Procycline LA 200 mg/ml solution for injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Oxytetracycline dihydrate

Dostupné s:

Interchem Ireland Ltd

ATC kód:

QJ01AA06

INN (Mezinárodní Name):

Oxytetracycline dihydrate

Dávkování:

200 milligram(s)/millilitre

Léková forma:

Solution for injection

Druh předpisu:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutické skupiny:

Cattle, Pigs, Sheep

Terapeutické oblasti:

oxytetracycline

Terapeutické indikace:

Antibacterial

Stav Autorizace:

Authorised

Datum autorizace:

2012-11-16

Charakteristika produktu

Health Products Regulatory Authority
20 March 2018
CRN000VLS
Page 1 of 5
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Procycline LA 200 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE
Oxytetracycline (as dihydrate) 200.0 mg
EXCIPIENTS
Sodium formaldehyde sulfoxylate 3.0 mg
For the full list of excipients, see section 6.1
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
_Procycline LA_ 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 sheep producing milk for human consumption.
Do not administer by the intravenous route.
Do not use in horses, dogs and cats. Do not use in animals with known
hypersensitivity to the active ingredient.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Health Products Regulatory Authority
20 March 2018
CRN000VLS
Page 2 of 5
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 BY THE PERSON ADMINISTERING THE
VETERINARY
MEDICINAL PRODUCT TO ANIMALS
This product contains dimethylacetamide (DMAC) and care should be
taken to
prevent absorption through the skin. Wash hands after use.
4.6 ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Transient local reactions may occur at the injection site
Use of tetracycline during the period of tooth development, including
late pregnancy,
may lead to tooth discolouration.Occasional allergic reactions occur
but these are
rare.
4.7 USE DURING PREGNANCY, LACTATION OR LAY
Use of tetracycline during the perio