Terrexine DC 250mg Intramammary Suspension for Dry Cows

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 veterinary medicinal product is only established against the
pathogens mentioned in Section 4.2 Indications for use for each target species.
Consequently, serious acute mastitis (potentially fatal) due to other pathogen
species, particularly , 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
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 veterinary medicinal product if you know you are sensitised, or if
you have been advised not to work with such preparations.
Handle this veterinary medicinal 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 package leaflet or the label to the physician. Swelling of
the face, lips or eyes or difficulty breathing are more serious symptoms and require
urgent medical attention.
Wash hands after use.
The cleaning towels provided with the intramammary veterinary medicinal product
contain isopropyl alcohol.

Revised: November 2024
AN: 01334/2023 - 01709/2023 – 01932/2024
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.
Special precautions for the protection of the environment
Not Applicable.
Other precautions
Not Applicable.
4.6 Adverse reactions (frequency and seriousness)
Very rare
(<1 animal / 10,000 animals
treated, including isolated
reports):
Hypersensitivity reactions (restlessness, tremor,
swelling of mammary gland, eyelids and lips)
1
Immediate reactions observed in some animals which can lead to death.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
4.7 Use during pregnancy, lactation or lay
Pregnancy:
The veterinary medicinal product is 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.
Lactation:
The veterinary medicinal product must not 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 Amount(s) to be administered and administration route
For intramammary use.
The intramammary syringe must only be used once.
The contents of one intramammary syringe should be infused into the teat canal of
each quarter immediately after the last milking of the lactation. Do not bend the
nozzle. Avoid contamination of the nozzle after removing the cap. Before infusion,
the teat should be thoroughly cleaned and disinfected (e.g. with the cleaning towel
provided).

Revised: November 2024
AN: 01334/2023 - 01709/2023 – 01932/2024
Option 1: For short nozzle intramammary administration hold the barrel of the
intramammary 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 intramammary 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 intramammary syringe firmly on 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 intramammary
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.

Revised: November 2024
AN: 01334/2023 - 01709/2023 – 01932/2024
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 periods
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.
5.