Promox LA 150 mg/ml Suspension for Injection

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv bestanddel:

Amoxicillin trihydrate

Tilgængelig fra:

Interchem Ireland Ltd

ATC-kode:

QJ01CA04

INN (International Name):

Amoxicillin trihydrate

Dosering:

150 milligram(s)/millilitre

Lægemiddelform:

Suspension for injection

Recept type:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Cattle, Pigs, Sheep

Terapeutisk område:

amoxicillin

Terapeutiske indikationer:

Antibacterial

Autorisation status:

Authorised

Autorisation dato:

2012-06-08

Produktets egenskaber

Health Products Regulatory Authority
30 January 2018
CRN000V5N
Page 1 of 4
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Promox LA 150 mg/ml Suspension for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Substance
Amoxicillin (as Amoxicillin Trihydrate) 150 mg
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
A white to off white suspension for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle, sheep and pigs
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of diseases caused by a wide range of Gram-positive
and
Gram-negative organisms including:
_Clostridium spp._
_Corynebacterium spp._
_Erysipelas spp._
_Fusiformis spp._
_Haemophilus spp._
_Pasteurella spp._
_Salmonella spp._
_Streptococci_
_Staphylococci_.
SPECIFIC INDICATIONS
Pneumonia, skin and soft tissue infections, abscesses, wounds,
joint/navel ill.
4.3 CONTRAINDICATIONS
Not for intravenous administration.
Health Products Regulatory Authority
30 January 2018
CRN000V5N
Page 2 of 4
Do not use in animals with known hypersensitivity to the active
ingredients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Massage the injection site after administration. In adult cattle, the
volume should be
divided between two injection sites.
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
Penicillin and cephalosporins may cause hypersensitivity (allergy)
following injection,
inhalation, ingestion or skin contact. Hypersensitivity to penicillin
may lead to cross
sensitivity to cephalosporins and vice versa.
Allergic reaction to these substances can occasionally be serious.
1. Do not handle this product if you know you are