אנטיסדן וטרינרי

البلد: إسرائيل

اللغة: العبرية

المصدر: Ministry of Health

العنصر النشط:

ATIPAMEZOLE HYDROCHLORIDE

متاح من:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

الشكل الصيدلاني:

תמיסה להזרקה

تركيب:

ATIPAMEZOLE HYDROCHLORIDE 5 MG/ML

طريقة التعاطي:

תת-עורי, תוך-שרירי

نوع الوصفة الطبية :

מרשם נדרש

المصنعة من قبل:

ORION CORPORATION ORION PHARMA,FINLAND

تاريخ الترخيص:

2014-10-31

نشرة المعلومات

_The format of this leaflet was determined by the Ministry _
_of Health and its content was checked and approved by it._
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME
OF
THE
VETERINARY
MEDICINAL
PRODUCT
Antisedan Veterinary
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient:
Atipamezole hydrochloride 5 mg/ml
For a full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Clear and colourless solution for Injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Elimination of the sedative effects of medetomidine in dogs
and cats.
See section 4.4 for restrictions.
4.3
CONTRAINDICATIONS
None.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
When any combination of butorphanol or medetomidine or
dexmedetomidine and ketamine have been used, atipamezole
should not be used to reverse the effect in dogs.
4.5
SPECIAL PRECAUTIONS FOR USE
i. Special precaution(s) for use in animals
With the exception of those drugs mentioned within the
SPC, the concurrent use of drugs affecting the CNS is not
recommended.
Antisedan should not be administered within 30-40 minutes
of the administration of ketamine in cats.
ii. Special precautions to be taken by the person
administering the veterinary medicinal product to animals
Due to the potent pharmacological activity of atipamezole,
skin contact with this product should be avoided and
impervious gloves should be worn during administration.
Care should be taken to avoid accidental self-injection. If
accidental self-injection occurs, seek immediate medical
attention showing a copy of the package leaflet. Do not
drive. The patient should not be left unattended. In case
of accidental spillage, wash the affected area immediately
with clean running water. Seek medical attention if irritation
persists. In case of accidental ingestion, seek medical advice
immediately.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
In dogs a transient hypotensive effect has been observed
during the first ten minutes post-injection. Vo