1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cobactan LA 7.5% w/v suspension for injection for swine

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml contains:

Active substance:

Cefquinome (as sulfate) 75 mg

For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection

White to off-white resuspendable suspension

4. CLINICAL PARTICULARS

4.1 Target species

Pigs

4.2 Indications for use, specifying the target species

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocidasensitive to cefquinome.

4.3 Contraindications

Do not use in animals which are known to be hypersensitive to cephalosporin antibiotics or to other β-lactam antibiotics, or to any of the excipients.

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

4.4 Special warnings

In food borne pathogens, co-resistance can occur for various antimicrobial substances including aminoglycosides, sulphonamides and trimethoprim compounds, chloramphenicol, ciprofloxacin, gentamycin and tetracycline.

4.5 Special precautions for use

Special precautions for use in animals

Cobactan LA 7.5% w/v suspension for injection for swine 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, Cobactan LA 7.5% w/v suspension for injection for swine 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, Cobactan LA 7.5% w/v suspension for injection for swine should only be used based on susceptibility testing.

Cobactan LA 7.5% w/v suspension for injection for swine 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.

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.

1. Do not handle this product if you know you are sensitized to penicillins and cephalosporins, or if you have been advised not to work with such preparations.

2. Handle this product with great care to avoid exposure by accidental contact with the skin and accidental self-injection. Wash exposed skin after use.

3. 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.

4. Persons developing a reaction after contact with the product should avoid handling the product (and other cephalosporins and penicillin containing products) in future.

4.6 Adverse reactions (frequency and seriousness)

After intramuscular injection of the medicinal product, limited macroscopic lesions were observed at the injection site of treated animals (2x5cm area). The lesions were reversible. For some animal this took up to 14 days after treatment. Pain at injection is commonly observed.

4.7 Use during pregnancy, lactation or lay

There is no evidence of reproductive toxicity (including teratogenicity) in pigs. Laboratory studies in rats and rabbits have not shown any teratogenic, foetotoxic or maternotoxic effects. Use only according to the benefit/risk assessment by the responsible veterinarian.

4.8 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. Resistance mechanism in Gram-negative organisms due to extended spectrum beta-lactamases (ESBL) and in Gram-positive organisms due to alteration of penicillin binding proteins (PBPs) may lead to cross-resistance with other beta-lactams.

4.9 Amounts to be administered and administration route

For intramuscular administration: two injections with 48 hours interval.

3.0 mg cefquinome/kg bodyweight (equivalent to 1 ml of Cobactan LA 7.5% w/v/25 kg bodyweight).

Shake the vial well before using.

It is recommended to divide the dose so that no more than 3 ml of the product are injected at one site. Do not use the same injection site more than once during a course of treatment.

The rubber stopper of the vial may be safely punctured up to 20 times. Otherwise, automatic syringe equipment, or a suitable draw-off needle, should be used to avoid excessive puncturing of the closure.

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

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Overdoses of 3x the recommended dose have been systemically well tolerated.

4.11 Withdrawal period(s)

Pigs (meat and offal): 7 days

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: cephalosporins and related substances

ATCvet code: QJ01DE90

5.1 Pharmacodynamic properties

Cefquinome is an antibacterial of the cephalosporin group which acts by inhibition of cell wall synthesis. It is bactericidal, is time dependant and is characterised by its broad therapeutic spectrum of activity. As a fourth generation cephalosporin, it combines high cellular penetration and a high stability against beta-lactamases which predict a lower probability for selection. 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. Resistance mechanism in Gram negative organisms due to extended spectrum beta-lactamases (ESBL) and in Gram-positive organisms due to alteration of penicillin binding proteins (PBPs) may lead to cross-resistance with other beta-lactams.

In vitro activity has been demonstrated against Actinobacillus pleuropneumoniae, Haemophilus parasuis and Pasteurella multocida.

A total of 178 Actinobacillus pleuropneumoniae,43 Haemophilus parasuisand 185 Pasteurella multocidaisolated between 2004 and 2010 from the respiratory tract of diseased pigs across Europe were investigated.

Actinobacillus pleuropneumoniaeand Haemophilus parasuishave a MIC₉₀of 0.032 µg/ml.The MIC₉₀for Pasteurella multocidais 0.063 µg/ml.

In food borne pathogens, co-resistance can occur for various antimicrobial substances including aminoglycosides, sulphonamides and trimethoprim compounds, chloramphenicol, ciprofloxacin, gentamycin and tetracycline.

5.2 Pharmacokinetic particulars

After intramuscular administration of Cobactan LA 7.5% w/v at the recommended dose maximum serum concentrations (C_max) in the range of 0.86 µg/ml and 0.88 µg/ml are reached after approximately 1 hour. Terminal half life is around 9 hours.

Cefquinome binds poorly to plasma proteins in pigs (about 14%).It is excreted mainly via the urine.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Aluminium stearate

Triglycerides medium-chain

6.2 Incompatibilities

Do not mix with other veterinary medicinal products

6.3 Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years

Shelf-life after first opening of the container: 28 days

6.4. Special precautions for storage

Do not store above 25°C.

6.5 Nature and composition of immediate packaging

50 ml, 100 ml and 250 ml type II glass vials sealed with chlorobutyl rubber stoppers

Box of one 50 ml glass vial

Box of one 100 ml glass vial

Box of one 250 ml glass vial

Not all pack sizes may be marketed.

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

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Intervet International B.V.

Wim de Körverstraat 35

5831 AN Boxmeer

The Netherlands

Tel.: +31 /485 587 600

Fax.: +31 /485 577 333

8. MARKETING AUTHORISATION NUMBER

Vm 01708/4573

9. DATE OF FIRST AUTHORISATION

18 May 2012

10 DATE OF REVISION OF THE TEXT

May 2012