Cyclofin 300 mg/ml + 20 mg/ml Solution for Injection for Cattle

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Flunixin, Oxytetracycline

Available from:

Dechra Limited

ATC code:

QJ01AA56

INN (International Name):

Flunixin, Oxytetracycline

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Cattle

Therapeutic area:

Antimicrobial; Anti Inflammatory

Authorization status:

Authorized

Authorization date:

2023-09-05

Summary of Product characteristics

Issued: September 2023
AN: 00179/2022
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
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 (as oxytetracycline dihydrate) 300 mg
Flunixin (as flunixin meglumine) 20 mg
Excipient:
Sodium Formaldehyde Sulphoxylate 2.0 mg
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Solution for injection.
A orange to reddish-brown solution, practically free from visible
particles.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of bovine respiratory disease caused by _Mannheimia
_
_(Pasteurella) haemolytica_ where an anti-inflammatory and
anti-pyretic effect is
required.
4.3
CONTRAINDICATIONS
Do not use in in animals suffering from cardiac, hepatic, or renal
disease,
where there is a possibility of gastrointestinal ulceration or
bleeding.
Do no 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.
Issued: September 2023
AN: 00179/2022
Page 2 of 7
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Cross-resistance has been shown between oxytetracycline and other
antimicrobials belonging to the tetracyclines class in _Mannheimia
(Pasteurella) _
_haemolytica_. When susceptibility testing has shown resistance to
other
tetracycline antimicrobials the use of oxytetracycline should be
carefully
considered because its effectiveness may be reduced.
4.5
SPECIAL PRECAUTIONS FOR USE
i)
Special precautions for use in animals
Use in any animals less than 6 weeks of age or in aged animals may
involve
additional risk. If such use cannot be avoided, animals may require a
reduced
dosage and careful cli