Oxytetracycline 200 mg/ml L.A. solution for injection for cattle

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Oxytetracycline hydrochloride

Disponibil de la:

Kela n.v.

Codul ATC:

QJ01AA06

INN (nume internaţional):

Oxytetracycline hydrochloride

Dozare:

200 milligram(s)/millilitre

Forma farmaceutică:

Solution for injection

Tip de prescriptie medicala:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupul Terapeutică:

Cattle

Zonă Terapeutică:

oxytetracycline

Indicații terapeutice:

Antibacterial

Statutul autorizaţiei:

Authorised

Data de autorizare:

1988-10-01

Caracteristicilor produsului

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Oxytetracycline 200 mg/ml L.A. solution for injection for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Oxytetracycline
200 mg
As Oxytetracycline hydrochloride
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION IS
ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Sodium formaldehyde sulfoxylate
5 mg
N-Methylpyrrolidone
0.50 ml
Magnesium chloride
Povidone
Ethanolamine
Water for injections
A clear, pale yellow to brown solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Treatment of prophylaxis of susceptible bacterial infections.
Some specific indications are: respiratory infections such as
pasteurellosis, bronchopneumonia, bovine
respiratory disease complex.
3.3
CONTRAINDICATIONS
Do not use in animals with severe renal insufficiency.
Do not use in cases of hypersensitivity to the active substance.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Warm the solution to body temperature before use.
Use of the product should be based on susceptibility 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 susceptibility of the target bacteria.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
Laboratory studies in rabbits and rats with the excipient N-methyl
pyrrolidone have shown evidence of
foetotoxic effects. Women of childbearing age, pregnant women or women
suspected of being
pregnant should use the veterinary medicinal product with serious
caution to avoid accidental self-
injection.
In order to prevent any possible reaction, direct contact with the
drug must be avoided.
Special precautions for the protection of the environment:
Not applicable.
3.6
ADVERS