ENROTRIL MAX 100 MG/ML SOLUTION FOR INJECTION FOR CATTLE
Ülke: İrlanda
Dil: İngilizce
Kaynak: HPRA (Health Products Regulatory Authority)
Ürün özellikleri
(SPC)
26-09-2015
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Aktif bileşen:
ENROFLOXACIN
Mevcut itibaren:
Norbrook Laboratories Limited
ATC kodu:
QJ01MA90
INN (International Adı):
ENROFLOXACIN
Doz:
100 Mg/Ml
Farmasötik formu:
Solution for Injection
Reçete türü:
POM
Terapötik grubu:
Bovine
Terapötik alanı:
Enrofloxacin
Terapötik endikasyonlar:
Antibacterial
Yetkilendirme durumu:
Authorised
Yetkilendirme tarihi:
2010-09-03
Ürün özellikleri
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.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 11/09/2015_
_CRN 7020157_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
(i)
Special precautions for use in animals
Normal sterile precautions should be taken.
Official and local antimicrobial policies should be taken into account when the product is u
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