Diacef

Each ml contains:

Active substance:
Ceftiofur (hydrochloride)…………………………….. 50 mg
(equivalent to 53.48 mg ceftiofur hydrochloride)

Excipients:
For the full list of excipients, see section 6.1.

Injectable
suspension Homogeneous and lump-free suspension of white-cream colour

: Pigs and cattle

4.2 Indications for use, specifying target species

Infections associated with ceftiofur-sensitive bacteria.

In swine:
For the treatment of respiratory bacterial diseases associated with Pasteurella multocida, Actinobacillus pleuropneumoniae and Streptococcus suis.

In cattle:

For the treatment of respiratory bacterial diseases associated with Mannheimia haemolytica (formerly Pasteurella haemolytica), Pasteurella multocida and Histophilus somni (formerly Haemophilus somnus).
For the treatment of acute interdigital necrobacillosis (whitlow, pododermatitis), associated with Fusobacterium necrophorum and Porphyromonas asaccharolytica (formerly Bacteroides melaninogenicus).
For the treatment of bacterial components of acute postpartum (puerperal) metritis within 10 days after delivery associated with ceftiofur-sensitive Escherichia coli, Trueperella pyogenes (formerly Arcanobacterium pyogenes) and Fusobacterium necrophorum, when treatment with another antimicrobial has failed.

Do not use in cases of hypersensitivity to the active substance, other beta-lactam antibiotics or any of the excipients.
Do not inject intravenously.
Do not use in poultry (or their eggs) due to the risk of spreading antimicrobial resistance to humans.

None.

Special precautions for use in animals
This veterinary medicinal product selects resistant strains such as broad-spectrum beta-lactamase (BLAE) carrying bacteria that may pose a risk to human health if those strains are spread to humans, e.g. through food. For this reason, this veterinary medicinal product should be reserved for the treatment of clinical conditions that have responded poorly or that are expected to respond poorly (refers to very acute cases that require treatment without a bacteriological diagnosis) to first-line treatment. When using the veterinary medicinal product, official, national and regional antimicrobial recommendations should be taken into account. Greater use than intended or use that deviates from the instructions provided in the label may increase the prevalence of these resistances. Whenever possible, the use of this veterinary medicinal product should be based on susceptibility testing.
Do not use as prophylaxis in case of retained placenta.
This veterinary medicinal product is intended for the treatment of specific animals. Do not use for disease prevention or as part of herd health programs. The treatment of groups of animals should be strictly limited to active outbreaks of disease in accordance with the approved conditions of use.
Specific precautions to be taken by the person administering the veterinary medicinal product to animals
Penicillins and cephalosporins may cause hypersensitivity (allergy) after injection, inhalation, ingestion or contact with the skin. Hypersensitivity to penicillins can lead to cross-reactions with cephalosporins and vice versa. Allergic reactions to these substances can sometimes be serious.
Do not handle the veterinary medicinal product in case of known hypersensitivity or if you have been instructed not to work with such preparations.
Handle the veterinary medicinal product with great caution to avoid exposure, taking all recommended precautions.
In case of accidental self-injection or if you develop symptoms after exposure such as skin rashes, consult a doctor immediately and show the leaflet or label. Swelling of the face, lips, or eyes, or shortness of breath are more serious symptoms that require urgent medical attention.
Wash hands after use.

Non-dose-related hypersensitivity reactions may occur. Allergic reactions (e.g., skin reactions, anaphylaxis) have been reported very rarely during clinical studies.
In pigs, mild injection site reactions, such as discoloration of fascia or fat, have been observed during the 20 days after injection on very rare occasions during clinical studies.
In cattle, oedema/swelling at the injection site was observed after subcutaneous injection of this veterinary medicinal product. Mild to moderate chronic local inflammation was observed in most animals up to 18 days after injection very frequently during clinical studies.

