OPTISON Dispersion for injection (2019)
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Περιεχόμενα
Name of the medicinal product
OPTISON 0.19 mg/ml dispersion for injection.
Qualitative and quantitative composition
OPTISON consists of perflutren-containing microspheres of heat treated human albumin, suspended in human albumin solution, 1%. Concentration: Perflutren-containing microspheres, 5-8 10<sup>8</sup>/ml ...
Pharmaceutical form
Dispersion for injection. Clear solution with white microsphere layer on top.
Therapeutic indications
This medicinal product is for diagnostic use only. OPTISON is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification ...
Posology and method of administration
OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging. Before administering OPTISON, please see section 6.6 for instructions for use/handling. This ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Pulmonary hypertension with a systolic pulmonary artery pressure >90 mm Hg.
Special warnings and precautions for use
Hypersensitivity has been reported. Care should therefore be exercised. A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. Use during anaesthesia with halothane and oxygen has not been studied.
Pregnancy and lactation
Pregnancy The safety of OPTISON for use during human pregnancy has not been established. In pregnant rabbits exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) ...
Effects on ability to drive and use machines
No studies on the effects on the ability to drive and use machines have been performed.
Undesirable effects
Adverse reactions to OPTISON are rare and usually of a non-serious nature. In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, ...
Overdose
No case of overdose has been reported. In the Phase I trial, healthy volunteers have received up to 44.0 ml of OPTISON and experienced no significant adverse events.
Pharmacodynamic properties
Pharmacotherapeutic group: Ultrasound contrast medium ATC Code: V08DA01 When used in conjunction with diagnostic ultrasound, OPTISON provides opacification of cardiac chambers, improvement in delineation ...
Pharmacokinetic properties
Following intravenous injection of 0.21 to 0.33 ml/kg of OPTISON to healthy volunteers, the perflutren component of OPTISON was rapidly and nearly completely eliminated in less than 10 minutes with a dominating ...
Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity and genotoxicity. In the rabbit embryotoxicity study, a significant ...
List of excipients
Human albumin Sodium chloride N-acetyltryptophan Caprylic acid Sodium hydroxide (pH adjustment) Water for injections
Incompatibilities
OPTISON must not be mixed with other medicinal products. A separate syringe should be used.
Shelf life
Shelf life Unopened vial in the outer packaging: 2 years. Finished product after rubber stopper perforation: 30 minutes.
Special precautions for storage
Store upright in a refrigerator (2°C-8°). Storage at room temperature (up to 25°) for 1 day is acceptable. Do not freeze.
Nature and contents of container
3 ml type I glass vial, closed with bromobutyl rubber stopper, and sealed with aluminium cap with coloured plastic flip-off top. OPTISON is supplied as: 1 vial of 3 ml or 5 vials of 3 ml. Not all pack ...
Special precautions for disposal and other handling
Like all parenteral products, the vials of OPTISON should be inspected visually for integrity of the container. Vials are intended for single use only. Once the rubber stopper has been penetrated, the ...
Marketing authorization holder
GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway
Marketing authorization number(s)
1 3 ml presentation: EU/1/98/065/001 5 3 ml presentation: EU/1/98/065/002
Date of first authorization / renewal of the authorization
Date of first authorisation: 18 May 1998 Date of latest renewal: 12 June 2008
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