DOMITOR VETERINARY

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

MEDETOMIDINE HYDROCHLORIDE

Available from:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

MEDETOMIDINE HYDROCHLORIDE 1 MG/ML

Administration route:

I.M, I.V, S.C

Prescription type:

Required

Manufactured by:

ORION CORPORATION ORION PHARMA,FINLAND

Therapeutic indications:

Dogs: For restraint, sedation and analgesia associated with clinical examinations and procedures, minor surgery and pre-anaesthesia. As a premedicant before halothane general anaesthesia and as a premedicant before general anaesthesia with propofol. Cats: For restraint and sedation. In combination with ketamine for induction of general anaesthesia prior to surgical procedures.

Authorization date:

2016-12-31

Patient Information leaflet

_ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_ןכרצל ןולעב )תוחיטב עדימ ( הרמחה לע
העדוה_
_ ןכדועמ(_
_ ןכדועמ(_
_05.2013_
_05.2013_
_)_
_)_ :ךיראת
26/05/2015 :םושירה רפסמו תילגנאב רישכת םש
DOMITOR VETERINARY
082 58 92306 00 :םושירה לעב םש
יו.יב גנידלוה לארשי סיטאוז
! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
תויוותה
ןיא יתמ
שמתשהל
?רישכתב
תודחוימ תורהזא
שומישל תועגונה
:הפורתב
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
A clinical examination should be carried out in
all animals before the use of drugs for
sedation and/or general anaesthesia
.
Care should be taken when using Domitor in
animals with cardiovascular disease
.
Care should be taken when combining
medetomidine with other anaesthetics
or sedatives. Before using any
combinations consult the
contraindications and warnings that
םדאל תוחיטב תוארוהו תויחנה
:היחל הפורת ןתונה
םימב םייניעה תא ףוטשל שי
םימרוז
-כ ךשמל
15
.תוקד
לש הקרזה וא העילב לש הדימב
תלבקל תונפל שי – הפורתה
יאופר לופיט
תיוות גיצהלו
.רישכתה
ילכו בל תולחממ םילבוסה םישנא
בל תלחמ ,םד ץחל רתי ןוגכ( םד
טוקנל םהילע – ) 'דכו ,תיתקיפס
הפורתב שומישב תוריהז הנשמ
.הילא הפישח עונמל תנמ לע
appear on the concomitant product’s
data sheet
.
Special care is recommended when treating
very young animals and older animals
.
Domitor, ketamine and propofol are
metabolised in the liver and excreted
primarily via the kidneys. Pre-existing
liver or kidney pathology should be
carefully evaluated to confirm adequate
function prior to using these products
.
In

Summary of Product characteristics

_The format of this leaflet was determined by the Ministry of Health
and its content was _
_checked and approved by it._
DOMITOR PACKAGE INSERT
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
DOMITOR VETERINARY
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENT:
Medetomidine hydrochloride 1 mg/ml
EXCIPIENTS:
Methyl parahydroxybenzoate 1 mg/ml
Propyl parahydroxybenzoate
0.2 mg/ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for Injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs and Cats.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
DOGS: For restraint, sedation and analgesia associated with clinical
examinations and
procedures, minor surgery and pre-anaesthesia. As a premedicant before
halothane
general anaesthesia and as a premedicant before general anaesthesia
with propofol.
CATS: For restraint and sedation. In combination with ketamine for
induction of general
anaesthesia prior to surgical procedures.
4.3
CONTRAINDICATIONS
Do not use in animals with heart failure, respiratory disease or
impaired liver or kidney
function, animals in shock, seriously debilitated animals, or animals
that are stressed
due extreme heat, cold or fatigue. Do not use in conjunction with
sympathomimetic
amines.
Do not use in dogs under 12 weeks of age.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
When Domitor is administered, the animal should be allowed to rest in
a maximally quiet
place. Before any procedure is started or other drugs are
administered, sedation should
be allowed to reach its peak effect, which occurs at about 10 to 30
min, depending
on route of administration.
In extremely nervous, excited or agitated animals, the levels of
endogenous catecholamines
may be high. The pharmacological response elicited by alpha-2 agonists
(e.g. medetomidine)
in such animals is often reduced, with depth and duration of sedative
and analgesic
effects ranging from slightly diminished to non-existent. Highly
agitated animals should
therefore be put at ease and allowed to rest quietly