Cemay 50 mg/ml Suspension for Injection for Pigs and Cattle

Composition

Each ml contains:

Active substance:

Ceftiofur…… 50.0 mg

(equivalent to 53.48 mg ceftiofur hydrochloride)

Excipients:

Qualitative composition of excipients and other constituents

Hydrogenated soya lecithin

Sorbitan oleate

Cottonseed oil

A white or slightly yellow coloured suspension.

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Pharmacological properties

4.1 ATCvet code:

ATC Vet Code: QJ01DD90.

4.2 Pharmacodynamics

Ceftiofur is a third generation cephalosporin, which is active against many Gram-positive and Gram-negative bacteria, including β-lactamase producing strains. 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 otherwise 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: Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis. Bordetella bronchiseptica is intrinsically non-susceptible to ceftiofur.

It is also active against bacteria involved in respiratory disease in cattle: Pasteurella multocida, Mannheimia haemolytica, Histophilus somni; 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, Trueperella pyogenes (Arcanobacterium pyogenes) and Fusobacterium necrophorum, sensitive to ceftiofur.

Minimal inhibitory concentration breakpoints (µg/ml) for sensitivity (S), intermediate sensitivity (I) and resistance (R) of ceftiofur against bovine and porcine respiratory pathogens (CLSI, 2013):

No breakpoints have been determined to date for the pathogens associated with foot rot or acute post-partum metritis in cows.

4.3 Pharmacokinetics

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.

In pigs given a single intramuscular dose of 3 mg/kg body weight (bw), maximum plasma concentrations of 9.6 µg/mL ± 2.9 were reached after 2 hour; the terminal elimination half-life (t½) of desfuroylceftiofur was 16.6 ± 3.2 hours. No accumulation of desfuroylceftiofur has been observed after a dose of 3 mg ceftiofur/kg bw/day administered daily over 3 days.

The elimination occurred mainly via the urine (more than 70%). Average recoveries in faeces accounted for approximately 12-15% of the drug.

Ceftiofur is completely bioavailable following intramuscular administration.

After a single 1 mg/kg dose given subcutaneously to cattle, maximum plasma levels of 2.4 ± 0.7 μg/mL are reached within 2.8 hours after administration. In healthy cows, a Cmax of 2.25 ± 0.79 μg/mL was reached in the endometrium 5 ± 2 hours after a single administration. Maximum concentrations reached in caruncles and lochiae of healthy cows were 1.11 ± 0.24 μg/mL and 0.98 ± 0.25 μg/mL, respectively.

The terminal elimination half-life (t½) of desfuroylceftiofur in cattle is 9.0 ± 1.9 hours. No accumulation was observed after a daily treatment over 5 days. The elimination occurred mainly via the urine (more than 55%); 31% of the dose was recovered in the faeces.

Ceftiofur is completely bioavailable following subcutaneous administration.

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Target species

Pig and cattle.

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Indications

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 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, Trueperella pyogenes (Arcanobacterium pyogenes) and Fusobacterium necrophorum, sensitive to ceftiofur.

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

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Dosage

Pigs: intramuscular use

3 mg ceftiofur /kg bw/day, corresponding to 1 ml/16 kg bw/day, for 3 days.

Cattle: subcutaneous use

-Respiratory disease: 1 mg ceftiofur /kg bw/day, corresponding to 1 ml/50 kg bw/day for 3 to 5 days.

-Acute interdigital necrobacillosis: 1 mg/kg bw/day, corresponding to 1 ml/50 kg bw/day for 3 consecutive days.

-Acute post-partum metritis within 10 days after calving: 1 mg/kg bw/day, corresponding to 1 ml/50 kg bw/day for 5 consecutive days.

In case of acute post-partum metritis, additional supportive therapy might be required in some cases.

A maximum volume of 6 ml may be administered in each injection site. Subsequent injections must be given at different sites.

To ensure a correct dosage body weight should be determined as accurately as possible. The use of suitably calibrated measuring equipment is recommended. As the vial cannot be broached more than 40 times, the user should choose the more appropriate vial size.

Shake the bottle well for 30 seconds before use to bring the veterinary medicinal product back into suspension.

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Contraindications

Do not use in cases of hypersensitivity to the active substance, to other beta-lactam antibiotics or to any of the excipients

Do not inject intravenously.

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

Do not use in cases where resistance to ceftiofur or to other cephalosporins or beta-lactam antibiotics has occurred.

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Adverse reactions

Pig:

Common (1 to 10 animals / 100 animals treated): Injection site reaction1

Very rare (<1 animal / 10 000 animals treated, including isolated reports): Hypersensitivity reaction2; Allergic reactions (skin reaction, anaphylaxis)3

1Mild, such as residual lesions in the intermuscular connective tissue consisting of round clear areas, for up to 20-22 days after injection.

2Unrelated to dose.

3In this case the treatment should be withdrawn.

3Treatment should be withdrawn.

Cattle:

Common (1 to 10 animals / 100 animals treated): Injection site inflammation1(e.g. injection site inflammation, injection site oedema, discoloration2)

Very rare (<1 animal / 10 000 animals treated, including isolated reports): Hypersensitivity reaction3; Allergic reactions (e.g. allergic skin reaction, anaphylaxis).4

1 Mild, clinical resolution by 10 days after injection.

2 Of the subcutaneous tissue and/or fascial surface of the muscle, may persist for 32 days or more.

3Unrelated to dose.

4Treatment should be withdrawn.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

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Warnings

Special precautions for safe use in the target species:

The veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal product is used. Increased use, including use of the veterinary medicinal product deviating from the instructions given in the SPC, may increase the prevalence of such resistance. Whenever possible, the veterinary medicinal product should only be used based on susceptibility testing. The veterinary medicinal product 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 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.

Do not handle this veterinary medicinal 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, seek medical advice immediately and show the package leaflet of the label to the physician.

Swelling of the face, lips or eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.

Handle this veterinary medicinal product with great care to avoid exposure. Wash hands after use.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Special precautions for the protection of the environment:

Not applicable.

3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance

<Not applicable.>

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Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy or lactation.

Pregnancy and lactation:

Laboratory studies have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

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Interactions

The bactericidal properties of cephalosporins are antagonized by simultaneous use of bacteriostatic antibiotics (macrolides, sulphonamides and tetracyclines).

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Overdose

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.

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Special warnings

None.

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Withdrawal period

Pigs:

- Meat and offal: 5 days.

Cattle:

- Meat and offal: 8 days

- Milk: Zero hours.

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Incompatibilities

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

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Immediate packaging

Vial of polypropylene with closures of bromobutyl rubber and aluminium cap.

Package sizes:

Cardboard box with 1 vial of 100 ml.

Cardboard box with 1 vial of 250 ml.

Not all pack sizes may be marketed.

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Storage

This veterinary medicinal product does not require any special storage conditions.

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Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days.

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Disposal of unused product

Medicines should not be disposed of via wastewater or household waste.

Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.

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Additional information

Vm 42204/4000

8 DATE OF FIRST AUTHORISATION

04 September 2013

9 DATE OF THE LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTICS

December 2025

10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCT

Veterinary medicinal product subject to prescription.

Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.

Approved 13 May 2026

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Registration holder

Laboratorios Maymo S.A.U.

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