CERENIA INJECTION VETERINARY

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

MAROPITANT AS CITRATE MONOHYDRATE

Доступно од:

ZOETIS ISRAEL HOLDING B.V., ISRAEL

Фармацеутски облик:

SOLUTION FOR INJECTION

Састав:

MAROPITANT AS CITRATE MONOHYDRATE 10 MG/ML

Пут администрације:

S.C

Тип рецептора:

Required

Произведен од:

FAREVA AMBOISE, FRANCE

Терапеутске индикације:

In dogs above age 8 weeks and cats above age 16 weeks : for the prevention of vomiting except that induced by motion sickness.For the treatment of vomiting, in combination with other supportive measures.Dogs age 8 - 10 weeks must be under close medical supervision or hospitalized.

Датум одобрења:

2015-03-31

Информативни летак

תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
INDICATION
N/A
N/A
CONTRAINDICATIONS
N/A
N/A
POSOLOGY, DOSAGE &
ADMINISTRATION
N/A
N/A
SPECIAL WARNINGS AND
SPECIAL PRECAUTIONS
FOR USE
N/A
Dogs:
Although Cerenia Injection Veterinary
has been demonstrated to be effective in
both the treatment and prevention of
emesis induced by chemotherapy, it was
found more efficacious if used
preventively. Therefore, it is
recommended to administer the
antiemetic prior to administration of the
chemotherapeutic agent.
Use only according to the benefit-risk
assessment by the responsible
veterinarian.
As maropitant is accumulated in
the body during a 14 day treatment
period due to metabolic saturation,
careful monitoring of liver
function and any adverse events
should be implemented during
long term treatment.
Cerenia Injection Veterinary should be
used with caution in animals suffering
from or with predisposition for cardiac
diseases as maropitant has affinity to
Ca- and K-ion channels. Increases of
approximately 10% in the QT interval
of the ECG were observed in a study
on healthy beagle dogs administered 8
mg/kg orally; however, such an
increase is unlikely to be of clinical
significance.
In laboratory studies, maropitant has
been shown to be a potential eye
irritant.
INTERACTION WITH OTHER
MEDICAMENTS AND
OTHER FORMS OF
INTERACTION
N/A
N/A
FERTILITY, PREGNANCY
AND LACTATION
N/A
N/A
ADVERSE EVENTS
יאוול תועפות לש הרקמ לכב
תעפות לש הרקמב וא הרומח
ךילע ,ןולעב הרכזוה אלש יאוול
רנירטווה אפורה םע ץעייתהל
.דימ

Карактеристике производа

because
conclusive
reproductive
toxicity
studies
have
not
been
conducted
in
any
animal species.
4.8
INTERACTION
WITH
OTHER
MEDICINAL
PRODUCTS AND OTHER FORMS OF INTERACTION
Cerenia
Injection
Veterinary
should
not
be
used
concomitantly
with
Ca-channel
antagonists as maropitant has affinity to Ca-
channels.
Maropitant
is
highly
bound
to
plasma
proteins and may compete with other highly
bound medicines.
4.9
AMOUNTS
TO
BE
ADMINISTERED
AND
ADMINISTRATION ROUTE
For subcutaneous use in dogs and cats.
Cerenia
Injection
Veterinary
should
be
injected
subcutaneously,
once
daily,
at
a
dose
of
1
mg/kg
bodyweight
(1
ml/10
kg
bodyweight) for up to 5 consecutive days.
In
dogs,
Cerenia
Injection
Veterinary
can
be used to treat or prevent vomiting when
administered
once
daily.
Cerenia
Injection
Veterinary may be administered for up to five
days.
To
prevent
vomiting,
Cerenia
Injection
Veterinary
solution
for
injection
should
be
administered more than 1 hour in advance.
The effect duration is approximately 24 h and
therefore treatment can be given the night
before administration of an agent that may
cause emesis, e.g. chemotherapy.
As the pharmacokinetic variation is large and
maropitant
accumulates
in
the
body
after
once-daily
repeated
administration,
lower
doses than recommended might be sufficient
in some individuals and when repeating the
dose.
4.10 OVERDOSE
(SYMPTOMS,
EMERGENCY
PROCEDURES, ANTIDOTES), IF NECESSARY
Apart from transient reactions at the injection
site following subcutaneous administration,
Cerenia Injection Veterinary was well tolerated
in dogs and young cats injected daily with
up to 5 mg/kg (5 times the recommended
dose) for 15 consecutive days (3 times the
recommended
duration
of
administration).
No data have been presented on overdoses
in adult cats.
4.11 WITHDRAWAL PERIOD(S)
Not applicable.
5.
PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Antiemetics.
ATCvet code: QA04AD90.
Maropitant
is
a
potent
and
selective
neurokinin (NK
1
) receptor antagonist, which
acts by inhibiting the binding of substance
P