Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Ivermectin
Norbrook Laboratories (Ireland) Limited
QP54AA01
Ivermectin
0.08 percent weight/volume
Oral suspension
POM: Prescription Only Medicine as defined in relevant national legislation
ivermectin
Authorised
2001-01-12
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 Read the complete document