LUTATHERA Solution for infusion (2021)
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Περιεχόμενα
1. Name of the medicinal product
Lutathera 370 MBq/mL solution for infusion.
2. Qualitative and quantitative composition
One mL of solution contains 370 MBq of lutetium (<sup>177</sup>Lu) oxodotreotide at the date and time of calibration. The total amount of radioactivity per single dose vial is 7,400 MBq at the date and ...
3. Pharmaceutical form
Solution for infusion. Clear, colourless to slightly yellow solution.
4.1. Therapeutic indications
Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP-NETs) ...
4.2. Posology and method of administration
Lutathera should be administered only by persons authorised to handle radiopharmaceuticals in designated clinical settings (see section 6.6) and after evaluation of the patient by a qualified physician. ...
4.3. Contraindications
Hypersensitivity to the active substance, to any of the excipients listed in section 6.1. Established or suspected pregnancy or when pregnancy has not been excluded (see section 4.6). Kidney failure with ...
4.4. Special warnings and precautions for use
Individual benefit/risk justification For each patient, the radiation exposure must be justifiable by the likely benefit. The activity administered should in every case be as low as reasonably achievable ...
4.5. Interaction with other medicinal products and other forms of interaction
Somatostatin and its analogues competitively bind to somatostatin receptors and may interfere with the efficacy of Lutathera. Therefore, administration of long acting somatostatin analogues should be avoided ...
4.6. Fertility, pregnancy and lactation
Women of childbearing potential When an administration of radiopharmaceuticals to a woman of childbearing potential is intended, it is important to determine whether or not she is pregnant. Any woman who ...
4.7. Effects on ability to drive and use machines
Lutathera has no or negligible influence on the ability to drive and use machines. Nevertheless, the general condition of the patient and the possible adverse reactions to treatment must be taken into ...
4.8. Undesirable effects
Summary of safety profile The overall safety profile of Lutathera is based on pooled data from patients from clinical trials (NETTER-1 phase III and Erasmus phase I/II Dutch patients) and from compassionate ...
4.9. Overdose
Overdose is unlikely with Lutathera as this medicinal product is supplied as a single dose and ready to use product containing a predefined amount of radioactivity. In the case of overdose, an increase ...
5.1. Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Other therapeutic radiopharmaceuticals <b>ATC code:</b> V10XX04 Mechanism of action Lutetium (<sup>177</sup>Lu) oxodotreotide has a high affinity for subtype 2 somatostatin ...
5.2. Pharmacokinetic properties
Absorption The medicinal product is administered intravenously and is immediately and completely bioavailable. Organ uptake At 4 hours after administration, the distribution pattern of lutetium (<sup> ...
5.3. Preclinical safety data
Toxicological studies with rats have demonstrated that a single intravenous injection of up to 4,550 MBq/kg was well tolerated and no deaths were observed. When testing the cold compound (non-radioactive ...
6.1. List of excipients
Acetic acid Sodium acetate Gentisic acid Ascorbic acid Pentetic acid Sodium chloride Sodium hydroxide Water for injections
6.2. Incompatibilities
This medicinal product must not be mixed with other medicinal products except those mentioned in section 4.2.
6.3. Shelf life
72 hours from the date and time of calibration.
6.4. Special precautions for storage
Store below 25°C. Store in the original package to protect from ionizing radiation (lead shielding). Storage of radiopharmaceuticals should be in accordance with national regulation on radioactive materials. ...
6.5. Nature and contents of container
Clear colourless Type I glass vial, closed with a bromobutyl rubber stopper and aluminium seal. Each vial contains a volume varying from 20.5 to 25.0 mL of solution corresponding to an activity of 7,400 ...
6.6. Special precautions for disposal and other handling
For single use only. General warning Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and ...
7. Marketing authorization holder
Advanced Accelerator Applications, 20 rue Diesel, 01630 Saint Genis Pouilly, France
8. Marketing authorization number(s)
EU/1/17/1226/001
9. Date of first authorization / renewal of the authorization
Date of first authorisation: 26 September 2017
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