PROHANCE Solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
ProHance 279.3 mg/ml, solution for injection.
Qualitative and quantitative composition
Gadoteridol 279.3mg/ml (0.5M).
Pharmaceutical form
Sterile solution for intravenous injection.
Therapeutic indications
This medicinal product is for diagnostic use only. Using Magnetic Resonance Imaging (MRI), ProHance provides contrast enhancement of the brain, spine and surrounding tissues resulting in improved visualization ...
Posology and method of administration
Posology The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patients body weight, and should not exceed the recommended ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to other gadolinium-based contrast. ProHance is contraindicated in children under 6 months of age.
Special warnings and precautions for use
Patients with a history of allergy, drug reactions, or other hypersensitivity-like disorders should be closely observed during the procedure and the contrast medium administration, as well as for the time ...
Interaction with other medicinal products and other forms of interaction
There are no known drug interactions with gadoteridol. No clinically significant changes or trends in laboratory tests were seen in clinical trials with ProHance.
Fertility, pregnancy and lactation
Fertility There are no fertility data. Pregnancy There are no data from the use of gadoteridol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive ...
Effects on ability to drive and use machines
On the basis of the pharmacokinetic and pharmacodynamic profiles, no or negligible influence is expected with the use of ProHance on the ability to drive or use machines.
Undesirable effects
The accepted safety considerations and procedures that are required for Magnetic Resonance Imaging are applicable when ProHance is used for contrast enhancement. The following adverse reactions have been ...
Overdose
There have been no cases of overdose reported to date, consequently, neither signs nor symptoms of overdosage have been identified. In the event of overdosage occurring, the patient should be observed ...
Pharmacodynamic properties
Pharmacotherapeutic group: magnetic resonance imaging contrast media ATC code: V08CA04 Mechanism of action Gadoteridol is a non-ionic paramagnetic contrast medium for Magnetic Resonance Imaging. When placed ...
Pharmacokinetic properties
Distribution The pharmacokinetics of intravenously administered gadoteridol in normal subjects conforms to a two-compartment open model with mean distribution and elimination half-lives (reported as mean ...
Preclinical safety data
Preclinical data indicate no additional risks for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity. Carcinogenicity studies have not been conducted. ...
List of excipients
Calteridol calcium Tromethamine Hydrochloric acid Sodium hydroxide Water for injections
Incompatibilities
ProHance should not be admixed with any other drug.
Shelf life
36 months.
Special precautions for storage
Store at room temperature (15-3°C.), protect from light. ProHance should not be frozen.
Nature and contents of container
Vials: Type 1 glass vials with grey butyl stoppers and aluminium seals containing 5,10, 15 or 20ml.
Special precautions for disposal and other handling
The peel-off tracking label on the vials should be stuck onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose used should also be recorded. Any unused medicinal ...
Marketing authorization holder
Bracco International B.V., Strawinskylaan 3051, 1077 ZX, Amsterdam, The Netherlands
Marketing authorization number(s)
PL14447/0001
Date of first authorization / renewal of the authorization
29 October 1992 / 24 April 2001
Date of revision of the text
5 February 2020
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