Albex Gold 200 mg/ml oral suspension for cattle

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Albendazole

Available from:

Chanelle Pharmaceuticals Manufacturing Limited

ATC code:

QP52AC11

INN (International Name):

Albendazole

Dosage:

200 milligram(s)/millilitre

Pharmaceutical form:

Oral suspension

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

albendazole

Authorization status:

Authorised

Authorization date:

2019-07-19

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Albex Gold 200 mg/ml oral suspension for cattle
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Albendazole
200.0 mg
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT
INFORMATION IS ESSENTIAL
FOR PROPER
ADMINISTRATION OF THE VETERINARY MEDICINAL
PRODUC
t
_ _
Methyl Parahydroxybenzoate (E218)
2.0 mg
Propyl Parahydroxybenzoate
0.2 mg
Citric Acid Monohydrate
Sodium Citrate
Xanthan Gum
Povidone 90
Polysorbate 20
Propylene Glycol
Simethicone Emulsion
White to off white suspension.
3.
CLINICAL PARTICULARS
3.1
TARGET SPECIES
Cattle.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of benzimidazole susceptible mature and developing
immature forms of
gastrointestinal roundworms, lungworms, tapeworms and adult liver
fluke in cattle. The product
is also ovicidal against fluke and roundworm eggs.
ROUNDWORMS
:
_Ostertagia, _
_Chabertia_
_, _
_Haemonchus, Trichostrongylus, Nematodirus, _
_Oesophagostomum, Bunostomum, Cooperia _
and
_Strongyloides _
spp
_. _
It is usually effective against inhibited larvae of
_Cooperia _
and
_Ostertagia. _
LUNGWORMS
:
_Dictyocaulus_
_viviparus._
TAPEWORMS
:
_Moniezia _
spp
_. _
ADULT LIVER FLUKE
:
_Fasciola hepatica_
.
The product is ovicidal and will kill fluke and roundworm eggs.
3.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
Cattle suffering from severe lung damage due to heavy lungworm
infection may continue to
cough for some weeks after treatment.
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