PRIMOVIST Solution for injection (2019)
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Περιεχόμενα
Name of the medicinal product
Primovist 0.25 mmol/ml, solution for injection, pre-filled syringe.
Qualitative and quantitative composition
Each ml contains 0.25 mmol gadoxetate disodium (Gd-EOB-DTPA disodium), equivalent to 181.43 mg gadoxetate disodium. 1 prefilled syringe with 5.0 ml contains 907 mg gadoxetate disodium, 1 prefilled syringe ...
Pharmaceutical form
Solution for injection, prefilled syringe. Clear, colourless to pale yellow liquid free from visible particles.
Therapeutic indications
Primovist is indicated for the detection of focal liver lesions and provides information on the character of lesions in T1-weighted magnetic resonance imaging (MRI). Primovist should be used only when ...
Posology and method of administration
Method of administration Primovist is a ready-to-use aqueous solution to be administered undiluted as an intravenous bolus injection at a flow rate of about 2 ml/sec. After the injection of the contrast ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
The usual safety precautions for MRI must be observed, e.g. exclusion of cardiac pacemakers and ferromagnetic implants. Diagnostic procedures that involve the use of contrast agents should be carried out ...
Interaction with other medicinal products and other forms of interaction
As transport of gadoxetate to the liver may be mediated by OATP transporters it cannot be excluded that potent OATP inhibitors could cause drug interactions reducing the hepatic contrast effect. However, ...
Fertility, pregnancy and lactation
Pregnancy There are no data from the use of gadoxetate in pregnant women. Animal studies have shown reproductive toxicity at repeated high doses (see section 5.3). Primovist should not be used during pregnancy ...
Effects on ability to drive and use machines
Primovist has no influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The overall safety profile of Primovist is based on data from more than 1,900 patients in clinical trials, and from post-marketing surveillance. The most frequently observed ...
Overdose
No cases of overdose have been reported and no symptoms could be characterised. Single doses of Primovist as high as 0.4 ml/kg (0.1mmol/kg) body weight were tolerated well. In a limited number of patients, ...
Pharmacodynamic properties
Pharmacotherapeutic group: paramagnetic contrast media ATC code: V08CA10 Mechanism of action Primovist is a paramagnetic contrast agent for magnetic resonance imaging. The contrast-enhancing effect is ...
Pharmacokinetic properties
Distribution After intravenous administration the concentration time profile of Gd-EOB-DTPA was characterised by a bi-exponential decline. Gd-EOB-DTPA distributes in the extracellular space (distribution ...
Preclinical safety data
Preclinical data reveal no special hazard for humans based on conventional studies of acute and subchronic toxicity, genotoxicity and contact-sensitising potential. Cardiac safety In telemetered conscious ...
List of excipients
Caloxetate trisodium Hydrochloric acid (for pH adjustment) Sodium hydroxide (for pH adjustment) Trometamol Water for injections
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 5 years (glass prefilled syringe). 3 years (plastic prefilled syringe). The product should be used immediately after opening.
Special precautions for storage
This medicinal product does not require any special storage precautions.
Nature and contents of container
Glass syringes: 10 ml prefilled syringes consisting of a colourless siliconized PhEur type I glass barrel, a siliconized chlorobutyl elastomer plunger stopper, a chlorobutyl elastomer rubber tip cap, a ...
Special precautions for disposal and other handling
Inspection This medicinal product is a clear, colorless to pale yellow solution. It should be visually inspected before use. Primovist should not be used in case of severe discoloration, the occurrence ...
Marketing authorization holder
Bayer plc, 400 South Oak Way, Reading, RG2 6AD
Marketing authorization number(s)
PL 00010/0555
Date of first authorization / renewal of the authorization
Date of first authorisation: 10 November 2004 Date of renewal of the authorisation: 26 March 2014
Date of revision of the text
02 October 2019
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