Paramectin 0.08% w/v Drench for Sheep

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

Ivermectin

Διαθέσιμο από:

Norbrook Laboratories (Ireland) Limited

Φαρμακολογική κατηγορία (ATC):

QP54AA01

INN (Διεθνής Όνομα):

Ivermectin

Δοσολογία:

0.08 percent weight/volume

Φαρμακοτεχνική μορφή:

Oral suspension

Τρόπος διάθεσης:

POM: Prescription Only Medicine as defined in relevant national legislation

Θεραπευτική περιοχή:

ivermectin

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2001-01-12

Αρχείο Π.Χ.Π.

Health Products Regulatory Authority
27 February 2019
CRN008TRM
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Paramectin 0.08% w/v Drench for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active Ingredient
Ivermectin 0.8 mg
Excipient(s)
Benzyl alcohol (E1519) 0.03 ml
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral solution.
A clear yellow pale liquid.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of the following gastrointestinal nematodes,
lungworms and nasal bots of sheep.
GASTROINTESTINAL ROUNDWORMS (ADULT AND FOURTH STAGE LARVAE):
_Haemonchus contortus_[adult, L4 and inhibited L4],
_Ostertagia (Teladorsagia) circumcincta _[adult, L4 and inhibited L4]
_Trichostrongylus _spp
_Cooperia curticei_ (adults)
_Cooperia oncophora_ [adult and L4]
_Nematodirus _spp including _N. battus_
_Strongyloides papillosus_
_Oesophagostomum columbianum_ [adult and L4]
_Oesophagostomum venulosum_ (adults)
_Chabertia ovina _(adults)
LUNGWORMS(ADULT AND IMMATURE):
_Dictyocaulus filaria_
NASAL BOT (ALL LARVAL STAGES):
_Oestrus ovis_
4.3 CONTRAINDICATIONS
Do not use in sheep known to be hypersensitive to ivermectin.
See section 4.7.
Health Products Regulatory Authority
27 February 2019
CRN008TRM
Page 2 of 4
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
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 devise (if any).
Suspected clincal cases of resistance to anthelmintics should be
further investigated using appropriate tests (e.g. Faecal Egg
Count Reduction Test). Where the results of the test(s) strongly
suggest resista