceftiofur and other ß-lactam antibiotics.
Do not use in case of known resistance to the active substance.
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In case of the occurrence of allergic reaction the treatment should be withdrawn.
Ceftiocyl 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, Ceftiocyl 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, Ceftiocyl should only be used based on susceptibility testing. Ceftiocyl 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.
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. In case of accidental injection or 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 in breathing are more serious symptoms and require urgent medical attention.
Wash hands after use.
Adverse reactions (frequency and seriousness)
Hypersensitivity reactions unrelated to dose can occur. Allergic reactions (e.g. skin reactions, anaphylaxia) may occasionally occur.
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.
In cattle, mild inflammatory reactions at the injection site, such as tissue oedema and discoloration of the subcutaneous tissue and/or fascial surface of the muscle may be observed. Clinical resolution is reached in most animals by 10 days after injection although slight tissue discoloration may persist for 28 days or more.
Use during pregnancy and lactation
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.
Interaction with other medicinal products and other forms of interaction
Erythromycins and tetracyclines may have an antagonistic effect on cephalosporins whereas aminoglycosides may have a potentiating effect.
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.
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Pigs: Meat and offal: 6 days
Cattle: Meat and offal: 8 days
Milk: zero hours
Shelf life after first opening the immediate packaging: 28 days
This veterinary medicinal product does not require any special storage conditions.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Cardboard box containing 1 dark type I glass vial of 100 ml closed with a bromobutyl rubber stopper and aluminium cap.
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