Santiola 50 mg/ml solution for injection for cattle and sheep

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Closantel sodium dihydrate

Disponível em:

Krka, d.d., Novo mesto

Código ATC:

QP52AG09

DCI (Denominação Comum Internacional):

Closantel sodium dihydrate

Dosagem:

50 milligram(s)/millilitre

Forma farmacêutica:

Solution for injection

Tipo de prescrição:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapêutico:

Cattle, Sheep

Área terapêutica:

closantel

Indicações terapêuticas:

Anthelmintic

Status de autorização:

Authorised

Data de autorização:

2018-02-02

Características técnicas

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,