Closiver 5 mg/ml + 125 mg/ml Solution for Injection for Sheep

Nazione: Irlanda

Lingua: inglese

Fonte: HPRA (Health Products Regulatory Authority)

Principio attivo:

Ivermectin, Closantel

Commercializzato da:

Norbrook Laboratories Limited

Codice ATC:

QP54AA51

INN (Nome Internazionale):

Ivermectin, Closantel

Dosaggio:

5/125 milligram(s)/millilitre

Forma farmaceutica:

Solution for injection

Tipo di ricetta:

LM: Licensed Merchant as defined in relevant national legislation

Gruppo terapeutico:

Sheep

Area terapeutica:

ivermectin, combinations

Indicazioni terapeutiche:

Endectoparasiticides

Stato dell'autorizzazione:

Authorised

Data dell'autorizzazione:

2010-10-01

Scheda tecnica

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Closiver 5 mg/ml + 125 mg/ml Solution for Injection for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Ivermectin
5 mg
Closantel
125 mg
(Equivalent to Closantel sodium dihydrate)
135.9 mg
EXCIPIENTS:
Sodium formaldehyde sulphoxylate
5 mg
For the full list of excipients, see Section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear amber solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
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_
_ _
_1_
_4_
_/_
_1_
_0_
_/_
_2_
_0_
_1_
_6_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_5_
_0_
_3_
_3_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of mixed trematode (fluke) and nematode or arthropod
infestations due to gastrointestinal
roundworms, trematodes, lungworms, nasal bots and mites of sheep.
Gastrointestinal roundworms
_Teladorsagia circumcincta_ (including inhibited L4),_ Ostertagia
trifurcata_ (adult and L4),_ Haemonchus contortus_
(including inhibited L4),_ Trichostrongylus axei_ (adult),_
Trichostrongylus colubriformis_ (adult and L4),_ T. vitrinus_
(adult)_ Cooperia curticei_ (adult and L4),_ Oesophagostomum
columbianum_ (adult and L4),_ O. venulosum_ (adult)
_Chabertia ovina_ (adult and L4)_ Nematodirus filicollis_ (adult and
L4),_ Trichuris ovis_ (adult).
[L4 = fourth stage larvae]
Lungworms
_Dictyocaulus filaria_ (adult and 4
th
stage larva