Engemycin Spray, 25 mg/mL, cutaneous spray, suspension for cattle, sheep and pigs

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

العنصر النشط:

Oxytetracycline hydrochloride

متاح من:

Intervet Ireland Limited

ATC رمز:

QD06AA03

INN (الاسم الدولي):

Oxytetracycline hydrochloride

جرعة:

25 milligram(s)/millilitre

الشكل الصيدلاني:

Cutaneous spray, suspension

نوع الوصفة الطبية :

POM: Prescription Only Medicine as defined in relevant national legislation

المجموعة العلاجية:

Cattle, Pigs, Sheep

المجال العلاجي:

oxytetracycline

الخصائص العلاجية:

Antibacterial

الوضع إذن:

Authorised

تاريخ الترخيص:

2009-10-02

خصائص المنتج

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Engemycin Spray, 25 mg/ml, cutaneous spray, suspension for cattle,
sheep and pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCES:
23,15 mg Oxytetracycline equivalent to 25,00 mg Oxytetracycline
hydrochloride
EXCIPIENTS:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
QUANTITATIVE
COMPOSITION
IF THAT INFORMATION
IS ESSENTIAL
FOR PROPER ADMINISTRATION OF THE
VETERINARY MEDICINAL PRODUC
t
_ _
Patent blue V (E131)
1,25 mg
Polysorbate 80
Isopropyl alcohol
Mixture of hydrocarbons on butane basis (n-
butane. isobutane, propane), with denaturant
Green to green-blue suspension
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle, sheep and pigs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For the treatment of the following infections caused by, or associated
with, organisms sensitive to
oxytetracycline in cattle, sheep and pigs:
Treatment of foot infections caused in particular by:
_Dichelobacter nodosus, Fusobacterium _
_necrophorum_
and other
_Fusobacterium_
spp., and
_Bacteroides _
spp
_._
Supporting treatment of superficial wound infections following surgery
or physical injuries, e.g., tail
biting in pigs, scratches and abrasions.
3.3
CONTRAINDICATIONS
Do not use for treatment of teats in order to prevent the veterinary
medicinal product from getting into
milk.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
The animals should be treated in a well ventilated area.
Do not spray in or near the eyes.
Use of the veterinary medicinal product should be based on
susceptibility testing of the bacteria
isolated from the animal. If this is not possible, therapy should be
based on local (regional, farm level)
epidemiological information about susceptibility of the target
bacteria.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals