Cyclosol LA

1 x 250 ml

Solution for injection

Active substance

Oxytetracycline (Oxytetracycline dihydrate) : 200 mg/ml

ATC code

QJ01AA06 Oxytetracycline

QJ01AA Tetracyclines

QJ01A Tetracyclines

QJ01 Antibacterials for systemic use

QJ Antiinfectives for systemic use

Species

Cattle and pigs.

Indications

Cattle: For the treatment of respiratory infections caused by oxytetracycline susceptible organisms such as Arcanobacterium (Actinomyces) pyogenes and Haemophilus somnus.

Pigs: For the treatment of respiratory infections caused by oxytetracycline susceptible organisms such as Pasteurella Multocida.

Dose to be administered and administration route

Administration route: intramuscular use (deep). It is strongly recommended to divide the intramuscular dosages over two or more injection sites - maximum 15 ml per injection site in cattle over 150 kg body weight and 7 ml in pigs and calves. Injection sites should be alternated.

Pigs

20 mg oxytetracycline per kg bodyweight, if necessary repeat after 72 hours.

Cattle not producing milk for human consumption

20 mg oxytetracycline per kg bodyweight, if necessary repeat after 72 hours.

Cattle producing milk for human consumption

20 mg oxytetracycline per kg bodyweight as a single injection only.

To ensure a correct dosage, body weight should be determined as accurately as possible.

Adverse reactions

Cattle:

Rare

(1 to 10 animals / 10,000 animals treated):

Hypersensitivity reaction (including anaphylaxis ^a)

Hepatic toxicosis, Haematologic effects

Very rare

(<1 animal / 10,000 animals treated, including isolated reports):

Injection site reactions ^b

Undetermined frequency (cannot be estimated from the available data)

Photosensitivity ^c

Decreased milk production ^d

a Which may be fatal. In case of a serious anaphylactic reaction in cattle the administration of epinephrine, antihistamines and corticosteroids should be considered.

b Transient swelling and/or yellow staining (and local necrosis) will occur following intramuscular administration. Swelling will be visible for several days after injection.

c When exposed to intensive sunlight, particularly treated animals with poor skin pigmentation. d Small drop in lactating animals for up to 3 days following injection.

Pigs:

Rare

(1 to 10 animals / 10,000 animals treated):

Hepatic toxicosis, Haematologic effects

Undetermined frequency (cannot be estimated from the available data)

Photosensitivity^a, Injection site reactions^b, Decreased milk production^c

a When exposed to intensive sunlight, particularly treated animals with poor skin pigmentation.

b Transient swelling and/or yellow staining (and local necrosis) will occur following intramuscular administration. Swelling will be visible for several days after injection.

c Small drop in lactating animals for up to 3 days following injection.

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 its local representative or the national competent authority via the national reporting system. See the package leaflet for contact details.