Cobactan® 2.5 % suspension for injection

Summary of product characteristics

  1. NAME OF THE VETERINARY MEDICINAL PRODUCT

    COBACTAN® 2.5% suspension for injection
    Cephaguard® 2.5% suspension for injection (UK and Ireland)

  2. QUALITATIVE AND QUANTITATIVE COMPOSITION

    Each ml contains:

    Active substance:
    Cefquinome 25mg (equivalent to 29.64 mg/ml Cefquinome sulphate).

    Excipients:
    Ethyl oleate ad 1 ml

  3. PHARMACEUTICAL FORM

    Suspension for injection

  4. CLINICAL PARTICULARS
    1. Target species

      Cattle and pigs

    2. Indications for use, specifying the target species

      For the treatment of bacterial infections in cattle and pigs caused by the Gram positive and Gram negative microorganisms sensitive to cefquinome.

      Cattle:

      • Respiratory disease caused by Pasteurella multocida and Mannheimia haemolytica
      • Digital dermatitis, infectious bulbar necrosis and acute interdigital necrobacillosis (foul in the foot)
      • Acute E.coli mastitis with signs of systemic involvement

      Calves:

      • E.coli septicaemia in calves

      Pigs:

      • For the treatment of bacterial infections of the lungs and respiratory tract caused by Pasteurella multocida, Haemophilus parasuis, Actinobacillus pleuropneumoniae, Streptococcus suis and other cefquinome-sensitive organisms
      • Mastitis-Metritis-Agalactia syndrome (MMA) with involvement of E.coli, Staphylococcus spp., Streptococcus spp. and other cefquinome sensitive organisms

      Piglets:

      • Reduction of mortality in cases of meningitis caused by Streptococcus suis.

      For the treatment of:

      • Arthritis caused by Streptococcus ssp., E. coli and other cefquinome-sensitive organisms.
      • Epidermitis (mild or moderate lesions) caused by Staphylococcus hyicus.
    3. Contraindications

      Do not use Cobactan 2.5% in animals, which are known to be hypersensitive to ß-lactam antibiotics.
      Do not administer to animals less than 1.25 kg body weight.

    4. Special warnings

      None.

    5. Special precautions for use

      Special precautions for use in animals

      Shake the vial well before using.

      The product does not contain an antimicrobial preservative. Swab the septum before removing each dose. Use a dry sterile needle and syringe. An appropriately graduated syringe must be used to allow accurate administration of the required dose volume. This is particularly important when injecting small volumes, for example when treating piglets. The cap may be safely punctured up to 25 times. The 50ml vial should be used for treating small piglets. When treating groups of animals, use a draw-off needle.

      Use of the product should be based on susceptibility testing and take into account official and local antimicrobial policies.

      To prevent the claimed infections in piglets, attention should be paid to hygiene and ventilation, and overcrowding should be avoided. When the first piglets are affected, careful examination of the other animals of the same pen is recommended to enable an early treatment.

      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 sensitivity 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 preparation.
      • Handle this product with great care to avoid exposure, taking all recommended precautions.
      • 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.
    6. Adverse reactions (frequency and seriousness)

      Use of the product may result in localized tissue reaction. Tissue lesions are repaired 15 days after the last administration of the product.
      Hypersensitivity reactions to cephalosporins occur rarely.
      Hypersensitivity type reactions in cattle have been reported as individual isolated cases.

    7. Use during pregnancy and lactation

      There is no available information indicating reproductive toxicity in cattle or pigs. In reproduction toxicity studies in laboratory animals cefquinome did not reveal any effect on reproduction or teratogenic potential.

    8. Interaction with other medicinal products and other forms of interaction

      It is known that a cross sensitivity to cephalosporin exists for bacteria sensitive to the cephalosporin group.

    9. Amounts to be administered and administration route

      Dosing of Cobactan 2.5%
      SpeciesIndicationDosageFrequency
      Cattle
      • Respiratory disease caused by Pasteurella multocida and M. haemolytica 1 mg cefquinome/kg bw (2 ml/50 kg bw) Once daily for 3 or 5 consecutive days
      • Digital dermatitis, infectious bulbar necrosis and acute interdigital necrobacillosis (foul in the foot)
      		1 mg cefquinome/kg bw (2 ml/50 kg bw)Once daily for 3 or 5 consecutive days
      • Acute E. coli mastitis with signs of systemic involvement
      		1 mg cefquinome/kg bw (2 ml/50 kg bw)Once daily for 2 consecutive days
      Calves
      • E. coli septicaemia
      		2 mg cefquinome/kg bw (4 ml/50 kg bw)Once daily for 3 or 5 consecutive days
      Pigs
      • Respiratory disease
      		2 mg Cefquinome/kg bw (2 ml/25 kg bw)Once daily for 3 consecutive days.
      • MMA
      		2 mg Cefquinome/kg bw (2ml/25 kg bw)Once daily for 2 consecutive days.
      Piglets
      • Meningitis
      • Arthritis
      • Epidermitis
      		2 mg Cefquinome/kg bw (2ml/25 kg bw)Once daily for 5 consecutive days

      All treatments to be given by intramuscular injection. Studies have indicated the advisability of giving second and subsequent injections at a different injection site. The localization for the injection site is preferably the neck resp. cervical region.

