Anupco


ANCOFUR 50

Suspension for injection

COMPOSITION

Ceftiofur (as hydrochloride) 50 mg – excipients up to 1 ml.

PHARMACOLOGICAL PROPERTIES

Ceftiofur is a late generation cephalosporin, which is active against many Gram-positive and Gram-negative bacteria. Ceftiofur inhibits the bacterial cell wall synthesis, thereby exerting bactericidal properties.

Beta-lactams act by interfering with synthesis of the bacterial cell wall. Cell wall synthesis is dependent on enzymes that are called penicillin-binding proteins (PBP’s). Bacteria develop resistance to cephalosporins by four basic mechanisms: 1) altering or acquiring penicillin binding proteins insensitive to an otherwie effective β-lactam; 2) altering the permeability of the cell to β-lactams; 3) producing β-lactamases that cleave the β-lactam ring of the molecule, or 4) active efflux.

Some β-lactamases, documented in Gram-negative enteric organisms, may confer elevated MICs to varying degrees to third and fourth generation cephalosporins, as well as penicillins, ampicillins, β-lactam inhibitor combinations, and first and second generation cephalosporins.

Ceftiofur is active against the following microorganisms which are involved in respiratory diseases in pigs: Pasturella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis. Bordetella bronchiseptica is intrinsically non-susceptible to ceftiofur. It is also active against bacteria involved in respiratory diseases in cattle: Pasteurella multocida, Mannheimia spp. (former Pasteurella haemolytica), Haemophillus somnus; bacteria involved in acute bovine foot rot (interdigital necrobacillosis) in cattle: Fusobacterium necrophorum, Bacteroides melaninogenicus (Porphyromonas asaccharolytica); and bacteria associated with acute post-partum (puerperal) metritis in cattle: Escherichia coli, Arcanobacterium pyogenes and Fusobacterium necrophorum.

After administration, ceftiofur is quickly metabolised to desfuroylceftiofur, the principal active metabolite. Desfuroylceftiofur has an equivalent anti-microbial activity to ceftiofur against the bacteria involved in respiratory disease in animals. The active metabolite is reversibly bound to plasma proteins. Due to transportation with these proteins, the metabolite concentrates at a site of infection, is active and remains active in the presence of necrotic tissue and debris. Ceftiofur is completely bio-available following intramuscular administration in pigs and subcutaneous administration in cattle. The elimination occurred mainly via the urine (more than 55%); 31% of the dose was recovered in the faeces.

INDICATIONS

Infections associated with bateria sensitive to ceftiofur:

In pigs:

- For the treatment of bacterial respiratory disease associtade with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.

In cattle:

- 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 the 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. The indication is restricted to cases where treatment with another antimicrobial has failed.

CONTRA-INDICATIONS

Do not administer to an animal previously found to be hypersensitive to ceftiofur and other β-lactam antibiotics.

Do not inject intravenously.

Do not use in poultry (including eggs) due to risk of spread of antimicrobial resistance to humans.

DOSAGE AND ADMINISTRATION

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 necrobacillus: 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.

UNDESIRABLE EFFECTS

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 discolouration 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 edema and discolouration 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 discolouration may persist for 28 days or more.

SPECIAL PRECAUTIONS FOR USE AND WARNINGS

Shake the bottleáwell before use to rbing the product back into suspension.

In case of the occurrence of allergic reaction the treatment should be withdrawn.

ANCOFUR 50á suspension for injection for pigs and cattle 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 humand e.g. via food. For this reason ANCOFUR 50 suspension for injection for pigs and cattle 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 whená 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 ANCOFUR 50 suspension for injection for pigs and cattle should only be used based on susceptibility testing.

ANCOFUR 50 suspension for injection for pigs and cattle is intended for treatment of individual animals. Do not use for disease prevention or as part of herd health programs. 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. Do not handle this product if you know you are sensitized, 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 breathing are more serious symptoms and require urgent medical attention.

WITHDRAWAL PERIODS

Pigs: meat and offal: 5 days

Cattle: meat and offal: 8 days. Milk: zero days.

PACK SIZE

Glass vials of 100 ml

Please be aware that product specifications and availability can differ between countries. For detailed information in this regard, please contact us.

 

 

 

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