INVEGA Prolonged-release tablet (2021)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
INVEGA 3 mg prolonged-release tablets. INVEGA 6 mg prolonged-release tablets. INVEGA 9 mg prolonged-release tablets. INVEGA 12 mg prolonged-release tablets.
Qualitative and quantitative composition
Each prolonged-release tablet contains 3 mg of paliperidone. Each prolonged-release tablet contains 6 mg of paliperidone. Each prolonged-release tablet contains 9 mg of paliperidone. Each prolonged-release ...
Pharmaceutical form
Prolonged-release tablet. Trilayer capsule-shaped white tablets of 11 mm in length and 5 mm in diameter printed with PAL 3. Trilayer capsule-shaped beige tablets of 11 mm in length and 5 mm in diameter ...
Therapeutic indications
INVEGA is indicated for the treatment of schizophrenia in adults and in adolescents 15 years and older. INVEGA is indicated for the treatment of schizoaffective disorder in adults.
Posology and method of administration
Posology Schizophrenia (adults) The recommended dose of INVEGA for the treatment of schizophrenia in adults is 6 mg once daily, administered in the morning. Initial dose titration is not required. Some ...
Contraindications
Hypersensitivity to the active substance, risperidone, or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
Patients with schizoaffective disorder treated with paliperidone should be carefully monitored for a potential switch from manic to depressive symptoms. QT interval Caution should be exercised when INVEGA ...
Interaction with other medicinal products and other forms of interaction
Caution is advised when prescribing INVEGA with medicines 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. Paliperidone was not teratogenic in animal studies, but other types of reproductive toxicity were observed (see section ...
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 (see section 4.8). Therefore, patients should be advised not ...
Undesirable effects
Adults Summary of the safety profile The adverse drug reactions (ADRs) most frequently reported in clinical trials with adults were headache, insomnia, sedation/somnolence, parkinsonism, akathisia, tachycardia, ...
Overdose
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>Pharmacologic group:</b> Psycholeptics, other antipsychotics <b>ATC code:</b> N05AX13 INVEGA contains a racemic mixture of (+)- and (-)-paliperidone. Mechanism of action Paliperidone is a selective ...
Pharmacokinetic properties
The pharmacokinetics of paliperidone following INVEGA administration are dose proportional within the available dose range. Absorption Following a single dose, INVEGA exhibits a gradual ascending release ...
Preclinical safety data
Repeat-dose toxicity studies of paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals. Paliperidone was not teratogenic ...
List of excipients
3 mg <u>Core:</u> Polyethylene oxide 200K Sodium chloride Povidone (K29-32) Stearic acid Butyl hydroxytoluene (E321) Ferric oxide (yellow) (E172) Polyethylene oxide 7000K Ferric oxide (red) (E172) Hydroxyethyl ...
Incompatibilities
Not applicable.
Shelf life
2 years.
Special precautions for storage
<u>Bottles:</u> Do not store above 30°C. Keep the bottle tightly closed in order to protect from moisture. <u>Blisters:</u> Do not store above 30°C. Store in the original package in order to protect from ...
Nature and contents of container
Bottles: White high-density polyethylene (HDPE) bottle with induction sealing and polypropylene child-resistant closure. Each bottle contains two 1 g dessicant silica gel (silicone dioxide) pouches (pouch ...
Special precautions for disposal and other handling
No special requirements for disposal.
Marketing authorization holder
Janssen-Cilag International NV, Turnhoutseweg 30, B-2340 Beerse, Belgium
Marketing authorization number(s)
<u>3 mg:</u> EU/1/07/395/001-005 EU/1/07/395/021-025 EU/1/07/395/041-044 EU/1/07/395/057-058 EU/1/07/395/065-067 <u>6 mg:</u> EU/1/07/395/006-010 EU/1/07/395/026-030 EU/1/07/395/045-048 EU/1/07/395/059-060 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 25 June 2007 Date of latest renewal: 14 May 2012
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