Cepritect

Main information

  • Trade name:
  • Cepritect 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:
  • Cepritect 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:
  • 02000/4423
  • Authorization date:
  • 23-11-2017
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Revised: June 2018

AN: 00134/2018

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Cepritect 250 mg Intramammary Suspension for Dry Cows [AT, BG, CZ, EE, FR,

HU, IE, IT, LV, LT, PL, PT, SK, ES].

Stapenor DCefa 250 mg Intramammary Suspension for Dry Cows [DE]

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substance:

Each intramammary syringe of 3g contains

Cefalonium

(as Cefalonium Dihydrate)

250 mg

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Intramammary Suspension.

Homogeneous white to beige coloured suspension.

4.

CLINICAL PARTICULARS

4.1

Target species

Dairy 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 cephalosporins, other β-lactam

antibiotics or to any of the excipients.

Please refer to section 4.7

4.4

Special warnings for each target species

None.

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4.5

Special precautions for use

Special precautions for use in animals

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.

Use of the product deviating from the instructions given in the SPC may increase the

prevalence of bacteria resistant to cefalonium and may decrease the effectiveness of

treatment with other beta lactams.

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

section 4.2 of the SPC. 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 cephalosporins may cause sensitisation (allergy) following injection,

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

sensitivity to cephalosporin 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. Swellings of the face, lips or eyes

or difficulty breathing are more serious symptoms and require urgent medical

attention.

The cleaning towels provided with the intramammary product contain isopropyl

alcohol. Wear protective gloves if skin irritation due to isopropyl alcohol is known or

suspected. Avoid contact with eyes because isopropyl alcohol can cause eye

irritation.

4.6

Adverse reactions (frequency and seriousness)

In very rare cases immediate hypersensitivity reactions were observed in some

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

reactions can 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) during the

course of one treatment)

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

4.7

Use during pregnancy, 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.

Not to be used in cows that are lactating.

4.8

Interaction with other medicinal products and other forms of interaction

Cephalosporins should not be administered concurrently with bacteriostatic

antimicrobials. Concomitant use of cephalosporins 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. Avoid contamination of the nozzle

after removing the cap. Before infusion, thoroughly clean and disinfect the end of the

teat with the cleaning towel provided.

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 short exposed part of the nozzle.

Option 1: For short nozzle intramammary administration.

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.

Option 2: For full nozzle intramammary administration.

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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(s)

Meat and offal: 21 days

Milk:

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

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

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Antibacterials for intramammary use, first-generation

cephalosporins.

ATCvet code: QJ51DB90.

5.1

Pharmacodynamic properties

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

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

activity is not impaired in the presence of milk.

Three mechanisms of resistance to cephalosporin 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 cephalosporin

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

negative bacteria resistance may consist in the production of β-lactamases,

especially extended-spectrum β-lactamases.

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Cefalonium is active against: Staphylococcus aureus, Streptococcus agalactiae,

Streptococcus

dysgalactiae,

Streptococcus

uberis,

Trueperella

pyogenes,

Escherichia coli and Klebsiella spp.

5.2

Pharmacokinetic particulars

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

remain up to 10 weeks after infusion.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Aluminium distearate

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

6.4.

Special precautions for storage

Do not store above 25

6.5

Nature and composition of immediate packaging

Single dose 3g white LDPE syringes with a white LDPE dual push-fit cap.

Cartons of 24 and 60 syringes or buckets of 120 syringes including 24, 60 or 120

individually wrapped teat cleaning towels containing isopropyl alcohol.

Not all pack sizes may be marketed.

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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

Norbrook Laboratories Limited

Station Works

Camlough Road

Newry

Co. Down

BT35 6JP

Northern Ireland

8.

MARKETING AUTHORISATION NUMBER

Vm 02000/4423

9.

DATE OF FIRST AUTHORISATION

23 November 2017

10.

DATE OF REVISION OF THE TEXT

June 2018

Approved: 19 June 2018

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