Autoworm First Grazer 8750 mg Pulsatile-Release Intraruminal Device

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

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Active ingredient:

Oxfendazole

Available from:

Zoetis UK Limited

ATC code:

QP52AC02

INN (International Name):

Oxfendazole

Pharmaceutical form:

Pulsatile-release intraruminal device

Prescription type:

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

Therapeutic group:

Cattle

Therapeutic area:

Anthelmintic

Authorization status:

Authorized

Authorization date:

1998-08-21

Summary of Product characteristics

                                Revised: August 2020
AN: 00656/2020
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERSITICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Autoworm First Grazer 8750 mg Pulsatile-Release Intraruminal Device
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENT
mg/tablet
Oxfendazole
1250.0
EXCIPIENTS
Indigo Carmine Lake (E132)
20.0
Each intraruminal device contains:
7 tablets each containing oxfendazole 1250 mg
1 PVC cap segment
7 PVC tablet segments
8 silicone rubber sealing washers
1 magnesium alloy core
1 steel end-weight
For a full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
Pulsatile-release intraruminal device
A cylindrical device
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle weighing between 100 kg and 400 kg
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For administration to cattle weighing between 100 kg and 400 kg at the
time the
bolus is given. Designed for dosing prior to turnout of cattle in
their first grazing
season.
In
grazing
cattle,
the
device
will
deliver
seven
doses
of
oxfendazole
for
the
treatment of both adult and immature gastro-intestinal roundworms and
lungworms
and tapeworms at regular intervals of approximately three weeks during
a period of
approximately 21 weeks, the first dose being released around three
weeks after
administration. The device thus delivers a programmed therapeutic
anthelmintic
dosing regime over a period of approximately twenty-one weeks.
Revised: August 2020
AN: 00656/2020
Page 2 of 7
Oxfendazole is an established treatment for:
Gastro-intestinal roundworms: _Telodorsagia (Ostertagia), Haemonchus,
_
_Trichostrongylus, Nematodirus, Cooperia_, _Capillaria,
Oesophagostomum, _
_Chabertia, Trichuris;_
Lungworms: _Dictyocaulus viviparus_;
Tapeworms: _Moniezia_, heads and segments.
At the recommended dose rate in cattle, oxfendazole is effective
against
inhibited/arrested larvae of _Cooperia_ and usually effective against
inhibited/arrested larvae of _Ostertagia_.
It is also ovicidal against nematode eggs.
4.3
CONTRA-INDICATIONS
Do not administer to
                                
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