      To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.

    10. Overdose (symptoms, emergency procedures, antidotes), if necessary

      Overdoses of 20 mg/kg/day in cattle and 10 mg/kg/day in pigs and piglets have been well tolerated.

    11. Withdrawal period(s)

      Withdrawal periods indicated for different species
      SpeciesProductWithdrawal Period
      CattleMeat5 days
      CattleMilk24 hours
      PigsMeat and offal3 days

  5. PHARMACOLOGICAL PROPERTIES

    Pharmaceutic group: Cephalosporins and related substances
    ATCvet code: QJ01DA91

    The antibacterial drug Cefquinome is a broad-spectrum cephalosporin of the fourth-generation which acts by inhibition of the cell wall synthesis. It is bactericidal and is characterized by its broad therapeutic spectrum of activity and a high stability against penicillinases and beta-lactamases.

    1. Pharmacodynamic properties

      In vitro activity has been demonstrated against common Gram positive and Gram negative bacteria including Escherichia coli, Citrobacter spp., Klebsiella spp., Mannheimia haemolytica, Pasteurella multocida, Proteus spp., Salmonella spp., Serratia marcescens, Haemophilus somnus, Arcanobacterium pyogenes, Bacillus spp., Corynebacterium spp., Staphylococcus spp., Streptococcus spp., Bacteroides spp., Clostridium spp., Fusobacterium spp., Prevotella spp., Actinobacillus spp. and Erysipelothrix rhusiopathiae.
      Bacterial strains were isolated between 1999 and 2002 from cattle and pigs presenting diseases corresponding to target indications in Germany, France, The Netherlands and United Kingdom. From a sample of more than 350 isolates, 97.7% were found to be susceptible to cefquinome (resistance breakpoint of 4 µg/mL). These susceptible strains had MIC levels ranging from < 0.004 to 2 µg/mL.
      Cefquinome as a fourth generation cephalosporin combines high cellular penetration and ß-lactamase stability. In contrast to cephalosporins of previous generations, cefquinome is not hydrolysed by chromosomally-encoded cephalosporinases of the Amp-C type or by plasmid mediated cephalosporinases of some enterobacterial species. However, some Extended Spectrum beta-lactamases (ESBL) can hydrolyse cefquinome and cephalosporins of other generations. The potential for resistance development against cefquinome is rather low. High-level resistance to cefquinome would require the coincidence of two genetic modifications, i.e. hyperproduction of specific ß-lactamases as well as decreased membrane permeability.

    2. Pharmacokinetic particulars

      In cattle peak serum concentrations of about 2 µg/ml are reached within 1.5-2 hours after intramuscular or subcutaneous administration at the dose of 1 mg/kg. Cefquinome has a relatively short half-life (2.5 hours), is < 5 % protein bound and excreted unchanged in the urine. Cefquinome is not absorbed after oral administration.
      In pigs or piglets, at 2 mg/kg dosage, maximum serum concentrations of around 5 µg/ml are measured within 15 to 60 minutes after intramuscular injection. The average half-life is about 9 hours.
      Cefquinome binds poorly to plasma proteins and therefore penetrates into the cerebrospinal fluid (CSF) and the synovial fluid in pigs. The concentration profile is similar between the synovial fluid and the plasma. The concentrations reached in the CSF 12 hours after treatment are similar to those in plasma.

  6. PHARMACEUTICAL PARTICULARS
    1. List of excipients

      Ethyl oleate

    2. Incompatibilities

      None known

    3. Shelf life

      2 years.
      After first broaching the container: 28 days

    4. Special precautions for storage

      Do not store above 25 ° C.
      Keep vial in outer carton.

    5. Nature and composition of immediate packaging

      50ml and 100ml colourless glass bottles, type II with grey epichlorhydrine rubber stoppers, fluoro polymer coated, type I closure and sealed with aluminum caps.

    6. Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

      Any unused product or waste material should be disposed of in accordance with national requirements.

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Cobactan 2.5%