RESFLAM 300/20 MG/ML SOLUTION FOR INJECTION FOR CATTLE
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
24-01-2015
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Active ingredient:
OXYTETRACYCLINE DIHYDRATE, FLUNIXIN MEGLUMINE
Available from:
Norbrook Laboratories Limited
ATC code:
QJ01AA56
INN (International Name):
OXYTETRACYCLINE DIHYDRATE, FLUNIXIN MEGLUMINE
Dosage:
30/20
Pharmaceutical form:
Solution for Injection
Prescription type:
POM
Therapeutic group:
Bovine
Therapeutic area:
Oxytetracycline, combinations
Therapeutic indications:
Antibacterial
Authorization status:
Authorised
Authorization date:
2009-09-25
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Resflam 300/20 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
Excipients
Sodium Formaldehyde Sulphoxylate
4.0 mg
For the 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 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 09/01/2015_
_CRN 7018527_
_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 based on su
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