ESMOLOL HYDROCHLORIDE Powder for concentrate solution (2018)
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Περιεχόμενα
Name of the medicinal product
ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for infusion.
Qualitative and quantitative composition
A vial of 50 ml contains 2500 mg esmolol hydrochloride. Each ml of reconstituted concentrate for solution for infusion contains 50 mg esmolol hydrochloride (50 mg/ml). Each ml of the diluted solution for ...
Pharmaceutical form
Powder for concentrate for solution for infusion. The powder is white to almost white.
Therapeutic indications
ESMOLOL HYDROCHLORIDE 2500 mg powder is indicated for supraventricular tachycardia (except for pre- excitation syndromes), and for the rapid control of ventricular rate in patients with atrial fibrillation ...
Posology and method of administration
ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for infusion MUST NOT BE ADMINISTERED WITHOUT RECONSTITUTION/DILUTION. The reconstituted/diluted solution for infusion must be used immediately ...
Contraindications
Hypersensitivity to the active substance; Severe sinus bradycardia (less than 50 beats per minute); Sick sinus-syndrome; severe AV-nodal conductance disorders (without pacemaker); 2nd or 3rd degree AV-block; ...
Special warnings and precautions for use
Warnings ESMOLOL HYDROCHLORIDE 2500 mg powder for concentrate for solution for infusion must be reconstituted/diluted and used immediately after opening (see section 6). Incorrect dilutions of ESMOLOL ...
Interaction with other medicinal products and other forms of interaction
Care should always be exercised whenever ESMOLOL HYDROCHLORIDE 2500 mg powder is used with other antihypertensive agents or other drugs that may cause hypotension or bradycardia: the effects of ESMOLOL ...
Fertility, pregnancy and lactation
Pregnancy There are limited amount of data from the use of esmolol hydrochloride in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Esmolol hydrochloride is not recommended ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
In case of undesirable effects, the dose of ESMOLOL HYDROCHLORIDE 2500 mg powder can be reduced or discontinued. Most of the undersirable effects observed have been mild and transient. The most important ...
Overdose
Cases of massive accidental overdoses with concentrated solutions of ESMOLOL HYDROCHLORIDE 2500 mg powder have occurred. Some of these overdoses have been fatal while others resulted in permanent disability. ...
Pharmacodynamic properties
Pharmacotherapeutic group: Beta-blocking agents, selective ATC code: C07AB09 Esmolol hydrochloride is a beta-selective (cardioselective) receptor blocking agent. At therapeutic doses esmolol hydrochloride ...
Pharmacokinetic properties
The kinetics of esmolol hydrochloride are linear in healthy adults, the plasma concentration is proportional to the dose. If a loading dose is not used then steady-state blood concentrations are reached ...
Preclinical safety data
No teratogenic effect has been observed in animal studies. In rabbits an embryo toxic effect has been observed (increase in fetal resorption) which was probably caused by esmolol hydrochloride. This effect ...
List of excipients
None.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
60 months. The in-use storage condition is 25°C. The opened, reconstituted and diluted product is physicochemically stabile during 24 hours at 25°C. From microbiological point of view the product must ...
Special precautions for storage
This medicinal product does not require any special storage conditions. For storage conditions of the reconstituted solution see section 6.3.
Nature and contents of container
A clear, colourless, 50 ml glass vial with a bromobutyl rubber stopper and a flip off seal containing 2500 mg powder for concentrate for solution for infusion. The vial is packed in an outer cardboard ...
Special precautions for disposal and other handling
ESMOCARD LYO 2500 mg powder for concentrate for solution for infusion MUST NOT BE ADMINISTERED WITHOUT RECONSTITUTION/DILUTION. The powder must be reconstituted/diluted before use. The reconstituted/diluted ...
Marketing authorization holder
Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, A-3002 Purkersdorf, Austria
Marketing authorization number(s)
PL 30414/0008
Date of first authorization / renewal of the authorization
Date of first authorisation: 04/10/2010
Date of revision of the text
22/11/2018
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