Santiola 50 mg/ml Solution for Injection for Cattle and Sheep

Nchi: Uingereza

Lugha: Kiingereza

Chanzo: VMD (Veterinary Medicines Directorate)

Viambatanisho vya kazi:

Closantel

Inapatikana kutoka:

Krka d.d., Novo Mesto

ATC kanuni:

QP52AG09

INN (Jina la Kimataifa):

Closantel

Dawa fomu:

Solution for injection

Dawa ya aina:

POM-V - Prescription Only Medicine – Veterinarian

Kundi la matibabu:

Cattle, Sheep

Eneo la matibabu:

Anthelmintic

Idhini hali ya:

Expired

Idhini ya tarehe:

2018-03-06

Tabia za bidhaa

Revised: August 2019
AN: 00461/2019
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Santiola 50 mg/ml solution for injection for cattle and sheep (BG, CZ,
EE, GB, HR,
HU, IE, LT, LV, RO, SI, SK)
Santiola vet 50 mg/ml solution for injection for cattle and sheep (DK,
SE)
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)
Revised: August 2019
AN: 00461/2019
Page 2 of 7
_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)
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 t