Boehringer Pimobendan 0.75 Mg/Ml Solution For Injection For Dogs
Revised: June 2016
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
Boehringer Pimobendan 0.75 mg/ml Solution for Injection for Dogs
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains:
Pimobendan 0.75 mg
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Clear colourless solution for injection
4. CLINICAL PARTICULARS
4.1 Target species
4.2 Indications for use, specifying the target species
To initiate treatment of canine congestive heart failure originating from valvular insufficiency (mitral and/or tricuspid regurgitation) or dilated cardiomyopathy.
The product should not be used in cases of hypertrophic cardiomyopathies or clinical conditions where an augmentation of cardiac output is not possible for functional or anatomical reasons (e.g. aortic stenosis).
See also section 4.7.
4.4 Special warnings
4.5 Special precautions for use
Special precautions for use in animals
In the event of accidental subcutaneous injection, temporary swelling and mild resorptive inflammatory reactions may occur at or below the injection site.
For single administration only.
Special precautions to be taken by the person administering the veterinary medicinal product to
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
4.6 Adverse reactions (frequency and seriousness)
A moderate positive chronotropic effect and vomiting may occur in rare cases.
In rare cases transient diarrhoea, anorexia or lethargy have been observed.
4.7 Use during pregnancy, lactation or lay
In studies with rats and rabbits pimobendan had no effect on fertility. Embryotoxic effects only occurred at maternotoxic doses. In rat experiments it has been shown that pimobendan is excreted into milk. Therefore, the product should only be administered to pregnant and lactating bitches if the expected therapeutic benefits outweigh the potential risk (see also section 4.3).
4.8 Interaction with other medicinal products and other forms of interaction
In pharmacological studies no interaction between the cardiac glycoside ouabain and pimobendan was detected. The pimobendan-induced increase in contractility of the heart is attenuated in the presence of the calcium antagonist verapamil and the ß-antagonist propranolol.
4.9 Amounts to be administered and administration route
Single intravenous injection at a dosage of 0.15 mg pimobendan/kg body weight (i.e. 2 ml/10 kg body weight).
A 5 ml and a 10 ml vial can treat up to a 25 kg and 50 kg body weight dog respectively.
Each vial is for single use only.
Vetmedin flavour tablets or Vetmedin hard capsules for dogs may be used for continuation of treatment at the recommended dosage, to be started 12 hours after administration of the injection.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
In the case of overdose symptomatic treatment should be initiated.
4.11 Withdrawal period(s)
5. PHARMACOLOGICAL PROPERTIES
Pharmacotherapeutic group: Cardiac stimulant (phosphodiesterase inhibitor)
ATCvet code: QC01CE90
5.1 Pharmacodynamic properties
Pimobendan, a benzimidazole-pyridazinone derivative, is a non-sympathomimetic, non-glycoside inotropic substance with potent vasodilatative properties.
Pimobendan exerts its stimulatory myocardial effect by a dual mechanism of action: increase in calcium sensitivity of cardiac myofilaments and inhibition of phosphodiesterase (type III). It also exhibits a vasodilating action through an inhibitory action on phosphodiesterase III activity.
5.2 Pharmacokinetic particulars
Due to the intravenous administration, the bioavailability is 100 %.
After intravenous administration the volume of distribution is 2.6 L/kg indicating that pimobendan is distributed readily into the tissues. The mean plasma protein binding is 93 %.
The compound is oxidatively demethylated to its major active metabolite (UD-CG 212). Further metabolic pathways are phase II conjugates of UD-CG 212, in essence glucuronides and sulfates.
Following intravenous adminsitration, the plasma elimination half-life of pimobendan is 0.4 + 0.1 hours, consistent with the high clearance of 90 + 19 ml/min/kg and a short mean residence time of 0.5 +0.1 hours.
The main active metabolite is eliminated with plasma elimination half-life of 2.0 ± 0.3 hours. Almost the entire dose is eliminated via faeces.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Disodium hydrogen phosphate dodecahydrate
Sodium dihydrogen phosphate dihydrate
Water for Injection
6.3 Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale: 36 months.
Use immediately after opening.
6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.
6.5 Nature and composition of immediate packaging
Single-use 5 ml or 10 ml colourless injection glass vial with a rubber stopper and sealed with an aluminium cap, packed singly in a cardboard box.
Not all pack sizes may be marketed.
6.6 Special precautions for the disposal of unused veterinary medicinal products 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 requirements.
7. MARKETING AUTHORISATION HOLDER
Boehringer Ingelheim Ltd
8. Marketing Authorisation number
9. DATE OF FIRST AUTHORISATION
26 September 2012
10. Date of revision of the text
Prohibition of sale, supply and/or use
Approved: 03 June 2016
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