OXTRA VETERINARY

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

OXYTETRACYCLINE HYDROCHLORIDE

متاح من:

ROMAT LTD

الشكل الصيدلاني:

PESSARY

تركيب:

OXYTETRACYCLINE HYDROCHLORIDE 1 G

طريقة التعاطي:

INTRAUTERINE

نوع الوصفة الطبية :

Required

المصنعة من قبل:

FATRO S.P.A., ITALY

الخصائص العلاجية:

Cattle - therapy and prevention of bacterial infections of the genital tract caused by microorganisms sensitive to oxytetracyline, in particular in retained placenta and endometritis.

تاريخ الترخيص:

2020-05-31

نشرة المعلومات

CONSUMER LEAFLET FOR A VETERINARY PRODUCT
This medicine is marketed according to a veterinarian’s prescription
only.
For animal use only
1.
NAME, FORM AND STRENGTH OF THE VETERINARY MEDICINE
OXTRA VETERINARY, effervescent pessaries for intrauterine use
2.
ACTIVE INGREDIENT and its quantity in a dose unit
Each pessary contains:
Oxytetracycline HCl, equivalent to 1 g Oxytetracycline
For inactive excipients – see section 13 (“Additional
information”)
3.
WHAT IS THE MEDICINE INTENDED FOR
In cows: therapy and prevention of bacterial infections of the genital
tract
caused
by
microorganisms
sensitive
to
oxytetracycline,
particularly
retained placenta and endometritis.
Therapeutic group: Broad-spectrum antibiotics.
4.
CONTRAINDICATIONS
The product is contraindicated in cows which have shown
hypersensitivity
to the tetracyclines in general or to any one of the excipients.
5.
SIDE EFFECTS
No side effects were reported for the product.
Side effects can be reported to the Ministry of Health by clicking on
the link
"Adverse Drug Reactions Report" that appears on the home page of the
Ministry of Health web site (www.health.gov.il), which leads to an
online
form for reporting side effects. Alternatively you can use the
following link:
https://sideeffects.health.gov.il_ _
6.
TARGET SPECIES
Cows.
7.
DOSAGE AND ADMINISTRATION
Administer by the intrauterine route.
Cows: 2-4
pessaries/day in a single administration. Repeat, if necessary,
after 24 hours.
8.
HOW TO USE THE PRODUCT
Wear gloves during administration of the product and have regard for
the
usual hygiene procedures.
9.
WITHDRAWAL PERIOD
Before slaughter: 10 days.
Milk: 84 hours.
10.
WARNINGS
•
Special warnings for the use of the medicinal product in the target
species
Repeated or prolonged use should be avoided; improve the
management of the cows regarding cleanliness and disinfection.
•
Special warnings for safe use in animals
Use
of
the
product
should
be
based
on
sensitivity
testing
against
bacteria isolated from the animals to be treated. If this is not
poss

خصائص المنتج

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
OXTRA VETERINARY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pessary contains:
ACTIVE SUBSTANCE:
oxytetracycline..................................................1 g
equivalent to oxytetracycline hydrochloride.....1.08 g
For a complete list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Effervescent intrauterine pessaries.
4.
CLINICAL PARTICULARS
4.1.
TARGET SPECIES
Cows.
4.2.
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Cattle - therapy and prevention of bacterial infections of the genital
tract caused by microorganisms
sensitive to oxytetracyline, in particular in retained placenta and
endometritis.
4.3.
CONTRAINDICATIONS
The
product
is
contraindicated
in
subjects
which
have
shown
hypersensitivity
to
the
tetracyclines in general or to any one of the excipients.
4.4.
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Repeated or prolonged use should be avoided, improve management
procedures including
cleanliness and disinfection.
4.5.
SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Use of the product should be based on sensitivity testing against
bacteria isolated from the
animals to be treated. If this should not be possible, therapy should
be based on local
(regional
or
from
breeding
establishments)
epidemiological
information
regarding
the
susceptibility of the target bacteria.
Use of the product in a way not complying with the instructions
supplied may increase the
prevalence of bacteria resistant to the tetracyclines and may decrease
the efficacy of
treatment with other antibiotics of the same class or different
classes, owing to potential
cross-resistance.
2/4
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL
PRODUCT TO ANIMALS
Persons with known hypersensitivity to oxytetracycline, to other
tetracyclines or to any of
the excipients must avoid contact with the veterinary medicinal
product. Wear gloves during
administration of the product and have regard for the u