SUMMARY OF PRODUCT CHARACTERISTICS

Multishield DC Intramammary Suspension for Cows

[Multishield Secado (ES)]

[Multimast Dry Cow Vet (DK)]

[Cymastin DC (CZ, HU, SK)]

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 4.5g intramammary syringe contains

Active Substances:

Neomycin 70 000 IU

(corresponding to Neomycin Sulphate 100 mg)

Penethamate 77.2 mg

(corresponding to Penethamate Hydriodide 100 mg)

Benzylpenicillin 227.2 mg

(corresponding to Procaine Benzylpenicillin 400 mg)

Excipients:

For a full list of excipients, see section 6.1.

Intramammary suspension.

A smooth, off white, oily suspension.

4.1 Target species

Cows (at dry off)

4.2 Indications for use

In cows at drying off:

Treatment of subclinical mastitis caused by bovine mastitis organisms sensitive to the combination of active substances, penicillin and neomycin, and as part of strategy for the prevention of new infections occurring during the dry period.

4.3 Contraindications

Do not use in lactating cows.

Do not use in animals which are known to be hypersensitive to β-lactam antibiotics, cephalosporin antibiotics, neomycin or other aminoglycoside antibiotics or to iodine.

Do not use in cows with clinical mastitis.

4.4 Special warnings

None.

4.5 Special Precautions for Use

Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.

Official, national and regional antimicrobial policies should be taken into account when the product is used

The therapeutic efficacy of the product is only established against pathogens that are sensitive to the active substances.

Serious acute mastitis [potentially lethal] due to pathogens like Pseudomonas aeruginosa, can occur after drying off despite preventive treatment. Good aseptic practices should be thoroughly respected in order to reduce that risk; cows should be housed in a hygienic paddock far from the milking parlour and regularly checked several days after drying off.

medicinal product to animals

Operators should avoid contact with this preparation as occasionally skin allergy may occur.

Penicillins and cephalosporins may cause sensitisation following injection, inhalation, ingestion or skin contact. Sensitivity 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 that you are sensitised or if you have been advised not to work with such preparations.

If you develop symptoms such as a skin rash following exposure, seek medical advice and show this warning to the doctor. Swelling of the face, lips or eyes, or difficulty with breathing are more serious symptoms and require urgent medical attention.

4.6 Adverse reaction (frequency and seriousness)

Allergic reactions (allergic skin reactions, anaphylaxis)

Penicillins may cause hypersensitivity following administration. Allergic reactions to these substances may occasionally be serious.

4.7 Use during pregnancy and lactation

The product is not recommended for use in lactating cows, except at the drying off stage.

4.8 Interaction with other medicinal products and other forms of interactions

No data available.

4.9 Amounts to be administered and administration route

100 mg of neomycin sulphate, 100 mg of Penethamate Hydriodide and 400 mg of Procaine Benzylpenicillin into each quarter.

Single intramammary administration

The contents of one syringe should be infused into each quarter via the teat canal immediately after the final milking of a lactation.

Before instillation, the udder should be milked out completely. The teat and its orifice should be thoroughly cleaned and disinfected with a cleaning towel. Care should be taken to avoid contamination of the injector nozzle. Gently insert the content of one syringe into each quarter. Disperse the product by gentle massage of the teat and udder. The syringe must only be used once.

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

Overdosing may invalidate the stated milk and meat withdrawal times.

4.11 Withdrawal periods

Meat and Offal: 28 days.

Milk: 96 hours post calving in cows with a dry period of more than 50 days.

50 days plus 96 hours after treatment from cows with a dry period of 50 days or less.

Pharmacotherapeutic group: Combination of antibacterials for intramammary use,

Beta-lactam antibacterials with other antibacterials.

ATCvet Code:QJ51RC

5.1 Pharmacodynamic properties:

The product contains an aminoglycoside (neomycin sulphate) and two penicillin derivatives (procaine benzyl penicillin and penethamate hydriodide).

Aminoglycosides disturb the permeability of the bacterial cell membrane by an effect exerted during cell wall development. Once the aminoglycoside has entered the cell, it binds to receptors on the ribosome, inducing misreading of the genetic code. Neomycin in common with other aminoglycosides has activity predominantly against gram negative organisms.

Neomycin has been shown to have synergistic activity with β-lactam antibiotics against Gram positive bacteria.

Penicillins have a time-dependent, bacteriocidal effect by interfering with microbial cell wall synthesis. They inhibit the activity of transpeptidase enzymes which catalyse cross linkage of the glycopeptide polymer units that form the cell wall. Both Procaine benzylpenicillin and Penethamate hydroiodide are hydrolysed in the udder to release free penicillin.

Bovine mastitis organisms which can be treated with the product include sensitive isolates of Staphylococcus aureus, Streptococcus agalactiae, Streptococcus uberis, other sensitiveStreptococcus spp,Arcanobacterium pyogenesand sensitive isolates ofE.coli.

Penicillin resistance due to the production of penicillinase is a well-recognised feature of some Staphylococcus sppisolates however reported resistance levels vary considerably between geographical areas. The prevalence of resistance against neomycin remains low in those species.

5.2 Pharmacokinetic Particulars

Penethamate hydriodide is an ester of benzylpenicillin which is rapidly hydrolysed at pH 7.3 to liberate free penicillin which quickly distributes throughout the udder tissue.

Procaine benzylpenicillin is a complex, sparingly soluble organic salt of benzylpenicillin and its use, in combination with a slow-release base, is intended to delay release of the active penicillin moiety at the site of administration and so give rise to a prolonged duration of action.

Neomycin is a poorly lipid soluble, basic aminoglycoside that shows a high degree of binding to udder tissue and has low systemic absorption thus it persists in the udder for a prolonged period after administration.

6. PHARMACEUTICAL PARTICULARS

Liquid paraffin

Aluminium di/tristearate.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

Syringes are for single use only.

6.4 Special Precautions for Storage

Do not store above 25°C.

Do not refrigerate or freeze

6.5 Nature and contents of immediate packaging

Low density Polyethylene intramammary syringe, containing 4.5g intramammary suspension.

Syringes packed in cartons of 24 syringes or buckets of 120 syringes.

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 product

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

Cross Vetpharm Group Ltd

Broomhill Road

Tallaght

Dublin 24

Ireland

8. MARKETING AUTHORISATION NUMBER

Vm:12597/4058

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date:02 May 2013

10. DATE OF REVISION OF THE TEXT

Date: December 2013

PROHIBITION OR SUPPLY SALE AND OR USE

23 December 2013