TRAMAZOLE 10 % ORAL DRENCH
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-02-2016
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Active ingredient:
ALBENDAZOLE
Available from:
Univet Limited
ATC code:
QP52AC11
INN (International Name):
ALBENDAZOLE
Dosage:
10 %w/v
Pharmaceutical form:
Oral Suspension
Prescription type:
LM-Licensed Merchant
Therapeutic group:
Bovine, Ovine
Therapeutic area:
Albendazole
Therapeutic indications:
Endoparasiticide
Authorization status:
Authorised
Authorization date:
2004-01-09
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Tramazole 10% Oral Drench
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Oral suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cattle and Sheep.
ACTIVE SUBSTANCE
Albendazole
10% w/v
EXCIPIENTS
Green S E142
0.0018% w/v
Propyl Parahydroxybenzoate E216
0.02 % w/v
Methyl Parahydroxybenzoate E218
0.2 % w/v
For a full list of excipients see section 6.1
HEALTH PRODUCTS REGULATORY AUTHORITY
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_Date Printed 29/01/2016_
_CRN 7022792_
_page number: 1_
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Tramazole 10% is a broad spectrum multi-purpose anthelmintic for the control of mature and developing immature
forms of gastrointestinal roundworms, lungworms, tapeworms and adult liver fluke in cattle and sheep. The product is
also ovicidal against fluke and worm eggs.
In CATTLE it is active against the following species:
ROUNDWORMS: Ostertagia, 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.
In SHEEP it is active against benzimidazole-susceptible strains of the following species:
ROUNDWORMS: Ostertagia, Haemonchus, Trichostrongylus, Nematodirus (including N. battus), Chabertia and
Oesophagostomum. It is usually effective against inhibited larvae of Ostergia.
LUNGWORMS: Dictyocaulus filaria,
TAPEWORMS: Moniezia spp.
ADULT LIVER FLUKE: Fasciola hepatica.
Tramazole 10% is ovicidal and will kill fluke and worm eggs, thus reducing pasture contamination.
4.3 CONTRAINDICATIONS
Do not use in animals with kn
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