Cyclofin 300 mg/ml + 20 mg/ml solution for injection for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Oxytetracycline; Flunixin

Available from:

Dechra Regulatory B.V.

ATC code:

QJ01AA56

INN (International Name):

Oxytetracycline; Flunixin

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

oxytetracycline, combinations

Authorization date:

2023-09-15

Summary of Product characteristics

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cyclofin 300 mg/ml + 20 mg/ml solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Oxytetracycline 300 mg (equivalent to 323.5 mg of oxytetracycline
dihydrate)
Flunixin 20 mg (equivalent to 33.2 mg of flunixin meglumine)
EXCIPIENT:
QUALITATIVE
COMPOSITION OF
EXCIPIENTS AND OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Glycerol formal
Polyethylene glycol 200
Magnesium oxide, light
Sodium Formaldehyde Sulphoxylate
2.0 mg
Ethanolamine
Water for injection
Clear, orange to reddish-brown solution for injection, practically
free from visible particles.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of acute respiratory disease caused by
_Mannheimia haemolytica_
and
_Pasteurella _
_multocida_
where an anti-inflammatory and anti-pyretic effect is required.
3.3
CONTRAINDICATIONS
Do not use in animals suffering from cardiac, hepatic or renal
disease, where there is a possibility of
gastrointestinal ulceration or bleeding.
Do not use in dehydrated, hypovolaemic or hypotensive animals as there
is a potential risk of
increased renal toxicity.
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Do not use the veterinary medicinal product where there are signs of
blood dyscrasias or haemostasis
alteration.
3.4
SPECIAL WARNINGS
Cross-resistance has been shown between oxytetracycline and other
tetracyclines in
_Mannheimia _
_haemolytica_
and
_Pasteurella multocida_
. Use of oxytetracycline should be carefully considered when
susceptibility testing has shown resistance to tetracyclines because
its effectiveness may be reduced.
3.5
SPECIAL PRECAUTIONS FOR USE
2
Special precautions for safe use in the target species:
Use in any animals less than 6 weeks of age or in aged animals may
involve additional risk due to the
anti-