Noromectin 1.0 % w/v Solution for Injection for Sheep

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ivermectin

Verfügbar ab:

Norbrook Laboratories Limited

ATC-Code:

QP54AA01

INN (Internationale Bezeichnung):

Ivermectin

Dosierung:

1.0 percent weight/volume

Darreichungsform:

Solution for injection

Verschreibungstyp:

LM: Licensed Merchant as defined in relevant national legislation

Therapiegruppe:

Sheep

Therapiebereich:

ivermectin

Anwendungsgebiete:

Endectoparasiticides

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2001-06-29

Fachinformation

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 1.0% w/v Solution for Injection for Sheep.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance
Each ml:
Ivermectin
10.0 mg
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to pale yellow solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Indicated for the treatment of infections by the following species of
gastrointestinal roundworms, lungworms, nasal bots
and psoroptic mange (sheep scab).
GASTROINTESTINAL ROUNDWORMS (ADULTS AND FOURTH STAGE LARVAE):
_Ostertagia circumcincta_ (including inhibited larvae_), Haemonchus
contortus_ (including inhibited larvae),_ Trichostrongylus_
_axei_ (adults_),_
_Trichostrongylus colubriformis_ (adults)_,_
_Trichostrongylus vitrinus_ (adults_),_
_Cooperia curticei,_
_Nematodirus_
_filicollis_.
LUNGWORMS:
_Dictyocaulus filaria_ (adults and fourth stage larvae)
NASAL BOTS:
_Oestrus ovis_ (all larval stages)
MANGE MITES:
_Psoroptes ovis_
4.3 CONTRAINDICATIONS
Do not use in cases of known hypersensitivity to ivermectin.
Do not administer by the intravenous or intramuscular route.
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_
_9_
_/_
_0_
_8_
_/_
_2_
_0_
_1_
_5_
_C_
_R_
_N_
_ _
_7_
_0_
_2_
_1_
_3_
_7_
_9_
_p_
_a_
_g_
_e_
_ _
_n_
_u_
_m_
_b_
_e_
_r_
_:_
_ _
_1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Treatment of psoroptic ma