HyperCard 10 mg Coated Tablets for Cats

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Diltiazem hydrochloride

Saatavilla:

Dechra Regulatory B.V.

ATC-koodi:

QC08DB01

INN (Kansainvälinen yleisnimi):

Diltiazem hydrochloride

Annos:

10 mg/tablet

Lääkemuoto:

Coated tablet

Prescription tyyppi:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeuttinen alue:

diltiazem

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2008-11-10

Valmisteyhteenveto

Health Products Regulatory Authority
03 July 2019
CRN0095M3
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HyperCard 10 mg Coated Tablets for Cats
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains:
ACTIVE SUBSTANCE
Dilitazem
9.20
mg
(equivalent to 10 mg of Diltiazem Hydrochloride)
EXCIPIENTS
Tartrazine (E102)
0.11
mg
Titanium Dioxide (E171)
1.1
mg
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Coated tablet.
A yellow coated biconvex tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Cats
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the therapeutic treatment of feline primary hypertrophic
cardiomyopathy
4.3 CONTRAINDICATIONS
Do not use in animals suffering from AV block (2nd or 3rd),
hypotension or sick sinus syndrome.
Diltiazem should not be given to patients suffering from hepatic
disease.
Do not use in animals suffering from renal disease.
Do not use in cats less than 12 months old.
Do not use in cats weighing less than 3kg.
Do not use in animals that are hypersensitive to Diltiazem.
Do not use in cats with severe bradycardia or arterial hypotension.
Do not use in conjunction with ß-blockers, digitalis or digoxin.
Do not use in pregnant or lactating females.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Hepatic failure may increase the plasma concentration of diltiazem.
Monitor glucose levels carefully in diabetic animals.
Use with caution in cats suffering from congestive heart failure.
Cats with possible pre-existing thyroid problems or hyperthyroidism
should be treated for this first and then reassessed prior
to commencing treatment with Diltiazem.
Health Products Regulatory Authority
03 July 2019
CRN0095M3
Page 2 of 4
Clinical examination to assess the effectiveness of treatment should
be performed after 8 weeks.
Cardiac rate should be monitored prior to treatment commencing and at
every follow up visit.
SPECIAL PRECAUTIONS FOR THE PERSON AD