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View SPC - Veterinary Medicines Directorate

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View SPC - Veterinary Medicines Directorate

    Revised: October 2011

    AN: 00898/2011

    SUMMARY OF PRODUCT CHARACTERISTICS

    1. NAME OF THE VETERINARY MEDICINAL PRODUCT

    BE : Actikor 20 mg comprimés enrobés pour chiens/ filmomhulde tabletten

    voor honden

    DE : Actikor 20 mg Filmtabletten für Hunde

    DK : Actikor 20 mg filmovertrukne tabletter til hunde

    FI : Actikor 20 mg kalvopäällysteiset tabletit koiralle / filmdragerade

    tabletter för hundar

    FR : Actikor 20 mg comprimé pelliculé pour chiens

    IE : Actikor 20 mg film-coated tablets for dogs

    NL : Actikor 20 mg filmomhulde tabletten voor honden

    PL : Actikor 20 mg tabletki powlekane dla psów

    SE : Actikor 20 mg filmdragerade tabletter för hundar

    UK : Actikor 20 mg Film-coated Tablets for Dogs

    2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each film-coated tablet contains:

    Active substance:

    Benazepril 18.4 mg (equivalent to 20 mg of benazepril hydrochloride).

Excipient(s):

    For a full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Film-coated tablets

Tan coloured, oval, biconvex, film-coated tablets with a breakline on one side and plain

    on the other side.

The tablets can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dog

    4.2 Indications for use, specifying the target species

Dogs weighing more than 20 kg:

Treatment of congestive heart failure associated with, in particular, dilated

    cardiomyopathy or mitral insufficiency

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    Revised: October 2011

    AN: 00898/2011

    4.3 Contraindications

    Do not use in any dog that has evidence of cardiac output failure for example due to aortic stenosis.

    Do not use in cases of hypersensitivity to benazepril or to any other ACE inhibitors or to any of the excipient(s).

    For use in pregnant, lactating and breeding animals, please refer Section 4.7.

    4.4 Special warnings for each target species

None

    4.5 Special precautions for use

i. Special precautions for use in animals

     No evidence of renal toxicity has been observed in dogs during clinical trials. As

    is routine in cases of renal insufficiency, it is recommended to monitor plasma

    creatinine and urea during therapy.

    ii. Special precautions to be taken by the person administering the veterinary

    medicinal product to animals

     ACE inhibitors have been found to affect the unborn child during pregnancy in

    humans. Pregnant women should take special care to avoid accidental exposure,

    including hand-to-mouth contact.

     Wash hands after use.

     Benazepril may cause hypotension after oral ingestion.

     In case of accidental ingestion, particularly by children, seek medical advice

    immediately and show the package leaflet or the label to the physician.

    4.6 Adverse reactions (frequency and seriousness)

    At the start of the treatment, a decrease of the blood pressure and a transient increase of plasma concentrations of creatinine may occur. In rare cases fatigue or drowsiness may be observed and transient signs of hypotension, such as lethargy and ataxia may occur.

    4.7 Use during pregnancy, lactation or lay

    Studies in laboratory animals (rats) have shown embryotoxic effects of benazepril at non-maternotoxic doses (malformations of the foetal urinary system). Benazepril administered to cats at a daily dose of 10 mg / kg for 52 weeks resulted in the reduction of ovary / oviduct weights. In humans ACE inhibitors have been found to be teratogenic during pregnancy.

    Do not use in breeding, pregnant or lactating dogs as the safety of the product in these animals has not been tested.

    Page 2 of 6

    Revised: October 2011

    AN: 00898/2011

    4.8 Interaction with other medicinal products and other forms of interaction

None known in dogs

    In dogs with heart failure, Benazepril hydrochloride has been given in combination with digoxin, diuretics and anti-arrythmic drugs without demonstrable adverse interactions. In human, the combination of ACE inhibitors and NSAIDs can lead to reduced anti-hypertensive efficacy or impaired renal function. The combination of Actikor tablet and other anti-hypertensive agents (e.g. calcium channel blockers, ;-blockers or diuretics),

    anaesthetics or sedatives may lead to additive hypotensive effects. Therefore concurrent use of NSAIDs or other medications with a hypotensive effect should be considered with care. Renal function and signs of hypotension (lethargy, weakness etc) should be closely monitored and treated as necessary.

    Interactions with potassium preserving diuretics like spironolactone, triamterene or amiloride cannot be ruled out. It is recommended to monitor plasma potassium levels when using benazepril in combination with a potassium sparing diuretic as life threatening reactions are a possibility.

    4.9 Amounts to be administered and administration route

For oral use

    The therapeutic oral dose is 0.25 mg benazepril hydrochloride / kg body weight once daily, with or without food according to the following dose regime:

Dogs weighing 5-10 kg: ? Actikor 5 mg tablet

    Dogs weighing 11-20 kg: 1 Actikor 5 mg tablet.

    Dogs weighing 21-40 kg: ? Actikor 20 mg tablet

    Dogs weighing 41-80 kg: 1 Actikor 20 mg tablet.

