Embotape Oral Paste 40% w/w

Land: Bretland

Tungumál: enska

Heimild: VMD (Veterinary Medicines Directorate)

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Download Vara einkenni (SPC)
23-05-2018

Virkt innihaldsefni:

Pyrantel Embonate

Fáanlegur frá:

Cross Vetpharm Group Ltd

ATC númer:

QP52AF02

INN (Alþjóðlegt nafn):

Pyrantel Embonate

Lyfjaform:

Oral paste

Gerð lyfseðils:

POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person

Meðferðarhópur:

Horses

Lækningarsvæði:

Anthelmintic

Leyfisstaða:

Authorized

Leyfisdagur:

2004-05-12

Vara einkenni

                                Revised 02/06/2009 – AN 01842/2008
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF VETERINARY MEDICINAL PRODUCT
Embotape Oral Paste 40% w/w
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Per Syringe
Pyrantel embonate
11.4g
Excipients
Butylated Hydroxytoluene
0.0057g
For full list of excipients, please see section 6.1.
3.
PHARMACEUTICAL FORM
Oral Paste
_PALE YELLOW TO BUFF COLOURED PASTE_
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Horses and ponies.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Pyrantel embonate is a broad spectrum anthelmintic. Pyrantel embonate
is indicated for use in the horse for the control and treatment of
adult
infections of large and small strongyles, Pinworms, Roundworms,
Tapeworms.
Pyrantel embonate has a broad spectrum of activity, including activity
against:
Large strongyles:
_Stronglylus vulgaris, S. edentatus, S. equinus._
Small strongyles:
_Trichonema_ spp_. (Cyathostomes), Triodontophorus_
spp.
Pinworms
_:_
_Oxyuris equi, Probstmayria vivipara._
Large roundworms:
_Parascaris equorum._
Tape worms:
_Anoplocephala perfoliata._
1/6
Revised 02/06/2009 – AN 01842/2008
4.3
CONTRAINDICATIONS
Not for use in foals less than 4 weeks of age.
Contraindicated in known sensitivity to pyrantel and in severely
debilitated animals.
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 resistence 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 weight,
misadministeration of the product, or lack of calibration of the
dosing device(if any).
Suspected clinical cases of resistence 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
pharmacolo
                                
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