[Wagg & Purr] Pimobendan 0.75 mg/mL Injectable Solution for Dogs

Kraj: Australia

Język: angielski

Źródło: APVMA (Australian Pesticides and Veterinary Medicines Authority)

Składnik aktywny:

PIMOBENDAN

Dostępny od:

AVET HEALTH LIMITED

Forma farmaceutyczna:

PARENTERAL LIQUID/SOLUTION/SUSPENSION

Skład:

PIMOBENDAN PYRIDAZINONE Active 0.75 mg/ml

Sztuk w opakowaniu:

10 mL; 5 mL

Klasa:

VM - Veterinary Medicine

Dziedzina terapeutyczna:

CARDIOVASCULAR SYSTEM

Podsumowanie produktu:

Poison schedule: 4; Withholding period: N/A N/A; Host/pest details: DOG: [CONGESTIVE HEART FAILURE]

Status autoryzacji:

Registered

Data autoryzacji:

2023-07-01

Ulotka dla pacjenta

[Wagg & Purr] Pimobendan 0.75 mg/mL Injectable Solution for Dogs
92877/137035
Product Name:
APVMA Approval No:
Label Name:
[Wagg & Purr] Pimobendan 0.75 mg/mL Injectable Solution for Dogs
Signal Headings:
PRESCRIPTION ANIMAL REMEDY
KEEP OUT OF REACH OF CHILDREN
FOR ANIMAL TREATMENT ONLY
Constituent
Statements:
0.75 mg/mL Pimobendan
Claims:
To initiate treatment of congestive heart failure originating from
dilated cardiomyopathy or
valvular insufficiency (mitral and/or tricuspid regurgitation) in
dogs.
For use only by or under supervision of a veterinarian.
Net Contents:
5 mL
10 mL
Directions for Use:
Restraints:
Contraindications:
Contraindicated for use in animals with hypertrophic cardiomyopathies
or clinical conditions
where an augmentation of cardiac output is not possible for functional
or anatomical
reasons (e.g. aortic stenosis).
Contraindicated for use in dogs not showing signs of cardiac disease.
Precautions:
Use with caution in pregnant, lactating and breeding dogs. In studies
with rats and rabbits,
pimobendan had no effect on fertility and embryotoxic effects only
occurred at maternotoxic
doses. In rat experiments, it has been shown that pimobendan is
excreted into the milk.
[Wagg & Purr] Pimobendan 0.75 mg/mL Injectable Solution for Dogs
should only be used
administered to pregnant and lactating bitches if the expected
therapeutic benefits outweigh
the potential risk. RLP APPROVED
Studies into the effect of pimobendan on the reproductive function of
male dogs have not
been conducted.
Side Effects:
A moderate positive chronotropic effect and vomiting may occur in rare
cases. In rare cases
transient diarrhoea, anorexia or lethargy have been observed.
In the event of accidental subcutaneous injection, temporary swelling
and mild resorptive
inflammatory reactions may occur at or below the injection site.
Overdose
In case of overdosing symptomatic treatment should be initiated.
Dosage and
Administration:
Single use only. Use immediately after opening. Discard the unused
portion of the product
immediately a