Duocycline 10% Solution for Injection

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

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Fachinformation Fachinformation (SPC)
12-06-2017

Wirkstoff:

Oxytetracycline hydrochloride

Verfügbar ab:

Univet Limited

ATC-Code:

QJ01AA06

INN (Internationale Bezeichnung):

Oxytetracycline hydrochloride

Dosierung:

10 percent weight/volume

Darreichungsform:

Solution for injection

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiegruppe:

Cattle, Pigs, Sheep

Therapiebereich:

oxytetracycline

Anwendungsgebiete:

Antibacterial

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

1988-10-01

Fachinformation

                                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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