FLUKIVER 50 MG/ML SOLUTION FOR INJECTION

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

CLOSANTEL (AS CLOSANTEL SODIUM DIHYDRATE PH. EUR.)

Mevcut itibaren:

Elanco Animal Health, Eli Lilly and Company Limited

ATC kodu:

QP52AG09

INN (International Adı):

CLOSANTEL (AS CLOSANTEL SODIUM DIHYDRATE PH. EUR.)

Doz:

50 Mg/Ml

Farmasötik formu:

Solution for Injection

Reçete türü:

LM: Licensed Merchant as defined in relevant national legislation

Terapötik grubu:

Cattle

Terapötik alanı:

closantel

Terapötik endikasyonlar:

Endoparasiticide

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2012-10-12

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Flukiver 50 mg/ml Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE
Closantel (as Closantel sodium)
50 mg/ml
EXCIPIENTS
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
TREMATODES
_Fasciola hepatica_
_Fasciola gigantica_
NEMATODES
_Haemonchus placei_
_Bunostomum phlebotomum_
_Oesophagostomum radiatum_
ARTHROPODS
_Hypoderma bovis_
_Hypoderma lineatum_
4.3 CONTRAINDICATIONS
None.
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_
_1_
_/_
_0_
_3_
_/_
_2_
_0_
_1_
_7_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_5_
_8_
_0_
_6_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Do not exceed the stated dose.
Care should be taken to ensure that
all
injection procedures are correctly carried out
and body weights accurately
assessed.
Care should be taken to avoid the following practices because they
increase the risk of development of resistance and
could ultimately result in ineffective therapy:
- Too frequent and repeated use of anthelmintics from the same class,
over an extended period of time.
- Underdosing,
which may be due to underestimation of body weight,
misadministration of the product,
or lack of
calibration of the dosing device.
Suspected clinical cases of resistance to anthelmintics shoul