    The dose may be doubled (0.5 mg benazepril hydrochloride / kg body weight) still administered once daily, if judged clinically necessary and advised by the veterinary surgeon.

    In case of using halved tablets: Return any remaining half tablet to the opened blister pocket and store it below 30?C. Use the remaining half tablet for the next administration.

    4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

    In normal dogs, overdosage up to 200-fold of benazepril hydrochloride was asymptomatic. Transient reversible hypotension may occur in cases of accidental overdosage. Therapy should consist of intravenous infusion of warm isotonic saline.

    4.11 Withdrawal period(s)

Not applicable.

    Page 3 of 6

    Revised: October 2011

    AN: 00898/2011

    5. PHARMACOLOGICAL PROPERTIES

    Pharmaceutical group: Cardiovascular system, agents acting on the renin- angiotensin system, ACE inhibitors, plain, benazepril

    ATCvet code: QC09AA07

    5.1 Pharmacodynamic properties

Benazepril hydrochloride is a prodrug hydrolysed in vivo to its active metabolite,

    benazeprilat. Benazeprilat is a highly potent and selective inhibitor of angiotensin converting enzyme (ACE), thus preventing the conversion of inactive angiotensin I to active angiotensin II. Therefore, it blocks effects mediated by angiotensin II, including vasoconstriction of both arteries and veins, retention of sodium and water by the kidney.

    The product causes long-lasting inhibition of plasma ACE activity with more than 95% inhibition at peak effect and significant activity (>80%) persisting 24 hours after dosing.

    5.2 Pharmacokinetic particulars

    After oral administration of benazepril hydrochloride, peak levels of benazepril are attained rapidly (tmax 0.5 h) and decline quickly as the drug is partially metabolised by liver enzymes to benazeprilat. Unchanged benazepril and hydrophilic metabolites account for the remainder. Peak benazeprilat concentrations (Cmax of 26.7 ng/ml after a dose of 0.5 mg/kg benazepril hydrochloride) are achieved with a Tmax of 1.25h. The systemic bioavailability is incomplete (~13%) due to incomplete absorption (38%) and first pass metabolism.

    Benazeprilat concentrations decline biphasically: the initial fast phase (t=1.7h) 1/2

    represents elimination of free drug, while the terminal phase (t=19h) reflects the 1/2

    release of benazeprilat that was bound to ACE, mainly in the tissues. Benazepril and benazeprilat are extensively bound to plasma proteins, and in tissues are found mainly in the liver and kidney.

    There is no significant difference in the pharmacokinetics of benazeprilat when benazepril hydrochloride is administered to fed or fasted dogs.

    Repeated administration of Actikor tablet leads to slight bioaccumulation of benazeprilat (R=1.47 with 0.5 mg/kg), steady state being achieved within a few days (4 days). Benazeprilat is excreted via the biliary (54%) and urinary (46%) routes. The clearance of

    benazeprilat is not affected in dogs with impaired renal function and therefore no adjustment of Actikor tablet dose is required in cases of renal insufficiency.

    6. PHARMACEUTICAL PARTICULARS

    6.1 List of excipients

Colloidal anhydrous silica

    Cellulose, Microcrystalline

    Lactose monohydrate

    Pregelatinised maize starch

    Crospovidone

    Hypromellose

    Page 4 of 6

    Revised: October 2011

    AN: 00898/2011

    Iron oxide red (E172)

    Iron oxide yellow (E172)

    Macrogol 8000

    Purified Talc

    Titanium dioxide (E171)

    Zinc Stearate

6.2 Incompatibilities

    Not applicable.

6.3 Shelf -life

    Shelf life of veterinary medicinal product as packaged for sale - 3 years.

6.4 Special precautions for storage

    Do not store above 30?C.

    In case of using halved tablets: Return any remaining half tablet to the opened blister

    pocket. Use the remaining half tablet for the next administration.

6.5 Nature and composition of immediate packaging

    Tablets are presented in aluminium foil blister packs of 14, 28, 56, 84 and 140 tablets

    Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal product or

    waste materials derived from the use of such products

    Any unused veterinary medicinal product or waste materials derived from such

    veterinary medicinal products should be disposed of in accordance with local or national

    requirements.

7. MARKETING AUTHORISATION HOLDER

    Ecuphar NV

    Legeweg 157-i

    8020 Oostkamp

    Belgium

8. MARKETING AUTHORISATION NUMBER (S)

    BE: national phase of DCP ongoing

    DE: 401436.01.00

    DK: 47030

    FI: (28765)

    FR: national phase of DCP ongoing

    IE: 10491/002/002

    Page 5 of 6

    Revised: October 2011

    AN: 00898/2011 NL: REG NL 107546

    PL: national phase of DCP ongoing SE: 44446

    UK : Vm 32742/4007

    9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

    BE: national phase of DCP ongoing DE: 24-05-2011

    DK: 28-07-2011

    FI:

    FR: national phase of DCP ongoing IE: 17-06-2011

    NL: 07-06-2011

    PL: national phase of DCP ongoing SE: 09-06-2011

    UK : 29-07-2011

    10. DATE OF REVISION OF THE TEXT

Date: October 2011

    PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.

    Page 6 of 6

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