Los estudios de laboratorio efectuados en animales de laboratorio no han demostrado efectos teratogénicos, tóxicos para el feto, ni tóxicos para la madre.
No ha quedado demostrada la seguridad del medicamento veterinario durante la gestación en cerdas y vacas.
Utilícese únicamente de acuerdo con la evaluación beneficio/riesgo efectuada por el veterinario responsable.

Las propiedades bactericidas de los betalactámicos se neutralizan mediante el uso simultáneo de antibióticos bacteriostáticos (macrólidos, sulfonamidas y tetraciclinas).
Los aminoglucósidos pueden tener un efecto potenciador sobre las cefalosporinas.

• Porcino:

Vía intramuscular.
3 mg de ceftiofur/kg p.v./día durante 3 días consecutivos, equivalente a 1 ml de medicamento veterinario/16 kg p.v. en cada inyección.

• Bovino:

Vía subcutánea.
Enfermedades respiratorias: 1 mg de ceftiofur/kg p.v./día durante 3 a 5 días consecutivos, equivalente a 1 ml de medicamento veterinario/50 kg p.v. en cada inyección.
Necrobacilosis interdigital aguda: 1 mg de ceftiofur/kg p.v./día durante 3 días consecutivos, equivalente a 1 ml de medicamento veterinario/50 kg p.v. en cada inyección.
Metritis aguda posparto: 1 mg de ceftiofur/kg p.v./día durante 5 días consecutivos, equivalente a 1 ml de medicamento veterinario/50 kg p.v. en cada inyección.

La baja toxicidad de ceftiofur ha sido demostrada en porcino administrando intramuscularmente ceftiofur sódico en dosis 8 veces superiores a la dosis diaria recomendada de ceftiofur durante 15 días consecutivos.
En bovino, no se han observado signos de toxicidad sistémica después de elevadas sobredosificaciones por vía parenteral.

Porcino:

– Leche: cero días

Grupo farmacoterapéutico: Antibacterianos de uso sistémico. Cefalosporinas de tercera generación. Ceftiofur

Los betalactámicos actúan interfiriendo en la síntesis de la pared celular bacteriana. La síntesis de la pared celular depende de las enzimas denominadas proteínas de unión a penicilina (PBPs). Las bacterias desarrollan resistencia a las cefalosporinas por cuatro mecanismos básicos: 1) alterando las proteínas de unión a penicilina insensibles frente al betalactámico que de otra forma sería eficaz; 2) alterando la permeabilidad de la pared celular a betalactámicos; 3) produciendo betalactamasas capaces de abrir el anillo betalactámico de la molécula, o 4) difusión activa.

Las siguientes Concentraciones Mínimas Inhibitorias (CMI) han sido determinadas para ceftiofur en cepas europeas de bacterias diana (2009-2012), aisladas de animales enfermos:

ND: no determinada
Para ceftiofur, el CLSI (2013) ha recomendado los siguientes puntos de corte para patógenos respiratorios porcinos y bovinos:

Hasta hoy no se han determinado puntos de corte para los patógenos asociados con el panadizo o con la metritis aguda posparto en vacas.

Ceftiofur has complete bioavailability after administration subcutaneously.

6.1 List of Excipients

Aluminium Stearate

6.2 Main incompatibilities

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

Shelf life of the veterinary medicinal product put up for sale: 30 months
Shelf life after opening the primary packaging: 28 days

Store the vial in the outer packaging to protect it from light.

 Type

I colourless glass vial, with bromobutyl rubber stopper and aluminium capsule.

Any unused veterinary medicinal product or waste derived from it shall be disposed of in accordance with local regulations.

7. MARKETING AUTHORISATION HOLDER

SUPER’S DIANA, S.L.

8. MARKETING AUTHORISATION NUMBER(S)

2766 ESP

Date of first authorisation: 02 April 2013
Date of last renewal: 09 May 2018

May 2018

Conditions of dispensation: Medicinal product subject to veterinary prescription
Conditions of administration: Administration under the control or supervision of the veterinarian