SLENTROL

Kraj: Australia

Język: angielski

Źródło: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Składnik aktywny:

DIRLOTAPIDE

Dostępny od:

ZOETIS AUSTRALIA PTY LTD

INN (International Nazwa):

dirlotapide(5mg/mL)

Forma farmaceutyczna:

ORAL SOLUTION/SUSPENSION

Skład:

DIRLOTAPIDE UNGROUPED Active 5.0 mg/ml

Sztuk w opakowaniu:

150mL; 20mL; 50mL

Klasa:

VM - Veterinary Medicine

Wyprodukowano przez:

ZOETIS AUSTRALIA

Grupa terapeutyczna:

DOG - ADULT

Dziedzina terapeutyczna:

WEIGHT CONTROL

Wskazania:

WEIGHT MANAGEMENT DIET | OBESE | OVERWEIGHT

Podsumowanie produktu:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG - ADULT: [WEIGHT MANAGEMENT DIET]; Poison schedule: 4; Withholding period: ; Host/pest details: DOG - ADULT: [WEIGHT MANAGEMENT DIET]; As an aid in the management of overweight and obesity in adult dogs.NOT for use in cats or growing dogs. DO NOT use in breeding, pregnant, or lactating animals. DO NOT use in animals less than one year of age - safe use has not been established in this group. DO NOT use in dogs with impaired liver function.

Status autoryzacji:

Registered

Data autoryzacji:

2023-07-01

Ulotka dla pacjenta

COPY
IN
THE
HEADER
AND
FOOTER
WILL
NOT
APPEAR
ON
THE
FINAL
PRINTED
LABEL
LAB0201
VIAL LABEL
MAIN PANEL
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Slentrol®
DIRLOTAPIDE 5 MG/ML
Prepared:
31
July 2013
As an aid
in
the management of overweight and obesity
in
adult dogs
..
20 mL /50
ml/150
mL
RIGHT PANEL
READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT
Store in original container to protect from moisture.
Use within 3 months
of
opening.
APVMAApproval
No.
61961/41973
Zoetis Australia Pty Ltd
38-42 Wharf Road, West Ryde.
NSW
Store below
30'C
(Room temperature).
8:
Exp:
S:IREG AFFAIRSIAPVMA SUBMISSIONSISLENTROL\LABELILAB0201 JULY 2013.DOC
Page 1
of
9
RLP
Approv'''
LAB0201
LEAFLET
COPY
IN
THE
HEADER
AND
FOOTER
WILL
NOT
APPEAR
ON
THE
FINAL
PRINTED
LABEL
Prepared:
31
July 2013
PRESCRIPTION ANIMAL REMEDY
KEEP
OUT
OF REACH
OF
CHILDREN
FOR ANIMAL TREATMENT
ONLY
Slentrol®
As
an
aid
in
the management
of
overweight and obesity
in
adult dogs
Dirlotapide 5 mg/mL
Dirlotapide is a potent selective inhibitor
of
the microsomal triglyceride transfer
protein (MTP).
Inhibiting this protein causes body weight
Joss
in dogs
by
reducing
food intake and intestinal fat absorption.
This weight
Joss
is predominantly
of
fat
rather than lean body mass. The microsomal triglyceride transfer
protein (MTP)
is pivotal for the absorption and distribution
of
fat.
The inhibition
of
intestinal and
hepatic MTP reduces plasma cholesterol and triglyceride concentration.
The
selective inhibition
of
intestinal MTP also reduces intestinal fat absorption.
Dirlotapide has
in
vivo
selectivity
for
intestinal MTP compared to liver MTP, with a
ratio
of
37.5:1, thereby focusing its mode
of
action
on
the intestine (25% maximal
intestinal effect (ED25) at 0.16 mg/kg contrasting
to
similar inhibition
of
hepatic
MTP achieved at 6 mg/kg).
In
addition to reducing intestinal
fat
absorption, dirlotapide reduces food intake in
dogs
in
a dose dependent manner. This food inhibitory effect of dirlotapide
results from a primary local eff