Duocycline 10% Solution for Injection

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

Compra'l ara

Fitxa tècnica Fitxa tècnica (SPC)
12-06-2017

ingredients actius:

Oxytetracycline hydrochloride

Disponible des:

Univet Limited

Codi ATC:

QJ01AA06

Designació comuna internacional (DCI):

Oxytetracycline hydrochloride

Dosis:

10 percent weight/volume

formulario farmacéutico:

Solution for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Cattle, Pigs, Sheep

Área terapéutica:

oxytetracycline

indicaciones terapéuticas:

Antibacterial

Estat d'Autorització:

Authorised

Data d'autorització:

1988-10-01

Fitxa tècnica

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Duocycline 10% Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Solution for injection.
A clear amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
_Duocycline 10_ is recommended in the treatment of a wide range of
common systemic, respiratory and local infections
caused by, or associated with, organisms sensitive to Oxytetracycline.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
ingredient.
Do not use in sheep producing milk for human consumption.
Do not administer intravenously.
Do not use in horses, dogs and cats.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Each ml contains:
ACTIVE SUBSTANCE
Oxytetracycline Hydrochloride
100.0 mg
EXCIPIENTS
Sodium formaldehyde sulfoxylate
1.0
mg
For a full list of excipients, see section 6.1
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4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
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 
                                
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