Seclaris

Main information

  • Trade name:
  • Seclaris DC 250 mg Intramammary Suspension for Dry Cows
  • Pharmaceutical form:
  • Intramammary suspension
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Seclaris DC 250 mg Intramammary Suspension for Dry Cows
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Cattle
  • Therapeutic area:
  • Antimicrobial intramammary

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 15052/4139
  • Authorization date:
  • 13-12-2017
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Revised: December 2018

AN: 00941/2018

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Seclaris DC 250 mg Intramammary Suspension for dry cows [UK AT BG HR CY CZ

EE FR DE EL HU IE IT LV LT PL PT RO SK SI]

Seclaris Secado 250 mg Intramammary Suspension for dry cows [ES]

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Each intramammary syringe of 3 g contains:

Active substance:

Cefalonium (as cefalonium dihydrate)

250 mg

For the full list of excipients see section 6.1.

3.

PHARMACEUTICAL FORM

Intramammary suspension

Shiny off-white to yellowish ointment.

4.

CLINICAL PARTICULARS

4.1

Target species

Cattle (dry cow).

4.2

Indications for use, specifying the target species

For the treatment of subclinical mastitis at drying-off and the prevention of new

bacterial infections of the udder during the non-lactating period of cows caused by

Staphylococcus aureus, Streptococcus agalactiae, Streptococcus dysgalactiae,

Streptococcus uberis, Trueperella pyogenes, Escherichia coli and Klebsiella spp

susceptible to cefalonium.

4.3

Contraindications

Do not use in animals with known hypersensitivity to cefalosporins, other ß-lactam

antibiotics or to any of the excipients.

4.4

Special warnings for each target species

None.

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AN: 00941/2018

4.5

Special precautions for use

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

cefalonium which may also decrease the effectiveness of treatment with other beta

lactams. Dry cow therapy protocols should take local and national policies on

antimicrobial use into consideration, and undergo regular veterinary review.

The feeding to calves of milk containing residues of cefalonium that could select for

antimicrobial-resistant bacteria (e.g. ESBL) should be avoided up to the end of the

milk withdrawal period, except during the colostral phase.

The efficacy of the product is only established against the pathogens mentioned in

Section 4.2 “Indications for use”. Consequently, serious acute mastitis (potentially

fatal) due to other pathogen species, particularly Pseudomonas aeruginosa, can

occur after drying off. Good hygienic practices should be thoroughly respected in

order to reduce this risk.

Special precautions to be taken by the person administering the veterinary medicinal

product to animals

Wash hands after use.

Penicillin and cefalosporins may cause sensitisation (allergy) following injection,

inhalation, ingestion or skin contact. Sensitivity to penicillin may lead to cross-

sensitivity to cefalosporin and vice versa. Allergic reactions to these substances may

occasionally be serious.

Do not handle this product if you know you are sensitised, or if you have been

advised not to work with such preparations.

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 breathing are more serious symptoms and require urgent medical attention.

The cleaning towels supplied with this product contain isopropyl alcohol, which may

cause skin or eye irritation in some people. It is recommended to wear protective

gloves when administering the product and handling the cleaning towels.

4.6

Adverse reactions

In very rare cases immediate hypersensitivity reactions were observed in some

animals (restlessness, tremors, swelling of mammary gland, eyelids and lips). These

reactions may lead to death.

The frequency of adverse reactions is defined using the following convention:

- very common (more than 1 in 10 animals displaying adverse reaction(s))

- common (more than 1 but less than 10 animals in 100 animals)

- uncommon (more than 1 but less than 10 animals in 1,000 animals )

- rare (more than 1 but less than 10 animals in 10,000 animals)

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AN: 00941/2018

- very rare (less than 1 animal in 10,000 animals, including isolated reports).

4.7

Use during pregnancy, and lactation or lay

Intended for use during the last trimester of pregnancy once the lactating cow has

been dried off. There is no adverse treatment effect on the foetus.

Do not use in cows that are lactating.

