Oxycomplex NS Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Flunixin meglumine; Oxytetracycline hydrochloride

Available from:

Bimeda Animal Health Limited

ATC code:

QJ01AA56

INN (International Name):

Flunixin meglumine; Oxytetracycline hydrochloride

Dosage:

100, 20 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

oxytetracycline, combinations

Authorization status:

Authorised

Authorization date:

1994-06-10

Summary of Product characteristics

_[Version 9,03/2022] _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxycomplex NS Solution for Injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
Oxytetracycline Hydrochloride
100 mg
equivalent to Oxytetracycline
Flunixin Meglumine
20 mg
equivalent to Flunixin
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Magnesium Chloride
N-methyl pyrrolidone
Monoethanolamine
Sodium Formaldehyde Sulfoxylate
Water for injection
A clear yellow to amber liquid.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattl
E
.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the control and treatment of infectious diseases of cattle caused
by or associated with organisms
sensitive to oxytetracycline, where concurrent analgesic,
anti-inflammatory, anti-endotoxic or
antipyretic therapy is desired.
The veterinary medicinal product is especially indicated for the
treatment of respiratory disease
(particularly that associated with
_Pasteurella_
infection) and acute mastitis (in conjunction with
appropriate therapy).
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substances or to
any of the excipients.
Do not use in horses or donkeys.
Do not exceed the stated dose or duration of treatment.
Do not administer other NSAIDs concurrently or within 24 hours of each
other.
Use is contra-indicated in animals suffering from cardiac, hepatic or
renal disease, where there is the
possibility of gastro-intestinal ulceration or bleeding or where there
is evidence of a blood dyscrasia.
3.4
SPECIAL WARNINGS
Some NSAIDs may be highly bound to plasma proteins and compete with
other highly bound drugs to
produce an increase in non-bound pharmacologically active
concentrations, which can lead to toxic
effects.
Use in any animal 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
clinical management.
Avoid use in any dehydrated, hypo