FORTEKOR PLUS 5 MG PIMOBENDAN/10 MG BENAZEPRIL HCL FOR DOGS

Country: Australia

Language: English

Source: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Active ingredient:

BENAZEPRIL HYDROCHLORIDE; PIMOBENDAN

Available from:

ELANCO AUSTRALASIA PTY LTD

INN (International Name):

pimobendan(5mg/Tb)+benazepril HCl(10mg/Tb)

Pharmaceutical form:

ORAL TABLET

Composition:

BENAZEPRIL HYDROCHLORIDE UNGROUPED Active 10.0 mg/Tb; PIMOBENDAN PYRIDAZINONE Active 5.0 mg/Tb

Units in package:

30 tablets; 60 tablets

Class:

VM - Veterinary Medicine

Manufactured by:

ELANCO AUSTRALASIA

Therapeutic area:

CARDIOVASCULAR SYSTEM

Product summary:

Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]; For the treatment of congestive heart failure in dogs.See CONTRAINDICATIONS, PRECAUTIONS etc. on label.

Authorization status:

Registered

Authorization date:

2023-07-01

Patient Information leaflet

•
AUSTRALIAN GOVERNMENT
AUSTRALIAN PESTICIDES
AND
VETERINARY
MEDICINES AUTHORITY
RLP
APPENDIX 2
Approved
TEMPLATE FOR RELEVANT LABEL PARTICULARS (RLPS)
(VETERINARY PRODUCTS)
Select appropriate:
I!J
New
Product (include all applicable RLPs)
OR
[]Variation
(highlight instructions that are being varied). Approval no.
of
label being
varied:
Signal heading:
Product
name:
Active
constituent/s:
Statement of
CLAIMS:
Net contents:
Action
Pharmacologic
al
Properties
PRESCRIPTION ANIMAL REMEDY
KEEP
OUT
OF REACH OF CHILDREN
FOR ANIMAL
TREATMENT
ONLY
FORTEKOR
PLUS 5 mg PIMOBENDAN/10 mg BENAZEPRIL HCI FOR DOGS
Each tablet contains:
5 mg Pimobendan
10 mg Benazepril hydrochloride
FORTEKOR
PLUS is indicated
for
the treatment of congestive heart failure
in
dogs.
30 TABLETS [60 TABLETS!
FORTEKOR
PLUS is a combination
of
2
active substances: pimobendan and benazepril
hydrochloride.
Benazepril hydrochloride is an inhibitor
of
angiotensin-converting enzyme (ACE), thus
reducing the blood pressure and volume load on the heart
in
dogs with congestive
heart
failure. It has been shown that benazepril increased the time to
worsening
of
heart failure,
and the time to death or withdrawal from the study, improved global
clinical condition,
reduced cough and improved exercise tolerance
in
dogs with symptomatic congestive heart
failure caused
by
valvular disease
or
dilated cardiomyopathy.
Benazepril hydrochloride is indicated
for
the treatment
of
left-sided heart failure
in
dogs,
most commonly resulting from Mitral Regurgitation (MR) (Endocardiosis)
and Dilated
Cardiomyopathy (DCM). Benazepril hydrochloride, by inhibiting the
renin angiotensin
aldosterone system {RAAS), minimises the undesirable effects
of
vasoconstriction and
sodium retention mediated by this system.
The
end result
is
an improvement
in
the clinical
status
of
the dog.
FORTEKOR
leads to an extension
of
the life span
of
dogs with heart
failure and also improves clinical signs, notably a reduction
in
coughing, and improvement
to the quality of life.
Pimobendan is a non-sympathomi