ANTISEDAN VETERINARY

Kraj: Izrael

Język: angielski

Źródło: Ministry of Health

Składnik aktywny:

ATIPAMEZOLE HYDROCHLORIDE

Dostępny od:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

Forma farmaceutyczna:

SOLUTION FOR INJECTION

Skład:

ATIPAMEZOLE HYDROCHLORIDE 5 MG/ML

Droga podania:

S.C, I.M

Typ recepty:

Required

Wyprodukowano przez:

ORION CORPORATION ORION PHARMA,FINLAND

Wskazania:

Elimination of the sedative effects of medetomidine in dogs and cats.

Data autoryzacji:

2014-10-31

Ulotka dla pacjenta

_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_אפורל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_ ןכדועמ(_
_ ןכדועמ(_
_05.2013_
_05.2013_
_)_
_)_
ךיראת
:
03.03.2016
םושירה רפסמו תילגנאב רישכת םש
:
ANTISEDAN VETERINARY
141-85-92305-01
םושירה לעב םש
:
יו.יב גנידלוה לארשי סיטאוז
! דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
N/A
N/A
CONTRAINDICATIONS
N/A
N/A
POSOLOGY, DOSAGE &
ADMINISTRATION
המדרהמ תוששואתה תמירגל
רוטימוד ןתמ ידי לע התרשוהש
( ירנירטו
Medetomidine
)
ןונימב
40
=היח ג"ק/ג"קמ
0.4
/ל"מ
10
.היח ג"ק
( ירנירטו ןדסיטנא תתל שי
Atimeprazole
ןונימב )
200
=היח ג"ק/ג"קמ
0.4
/ל"מ
10
ג"ק
.היח
המדרהמ תוששואתה תמירגל
רוטימוד ןתמ ידי לע התרשוהש
( ירנירטו
Medetomidine
)
ןונימב
80
=היח ג"ק/ג"קמ
0.4
/ל"מ
5
.היח ג"ק
( ירנירטו ןדסיטנא תתל שי
Atimeprazole
ןונימב )
200
=היח ג"ק/ג"קמ
0.2
/ל"מ
5
ג"ק
היח
SPECIAL WARNINGS AND SPECIAL
PRECAUTIONS FOR USE
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.
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.
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

Charakterystyka produktu

Antisedan LPD 160719
Page 1 of 5
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 the 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
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
After administration of this veterinary medicinal product, the animals
should be
allowed to rest in a maximally quiet place.
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 LPD 160719
Page 2 of 5
Antisedan should not be administered within 30-40 minutes of the
administration of ketamine in cats.
If the effect of the alpha-2 agonist is
eliminated earlier, the residual effect of ketamine may cause
convulsions.
ii.
Special precautions to be taken by the person administering the
veterinary medicinal product to animals.
Due to the potent pharmacological activity of atipamezole, contact
with
skin or mucosal membranes 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 w