HEXASOL LA SOLUTION FOR INJECTION

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

OXYTETRACYCLINE DIHYDRATE, FLUNIXIN MEGLUMINE

Available from:

Norbrook Laboratories Limited

ATC code:

QJ01AA56

INN (International Name):

OXYTETRACYCLINE DIHYDRATE, FLUNIXIN MEGLUMINE

Dosage:

300

Pharmaceutical form:

Solution for Injection

Prescription type:

POM

Therapeutic group:

Bovine

Therapeutic area:

Oxytetracycline, combinations

Therapeutic indications:

Antibacterial

Authorization status:

Authorised

Authorization date:

1999-02-05

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Hexasol LA Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
_ACTIVE SUBSTANCE:_
Oxytetracycline
(as oxytetracycline dihydrate)
300 mg
Flunixin
(as flunixin meglumine)
20 mg
_EXCIPIENTS:_
Sodium Formaldehyde Sulphoxylate
4.0 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear dark amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of acute respiratory disease caused by oxytetracycline sensitive _Mannheimia _(_Pasteurella_) _haemolytica _and
_Pasteurella multocida _where an anti-inflammatory and anti-pyretic effect is required.
4.3 CONTRAINDICATIONS
Use is contraindicated in animals suffering from cardiac, hepatic or renal disease, where there is a possibility of gastrointestinal
ulceration or bleeding or where there is hypersensitivity to one of the ingredients of the product.
Avoid use in dehydrated, hypovolaemic or hypotensive animals as there is a potential risk of increased renal toxicity.
Do not use in cases of known resistance to tetracyclines.
Refer to section 4.11
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 06/01/2016_
_CRN 7022544_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS:
Use in any animals less than 6 weeks of age or in aged animals may involve additional risk due to the anti-prostaglandin effects of
flunixin on renal function. If such use cannot be avoided, animals may require careful clinical management.
Use of the product should be b