XEPLION Prolonged release suspension for injection (2021)
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Περιεχόμενα
Name of the medicinal product
Xeplion 25 mg prolonged release suspension for injection. Xeplion 50 mg prolonged release suspension for injection. Xeplion 75 mg prolonged release suspension for injection. Xeplion 100 mg prolonged release ...
Qualitative and quantitative composition
<u>25 mg prolonged release suspension for injection:</u> Each pre-filled syringe contains 39 mg paliperidone palmitate equivalent to 25 mg paliperidone. <u>50 mg prolonged release suspension for injection: ...
Pharmaceutical form
Prolonged release suspension for injection. The suspension is white to off-white. The suspension is pH neutral (approximately 7.0).
Therapeutic indications
Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone. In selected adult patients with schizophrenia and previous responsiveness ...
Posology and method of administration
Posology Recommended initiation of Xeplion is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid muscle in order to attain therapeutic concentrations ...
Contraindications
Hypersensitivity to the active substance, to risperidone or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Use in patients who are in an acutely agitated or severely psychotic state Xeplion should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted. ...
Interaction with other medicinal products and other forms of interaction
Caution is advised when prescribing Xeplion with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g. quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, ...
Fertility, pregnancy and lactation
Pregnancy There are no adequate data from the use of paliperidone during pregnancy. Intramuscularly injected paliperidone palmitate and orally administered paliperidone were not teratogenic in animal studies, ...
Effects on ability to drive and use machines
Paliperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred (see ...
Undesirable effects
Summary of the safety profile The adverse drug reactions (ADRs) most frequently reported in clinical trials were insomnia, headache, anxiety, upper respiratory tract infection, injection site reaction, ...
Overdose
Symptoms In general, expected signs and symptoms are those resulting from an exaggeration of paliperidones known pharmacological effects, i.e. drowsiness and sedation, tachycardia and hypotension, QT prolongation, ...
Pharmacodynamic properties
<b>Pharmacotherapeutic group:</b> Psycholeptics, other antipsychotics <b>ATC code:</b> N05AX13 Xeplion contains a racemic mixture of (+)- and (-)-paliperidone. Mechanism of action Paliperidone is a selective ...
Pharmacokinetic properties
Absorption and distribution Paliperidone palmitate is the palmitate ester prodrug of paliperidone. Due to its extremely low water solubility, paliperidone palmitate dissolves slowly after intramuscular ...
Preclinical safety data
Repeat-dose toxicity studies of intramuscularly injected paliperidone palmitate (the 1-month formulation) and orally administered paliperidone in rat and dog showed mainly pharmacological effects, such ...
List of excipients
Polysorbate 20 Polyethylene glycol 4000 Citric acid monohydrate Disodium hydrogen phosphate anhydrous Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections ...
Incompatibilities
This medicinal product must not be mixed with other medicinal products.
Shelf life
2 years.
Special precautions for storage
Do not store above 30°C.
Nature and contents of container
Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1 1⁄2-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 ...
Special precautions for disposal and other handling
Any unused product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Marketing authorization number(s)
EU/1/11/672/001 (25 mg) EU/1/11/672/002 (50 mg) EU/1/11/672/003 (75 mg) EU/1/11/672/004 (100 mg) EU/1/11/672/005 (150 mg)
Date of first authorization / renewal of the authorization
Date of first authorisation: 04 March 2011 Date of latest renewal: 16 December 2015
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