Enrotril Max 100 mg/ml Solution for Injection for Cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Enrofloxacin

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QJ01MA90

INN (International Name):

Enrofloxacin

Dosage:

100 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

enrofloxacin

Authorization status:

Authorised

Authorization date:

2010-09-03

Summary of Product characteristics

Health Products Regulatory Authority
27 February 2019
CRN008THN
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enrotril Max 100 mg/ml Solution for Injection for Cattle
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH ML CONTAINS:
ACTIVE SUBSTANCE
Enrofloxacin 100.0 mg
EXCIPIENTS
Benzyl alcohol (E1519) 20.0 mg
Butyl alcohol 30.0 mg
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
Clear yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment of bovine respiratory disease associated
with _Mannheimia haemolytica,Pasteurella multocida, _
_Histophilus somni_ and _Mycoplasma_ spp. where clinical experience,
supported where possible by sensitivity testing of the causal
organism, indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Do not use for prophylaxis
Do not use in case of disturbances in growth of cartilage and/or
during injury of locomotory system particularly on functionally
loaded joints or due to body weight loaded joints.
Do not use in cases of resistance against other fluoroquinolones, due
to the potential for cross-resistance.
Do not use in cases of known hypersensitivity to the active substance
or to any of the excipients.
Do not use in growing horses because of possible deleterious damage on
articular cartilage.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
(i)Special precautions for use in animals
Health Products Regulatory Authority
27 February 2019
CRN008THN
Page 2 of 4
Normal sterile precautions should be taken.
Official and local antimicrobial policies should be taken into account
when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which have responded poorly, or are expected to
respond poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinolones should only be used based on
susceptibility testin