Cosecure Cattle Bolus Continuous Release Intraruminal Device

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Copper; Cobalt; Sodium selenate

Dostopno od:

Bimeda Animal Health Limited

Koda artikla:

QA12CE99

INN (mednarodno ime):

Copper; Cobalt; Sodium selenate

Odmerek:

13.4, 0.5, 0.3 gram/100gram

Farmacevtska oblika:

Continuous-release intraruminal device

Tip zastaranja:

LR: Licensed Retailer as defined in national legislation

Terapevtsko območje:

selenium, combinations

Status dovoljenje:

Authorised

Datum dovoljenje:

2005-04-27

Lastnosti izdelka

Page 1 of 6
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Cosecure Cattle Bolus Continuous Release Intraruminal Device (UK,(NI),
Ireland)
Cosecure
Vet
Continuous
Release
Intraruminal
Device
(Denmark,
France,
Luxembourg)
Rumifert Continuous Release Intraruminal Device (Germany)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 100g bolus contains the following active substances:
Copper:
13.4g
Cobalt:
0.5g
Selenium, as sodium selenate
0.3g
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Continuous release intraruminal device.
A cylindrical, blue glass continual release intraruminal device
approximately 82mm x
24mm and weighing approximately 100g, referred to throughout the text
as a bolus.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Cattle (over 2 months and weighing at least 100 kg BW)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For prevention and treatment of copper and selenium deficiencies and
for improvement
of cobalt supply.
4.3
CONTRAINDICATIONS
Do not administer to non-ruminating calves or to animals weighing less
than 100kg
body weight. Do not administer to sheep.
See also Section 4.5, Special Precautions for Use
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
The product is not intended for treatment of acute clinical conditions
such as nutritional
muscular dystrophy.
Page 2 of 6
4.5
SPECIAL PRECAUTIONS FOR USE
(I)
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Prior to supplementation with any form of copper or selenium, it
should be
demonstrated that there is a need for extra trace elements to be given
to the
animals.
Additional copper should not be administered orally or by injection,
or selenium
by injection, within six months after administration of the product to
cattle at
pasture or within 4.5 months in cattle where the diet is supplemented
with
concentrates
unless
subjected
to
a
risk/benefit
analysis
performed
by
a
responsible veterinarian in each case.
Do not administer any aids to alter dissolution of the bolus.
The boluses are sensitive to sudden temperature changes such as t