Cyclosol LA 200 mg/ml solution for injection for cattle and pigs.

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytetracycline dihydrate

Available from:

Eurovet Animal Health B.V.

ATC code:

QJ01AA06

INN (International Name):

Oxytetracycline dihydrate

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Cattle, Pigs

Therapeutic area:

oxytetracycline

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1988-10-01

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclosol LA 200 mg/ml solution for injection for cattle and pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Oxytetracycline (as dihydrate)
200 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Sodium formaldehyde sulphoxylate dihydrate
5.0 mg
Povidone K17
50.0 mg
N-methyl pyrrolidone
380.0 mg
Magnesium oxide, light
Ethanolamine
Water for injections
A clear yellow to reddish-brown solution for injection.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle and pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
The veterinary medicinal product is indicated for the treatment of
infections caused by oxytetracycline
sensitive microorganisms.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, or to
any of the excipients.
Do not use in animals with serious liver and/or kidney disturbances.
Do not use by intravenous route.
3.4
SPECIAL WARNINGS
In case of a serious anaphylactic reaction the administration of
epinephrine, antihistamines and/or
corticosteroids should be considered.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
It is strongly recommended to divide the intramuscular dosages over
two or more injection sites (see
posology).
Use of the veterinary medicinal 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 veterinary medicinal product deviating from the
instructions given in the SPC may increase
the prevalence of bacteria resistant to oxytetracycline and may
decrease the effectiveness of treatment
with tetracyclines, due to the potential for cross resistance.
Special precautions to be taken by the person