Solantel 50 mg/ml Oral Suspension for Sheep

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Closantel sodium dihydrate

Available from:

Norbrook Laboratories (Ireland) Limited

ATC code:

QP52AG09

INN (International Name):

Closantel sodium dihydrate

Dosage:

50 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

closantel

Authorization status:

Authorised

Authorization date:

2016-08-26

Summary of Product characteristics

Health Products Regulatory Authority
16 July 2021
CRN00C33Q
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Solantel 50 mg/ml Oral Suspension for Sheep
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
​
Closantel
​
50.0 mg
​
(as Closantel Sodium Dihydrate
​
54.375 mg)
​
​
​
EXCIPIENT(S):
​
​
Propylene glycol (E1520)
​
217.6 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Oral suspension
Off-white to yellow suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Sheep
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the treatment of chronic and subacute fasciolosis (due to
_Fasciola hepatica _). The product is effective against mature and
late immature flukes (from 5 weeks immature).
For the treatment of _Oestrus ovis _(Sheep Nasal Bot Fly)_._
For the treatment of inhibited, L4 and adult stages of _Haemonchus
contortus_.
4.3 CONTRAINDICATIONS
Do not use in animals with known hypersensitivity to the active
substance or to any of the excipients.
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 device (if any).
Suspected clinical 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 resistance to a particular anthelmintic, an anthelmintic
belonging to another pharmacological class and having a different mode
of action should be used.
Resistance to closantel has been reported in
_Haemonchus _species outside the EU. The use of this product should be
based on
local (regio