Boehringer Pimobendan 0.75 mg/ml Solution for Injection for Dogs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Pimobendan

Available from:

Boehringer Ingelheim Limited

ATC code:

QC01CE90

INN (International Name):

Pimobendan

Pharmaceutical form:

Solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Dogs

Therapeutic area:

Cardio Vascular

Authorization status:

Expired

Authorization date:

2012-09-26

Summary of Product characteristics

Revised: June 2016
AN: 00061/2016
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Boehringer Pimobendan 0.75 mg/ml Solution for Injection for Dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
ACTIVE SUBSTANCE:
Pimobendan 0.75 mg
EXCIPIENTS:
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Clear colourless solution for injection
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Dogs
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
To
initiate
treatment
of
canine
congestive
heart
failure
originating
from
valvular
insufficiency
(mitral
and/or
tricuspid
regurgitation)
or
dilated
cardiomyopathy.
4.3
CONTRAINDICATIONS
The product should not be used in cases of hypertrophic
cardiomyopathies or
clinical conditions where an augmentation of cardiac output is not
possible for
functional or anatomical reasons (e.g. aortic stenosis).
See also section 4.7.
4.4
SPECIAL WARNINGS
None
4.5
SPECIAL PRECAUTIONS FOR USE
Revised: June 2016
AN: 00061/2016
Page 2 of 5
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
In the event of accidental subcutaneous injection, temporary swelling
and mild
resorptive inflammatory reactions may occur at or below the injection
site.
For single administration only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
VETERINARY MEDICINAL PRODUCT TO
ANIMALS
In case of accidental self-injection, seek medical advice immediately
and
show the package leaflet or the label to the physician.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
A moderate positive chronotropic effect and vomiting may occur in rare
cases.
In rare cases transient diarrhoea, anorexia or lethargy have been
observed.
4.7
USE DURING PREGNANCY, LACTATION OR LAY
In studies with rats and rabbits pimobendan had no effect on
fertility.
Embryotoxic effects only occurred at maternotoxic doses. In rat
experiments it
has been shown that pimobendan is excreted into milk. Therefore, the
product
should only be administered to pregnant and lactating bitches if the
expec