SONOVUE Powder and solvent for dispersion for injection (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
SonoVue 8 microlitres/mL powder and solvent for dispersion for injection.
Qualitative and quantitative composition
Each mL of the dispersion contains 8 μL sulphur hexafluoride microbubbles, equivalent to 45 micrograms. For the full list of excipients, see section 6.1.
Pharmaceutical form
Powder and solvent for dispersion for injection. White powder. Clear, colourless solvent.
Therapeutic indications
This medicinal product is for diagnostic use only. SonoVue is for use with ultrasound imaging to enhance the echogenicity of the blood, or of fluids in the urinary tract which results in an improved signal ...
Posology and method of administration
This product should only be used by physicians experienced in diagnostic ultrasound imaging. Emergency equipment and personnel trained in its use must be readily available. Posology Intravenous use The ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Intravenous use of SonoVue is contraindicated in patients known to have right-to-left shunts, severe pulmonary ...
Special warnings and precautions for use
Hypersensitivity reactions Use caution when treating anaphylaxis with epinephrine in patients on beta blockers since response may be poor or promote undesired alpha-adrenergic and vagotonic effects (hypertension, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Pregnancy, lactation, and fertility
Pregnancy No clinical data on exposed pregnancies are available. Animal studies do not indicate harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development ...
Effects on ability to drive and use machines
SonoVue has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Adult population Intravenous use The safety of SonoVue after intravenous administration was evaluated in 4653 adult patients who participated in 58 clinical trials. The undesirable effects reported with ...
Overdose
Since there have been no cases of overdose reported to date, neither signs nor symptoms of overdose have been identified. In a Phase I study doses up to 52 mL of SonoVue were administered to normal volunteers ...
Pharmacodynamic properties
Pharmacotherapeutic group: Ultrasound contrast media ATC code: VO8DA05 Sulphur hexafluoride is an inert, innocuous gas, poorly soluble in aqueous solutions. There are literature reports of the use of the ...
Pharmacokinetic properties
The total amount of sulphur hexafluoride administered in a clinical dose is extremely small, (in a 2 mL dose the microbubbles contain 16 µl of gas). The sulphur hexafluoride dissolves in the blood and ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity and toxicity to reproduction. Caecal lesions observed in some repeat-dose studies ...
List of excipients
Powder: Macrogol 4000 Distearoylphosphatidylcholine Dipalmitoylphosphatidylglycerol Sodium Palmitic acid Solvent: Sodium chloride 9 mg/mL (0.9%) solution for injection.
Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Shelf life
2 years. Once reconstituted, chemical and physical stability has been demonstrated for 6 hours. From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, ...
Special precautions for storage
The medicinal product does not require any special storage conditions. For storage conditions after reconstitution of the medicinal product, see section 6.3.
Nature and contents of container
Type I colourless glass vial containing 25 mg of dry, lyophilised powder in an atmosphere of sulphur hexafluoride closed with a grey butyl rubber stopper and sealed with an aluminium crimp seal with a ...
Special precautions for disposal and other handling
Before use examine the product to ensure that the container and closure have not been damaged. SonoVue must be prepared before use by injecting through the septum 5 mL of sodium chloride 9 mg/mL (0.9%) ...
Marketing authorization holder
Bracco International B.V., Strawinskylaan 3051, NL 1077 ZX, Amsterdam, The Netherlands
Marketing authorization number(s)
EU/1/01/177/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 March 2001 Date of latest renewal: 24 April 2006
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