Vetmedin® Chew Vetmedin Chew 1.25 mg chewable tablets for dogs Vetmedin Chew 5 mg chewable tablets for dogs Vetmedin Chew 10

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

PIMOBENDAN (UNII: 34AP3BBP9T) (PIMOBENDAN - UNII:34AP3BBP9T)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

For the treatment of canine congestive heart failure originating from dilated cardiomyopathy or valvular insufficiency (mitral and/or tricuspid valve regurgitation). (See also section “Dosage, routes and method of administration”). For the treatment of dilated cardiomyopathy in the preclinical stage (asymptomatic with an increase in left ventricular end-systolic and end-diastolic diameter) in Doberman Pinschers following echocardiographic diagnosis of cardiac disease (see section “Special warnings” and “Precautions for use in animals”). For the treatment of dogs with myxomatous mitral valve disease (MMVD) in the preclinical stage (asymptomatic with a systolic mitral murmur and evidence of increased heart size) to delay the onset of clinical symptoms of heart failure (see section “Special warnings” and “Special precautions for use in animals”). Do not use pimobendan in hypertrophic cardiomyopathies or in diseases in which an improvement in cardiac output cannot be achieved for functional or anatomical re

Product summary:

Heat sealed Aluminium// PVC/ Aluminium/ Polyamide blister containing 10 tablets. Cardboard box with 5 blisters of 10 tablets (50 tablets). Date on which the package leaflet was last approved Nov 2019

Authorization status:

unapproved drug other

Summary of Product characteristics

VETMEDIN CHEW- PIMOBENDAN TABLET, CHEWABLE
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
----------
VETMEDIN® CHEW
VETMEDIN CHEW 1.25 MG CHEWABLE TABLETS FOR DOGS
VETMEDIN CHEW 5 MG CHEWABLE TABLETS FOR DOGS
VETMEDIN CHEW 10 MG CHEWABLE TABLETS FOR DOGS
PIMOBENDAN
CLIENT INFORMATION SHEET
CLIENT INFORMATION SHEET FOR VETMEDIN CHEW (PIMOBENDAN)
Replacement product for Vetmedin (pimobendan) chewable tablets
CONTACT YOUR VETERINARIAN BEFORE ADMINISTERING THIS PRODUCT TO YOUR
DOG.
This Client Information Sheet contains important information about
VETMEDIN CHEW, a
product used as a temporary replacement for US FDA-approved VETMEDIN
chewable
tablets.
VETMEDIN CHEW is authorized for marketing in the United Kingdom and
Ireland to treat
congestive heart failure in dogs. You should read this information
before you start giving
VETMEDIN CHEW and review it each time the prescription is refilled as
there may be new
information.
This information sheet is provided only as a summary and does not take
the place of
instructions from your veterinarian. If you have received this product
from a pharmacy
and not directly from your veterinarian, you should contact your
veterinarian to inform
them that you have received this replacement product. TALK WITH YOUR
VETERINARIAN IF
YOU DO NOT UNDERSTAND ANY OF THIS INFORMATION OR IF YOU WANT TO KNOW
MORE
ABOUT VETMEDIN CHEW.
NOTE TO PRESCRIBING VETERINARIANS
The dose administered should be as stated in the FDA approved VETMEDIN
chewable
tablets package insert, accessible at:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5441e5b2-cdc0-477a-bd9a-
ec5f8d912281
WHY DID I RECEIVE VETMEDIN CHEW?
Because of a shortage in the supply of the FDA-approved VETMEDIN
chewable tablets,
the FDA is allowing temporary use of VETMEDIN CHEW in the United
States.
IS VETMEDIN CHEW THE SAME AS VETMEDIN CHEWABLE TABLETS?