OXYCOMPLEX NS SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE PH.EUR, FLUNIXIN AS FLUNIXIN MEGLUMINE

Available from:

Bimeda Chemicals

ATC code:

QJ01AA56

INN (International Name):

OXYTETRACYCLINE AS OXYTETRACYCLINE HYDROCHLORIDE PH.EUR, FLUNIXIN AS FLUNIXIN MEGLUMINE

Dosage:

100/20 Mg/Ml

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Oxytetracycline, combinations

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1994-06-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxycomplex NS Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
For a full list of excipients see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE 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.
Oxytetracycline NS is especially indicated for the treatment of respiratory disease (particularly that associated with
_Pasteurella _infection) and acute mastitis (in conjunction with appropriate therapy).
4.3 CONTRAINDICATIONS
Not suitable for animals with known hypersensitivity to the active ingredient.
Not suitable for 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.
Each ml contains:
Active Substances
Oxytetracycline Hydrochloride 100 mg
equivalent to Oxytetracycline
Flunixin Meglumine
20 mg
equivalent to Flunixin
Excipients
Sodium Formaldehyde
2 mg
Sulfoxylate
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 29/01/2016_
_CRN 7022759_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs to produce an incre