Macromectin 0.8 mg/ml oral solution for sheep

Land: Irland

Sprache: Englisch

Quelle: HPRA (Health Products Regulatory Authority)

Wirkstoff:

Ivermectin

Verfügbar ab:

Norbrook Laboratories (Ireland) Limited

ATC-Code:

QP54AA01

INN (Internationale Bezeichnung):

Ivermectin

Dosierung:

0.8 milligram(s)/millilitre

Darreichungsform:

Oral solution

Verschreibungstyp:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapiebereich:

ivermectin

Berechtigungsstatus:

Authorised

Berechtigungsdatum:

2005-09-02

Fachinformation

Health Products Regulatory Authority
27 February 2019
CRN008WXZ
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Macromectin 0.8 mg/ml oral solution for sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
​
ACTIVE SUBSTANCE:
​
​
​
Ivermectin
​0.8
mg/ml​
​
​
​
​
EXCIPIENTS:
​
​
​
Contains Benzyl alcohol (as preservative)
​0.03
​
ml
​
​
​
​
Excipients to 1ml (For full list of excipients, see Section 6.1)
​
​
3 PHARMACEUTICAL FORM
A pale yellow clear oral solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is indicated for the treatment and control of
gastrointestinal nematodes, lungworms, and nasal bots of sheep.
GASTROINTESTINAL WORMS
_Haemonchus contortus _[Adult, L4 and Inhibited L4], _Ostertagia
(Teladorsagia) circumcincta _[Adult, L4 and Inhibited L4],
_Trichostrongylus axei _[Adult and L4],_Trichostrongylus colubriformis
_[Adult and L4], _Trichostrongylus vitrinus _[Adult and
L4],_Cooperia curticei _[Adult and L4],_ Cooperia oncophora _[Adult
and L4], _Nematodirus battus _[Adult and L4], _Nematodirus _
_filicollis _[Adult and L4],_ Nematodirus spathiger _[Adult and L4],_
Strongyloides papillosus _[Adult and L4], _Oesophagostomum _
_columbianum _[Adult and L4], _Oesophagostomum venulosum _[Adult and
L4], and adult _Chabertia ovina_.
Benzimidazole resistant strains of _H. contortus_ and _Ostertagia
(Teladorsagia) circumcincta_ also controlled.
LUNGWORMS(ADULT AND IMMATURE)
_Dictyocaulus filaria_
NASAL BOT (ALL LARVAL STAGES)
_Oestrus ovis_
4.3 CONTRAINDICATIONS
None.
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 o