Enroxil Max 100 mg/ml solution for injection for cattle

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Enrofloxacin

متاح من:

Krka, d.d., Novo mesto

ATC رمز:

QJ01MA90

INN (الاسم الدولي):

Enrofloxacin

جرعة:

100 milligram(s)/millilitre

الشكل الصيدلاني:

Solution for injection

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجموعة العلاجية:

Cattle

المجال العلاجي:

enrofloxacin

الخصائص العلاجية:

Antibacterial

الوضع إذن:

Authorised

تاريخ الترخيص:

2008-09-19

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Enroxil Max 100 mg/ml solution for injection for cattle.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
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
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.
Treatment
of local
signs (inflammation,
milk quality and yield) associated with peracute/acute mastitis in
lactating
dairy cattle caused by_ E._
_coli_, where herd history and previous sensitivity testing indicate
enrofloxacin as the drug of
choice.
4.3 CONTRAINDICATIONS
Do not use for prophylaxis.
Do not administer in case of hypersensitivity to the active substance
or to any of the excipients.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
ACTIVE SUBSTANCE
Enrofloxacin
100 mg
EXCIPIENTS
Benzyl alcohol (E1519)
20 mg
Butyl alcohol
30 mg
For a full list of excipients, see section 6.1
H
E
A
L
T
H
P
R
O
D
U
C
T
S
R
E
G
U
L
A
T
O
R
Y
A
U
T
H
O
R
I
T
Y
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
___
_D_
_a_
_t_
_e_
_ _
_P_
_r_
_i_
_n_
_t_
_e_
_d_
_ _
_2_
_8_
_/_
_0_
_5_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_0_
_7_
_7_
_5_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.5 SPECIAL PRECAUTIONS FOR USE
I) SPECIAL PRECAUTIONS FO