XOFIGO Solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Xofigo 1100 kBq/mL solution for injection.
Qualitative and quantitative composition
Each mL of solution contains 1100 kBq radium Ra 223 dichloride (radium-223 dichloride), corresponding to 0.58 ng radium-223 at the reference date. Radium is present in the solution as a free ion. Each ...
Pharmaceutical form
Solution for injection. Clear, colourless isotonic solution with pH between 6.0 and 8.0.
Therapeutic indications
Xofigo monotherapy or in combination with luteinising hormone releasing hormone (LHRH) analogue is indicated for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC), ...
Posology and method of administration
Xofigo 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. ...
Contraindications
Xofigo is contraindicated in combination with abiraterone acetate and prednisone/prednisolone (see section 4.4).
Special warnings and precautions for use
Combination with abiraterone and prednisone/prednisolone or with systemic cancer therapies other than LHRH analogues An interim analysis from a clinical trial in chemotherapy-naïve patients with asymptomatic ...
Interaction with other medicinal products and other forms of interaction
No clinical interaction studies have been performed. As interactions with calcium and phosphate cannot be excluded, pausing supplementation with these substances and/or Vitamin D should be considered some ...
Fertility, pregnancy and lactation
Contraception in males Animal reproduction studies have not been conducted with Xofigo. Because of potential effects on spermatogenesis associated with radiation, men should be advised to use effective ...
Effects on ability to drive and use machines
Xofigo has no or negligible influence on the ability to drive and use machines.
Undesirable effects
Summary of the safety profile The overall safety profile of Xofigo is based on data from 600 patients treated with Xofigo in the phase III study. The most frequently observed adverse reactions (≥10%) in ...
Overdose
There have been no reports of inadvertent overdosing of Xofigo during clinical studies. There is no specific antidote. In the event of an inadvertent overdose, general supportive measures, including monitoring ...
Pharmacodynamic properties
Pharmacotherapeutic group: Therapeutic radiopharmaceuticals, other therapeutic radiopharmaceuticals, various therapeutic radiopharmaceuticals ATC code: V10XX03 Mechanism of action Xofigo is a therapeutic ...
Pharmacokinetic properties
General introduction Pharmacokinetic, biodistribution and dosimetry data have been obtained from 3 phase I studies. Pharmacokinetic data were obtained in 25 patients at activities ranging from 51 to 276 ...
Preclinical safety data
Systemic toxicity In single and repeated dose toxicity studies in rats, the main findings were reduced body weight gain, haematological changes, reduced serum alkaline phosphatase and microscopic findings ...
List of excipients
Water for injections Sodium citrate Sodium chloride Hydrochloric acid, dilute
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Shelf life: 28 days.
Special precautions for storage
This medicinal product does not require any special temperature storage conditions. Storage of Xofigo should be in accordance with national regulation on radioactive materials.
Nature and contents of container
Colourless Type I glass vial closed with a grey bromobutyl rubber stopper either with or without foil-clad made of Ethylene tetrafluoroethylene (ETFE), both capped with aluminium seal, containing 6 mL ...
Special precautions for disposal and other handling
General warnings Radiopharmaceuticals should be received, used and administered only by authorised persons in designated clinical settings. Their receipt, storage, use, transfer and disposal are subject ...
Marketing authorization holder
Bayer AG, 51368, Leverkusen, Germany
Marketing authorization number(s)
EU/1/13/873/001
Date of first authorization / renewal of the authorization
Date of first authorisation: 13 November 2013 Date of latest renewal: 21 June 2018
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