Land: Írland
Tungumál: enska
Heimild: HPRA (Health Products Regulatory Authority)
Closantel sodium dihydrate
Krka, d.d., Novo mesto
QP52AG09
Closantel sodium dihydrate
50 milligram(s)/millilitre
Solution for injection
POM: Prescription Only Medicine as defined in relevant national legislation
Cattle, Sheep
closantel
Anthelmintic
Authorised
2018-02-02
Health Products Regulatory Authority 20 August 2019 CRN009478 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE VETERINARY MEDICINAL PRODUCT Santiola 50 mg/ml solution for injection for cattle and sheep 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml contains ACTIVE SUBSTANCE: Closantel 50 mg (equivalent to closantel sodium dihydrate 54.375 mg) EXCIPIENTS: For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for injection. Clear light yellow to yellow or brown yellow solution. 4 CLINICAL PARTICULARS 4.1 TARGET SPECIES Cattle and sheep 4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES For treatment of the following trematodes (fluke), gastro-intestinal nematodes and arthropods if sensitive to closantel. _SHEEP_ _TREMATODES_ _Fasciola hepatica_(adult) _Fasciola gigantica _(adult and 8 weeks immature) NEMATODES _Haemonchus contortus _(adult and immature) _Oesophagostomum columbianum_ (adult and immature) _Gaigeria pachyscelis_ (adult and immature) _Chabertia ovina_ (adult and immature) ARTHROPODS _Oestrus ovis _(1 st , 2 nd and 3 rd instar) _CATTLE_ _TREMATODES_ _Fasciola hepatica_ (adult) _Fasciola gigantica_(adult and 8 week immature) NEMATODES _Haemonchus placei_ (adult and immature) _Bunostomum phlebotomum _(adult and immature) _Oesophagostomum radiatum_ (adult and immature) Health Products Regulatory Authority 20 August 2019 CRN009478 Page 2 of 5 ARTHROPODS _Hypoderma bovis_ (dermal stages) _Hypoderma lineatum _(dermal stages) 4.3 CONTRAINDICATIONS Do not use in cases of hypersensitivity to the active substance or to any of the excipients. 4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES Do not exceed the stated dose. Care should be taken to ensure that all injection procedures are correctly carried out and body weights accurately assessed. 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, Lestu allt skjalið