HyperCard 10 mg Coated Tablets for Cats

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: VMD (Veterinary Medicines Directorate)

Aktiivinen ainesosa:

Diltiazem Hydrochloride

Saatavilla:

Dechra Limited

ATC-koodi:

QC08DB01

INN (Kansainvälinen yleisnimi):

Diltiazem Hydrochloride

Lääkemuoto:

Coated tablet

Prescription tyyppi:

POM-V - Prescription Only Medicine – Veterinarian

Terapeuttinen ryhmä:

Cats

Terapeuttinen alue:

Cardio Vascular

Valtuutuksen tilan:

Authorized

Valtuutus päivämäärä:

2000-08-16

Valmisteyhteenveto

Revised: October 2015
AN: 00817/2015
Page 1 of 5
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
Diltiazem
Excipients
Tartrazine (E102)
Titanium dioxide (E171)
For a full list of excipients, see section 6.1.
Quantitative composition
9.20 mg (equivalent to 10 mg of
Diltiazem hydrochloride)
0.11 mg
1.1 mg
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 (2
nd
or 3
rd
), hypotension or sick
sinus syndrome.
Diltiazem should not be given to animals 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 3 kg.
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 β blockers, digitalis or digoxin.
Do not use in pregnant or lactating females.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
None.
Revised: October 2015
AN: 00817/2015
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
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.
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.
ii.
Special precautions for the person admini