4.8

Interaction with other medicinal products and other forms of interaction

Cefalosporins should not be administered concurrently with bacteriostatic

antimicrobials. Concomitant use of cefalosporins and nephrotoxic drugs may

increase renal toxicity.

4.9

Amounts to be administered and administration route

For intramammary use.

The contents of one syringe should be infused into the teat canal of each quarter

immediately after the last milking of the lactation. After milking is complete,

thoroughly clean and disinfect the end of the teat with the cleaning towel provided.

There are two options for administration of the product:

Option 1: For short nozzle intramammary administration

Hold the barrel of the syringe and the base of the cap in one hand and twist off the

small upper part of the cap above the indent mark (the base portion of the cap

remains on the syringe) Take care not to contaminate the nozzle.

Option 2: For full nozzle intramammary administration

Remove the cap fully by holding the barrel of the syringe firmly in one hand and with

the thumb push up and along the length of the cap until the cap clicks off. Take care

not to contaminate the nozzle.

Insert the nozzle into the teat canal and apply steady pressure on the syringe plunger

until the full dose has been delivered. Holding the end of the teat with one hand,

gently massage upwards with the other to aid dispersion of the antibiotic into the

quarter. After infusion it is advisable to dip the teats in an antiseptic preparation

specifically designed for this purpose.

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

Repeated doses in cattle on three consecutive days did not demonstrate or produce

any adverse effects.

4.11 Withdrawal period

Meat and offal: 21 days

Milk: 96 hours after calving if the dry period is longer than 54 days

58 days following the treatment if the dry period is less than or equal to 54 days

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5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: other beta-lactam antibacterials for intramammary use,

first-generation cefalosporins.ATCvet Code: QJ51DB90

5.1

Pharmacodynamics

Cefalonium is an antibacterial drug of the first generation cefalosporin group which

acts by inhibition of cell wall synthesis (bactericidal mode of action).

Three mechanisms of resistance to cefalosporin are known: reduced permeability of

the cell wall, enzymatic inactivation and absence of specific penicillin binding sites. In

Gram-positive bacteria and particularly staphylococci, the main cefalosporin

resistance mechanism is through alteration of penicillin binding proteins. In Gram-

negative bacteria resistance may consist in the production of (broad- or extended-

spectrum) β-lactamases.

Cefalonium is active against Staphylococcus aureus, Streptococcus agalactiae,

Streptococcus dysgalactiae, Streptococcus uberis, Trueperella pyogenes,

Escherichia coli and Klebsiella spp susceptible to cefalonium.

5.2

Pharmacokinetics

Cefalonium is extensively but slowly absorbed from the udder and excreted primarily

in the urine. Between 7 and 13% of the active substance is eliminated in urine on

each of the first three days post dosing whilst daily excretion in faeces is < 1% over

the same period.

Mean blood concentration remains fairly constant during approximately 10 days after

dosing which is consistent with slow but prolonged absorption of cefalonium from the

udder.

The long term persistence of cefalonium in the dry udder was examined over a time

span of 10 weeks after infusion. Effective levels of cefalonium in udder secreta

remained up to 10 weeks after infusion.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Aluminium stearate.

Liquid paraffin.

6.2

Major incompatibilities

None known.

6.3

Shelf life

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

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AN: 00941/2018

6.4.

Special precautions for storage

Do not store above 25°C.

6.5

Nature and composition of immediate packaging

White polyethylene syringes with red polyethylene caps.

Cleaning towels (70% viscose/30% polyester, alcohol impregnated) in paper

aluminium copolymer laminate sachets.

Pack sizes:

20 intramammary syringes and 20 cleaning towels

72 intramammary syringes and 72 cleaning towels

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 products should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

Ceva Animal Health Ltd

Unit 3, Anglo Office Park

White Lion Road

Amersham

Buckinghamshire

HP7 9FB

8.

MARKETING AUTHORISATION NUMBER

Vm 15052/4139

9.

DATE OF FIRST AUTHORISATION

13 December 2017

10.

DATE OF REVISION OF THE TEXT

December 2018

Approved: 05 December 2018

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