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PRODUCT MONOGRAPH INCLUDING PATIENT …
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION C XYREM® (sodium oxybate) Oral solution at 500 mg/mL CNS Depressant Jazz Pharmaceuticals Ireland Limited
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HIGHLIGHTS OF PRESCRIBING INFORMATION These …
pp.jazzpharma.comnightly dosage are based on body weight (2.2). Dosage for Adult Patients with Idiopathic Hypersomnia • XYWAV can be administered as a twice or once nightly regimen in adults (2.3). • Twice nightly: Initiate dosage at 4.5 g or less per night orally, divided into two doses. Titrate to effect in increments of up to 1.5 g per night per week,
HIGHLIGHTS OF PRESCRIBING INFORMATION …
pp.jazzpharma.com1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use FAZACLO safely and effectively. See …
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
pp.jazzpharma.com2 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any
XYREM XYREM. XYREM administered orally in two …
pp.jazzpharma.com• CNS depression: Use caution when considering the concurrent use of Xyrem with other CNS depressants (5.1). • Caution patients …
HIGHLIGHTS OF PRESCRIBING INFORMATION and platelet …
pp.jazzpharma.comBased on animal data and its mechanism of action ZEPZELCA can cause fetal harm when administered to a pregnant woman. Intravenous administration of a single dose of lurbinectedin (approximately 0.2 times the 3.2 mg/m 2 clinical dose) to pregnant animals during the period of organogenesis caused 100% embryolethality in rats.
SUMMARY OF PRODUCT CHARACTERISTICS
pp.jazzpharma.comcontinued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed (see below).
Serious or fatal hemorrhagic eventswith associated ...
pp.jazzpharma.comof VYXEOS is (daunorubicin 44 mg/m. 2. and cytarabine 100 mg/m. 2) liposome administered via intravenous infusion over 90 minutes on …
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