Siccamed+

STATEMENT OF THE ACTIVE SUBSTANCE (S) AND OTHER INGREDIENTS

1 intramammary syringe (5.4g of intramammary suspension) contains:
Active substance:
Cloxacillin 600 mg (as Cloxacillin benzathine)
Ampicillin 300 mg (as Ampicillin trihydrate)
Excipients: Aluminium Di stearate, Liquid Paraffin.

INDICATIONS

Siccamed+ is formulated for use in cows at the beginning of the drying period, i.e. immediately after the last milking. The drug is intended both for the treatment of existing mastitis and for the protection of the udder against further infections during the drying period. Siccamed+ works effectively against gram-positive and gram-negative microorganisms that cause udder infections, against Streptococcus agalactiae and other Streptococcus species, penicillin-resistant and sensitive staphylococci, Corinebacterium spp., Arcanobacteria spp., Escherichia coli and other sensitive gram-negative bacteria. Cloxacillin benzathine and ampicillin trihydrate in this formulation maintain effective antibacterial concentrations in the udder of dry cows for up to 10 weeks without tissue irritation.

CONTRAINDICATIONS

• Do not use in cows that have a short dry period.
• It is not intended for use in a period shorter than 49 days until the expected date of calving.
• Do not use in animals with known hypersensitivity to penicillins.
• It must not be used in the therapy of lactating cows.

ADVERSE REACTIONS

An allergic reaction is possible.

TARGET SPECIES

Cows, during the dry season.

DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINSITRATION

Intramammary use.
The drug Siccamed+ is applied during the dry season.

ADVICE ON CORRECT ADMINISTRATION

After the last milking during lactation, clean and disinfect the teats and inject the contents of one intramammary syringe into each quarter through the teat canal. Avoid contamination of the syringe tip. When treating heifers, it is important that the tip of the syringe does not penetrate the teat.

The following procedure is recommended:
The animal must be properly immobilized. Teats must be cleaned and disinfected. The nipple opening must be located and the tip of the syringe placed on the opening but not inserted into it. When the plunger of the injector is pressed, the antibiotic easily passes through the teat into the udder.

WITHDRAWAL PERIOD

The preparation is not used in cows that have a short drying period.
It is not intended for use in a period shorter than 49 days until calving.
Milk for human consumption can be used 156 hours after calving.
If the cow calves earlier than 49 days after the last treatment, milk for human consumption can be used after 56 (49+7) days after the last treatment.
The meat of treated animals cannot be used for 28 days after the application of the drug.

SPECIAL STORAGE PRECAUTIONS

Keep out from the reach of children
Store in original package at temperature of 25oC,
Shelf life: 2 years

SPECIAL WARNINGS

Special precautions for use in animals

• Use of the product should be based on susceptibility testing of bacteria isolated from milk samples obtained from the udder quarter(s) of each cow to be dried off. If this is not possible, therapy should be based on local (regional, farm level) risk based epidemiological information about the expected pathogen challenge, and susceptibility of target bacteria.
• Use of the product deviating from the instructions given in the SPC may contribute to the development of bacterial resistance to cloxacillin and ampicillin which may also decrease the effectiveness of treatment with other beta-lactamase resistant penicillins.
• Dry cow therapy protocols should take local and national policies on antimicrobial use into consideration, and undergo regular veterinary review.
• The feeding of waste milk containing residues of cloxacillin to calves should be avoided up to the end of the milk withdrawal period (except during the colostral phase), because it could select antimicrobial-resistant bacteria within the intestinal microbiota of the calf and increase the faecal shedding of these bacteria.
• The efficacy of the product has only been established for target organisms listed above.
• Consequently, the occurrence of a severe mastitis after drying-off (sometimes fatal) due to other organisms, especially Pseudomonas aeruginosa, is possible.
• To reduce this risk it is important to observe strict aseptic technique for the administration of the product. When applying to heifers, it is important that the tip of the syringe does not penetrate the teat.

The following procedure is recommended:

• The animal must be properly immobilized.
• Teats must be cleaned and disinfected.
• The teat opening must be located and the tip of the syringe placed on the opening, but not inserted into it.
• When the plunger of the injector is pressed, the antibiotic easily passes through the teat into the udder.
• Special precautions to be taken by the person administering the veterinary medicinal product to animals
• When applying this medicine, protective gloves should be used to prevent contact with the skin.
• Penicillins and cephalosporins can cause hypersensitivity (allergies) as a result of injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins can lead to cross-reaction with cephalosporins and vice versa. Persons with known sensitivities are advised not to handle this preparation. Allergic reactions to these substances can be very serious. If the symptoms manifest themselves as itching, you should seek medical help. Swelling of the face, lips, eyes or breathing problems are more serious symptoms and require immediate medical attention. Wash your hands after each use.

SPECIAL PRECAUTIONS FOR THE DIPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY

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