Cyclosol LA, 200 mg/ml Solution for Injection

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Oxytetracycline

Available from:

Eurovet Animal Health B.V.

ATC code:

QJ01A

INN (International Name):

Oxytetracycline

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle, Pigs

Therapeutic area:

Antimicrobial

Authorization status:

Authorized

Authorization date:

2002-04-24

Summary of Product characteristics

1
PART IB - 1
SUMMARY OF PRODUCT CHARACTERISTICS
CYCLOSOL LA
UK/V/0177/001/R/001
EUROVET ANIMAL HEALTH B.V.
THE NETHERLANDS
2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclosol LA, 200 mg/ml
Solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each millilitre contains:
ACTIVE SUBSTANCE
Oxytetracycline (as dihydrate)
200.0 mg
(Equivalent to 216 mg Oxytetracycline dihydrate)
EXCIPIENTS:
Sodium formaldehyde sulphoxylate dihydrate (preservative)
5.0 mg
Povidone (complexing agent)
50.0 mg
For a full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection
A clear yellow to reddish-brown aqueous solution.”
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle and pigs
4.2
INDICATION FOR USE
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._
4.3
CONTRAINDICATIONS
Hypersensitivity to tetracyclines. The use of oxytetracycline in
animals with an impaired liver
and/or kidney function should be avoided.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
It is strongly recommended to divide the intramuscular dosages over
two or more injection sites
3
(see posology).
For the 250 mL pack, the use of a multidose syringe is recommended. To
refill the syringe, the
use of a draw off needle is recommended to avoid excessive broaching
of the stopper.
It is recommended to use Cyclosol LA in the early stages of disease
and to evaluate the
response to treatment within 72 hours.
Resistance against oxytetracycline may vary. Use of the product should
be based on
susceptibility testing and taking into account official and local
antimicrobial policies.
Inappropriate use of the product may increase the prevalence of
bacteria resistant to
oxytetracycline and may decrease the effectiven