Voorbeelden van het gebruik van Xeplion in het Engels en hun vertalingen in het Nederlands
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In clinical trials, median increases in serum prolactin were observed in subjects of both genders who received Xeplion.
The following are all ADRs that were reported with paliperidone by frequency category estimated from Xeplion clinical trials.
Because paliperidone for use by monthly injections has already been authorised in the EU as Xeplion, the company also used data from Xeplion to support the use of Trevicta.
Caution is advised when prescribing Xeplion with medicinal products known to prolong the QT interval,
effects of paliperidone(see section 4.8), Xeplion should be used with caution in combination with other centrally acting medicinal products,
XEPLION should not be used in children
If you have severe liver problems XEPLION should be used with caution.
Therefore, you should not breastfeed when using XEPLION.
How does Xeplion work?
The active substance in Xeplion, paliperidone, is an antipsychotic medicine.
After initiation, the recommended injection cycle of Xeplion is monthly.
Two long-term studies lasting about a year were carried out with Xeplion.
Xeplion was more effective than placebo in reducing schizophrenia symptoms in the short-term.
Doses of risperidone long acting injection and Xeplion needed to attain similar paliperidone exposure at steady-state.
Xeplion should not be used to manage acutely agitated
Xeplion should be used cautiously in patients with a history of seizures
No interaction study between Xeplion and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur.
The CHMP noted that the studies comparing Xeplion with placebo and risperidone showed that the medicine is beneficial to patients with schizophrenia.
In two other studies(one long- and one short-term), Xeplion was not proven to be as effective as risperidone.
Although Xeplion was not studied on patients with hepatic impairment,