Resflam 300/20 mg/ml Solution for Injection for Cattle

Држава: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Oxytetracycline dihydrate; Flunixin meglumine

Доступно од:

Norbrook Laboratories (Ireland) Limited

АТЦ код:

QJ01AA56

INN (Међународно име):

Oxytetracycline dihydrate; Flunixin meglumine

Дозирање:

300, 20 milligram(s)/millilitre

Фармацеутски облик:

Solution for injection

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска област:

oxytetracycline, combinations

Статус ауторизације:

Authorised

Датум одобрења:

2009-09-25

Карактеристике производа

_ _
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)
Flunixin
300 mg
(as flunixin meglumine)
Excipients
20
mg
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.
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 antiprostaglandin 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 susceptability testing of the
bacteria isolated from the
animal.
If
this
is
not
possible,
therapy
should
be
based
on
local
(regional,
farm
level)
epidemiological information about susceptability of the target
bacteria.
Flunixin is toxic to avian scavengers. Do not administer to animals
susceptible to enter wild
fauna food chain. In case of death or sacrifice of treated animals,
ensure that they are not mad